Ti500 Globe Trotter Ic Stephan f120 GT v24 Ifu en

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F 120 GT

Neonatology Ventilator

Operating manual
®

Preface

Operating manual This manual provides you with clear and concise answers about the
operation and maintenance of the F 120 GT pediatric ventilator.
F 120 GT is a time-controlled constant flow ventilator with a constant,
pressure-limited flow for the short-term ventilation of infants and small
children.
This manual does not contain any information about repairs and
installation.
If malfunctions occur while operating the device, please contact your
authorized Fritz Stephan GmbH customer service team or the authorized
specialist dealer who supplied the device and familiarized you with its
function and operation.
The manufacturer warrants the safety and reliability of F 120 GT only
when it is used in compliance with the user manual.

NOTE
For information about the maintenance and care of F 120 GT, please see the service
manual. This also contains detailed information about the device design and function
as well as its individual components.

NOTE
The manufacturer offers training on the safe and efficient use of the F 120 GT
ventilator. Training material can also be requested. Contact [email protected]
for more information.

Fritz Stephan GmbH


- Medizintechnik -
Kirchstraße 19

56412 Gackenbach
Germany

Subject to technical modification.

As of: December 2017


Version: V2.4

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Table of contents

Table of contents
Table of contents ........................................................................................3
1 General information ...........................................................................5
1.1 Product combination ................................................................6
1.2 Device name and manufacturer ...............................................6
1.3 Intended use .............................................................................7
1.5 Packaging and waste disposal ..................................................8
1.6 Introduction .............................................................................9
1.7 Abbreviations and technical terms.........................................10
1.8 Pictograms .............................................................................12
1.9 Specifications.........................................................................14
2 Safety instructions............................................................................19
2.1 Danger warnings ....................................................................20
2.2 Warnings................................................................................21
2.3 Information about EMC according to IEC 60601-1-2 ...........25
3 Design and functional description....................................................27
3.1 General information ...............................................................27
3.2 Functional description ...........................................................29
3.3 Front view with patient component and tube system ............32
3.4 Control and indicators ...........................................................33
3.4.1 Ventilation modes .....................................................34
3.4.2 Heating system ..........................................................35
3.4.3 Selftest .......................................................................35
3.4.4 Alarm suppression .....................................................35
3.4.5 Adjusting the inspiration and expiration duration .....36
3.4.6 Alarm and monitoring indicators ..............................37
3.4.6.1 Alarm indicators...............................................37
3.4.6.2 Power supply monitoring .................................37
3.4.6.3 O2 monitor ........................................................38
3.5 Gas supply and monitoring ....................................................40
3.5.1 Dual flow meter .........................................................41
3.5.2 Oxygen supply for external devices ..........................42
3.6 Patient component .................................................................43

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 3


Table of contents

3.7 Patient tube systems...............................................................46


3.7.1 Reusable patient tube system ....................................46
3.8 Side view ...............................................................................49
3.9 Rear view ...............................................................................50
4 Preparation for use ...........................................................................51
4.1 Gas supply .............................................................................51
4.2 Power supply .........................................................................53
5 Checklist ..........................................................................................57
5.1 Checklist ................................................................................57
5.2 Daily checks before each use .................................................58
6 Operation .........................................................................................61
6.1 Switching on ..........................................................................61
6.2 Choosing the ventilation mode ..............................................61
7 Ventilation modes ............................................................................62
7.1 Intermittent mandatory ventilation ........................................62
7.2 Spontaneous breathing with positive end-expiratory pressure
(CPAP)...................................................................................64
7.3 Manual ventilation .................................................................65
8 Troubleshooting ...............................................................................67
9 Care and maintenance ......................................................................69
11 Accessory list ...................................................................................93
12 Warranty ..........................................................................................95
13 List of figures ...................................................................................97
14 List of tables.....................................................................................99
15 Notes ..............................................................................................101

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1.1 Product combination

1 General information

ATTENTION
Do not reuse disposable accessories!
Reconditioning necessary for reuse may lead to the deterioration of mechanical and
biological product properties, posing a significant risk to the patient. In addition,
reusing such accessories is highly dangerous and increases the risk of contamination
for the patient.

ATTENTION
The sole responsibility for selecting a suitable patient monitoring system that provides
reliable data about the correct functioning of the medical device and the condition of
the patient lies with the user of the ventilator. Different techniques can be used to
monitor patient safety, from the electronic monitoring of the correct functioning of the
medical device and the condition of the patient to simple direct observation of the
patient. The sole responsibility for selecting a suitable patient monitoring technique
lies with the user.

ATTENTION

All electrical cables and gas connections connected to the medical device must
comply with applicable standards.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 5


1 General information

1.1 Product combination

NOTE

Use only the accessories listed in chapter 11.

Certified F 120 GT can be operated with the following suction pumps as an


product combinations additional feature:

 ATMOPORT N
Manufacturer: ATMOS MedizinTechnik GmbH & Co. KG
 Medical Suction Unit OB Mini
Manufacturer: OSCAR BOSCAROL srl

1.2 Device name and manufacturer

Device name F 120 GT

Manufacturer Fritz Stephan GmbH


- Medizintechnik -
Kirchstraße 19
56412 Gackenbach

 +49 (0)6439 9125 – 0


 +49 (0)6439 9125 – 111
[email protected]
 www.stephan-gmbh.com

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1.3 Intended use

1.3 Intended use

F 120 GT is a ventilator for short-term and emergency invasive and non-


invasive ventilation of premature and newborn infants and small children
with a body weight of up to 20 kg.
The ventilator is used in cases of pulmonary insufficiency due to
immaturity of the lung in newborns, illness-related insufficiency, or
failure of the patient's entire breathing mechanism. The device is
designed as a functional component of the TI 500 GLOBE TROTTER
NEONATAL TRANSPORT SYSTEM.
The internal battery enables self-contained operation for a period of
approx. 90 minutes with heat or approx. 180 minutes without heat at
maximum charge capacity.

Applications The ventilator can be used in intensive care units, labor rooms, primary
care units for newborns, and for the inter- and intra-hospital
transportation between units or departments and medical facilities.
The ventilator may be used only by authorized personnel such as
physicians, qualified medical specialists, health workers, nurses, and
respiratory therapists.
The prescribed safety checks and preventative maintenance may be
conducted only by the manufacturer or personnel qualified in accordance
with the German Medical Devices Operator Ordinance (MPBetriebV).

1.4 Contraindications:

F 120 GT is not suitable for the long-term ventilation or ICU ventilation


of patients with severe lung disease.
Non-invasive ventilation is contraindicated in the following cases:
 No spontaneous breathing
 Fixed or functional airway obstruction
 Gastrointestinal bleeding or ileus

It is the sole responsibility of the user to select the most appropriate


ventilation mode based on the patient’s medical condition. The
continuous monitoring of the patient’s condition must be assured at all
times.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 7


1 General information

1.5 Packaging and waste disposal

Disposal of the The device packaging largely consists of recyclable or reusable materials.
packaging The cardboard packaging can be reused or disposed of as used paper.

Disposal of the device The manufacturer will accept the return of any old devices manufactured
and the battery by our company free of charge, and dispose of it correctly, thus making a
contribution to the environment.

Used batteries and the device itself must not be disposed of as household
waste. Proper disposal must be conducted by a certified electrical and
electronic waste recycling company. Disposal via municipal collection
points for waste electrical equipment is not permitted!

WARNING

Risk of explosion!
Do not throw the battery into a fire or open it with force!

NOTE
Before disposing of the device or any of its components, these must be cleaned and
disinfected.
Infectious disposable accessories must be disposed of as specified in the operating
manual!

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1.6 Introduction

1.6 Introduction

Device setup, operation, and maintenance is only permitted by trained


personnel who have the knowledge required to complete these tasks. All
relevant national laws, guidelines, and regulations as well as the following
instructions must be observed:
 The device must be operated by trained personnel only. Thorough
knowledge of the operating manual is required.
 Only use the device for the intended purpose described in the operating
manual.
 Read the operating manual carefully and comply with its instructions;
lasting safety for the patient and user is only ensured when the device is
operated correctly.
 The operating manual must be kept readily available at the place of use.
 Inadequate care and incorrect operation can cause downtime and
accidents.
 A function test must be performed by pressing the »Selftest« button
before each start-up. In this test, all indicator fields must light up, an
intermittent acoustic alarm must sound 5 times, and the valve must be
activated 5 times.
 A separate manual ventilator must be available in the immediate vicinity
of the F 120 GT ventilator.
 The F 120 GT ventilator may be operated only with the original
accessories supplied or specified by the manufacturer.

NOTE

F 120 GT must be operated from the front. The operator must have a sufficient view
of the control and display elements.

Warranty The manufacturer does not accept any warranty claims resulting from
incorrect operation or inadequate care and maintenance.
The device must be checked at regular intervals by properly trained staff.
The manufacturer recommends inspection and maintenance every six
months.
The manufacturer guarantees the safety and reliability of the device only
when it is operated in compliance with operating instructions.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 9


1 General information

1.7 Abbreviations and technical terms

Abbreviation/ Term Meaning


technical term
A Ampere (amp) Unit of electric current
Fig. Figure
AC Alternating current
AIR Medical compressed air
Battery Device for storing electrical energy in
the form of chemical energy
Bar Unit of measurement for pressure
Bpm Breaths per minute Breathing rate
cmH2O Unit of measurement for pressure
CPAP Continuous positive airway Spontaneous respiration with
pressure continuous positive airway pressure
DC Direct current
DIN German Institute for Standardization
Disc. Disconnection Interruption (pneumatic) of a
connection
EN European Standard
ETT Endotrachial tube
Exp. Expiration Exhalation
HPa Hectopascal Unit of pressure
Flow Volume flow
Hz Unit of measurement for frequency
Insp. Inspiration Inhalation
KPa Kilopascal Unit of pressure
Connection Connection
Cont. Continuous
LED Light emitting diode Light emitting diode
l/m Liters per minute

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1.7 Abbreviations and technical terms

Abbreviation/ Term Meaning


technical term
Mbar Unit of measurement for pressure
min. Minutes Unit of measurement for time
MPG Medical Devices Law
O2 Oxygen
PEEP Positive end expiratory Positive end expiratory pressure
pressure
PIP Peak inspiratory pressure Positive inspiratory peak pressure
Resp. Respiration
S Seconds Unit of measurement for time
IMV Intermittent mandatory Combined spontaneous breathing and
ventilation mechanical ventilation
Standby The device is ready for use
Temp. Temperature
V Volt Unit of electrical potential (voltage)
PU Packaging unit
W Watt Unit of power
CGS Central gas system
Tab. 1: Abbreviations and technical terms

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 11


1 General information

1.8 Pictograms

Pictogram Meaning
Selftest

Heating

Disconnection

Stenosis

Oxygen

Battery operation

O2 monitor

Do not oil!

O2 upper limit

O2 lower limit

Alternating voltage
DC
The instructions in the operating manual must be observed

Observe the operating manual

Protective conductor

Equipotential bonding

Oxygen sensor connection

Mechanical pressure relief valve "pop-off"

Operating hours counter

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1.8 Pictograms

Pictogram Meaning
Alarm transmitter

Gas inlet opening

Manufacturer

Manufacturing date

Serial number

Product number

Expiration date

Do not reuse

Keep dry

Keep away from sunlight

Temperature limits for storage and transport

Humidity limits for storage and transport

Atmospheric pressure limits for storage and transport

Warning

Do not use if the packaging is damaged

Recyclable materials

CE marking, indicates compliance with Directive 93/42/EEC concerning


medical devices
Tab. 2: Pictograms

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 13


1 General information

1.9 Specifications

Ambient conditions Operation Temperature 10-40° C


Rel. humidity 10-80%
Air pressure 500-1060 hPa
Allow to reach room temperature before using
the device.
Storage Temperature 5-40° C
Rel. humidity 10-80%
Air pressure 500-1060 hPa
Store in a dust-free place protected from
humidity and frost.

General information Class according to II b


Directive 93/42/EEC
Protection class IP X4

UMDNS code 18-098


GMDN code 36289
Inspection/ Every six months
maintenance cycle (authorized customer service team)
Dimensions (WxHxD) 300 x 387 x 525 mm
Weight 24 kg
Maximum pressure limit PLIM, max 74 mbar (SFC)

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1.9 Specifications

Power supply Power supply Connection 230 V AC 50/60 Hz


(100/115/250 V
available on request)

Protection class I type B according to


IEC 60601-1
Power consumption 100 VA
Device fuse 2x T 2A L 250 V
DIN 41571
Auxiliary power 2x T 10A L 250 V
sockets DIN 41571
On-board power supply 12 V DC external
(The device tolerates a
voltage range of 11 to
14 V DC)
Current consumption 9.6 A
Battery Nominal voltage 12 V DC
Nominal capacity 17 Ah
Fuse T 6.3A L 250 V
DIN 41571
Operating time 1.5 h
with heating
Operating time 3h
without heating
Charge time Approx. 19 h
The battery is only charged at a battery
temperature of 0-40 °C.

Gas supply Supply pressure Internal 0.3 bar


AIR 3-6 + 0.5 bar
O2 3-6 + 0.5 bar
Maximum flow Compressed air 10 l/min
O2 10 l/min
Gas consumption Conventional
(depends on the flow setting)
The gases must be dry and free of oil and dust.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 15


1 General information

Ventilation modes IMV Intermittent mandatory ventilation


Combined spontaneous breathing and
mechanical ventilation
CPAP Spontaneous respiration with continuous
positive airway pressure
Manual ventilation Manual ventilation
Test

Parameter Inspiration duration Adjustable between 0.25 and 2 s


Expiration duration Adjustable between 0.25 and 30 s
O2 flow Adjustable between 0 and 10 l/min
Compressed air flow Adjustable between 0 and 10 l/min
(AIR)
Oxygen level Adjustable between 21% and 100% O2

Patient component Positive end expiratory Adjustable from 0 to 10 cmH2O


pressure (PEEP)
Inspiratory ventilation Adjustable from 15 to 60 cmH2O
pressure
(pressure plateau)
Heated humidifier 12 V DC/10 W
Heated tube system 12 V DC/10 W
Content of humidifier 350 ml
bottle
Inspiration resistance <0.6 mbar at 5 l/min
Expiration resistance <0.6 mbar at 5 l/min

Tube system P1 Compliance 0.81 ml/mbar

O2 monitor Digital display 20% to 99% O2 in ventilator gas


Accuracy =  5 Vol %
Upper O2 limit Adjustable between 20% and 99% O2
visual and acoustic alarm when limit is
exceeded

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1.9 Specifications

Lower O2 limit Adjustable between 20% and 99% O2


visual and acoustic alarm when level drops
below this limit
Manual calibration Only if O2 concentration is 21%
(room air/compressed air)

Monitoring Disconnection Pressure of 12 mbar is not reached after


expiration duration + maximum inspiration
duration.
Stenosis Pressure has not fallen below 12 mbar after
2.2 s after the end of inspiration.

Interruption in power Acoustic alarm 120 seconds


supply connection
Malfunction in the Visual and acoustic alarm until the error is
ventilator's electronics eliminated
Supply voltage Current power source indicator
Ventilation pressure -10 to 60 mbar
gauge Accuracy: P =  (1.6%  P + 1 mbar)

Humidity Recommended ambient 18-26 °C


temperature
Liquid reservoir for Max. 144 ml
humidifier
Flow rate 2-20 l/min
Chamber temperature 26-45 °C
Maximum temperature < 41 °C
of delivered gas
Humidifier release Flow aH1 (rH2)
6 l/min > 33 mg/l (> 75%)
Warm-up time ~ 20 min
1
Absolute humidity
2
Relative humidity based on 37 °C (BTPS)

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 17


1 General information

Materials used PEEP valve Membrane Silicone rubber VMQ 55


Valve disk Anodized aluminum
Plateau valve Valve disk Anodized aluminum
Safety valve Silicone rubber VMQ 60
washer
Humidifier bottle Polysulfone (PSU), yellow
Patient component base Anodized aluminum
body, inspiration/
expiration nozzles
Humidifier tube Outer casing Teflon
Bubbling tube Brass, chromed (free from
chromium (VI))
Patient tube (reusable) Silicone rubber,
transparent, green
Y piece Polysulfone (PSU), yellow

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1.9 Specifications

2 Safety instructions

NOTE

Refers to instructions that draw attention to important facts.

The following safety instructions are repeated at relevant points in the


operating manual and must be observed at all times.

DANGER

Identifies potentially dangerous situations that result in death or life-threatening injury


if not avoided.

WARNING

Identifies potentially dangerous situations that may result in death or serious injury if
not avoided.

CAUTION

Identifies potentially dangerous situations that may result in minor or moderate injury
if not avoided.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 19


2 Safety instructions

2.1 Danger warnings

DANGER

The ventilator may be used only by trained and authorized medical specialists.
The device must be operated according to the instructions in this operating manual.

DANGER
The device must be checked at regular intervals by properly trained staff. The
manufacturer recommends inspections and maintenance by a suitably qualified
technician every six months.

DANGER

A functional test must always be performed before the device is operated (press the
»Selftest« button).

DANGER

The device is not certified for use in potentially explosive environments.

DANGER

The device may not be used in areas with contaminated air.

DANGER

Risk of explosion!
Do not use any combustible anesthetic gases.

DANGER

Use of the device in the vicinity of magnetic resonance imaging systems may
negatively impact its functionality, which may put the patient and operator at risk.

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2.2 Warnings

DANGER
Lack of an alternative ventilation method, such as a self-priming operator-powered
resuscitator (according to ISO 10651-4), may result in patient death if the ventilator
fails. Always have a separate manual breathing bag handy.

2.2 Warnings

WARNING
Only authorized customer service personnel is permitted to alter, modify, repair, or
open the device, or to replace the internal battery. When maintaining the device, only
use original spare parts from FRITZ STEPHAN GMBH.

WARNING
The ventilator suctions ambient air to create compressed air. It must therefore never
be covered during operation or positioned so that its operation or performance is
impaired. Failure to comply may result in device failure or damage and therefore pose
a risk to the patient.

WARNING

Using the ventilator in a contaminated environment may be dangerous.

WARNING
Do not operate the device outside the specified ambient conditions (see chapter 1.9).
Device functionality (e.g. battery performance, humidifier performance) may be
impaired.

WARNING
Burns may be caused by antistatic or electro-conductive patient tubing when using
electrical high-frequency surgical instruments at the same time. Therefore, do not use
antistatic or electro-conductive patient tubing or lines.

WARNING

During non-invasive ventilation, a CO2 monitor for measuring the expiratory CO2
level must be used.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 21


2 Safety instructions

WARNING

Treat the individual parts carefully to avoid mechanical damage.

WARNING

Only use correctly prepared parts to operate the device.

WARNING

The F 120 GT ventilator may be operated only with replacement parts originally
supplied or authorized by the manufacturer.

WARNING
Only use patient tubes and accessories that are intended for use with this ventilator.
Use of different patient tubes or accessories may impact the performance or safety of
the device.

WARNING

Do not cover the patient tube with blankets, towels or similar items that are not
intended to be used with the tube system! Otherwise, the tube system could overheat.

WARNING
When adding system components or sub-assemblies to the ventilation system of the
ventilator, the pressure gradient across the ventilation system, measured at the patient
connection port, may negatively affect the performance data of the ventilator.

WARNING

Only use dry compressed air! Humidity in the gas line can lead to technical
malfunctions of the device.

WARNING
After using the special alarm suppression state, make sure that the alarm is reactivated
before leaving the patient.

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2.2 Warnings

WARNING
Short-wave therapy devices, RF diathermy devices, defibrillators, and similar
equipment in close proximity to the device may impair device functionality. In such
cases, the patient and device must be monitored continuously.

WARNING

Never operate the ventilator with nitric oxide, helium, or mixtures containing helium.

WARNING

Never use the ventilator in a hyperbaric chamber.

WARNING
In the event of a power failure, the internal battery supplies power to the F 120 GT for
a duration of 90 minutes with the heating switched on or 180 minutes with the heating
switched off.
To optimize the capacity of the battery, the device must always be connected to the
power supply and the power switch must remain on when the device is not in use. If
the battery is empty, it will take at least 19 hours to charge. The higher the battery
level, the shorter the charge time. A safety circuit prevents the batteries from being
overcharged. The device cannot be operated with a discharged battery!

WARNING

The battery type used in F 120 GT does not reach its optimum capacity until it has
been recharged and emptied four or five times.

WARNING

It may not be possible to charge a completely empty battery, which will need to be
replaced in this case. This can only be done by the authorized customer service team.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 23


2 Safety instructions

WARNING

To ensure reliable operation of F 120 GT during transport, ensure that the vehicle
motor is operational before connecting it to external power supply sources.

WARNING
DIN EN 60601-1 and IEC 62353 in particular must be observed for medical devices
with an electrical connection. According to these directives, these devices may be
repaired only by the manufacturer or an entity explicitly authorized by the
manufacturer for this purpose.

WARNING
If connecting external electrical devices, the provisions of DIN EN 60601-1 must be
observed. All non-medical devices must be connected by means of an isolating
transformer (4 kV test voltage).

WARNING

Before replacing the oxygen supply or oxygen cylinder, set the O2 flow to the lowest
flow rate that is still acceptable.

WARNING

The content of the oxygen cylinders must be monitored. Never increase the flow rate
to compensate for an insufficient oxygen supply.

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2.3 Information about EMC according to IEC 60601-1-2

2.3 Information about EMC according to IEC 60601-1-


2

Electrical medical devices are subject to special precautions regarding


electromagnetic compatibility (EMC) and must be installed and put into
service according to the EMC information provided in the accompanying
documentation.

WARNING

Portable and mobile RF communications equipment can affect electrical medical


devices.

WARNING
Medical electrical equipment or systems should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the medical electrical
equipment or system should be monitored to verify its intended operation in the
configuration in which it is used.

WARNING
The use of accessories, transducers and cables other than those specified, with the
exception of transducers and cables sold by the manufacturer of the medical electrical
equipment or system as replacement parts for internal components, may result in
increased emissions or decreased immunity of the medical electrical equipment or
system.

WARNING
This device/system is to be used only by qualified medical personnel. This is a Class
A device/system according to CISPR 11. In a residential area, this device/system may
cause radio interferences, which means it may be necessary to take remedial measures
in this case, such as changing the alignment or arrangement of the F 120 ventilator,
shielding the device or filtering the connection to the site.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 25


®

3.1 General information

3 Design and functional description

3.1 General information

The F 120 GT ventilator is used for short-term neonatal and perinatal


ventilation. It has a volume- and time-controlled, constant-flow, pressure-
limited mode for controlled IMV ventilation, as well as a constant-flow,
pressure-limited mode for CPAP ventilation and manual ventilation.

The following settings can be made:

Inspiration duration: 0.25-2 sec


Expiration duration: 0.25-30 sec
O2 flow: 0-10 l/min
Compressed air flow (AIR): 0-10 l/min
Max. inspiration pressure: 15-60 mbar
End-expiratory pressure: 0 to 10 mbar

For controlled ventilation (IMV), the frequency indicator (digital) shows


a respiratory rate between 2 and 120 breaths per minute in accordance
with the setting.

NOTE
The ventilation frequency must be within a range of 2 to 120 breaths per minute. It is
calculated on the basis of the configured inspiration duration and the expiration
duration.
If the setting is not within the permitted range, the parameters are not accepted and the
ventilation frequency display will start to flash.
In this case, the settings must be adjusted.

In CPAP mode, the display is deactivated and three dashes ( - - - ) are


shown instead. The integrated dual flow meter mixes the oxygen and air.
Oxygen concentration is adjustable between 21 and 100% O2.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 27


3 Design and functional description

An O2 monitor with adjustable alarm limits provides acoustic and visual


monitoring of the oxygen concentration. Visual and acoustic monitoring
of power failure, disconnection and stenosis is also provided. The
electronic components of the device are checked by means of a selftest
and an electronic "watchdog" that provides permanent monitoring of the
ventilator hardware.

The device is equipped with a heating function to warm the patient's


respiratory gas. The heating system comprises a heating element for
patient gas humidification and a heated tube system that stabilizes the
temperature and prevents an accumulation of condensation. Heating can
be switched on and off.

The patient component P1 consists of the heated patient gas humidifier,


the PEEP valve, and the inspiration pressure valve, and can be autoclaved
at a temperature of up to 134 °C.
The F 120 GT ventilator has an integrated compressor that enables a self-
sufficient supply of compressed air. This compressor supplies F 120 GT
with compressed air when there is no external supply.

In addition to the 230 V power supply, F 120 GT can be connected to an


external 12 V on-board power supply (DC).
An internal battery guarantees voltage supply if no power supply or on-
board power supply is available. The ventilator switches automatically to
the available voltage supply, and this is also indicated on the visual
display.

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3.2 Functional description

3.2 Functional description

Fig. 1: Pneumatic diagram for F120 GT

No. Description No. Description


1 Air intake filter (coarse) 15 O2 pressure regulator HP 200 → 2.8-3 bar
2 Compressor 16 O2 check valve (HP line)
3 Fine filter 17 O2 outlet connection for multi-stage control valve
4 Pressure regulator 300 mbar 18 O2 pressure regulator (2.5 bar)
5 Air inlet 2.8-6 bar 19 Dual flow meter 0-10 l/min
6 Check valve for air 20 Pressure relief valve 40±20 mbar
7 Sinter filter for air power socket 21 O2 sensor
8 Pressure switch for compressor 22 Ventilation pressure gauge 0-60 mbar
9 O2 inlet 2.8-6 bar 23 Board set with pressure sensor
10 O2 check valve 24 Humidifier
11 Sinter filter for O2 power socket 25 Inspiration valve
12 O2 CGS pressure gauge 26 Expiration valve
13 Inlet O2 high pressure (< 200 bar) 27 Tube heating for insp./exp.
14 O2 pressure gauge for HP cylinder
pressure

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 29


3 Design and functional description

Gas supply F 120 GT has NIST connections on the back of the device for O2 (9) and
compressed air (5). If there is no connected compressed air or the supply
pressure is insufficient, the pressure switch (8) automatically switches on
the integrated compressor (2).
The O2 supply can also come from the oxygen cylinder of the incubator.
In this case, pressure is reduced to approx. 2.8 bar by the HD pressure
regulator (15). The check valves prevent gas reflux in any other supply
source. The CGS supply source has priority over the cylinder supply.
Fresh gas settings The fresh gas set by the dosing valves on the flow meter (19) is fed
through the breathing air humidifier (24) and thereby also warmed by a
heating element. It flows during inspiration and expiration. Closure of the
expiration valve (26) allows the lungs to be filled during inspiration. For
manual ventilation, the expiration valve (26) can be closed by hand.
If the configured inspiration pressure limit (plateau pressure) is reached
before the end of the selected inspiration duration, the excess gas is
discharged via the mechanical inspiration pressure valve (25).
In addition, the configurable pop-off valve (20) can be used to limit the
maximum pressure.
Opening of the expiration valve (26) enables expiration. During
expiration, the lungs are emptied of air due to the drop in pressure.
Expiration gas and fresh gas are discharged together via the expiration
valve (26). This has the following important result, which is common to
all constant-flow devices:
Minute volume The minute volume configured using the flow meter (19) is the maximum
volume of fresh gas that is available to the patient over the duration of
one minute. Depending on the configured ventilation cycle
(inspiration duration + expiration duration, breathing time ratio), it may
be the case that only a portion of the configured minute volume is
administered to the patient because some of the fresh gas is lost during
expiration and when the pressure plateau is reached and, as a result, this
lost fresh air is no longer available to the patient. Consequently, the
minute volume configured using the flow meter (19) must always be
higher than the inspiratory respiratory minute volume that is to be
administered to the patient.
Depending on the system, the end expiratory pressure increases based on
the configured flow, as indicated on the pressure gauge (22).
Due to the risk of overstretching the lungs in infants and small children,
the pressure limit is of critical importance during ventilation. In order to
administer a sufficient volume of gas despite this restriction, a constant
flow of gas (constant flow) is supplied.

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3.2 Functional description

This may be more than the patient's lungs can accommodate. As a result,
different breathing patterns may arise.

High-flow supply

Low-flow supply

Pressure limit Pressure limit

Fig. 2: Breathing patterns

High-flow supply If the flow rate of the supply is increased, the pressure limit is quickly
reached, in which case airway resistance becomes particularly noticeable
due to the formation of turbulence. The flow in the trachea remains at a
uniformly high level only for a short period of time, since the lungs with
low compliance continue to fill.

Low-flow supply With a low-flow supply, the configured pressure limit is reached at a later
point in time. In this case, the compliance of the lung is critical. It takes
longer for the pressure limit to be reached, and the flow, which gives rise
to less turbulence in this case, remains almost constant for a greater
portion of the inspiration duration.

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3 Design and functional description

3.3 Front view with patient component and tube


system

Fig. 3: Front view with patient component and tube system

1 Control and display unit 4 Patient component


2 Double flow meter and gas 5 Patient tube system
supply
3 Connection for oxygen
measuring cell and sealing plug

Connection for the To install the oxygen measuring cell, remove the sealing plug on the
oxygen measuring cell connection and insert the measuring cell. The sealing plug is used to seal
the ventilation system and protect the connection when recalibrating the
measuring cell, or for measuring the O2 concentration in the incubator.
The oxygen measuring cell is connected to the socket on the back side of
the device by means of a coiled cord.

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3.4 Control and indicators

3.4 Control and indicators

Fig. 4: Control and indicators

1 »IMV« button 9 Numerical switch for adjusting


the expiration duration
2 »CPAP« button 10 Display for breathing rate in
IMV mode (bpm)
3 »Heating« button 11 Numerical switch for adjusting
the inspiration duration
4 »Selftest« button 12 Numerical switch for adjusting
the O2 minimum alarm limit
5 »Alarm suppression« button 13 Numerical switch for adjusting
the O2 maximum alarm limit
6 Ventilation pressure gauge 14 »O2 calibration« button
7 »On/Off« switch 15 »O2 monitor On/Off« button
8 Monitoring display 16 Oxygen concentration monitor

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3 Design and functional description

3.4.1 Ventilation modes

»IMV« button The »IMV« button is used to activate intermittent mandatory ventilation.
In IMV ventilation mode, the respiratory rate can be controlled using the
two numerical switches for inspiration and expiration. The breathing rate
is calculated according to the set parameters and shown on the three-digit
digital display (see Fig. 4). The following settings are possible:

Inspiration duration Adjustable between 0.25 and 2 s


Expiration duration Adjustable between 0.25 and 30 s

»CPAP« button The »CPAP« button activates CPAP ventilation mode (continuous
positive pressure ventilation) with PEEP (positive end-expiratory
pressure). This mode supports spontaneous breathing.
In CPAP mode, the expiration valve remains open at all times. The
patient can breathe spontaneously thanks to the flow of fresh gas
supplied. The positive end-expiratory pressure (PEEP) is adjusted with
the expiration valve (see Fig. 3). During CPAP ventilation, the breathing
rate display shows three dashes (---) (see Fig. 4).

CAUTION

If the ventilator is switched off using the operating switch, the device saves the most
recently used ventilation mode and starts in this mode the next time it is switched on.

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3.4 Control and indicators

3.4.2 Heating system

F 120 GT has a heating system to warm the respiratory gas. It consists of


»Heating« button a ventilation gas humidifier, a heating element and a heated tube system,
which stabilizes the temperature and prevents condensation (see chapters
3.6 and 3.7). The heating system can be switched on and off by hand
using the »Heating« button. The resulting respiratory gas temperature is
approx. 2 °C below the measured incubator temperature.

WARNING
Do not operate the humidifier outside of the recommended ambient conditions
(see chapter 1.9, page 17: Humidity). Otherwise, its capacity for moisture release may
be affected.

3.4.3 Selftest

»Selftest« button Before start-up, use the »Selftest« button to ensure that the ventilator is
functioning correctly. When you press this button, all light indicators and
alarms are subjected to a functional test. In addition, the valves are
triggered five times.

3.4.4 Alarm suppression

»Alarm suppression« Button for suppressing all acoustic alarms for a period of 2 minutes. If the
button malfunction continues to persist beyond this period, the warning signal is
triggered again. The visual display of the alarm is not affected. The visual
and acoustic alarms are canceled permanently only once the malfunction
has been eliminated. You can also use this button to cancel the warning
signal that sounds when the device is switched off.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 35


3 Design and functional description

3.4.5 Adjusting the inspiration and expiration duration

Fig. 5: Timer for adjusting ventilation times

Use the two numerical switches to configure the expiration duration and
the inspiration duration. The corresponding breathing rate is shown on
the display.

NOTE
Ventilation frequency is only activated in connection with
"IMV" ventilation mode. In CPAP ventilation mode, 3 dashes ( - - - ) are shown in the
display.

NOTE
The ventilation frequency must be within a range of 2 to 120 breaths per minute. It is
calculated on the basis of the configured inspiration duration and the expiration
duration. If the setting is not within the permitted range, the parameters are not
accepted and the ventilation frequency display will start to flash. In this case, the
settings must be adjusted.

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3.4 Control and indicators

3.4.6 Alarm and monitoring indicators

3.4.6.1 Alarm indicators

Disconnection If the ventilation pressure is less than 12 cmH2O during IMV ventilation
after the expiration duration and maximum inspiration duration, the
disconnection display flashes and an acoustic alarm can be heard
(see

Fig. 18).

Stenosis If ventilation pressure in IMV mode does not drop below 12 cmH2O
within 2.2 s, the stenosis indicator flashes. An acoustic alarm is triggered
(see

Fig. 18).

O2 alarm If the O2 concentration rises above or drops below the declared alarm
limits, the O2 indicator flashes. An acoustic alarm is triggered (see
chapter 3.4.6.3).

3.4.6.2 Power supply monitoring

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 37


3 Design and functional description

The corresponding indicator lights up to indicate which type of electrical


supply is currently in use. In the event of complete failure of the power
supply, a clearly audible warning signal sounds for a period of approx. 30
seconds and the disconnection indicator flashes. Indicators at a glance:

Battery operation 12 V In the event of power failure, the internal battery supplies power to the
device and the corresponding indicator lights up. The ventilator can then
be operated for 1.5 h with heating and 3 h without heating.
Approximately 20 min before the battery is fully discharged, a warning
signal begins to sound at intervals of 20 s. This alarm cannot be
suppressed. When the battery is fully discharged, the device switches off
automatically and can no longer be operated.

External 12 V/DC An external 12 V/DC voltage supply (e.g. an on-board power supply)
power source supplies power to F 120 GT.

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3.4 Control and indicators

Power supply operation The regular power supply of 230 V/AC is connected. You also have the
option of having the device equipped for operation at 100/115 or
250 V/AC.

3.4.6.3 O2 monitor

O2 monitor The concentration of oxygen in the fresh gas as configured using the dual
O2
flow meter is displayed digitally on the O2 monitor.

O2 monitor »On/Off« You can activate and deactivate the monitor and the O2 alarm using the
button O2 monitor's »On/Off« button.

Adjusting the You can select the limits for the O2 alarm using the numercial switches
O2 alarm limits (upper limit) and (lower limit). If values drop below or exceed
the defined limits, a visual and acoustic alarm is triggered. The following
settings are possible:

Upper limit Adjustable between 20% and 99% O2


Lower limit Adjustable between 20% and 99% O2

WARNING
The alarm limits must be verified by medical personnel and possibly adapted to the
current patient situation. The alarm limits must always be based on the patient's needs.
Using extreme settings that are not medically indicated may render the alarm system
useless and put the patient at risk.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 39


3 Design and functional description

WARNING
If the O2 monitor is switched off, the oxygen concentration is no longer monitored.
If values drop below or exceed the configured limits, no alarm is reported in the
monitoring display.

Calibration button The O2 monitor must be recalibrated at regular intervals. For this purpose,
it is essential to suppress the oxygen supply by turning the dosing valve
clockwise and to press the calibration button with a sharp-ended object
21% (such as a pen).

CAUTION

The O2 sensor must only be saturated with compressed air during calibration!

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3.5 Gas supply and monitoring

3.5 Gas supply and monitoring

Fig. 6: Gas supply and monitoring

1 Dosing valve for external oxygen 4 Double flow meter


supply
2 Low pressure gauge O2 5 Oxygen concentration table
(0-10 bar/supply via central gas
supply or pressurized gas cylinder
with pressure regulator)
3 High pressure gauge O2 6 ISO connection for external
(0-315 bar/supplied via the oxygen supply
incubator oxygen cylinder)

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 41


3 Design and functional description

3.5.1 Dual flow meter

Fig. 7: Dual flow meter

1 O2 dosing valve Setting range: 0-10 l/min


2 AIR dosing valve Setting range: 0-10 l/min

The dual flow meter is used to adjust the respiratory gas flow and the
oxygen concentration. The middle of the float serves as a reading mark.
Dosing valves The dosing valves of the dual flow meter are used to mix oxygen (O2)
and compressed air (AIR) in the required ratio. The O2 concentration can
be adjusted within the range 21% and 100%. It is monitored with
adjustable upper and lower limits using visual and acoustic alarms (see
chapter 3.4.6.3).
If the O2 flow increases, the oxygen concentration in the respiratory gas
rises. However, if you want the total flow of the respiratory gas to remain
constant, the compressed air supply must be reduced accordingly.

CAUTION

The dosing valves of the dual flow meter must not be closed too tightly or they may
be damaged. This can result in leaks.

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3.5 Gas supply and monitoring

DANGER

If the O2 and AIR supply fails, ventilate the patient immediately using a manual
breathing bag.

O2/AIR table Use the table for a quick and easy reference of the mixing ratio of O2 and
air for the required oxygen concentration.

Fig. 8: O2/AIR table

3.5.2 Oxygen supply for external devices

Dosing valve for external External devices requiring an adjustable oxygen flow (e.g. the incubator)
oxygen supply can be supplied by F 120 GT. To this end, the corresponding device is
connected with the ISO connection for external oxygen supply. The
required O2 flow can then be adjusted gradually from 0.25 to 25 l/min at
the dosing valve.
The O2 concentration of the incubator can be checked briefly by the
integrated O2 monitor. Take the O2 sensor out of the measuring fitting
(see Fig. 3, item 3) and position it inside the incubator.

CAUTION

In this case, seal the O2 measuring fitting with the sealing plug.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 43


3 Design and functional description

3.6 Patient component

Fig. 9: Patient component

1 Expiration tube connection 5 Mounting screw


2 Inspiration tube connection 6 Inspiration valve with
adjustment knob
3 Push button for manual 7 Humidifier bottle
ventilation
4 Expiration valve with adjustment 8 Heating element with bubbling
knob tube

Connecting the The connections for the inspiration and expiration tubes are located to the
patient tubes left of the patient component. The connection sockets for the tube heating
system are located between these.

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3.6 Patient component

Installing and removing To install or remove the patient component, tighten or loosen the
the patient component mounting screw. When removing the patient component, use a protective
cap to prevent damage to the plugs and connections during cleaning and
transportation. Remove the protective cap when installing the patient
component again.

Expiration valve The expiration valve is closed electromagnetically during inspiration and
is opened during expiration.
The positive end-expiratory pressure (PEEP) can be adjusted using the
expiration valve. Turn the adjustment knob to the right (clockwise) to
increase the PEEP or turn it to the left (counterclockwise) to reduce it.
The adjustment range is between 0 and 10 cmH2O.

Inspiration valve The inspiration valve is a pneumatic valve for restricting inspiratory
pressure. It serves as a safety valve. If the configured pressure plateau is
exceeded, the valve is opened and the excess fresh air is discharged into
the environment. The adjustment range is between 15 and 60 cmH2O.

CAUTION
When configuring the expiration and inspiration valves, the ventilation pressure gauge
must be monitored because the scale values on the adjustment knobs only show
approximate values.

Pop-off valve On the back of F 120 GT, there is a second safety valve, the pop-off
valve (see Fig. 15), used to protect the patient from excessive gas
pressure. It is preset to 40 cmH2O for a flow of 5 l/min.

Push button for manual Press the red push button for manual ventilation (see Fig. 9) to close the
ventilation expiration valve mechanically while the button is being pressed. For
CPAP ventilation, the patient can be ventilated manually by pressing this
button. In this way, the system builds up the ventilation pressure that has
been configured for the inspiration valve.

Humidifier bottle The humidifier bottle is filled with distilled water and is used to saturate
the heated fresh gas with water vapor. Relative humidity increases to
approx. 85-95%.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 45


3 Design and functional description

DANGER

Risk of explosion!
Do not use any combustible anesthetic gases.

DANGER

Only fill the humidifier bottle up to the level marked on the bottle and only use sterile
aqua dest. for this purpose.

DANGER

Check for leaks following disinfection or sterilization.

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3.7 Patient tube systems

3.7 Patient tube systems

3.7.1 Reusable patient tube system

Fig. 10: Patient tube system

1 Heating coil connector 5 Adapter for the endotrachial


tube (ETT)
2 Heated inspiration tube 6 Face mask for short-term
3 Heated expiration tube ventilation and resuscitation
(available in three sizes)
4 Y-piece for connecting the tube
system to the patient

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 47


3 Design and functional description

The heated patient tube system consists of a silicone tube and a heating
Tube heating coil for inspiration and the same components for expiration. The heating
coils maintain the temperature and counteract the accumulation of
condensation. To connect the tube heating system to the patient
component, plug the two plugs into the two sockets. Then press the
»Heating« button to activate it.

WARNING

Always hold the patient tube by the sleeve when connecting and disconnecting it to
prevent damage.

1. Connect the inspiration tube to the red connection on the patient


component.
2. Connect the expiration tube to the neutral connection on the
patient component.
3. Connect the inspiration and expiration tube to the Y piece.
4. Attach the sealing cap to the Y piece and close the cap.
5. Connect the tube heating plug to the tube heating connection on
the patient component.
The patient tube system must be positioned for operation so that the
heated part of the tube system is outside the incubator.

Incubator
Heated part

Fig. 11: Reusable tube system for incubator

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3.7 Patient tube systems

3.7.2 Disposable patient tube system

Fig. 12: Disposable tube system P1 (art. no. 100761310)

1 Inspiration tube 3 Y piece


2 Expiration tube 4 Tube heater adapter (reusable)

WARNING

Always hold the patient tube by the sleeve when connecting and disconnecting it to
prevent damage.

NOTE
The inspiratory part of the patient tube system is partially heated and the expiratory
part is heated throughout with minimum condensation accumulating in the expiration
tube. No water traps are needed.

1. Connect the inspiration tube with the red adapter to the red
connection on the patient component.
2. Connect the expiration tube with the white adapter to the neutral
connection on the patient component.
3. Connect the inspiration and expiration tube to the Y piece.
4. Attach the sealing cap to the Y piece and close the cap.
5. Connect the tube heating plug to the tube heating connection on the
patient component.
The patient tube system must be positioned for operation so that the
heated part of the inspiration tube is outside the incubator.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 49


3 Design and functional description

Incubator
Heated part of expiration tube

Heated part of inspiration tube

Fig. 13: Disposable patient tube system for incubator

3.8 Side view

Fig. 14: Side view

1 Fan 2 Checklist
2 Drawer for documents

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3.9 Rear view

3.9 Rear view

Fig. 15: Rear view

1 Air filter for the internal 9 Fuses for the auxiliary power
compressor sockets
2 Connection for voltage source 10 Socket for connecting the
12 V/DC oxygen measuring cell
3 Pop-off valve 11 Auxiliary power sockets
4 Compressed air connection 12 Equipotential bonding socket
(NIST)
5 O2 connection (NIST) 13 Operating hours counter
6 »On/Off« power switch 14 Alarm speaker
7 Connection for power cables
230 V/AC
8 Power supply fuses

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®

4.1 Gas supply

4 Preparation for use

4.1 Gas supply

DANGER

Do not use flammable gases! Risk of explosion!

WARNING

Medical gases must be dry, and free of dust and oil.

Gas supply The compressor integrated in F 120 GT generates the compressed air
necessary for operation. The O2 supply comes from the oxygen cylinder
of the incubator. The O2 supply pressure can then be checked at the high
pressure gauge (measuring range 0 to 315 bar) on the front of the device
(see Fig. 6).

F 120 GT can also be operated with a central gas supply (CGS) or with
pressurized gas cylinders.

Central gas supply F 120 GT has NIST connections on the back of the device for O2
(CGS) (see Fig. 15) and compressed air (AIR). By means of angle connectors
(country-specific) and a connection tube, the device can be connected to
the relevant wall connection of the CGS. The O2 supply pressure of the
CGS can be checked on the O2 low pressure gauge (measuring range 0 to
10 bar) on the front of the device (see Fig. 6). The pointer must be in the
green range (3 to 6 bar).

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4 Preparation for use

Gas cylinders Oxygen and compressed air can also be supplied in gas cylinders. If using
gas cylinders, please note the following:
1. Secure the cylinders and screw the pressure regulators (set to 5 bar)
onto the cylinder valves.
2. Connect the O2 hose with pressure regulator to the O2 connection
(NIST) on the back of the device.
3. Connect the compressed air tube with pressure regulator to the
compressed air connection (NIST) on the back of the device.
4. Open the cylinder valves.

The O2 supply pressure of the CGS can be checked on the O2 low


pressure gauge (measuring range 0 to 10 bar) on the front of the device
(see Fig. 6). The pointer must be in the green range (3 to 6 bar).

DANGER

Do not oil or grease cylinder valves on O2 cylinders or on the O2 pressure regulator.


Risk of explosion!

Sample calculation: O2 The oxygen in the pressurized gas cylinder is highly pressurized. Due to
consumption the pressure, the volume in the cylinder is significantly reduced.
The oxygen content of a pressurized gas cylinder (O2 content) is
calculated by multiplying the oxygen cylinder pressure (Pcyl) with the
oxygen cylinder volume (Vcyl). In the F 120 GT, the O2 flow can be
adjusted between 0 and 15 l/min. This results in the following
consumption:

Calculating the O2 𝑂2 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 = (𝑃𝑐𝑦𝑙𝑖𝑛𝑑𝑒𝑟 − 𝑅𝑒𝑠𝑖𝑑𝑢𝑎𝑙 𝑝𝑟𝑒𝑠𝑠𝑢𝑟𝑒) ∗ 𝑉𝑐𝑦𝑙𝑖𝑛𝑑𝑒𝑟


cylinder content
Pcyl = 200 bar
Example
Residual pressure = 3 bar
Vcyl = 2 liters:
𝑂2 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 = 197 𝑏𝑎𝑟 ∗ 2 𝑙 ≅ 394 𝑙

394 l of oxygen is available from the cylinder.

Flow setting for 90% oxygen at a total flow of 4 l/min


Sample calculation:
patient supplied with O2 flow : 3.5 l/min
90% oxygen AIR flow : 0.5 l/min

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4.2 Power supply

𝑂2 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 394 𝑙
𝐵𝑒𝑡𝑟𝑖𝑒𝑏𝑠𝑧𝑒𝑖𝑡 = = ≅ 113 𝑚𝑖𝑛
𝑂2 𝑓𝑙𝑜𝑤 3.5 𝑙/𝑚𝑖𝑛

Sample calculation: Flow setting for 40% oxygen at a total flow of 6 l/min
patient supplied with O2 flow : 1.5 l/min
40% oxygen AIR flow : 4.5 l/min
𝑂2 𝑐𝑜𝑛𝑡𝑒𝑛𝑡 394 𝑙
𝑂𝑝𝑒𝑟𝑎𝑡𝑖𝑛𝑔 𝑡𝑖𝑚𝑒 = 𝑂2 𝑓𝑙𝑜𝑤
= 1.5 𝑙/𝑚𝑖𝑛 ≅ 263 𝑚𝑖𝑛

4.2 Power supply

Power supply operation F 120 GT can be operated with a power voltage of 230 V/AC. The device
230 V/AC is also available for operation with a power supply of 100/115/250 V on
request.

1. Check that the power voltage corresponds to the voltage stated on the
nameplate of F 120 GT.
2. Use the power cable to connect the ventilator to the wall socket.
3. Switch on the power switch on the back of the device (see Fig. 15).

Power supply operation Alternatively, the ventilator can be connected to an external DC voltage
12 V/DC source (12 V/DC) by a 3-pin coupling, cable and 12 V connector (see Fig.
15). Voltage fluctuations between 11 and 14 V/DC are tolerated by F 120
GT.

WARNING

To ensure reliable operation of F 120 GT during transport, ensure that the vehicle
motor is operational before connecting it to external power supply sources.

Battery operation In the event of a power failure or if an external power supply is not
available, the device is powered by the internal battery. The switchover
occurs automatically and is signaled by the battery icon lighting up in
power supply monitoring (see chapter 3.4.6). The internal battery
supplies the power to the device for a period of 1.5 h when the heating is
on and 3 h when the heating is switched off. The battery life depends on
the operating mode selected. If the device is being operated with a high
respiratory rate, the battery discharges more quickly than it does with a
low respiratory rate.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 55


4 Preparation for use

The device cannot be operated when the battery is discharged.

WARNING
If the battery capacity begins to run out, a warning signal is sounded every 20 s and
cannot be suppressed. The device can still be operated for approximately 20 min. as of
this point. If battery capacity drops below the critical level, the device switches off
automatically.

WARNING

The battery type used in F 120 GT does not reach its optimum capacity until it has
been recharged and emptied four or five times.

WARNING
To optimize the capacity of the battery, the device must always be connected to the
power supply and the power switch must remain on when the device is not in use. If
the battery is empty, it will take at least 19 hours to charge. The higher the battery
level, the shorter the charge time. A safety circuit prevents the batteries from being
overcharged.

WARNING
It may not be possible to charge a completely discharged battery, which will need to
be replaced in this case. This can only be done by the authorized customer service
team.

Equipotential bonding If equipotential bonding is necessary, a ground wire must be connected to


the socket provided on the back of the device.

Additional electrical Additional electrical devices can be connected to the 4 auxiliary power
devices sockets on the back of F 120 GT.

DANGER
The connection of devices to the auxiliary power sockets can increase the patient
leakage currents to values which could exceed the tolerable limit values as per DIN
EN 60601-1 following failure of a protective earth conductor. Electrical danger cannot
be ruled out in this case. This is why separating transformers must be used!

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4.2 Power supply

WARNING

During use, F 120 GT must have no more than 4 auxiliary power sockets accessible to
the user.

WARNING

Power failure also means failure of the auxiliary power sockets.

WARNING

Do not connect HF surgical devices to the auxiliary power sockets.

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®

5.1 Checklist

5 Checklist
The checklist is based on a device equipped with all options. The
checklist may be more extensive than the actual check to be performed.
All relevant checks must be carried out before the device is used. The
staff carrying out the tests must be well acquainted with the operating
manual.

Testing requirements  The last safety check must have been carried out as scheduled.
Visual check of the safety check sticker.
 The device is completely assembled and connected.
 The internal battery must be fully charged.

5.1 Checklist

A sticker on the right side of F 120 GT shows the checklist in abbreviated


form.

Checklist
Requires knowledge of the operating instructions

The following items must be checked before use:

Gas supply (compressed air, O2, etc.) Proper connection

Power supply Proper connection

Patient tube system Leak tightness

Patient component Function


PEEP valve
Plateau valve

Ventilation pressure gauge Function

Monitor Function

Alarm for ventilation system interruption Function


Function
Alarm for loss of power
Function
Alarm for low FiO2 concentration

Refer to the operating instructions in the event of


non-compliance with one of the aforementioned
items

Fig. 16: F 120 GT checklist

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 59


5 Checklist

5.2 Daily checks before each use

Check gas connections  Check central gas supply


- Close all cylinder valves
- All central gas supply pressures must be within the correct range
(3-6 bar).
- Visual check of the pressure gauges for O2 and AIR
 Check gas cylinders with pressure regulator
- Open the cylinder valves
- Disconnect the device from the central gas supply.
- The gas cylinders must have sufficient fill pressure.
- Visual check of the pressure gauge for O2
- If necessary, close the cylinder valve and install a full gas
cylinder.

Check the dual flow  Test the leak tightness of the dual flow meter
meter - Close all dosing valves
- The floats in the individual measuring tubes must move to zero
 Open the O2 dosing valve fully. The flow must be at least
10 l/min.
 Open the AIR dosing valve fully. The flow must be at least
10 l/min.

Check the inspiration  Set the required plateau pressure


valve  Connect the inspiration valve to the Y piece
 Check the plateau pressure on the ventilation pressure gauge

Check the expiration  Set the required PEEP


valve  Seal the tube system at the Y piece
 Check the ventilation pressure gauge. The configured PEEP value
must be displayed following inspiration.

Leakage test  The inspiratory pressure set to 40 cmH2O for a flow rate of
5 l/min must exceed a value of 30 cmH2O within the set
inspiration time of 1 s.

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5.2 Daily checks before each use

Test push button for manual  Press the push button and check the ventilation pressure gauge.
ventilation
Check backup power  When the power supply is disconnected, the device must remain
supply in operation and an acoustic alarm must be heard. Disconnection
flashes briefly in the monitoring display and the battery display
lights up (see chapter 3.4.6).

Check the  Select the IMV ventilation mode.


disconnection alarm  Open the Y piece.
 Check the alarm function. An acoustic and visual alarm must be
triggered.

Check the power failure  Use the On/Off button to switch the device off.
alarm  Check the alarm function. An acoustic and visual alarm must be
triggered for at least 7 s.

Switch on the device  The device selftest has been successfully completed.
 The O2 monitor is working.

Check the O2 monitor  The oxygen concentration is displayed digitally.


function  Test the alarm function by first raising and then lowering the alarm
limits. An acoustic and visual alarm must be triggered in both cases.
 Reset the alarm limits.

Heating  After the heating system is switched on, the humidifier bottle and
tubes must be warmed (to approx. 35-36 °C). This can be checked
manually.

Filter Check the compressor's air filter and replace it if necessary.

DANGER

Never operate device if it has failed one of the tests!

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 61


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6.1 Switching on

6 Operation

6.1 Switching on

1. Connect to the power supply


2. Turn on the power switch
3. Turn on the »On/Off« operating switch
4. Press the »Selftest« button
5. Monitor the selftest, during which the device performs functional
tests of all indicators, alarms and the expiration valve.

6.2 Choosing the ventilation mode

IMV 1. Press the »IMV« button (see chapter 3.4.1).


2. Use the »Inspiration« numerical switch to configure the inspiration
duration.
3. Use the »Expiration« numerical switch to configure the expiration
duration.
4. Configure an adequate constant flow using the dual flow meter.
5. Select the oxygen concentration and configure the O2 alarm limits.
6. Configure the upper pressure limit with the inspiration valve
(plateau).
7. Configure PEEP with the expiration valve.

CPAP 1. Press the »CPAP« button (see chapter 3.4.1).


2. Configure an adequate constant flow using the dual flow meter.
3. Select the oxygen concentration and configure the O2 alarm limits.
4. Configure PEEP with the expiration valve.

NOTE
When the ventilator is switched off, it saves the most recently used ventilation mode.
When the device is switched on again, it starts in the same mode. If this does not
happen and the ventilator starts in an undefined state, this may be due to a discharged
or defective CMOS battery. Despite this, the ventilator is still ready for operation once
the required ventilation mode has been selected again. However, the CMOS battery
should still be replaced as soon as possible.

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7 Ventilation modes

7 Ventilation modes

7.1 Intermittent mandatory ventilation

Intermittent mandatory ventilation (IMV) combines spontaneous


breathing with time-controlled, pressure-limited mechanical ventilation.
The patient can breathe spontaneously and unhindered between the
configurable intermittent mechanical ventilation breaths because the flow
is not interrupted during expiration. The frequency of the ventilator is
automatically less than the spontaneous breathing rate. The respiratory
rate configured and the value of the mechanical tidal volume determine
the ventilatory support provided by the ventilator. The user selects the
duration of inspiration and expiration in seconds. The following settings
are possible for F 120 GT:

Inspiration Adjustable between 0.25 and 2 seconds


duration:
Expiration Adjustable between 0.25 and 30 seconds
duration:

Calculating the The respiratory rate can be calculated as follows:


respiratory rate

InspirationTime  Expiration Time BreathingR ate  60 s


I InspirationTime
 Ratio 
E Expiration Time
60 s
BreathingR ate 
( InspirationTime  Expiration Time)

e. g. Insp  1.0 s
I 1.0s
Exp  2.0 s  Ratio 
E 2.0 s
60 s
BR 
1.0 s  2.0 s
BR  20 / min
This results in respiratory rates of 2-120 breaths per minute. The breath
rate appears on the digital display (see Fig. 4).

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7.1 Intermittent mandatory ventilation

For IMV ventilation, the expiration valve is closed during the adjusted
inspiration duration and then opened again. The flow and oxygen
concentration can be adjusted to the needs of the patient using the dual
flow meter (adjustable between 0 and 10 l/min). The ventilation
controlled by the device is not synchronized and therefore also occurs
during spontaneous inspiration and expiration.

Fig. 17: IMV ventilation

The resulting positive peak inspiratory pressure (PIP) can be restricted


using the inspiration valve (plateau). The pressure plateau remains
constant during inhalation. There is a greater number of spontaneous
breaths when the expiration duration is longer. Pressing the manual
ventilation button during controlled ventilation can cause artificial sigh
breathing or a longer inhalation phase.

Fig. 18: Disconnection and stenosis alarm for IMV ventilation

Disconnection In contrast to normal CPAP ventilation, the IMV mode in F 120 GT has
monitoring disconnection monitoring, which adjusts automatically to the set
expiration duration. If after the expiration duration and maximum
inspiration duration (2 s) a ventilation pressure of less than 12 cmH2O is
measured, the disconnection alarm is triggered (see chapter 3.4.6.1).

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7 Ventilation modes

Stenosis monitoring

Fig. 18 provides a visual recap of the functioning of stenosis monitoring.


If the ventilation pressure does not fall to less than the fixed alarm limit
of 12 cmH2O within 2.2 s, a stenosis alarm is triggered.

7.2 Spontaneous breathing with positive end-


expiratory pressure (CPAP)

The CPAP mode, spontaneous breathing under end-expiratory pressure,


helps to evolve the lung and distribute the inspiration air evenly.
Inspiration is made easier by the continuous positive airway pressure,
while expiration is made more difficult. During inspiration, the lungs are
filled exclusively by the patient's spontaneous breathing. The patient can
breathe spontaneously using the flow supplied and the configured PEEP.

Fig. 19: CPAP ventilation

The system works with a constant flow and limited pressure in


accordance with the continuous flow principle. The flow remains
constant during inspiration and expiration and, like the oxygen
concentration, can be measured and adjusted to suit the patient's

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®
7.2 Spontaneous breathing with positive end-expiratory pressure
(CPAP)

spontaneous breathing by means of the dual flow meter. The positive


end-expiratory pressure (PEEP) can be adjusted at the expiration valve
between 0 and 10 cmH2O and sustained during ventilation. Expiration gas
and excess fresh gas are discharged together via the expiration valve.

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7 Ventilation modes

NOTE

If you want the device-specific monitor to monitor disconnection, you may need to
switch to IMV with a longer expiration duration.

7.3 Manual ventilation

When you press the red push button (see Fig. 9, item 3), the expiration
valve is closed mechanically for the duration for which the button is
pressed. For CPAP ventilation, the patient can be ventilated manually by
pressing this button. In this way, the system can build up the ventilation
pressure set at the inspiration valve (pressure plateau).

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7.3 Manual ventilation

8 Troubleshooting

Alarm Priority Cause Corrective action


Disconnection flashes Medium  Power failure  Check the power supply
briefly  Faulty power supply and the connecting cable
Alarm tone sounds
Battery indicator lights up
Battery indicator flashes High  Battery charge level is  Restore the power supply
Alarm signal sounds below the critical value immediately
every 20 s  Charge battery
 If battery is defective
 Defective battery  Device may continue to be
used only under
continuous monitoring of
device functions
 Contact the customer
service team
Disconnection alarm High  Gas supply interruption  Check gas supply
 Check cylinder valves

 Leakage or  Check the patient tube


disconnection system

 Fresh gas flow  Increase fresh gas flow


too low
 Internal malfunction  Use external compressed
when creating air supply
compressed air  Contact the customer
service team
O2 alarm Medium  The O2 level exceeds or  Check O2 concentration
drops below the limits and adjust setting if
set for O2 concentration necessary
 Check O2 supply
 Calibrate oxygen sensor

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8 Troubleshooting

Alarm Priority Cause Corrective action


The O2 monitor displays Medium  Defective oxygen  Replace the oxygen sensor
»UU« or sensor/connecting cable or the cable

»__ __«.  Calibrate oxygen sensor


 Monitor FiO2 externally
 Defective storage  Contact the customer
battery service team

Stenosis alarm High  Blocked expiration  Check patient tube system


tube/resistance too high  Check bacteria filter if
necessary
 Defective expiration  Replace the patient
valve component
 Contact the customer
service team
 Flow setting too high  Check flow setting
Heating not working Medium  Heating defective  Continue ventilation if no
risk to the patient exists.
 Contact the customer
service team
 Heating plug not  Check patient tube system
secured correctly
 Defective fuse  Check fuse and replace if
necessary
 Weak battery  Restore the power supply

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7.3 Manual ventilation

9 Care and maintenance

WARNING
The device must be disconnected from the patient before performing any maintenance
or service activities.
Following maintenance or service activities, a function test as described in chapter 5
must be performed.

9.1 General information on treatment

CAUTION
As with device operation, cleaning and disinfection work on the device must only be
performed by trained employees.

The processes for the treatment of this medical device as described in this manual are
recommendations only. The requirements regarding hygiene and workplace safety
must always be observed during the treatment of medical products.

Routine cleaning must be carried out at regular intervals according to local hospital
guidelines.
All disposable parts must be disposed of in an environmentally friendly manner
according to local hospital guidelines and hygiene regulations.

Automated thermal treatment should be given priority where possible.

Do not sterilize the complete device in an autoclave, under pressure, or using ethylene
oxide (EO).

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9 Care and maintenance

9.2 Information about cleaning agents and


disinfectants

CAUTION
When using cleaning agents and disinfectants, pay attention to the correct
concentration and dwell time to prevent damage to the materials.
Always closely follow the cleaning agent manufacturer’s instructions on using the
cleaning agent!

When using agents other than those specified, please contact the manufacturer of the
disinfectant to confirm its compatibility with ventilation and inhalation systems
(safety data sheet, toxicity).

When using cleaning agents and disinfectants, observe the rules established by the
professional associations on the use of cleaning agents and disinfectants.

Do not use any highly alkaline cleaning agents! These can severely corrode and
damage anodized surfaces.
Do not use phosphoric acid to neutralize alkaline cleaning agents! Phosphorous acid
can severely corrode and damage anodized surfaces.

Do not use petroleum-based cleaning agents, acetone, or other harsh cleaning agents!
These agents can damage the device material and cause malfunctions.

Do not use any disinfectants based on amines or their derivatives! These agents can
damage the plastics and silicone in the device and cause malfunctions.

Do not use any disinfectants containing oxygen, chlorine or halogen donors or


phenols and their derivatives! These agents can damage the device material and cause
malfunctions.

Do not use any rinse aids or other drying agents!

Do not immerse the main device in liquids! Use cleaning solutions sparingly for wipe
disinfection!
Excess liquid may enter the housing and damage the device.

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7.3 Manual ventilation

9.3 Automated cleaning and disinfection

For automated cleaning, configure the automated cleaning and


disinfection equipment according to the manufacturer’s operating
instructions.

CAUTION

Use only automated cleaning and disinfection equipment that complies with DIN EN
ISO 15883-1!

The parts to be cleaned must be disassembled according to the


instructions in this user manual before treatment. Load the automated
cleaning and disinfection equipment in such a way that the inner and
outer surfaces of the parts can be reached by the cleaning agent and no
spots are missed.
All parts must be arranged to avoid the formation of water pockets, such
as those that may occur with hanging loops of tubing or kinked tubing.
Select a suitable program (e.g. anesthesia program). Cleaning should take
at least 5 minutes at 40-60 °C.

Cleaning is followed by thermal disinfection at 80-95 °C. The dwell time


Thermal disinfection
depends on the temperature of the disinfection program as follows:

Efficacy ranges:
A: For killing vegetative bacteria (including mycobacteria) and fungi
(including fungal spores)
AB: Same as A, and for the inactivation of viruses

Efficacy range A Efficacy range AB


Ao 600 3000
Disinfection at 80 °C 10 min. 50 min.
Disinfection at 85 °C 3.2 min. 15.8 min.
Disinfection at 90 °C 1 min. 5 min.
Disinfection at 95 °C 0.1 min. 0.5 min.
Tab. 3: Efficacy ranges according to EN ISO 15883-1

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9 Care and maintenance

Demineralized water must be used for all interim rinses and the final
rinse.
Once the disinfection program has finished, remove the parts from the
automated cleaning and disinfection equipment and check the visible
surfaces for visible residual contamination. If necessary, repeat the
cleaning and disinfection process. After this, dry the treated parts
thoroughly (in a drying cabinet if necessary).

Cleaning agents With regard to material compatibility, suitable cleaning agents are
enzymatic and mildly alkaline, such as neodisher® Mediclean from Dr.
Weigert GmbH in Hamburg.

Products based on the following are not suitable because they could
possibly damage materials:
- Highly alkaline solutions
- Petroleum or acetone
- Oxygen-releasing or chlorine-releasing compounds
- Halogen-releasing compounds
- Phenols and their derivatives
- Amines and their derivatives
- Strong organic acids
Products listed in the most current version of the DGHM list published by
the Deutsche Gesellschaft für Hygiene und Mikrobiologie (German
Society of Hygiene and Microbiology) (mhp-Verlag, Wiesbaden) are
recommended for users in the Federal Republic of Germany.

CAUTION
Do not use disinfectants in automated cleaning and disinfection equipment!
Do not use any rinse aids or other drying agents!
These could damage the parts to be treated.
For more information about the use of cleaning agents, see chapter 9.2.

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7.3 Manual ventilation

9.4 Manual cleaning and disinfection

WARNING

Manual treatment cannot be validated and does not deliver reproducible results.
For this reason, automated treatment should be preferred where possible.

Manual cleaning To manually clean the individual parts, pre-rinse them in warm water.
Then clean the individual parts in the cleaning and disinfectant solution,
if necessary using soft brushes or sponges. All secretions and other
deposits and contamination must be completely removed.

Manual disinfection To manually disinfect the individual parts, place them in the ready-to-use
disinfectant solution (instrument disinfection agent). All of the parts must
be fully covered by the disinfectant, and they must be free from bubbles.
After the dwell time, the disinfectant must be completely rinsed off using
demineralized water. Afterwards, the parts must be dried thoroughly.
Once manual disinfection is complete, check the parts for visible residual
contamination. If necessary, repeat the manual disinfection process.

Cleaning agents With regard to material compatibility, suitable cleaning agents and
disinfectants are instrument disinfection agents that use alcohol and
aldehydes as the active ingredient, such as gigasept® ff from Schülke &
Mayr.
Products based on the following are not suitable because they could
possibly damage materials:
- Highly alkaline solutions
- Petroleum or acetone
- Oxygen-releasing or chlorine-releasing compounds
- Halogen-releasing compounds
- Phenols and their derivatives
- Amines and their derivatives
- Strong organic acids
Products listed in the most current version of the DGHM list published by
the Deutsche Gesellschaft für Hygiene und Mikrobiologie (German
Society of Hygiene and Microbiology) (mhp-Verlag, Wiesbaden) are
recommended for users in the Federal Republic of Germany.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 75


9 Care and maintenance

9.5 Cleaning and disinfection of device surfaces

Use ready-to-use disinfectant solution to disinfect the surfaces of the


device. Completely wipe down the surfaces using the wiping cloth. The
wiping cloth should only be moist.

WARNING

When using wipe disinfection, ensure that no liquid enters the device. Liquid ingress
can impair the operation of the device and thereby pose a risk to the patient.

All disinfectant residue must be completely removed afterwards.

Disinfectants With regard to material compatibility, suitable for wipe disinfection are
aldehyde-free quick disinfecting wipes such as Bacillol® wipes or tissues
from Paul Hartmann AG.

9.6 Sterilization

Components labeled in this operating manual as suitable for sterilization


can be sterilized with hot steam at temperatures of up to 134 °C.

NOTE

Only use vacuum steam sterilizers, preferably ones with a fractionated vacuum.

The hot steam sterilizer must be loaded according to the manufacturer’s


instructions for use and the corresponding program started.

Temperature Hold/dwell time


134 °C 3-18 min
Tab. 4: Standard procedure for steam sterilization*

*All standard steam sterilization procedures can be used.

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7.3 Manual ventilation

9.7 Carrying out the treatment

9.7.1 Reusable patient tube system

CAUTION
When disconnecting the patient tubes, always grasp them by the connection sleeves
and not by the support bracket.

Do not allow the tubes from the tube system to twist around or catch on the cable
bridge!
If the tubes become twisted or caught on the cable bridge, the tube heater may be
damaged and not work properly.

Do not use any rinse aids or other drying agents!


For more information about the use of cleaning agents, see chapter 9.2.

Instructions
Place of use Remove surface dirt with a disposable cloth/paper towel
Storage and transport Do not allow the patient tube system to catch on the cable bridge!
Cleaning preparations 1. Remove the Y piece.
2. Remove large impurities immediately after use (within a maximum
of 2 h). This also helps to prevent unwanted blood staining.
3. Use only running water or aldehyde-free disinfectant solutions,
which have been tested for effectiveness and are suitable for
disinfecting silicone tubes.
4. To manually remove contamination, use only a soft brush or a clean,
soft cloth intended specifically for this purpose only.
5. Rinse all lumina for at least 1 min. under running water.
6. Disinfectants used for pretreatment are only for personal protection
and do not replace the need for disinfection after cleaning is
completed.

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9 Care and maintenance

Instructions
Cleaning: automatic 1. Place the ventilation tubes in the automated cleaning and disinfection
equipment so that they do not touch one another for the most part.
2. Connect all ventilation tube lumina to the rinse connection of the
cleaning and disinfection equipment.
3. Start the program.
4. Once the program stops, remove the ventilation tubes from the
cleaning and disinfection equipment.
Further information on automatic cleaning can be found in chapter 9.3.
Cleaning: manual 1. Immerse the individual parts in ready-to-use disinfectant solution.
Disinfection All of the parts must be fully covered by the disinfectant.
Drying 2. Move the parts around in the solution several times until all air
bubbles have been removed.
3. Clean the parts on the inside and outside with a soft brush.
4. After the dwell time, rinse off all of the disinfectant.
5. Dry the parts thoroughly.
6. After completion, check the parts for visible external residual
contamination. If necessary, repeat the manual cleaning and
disinfection process.
Further information on manual cleaning and disinfection can be found in
chapter 9.4.
Maintenance No maintenance required for cleaning. Oils can damage silicone!
Inspection and functional After disinfection and before each use, check all parts for damage
checks (cracks, breaks, hardening, etc.) and ensure that the connection plug
screw fitting is tight. Tighten the screw fitting if necessary.
Do not reuse damaged parts.
Packaging Standardized packaging material can be used for the packable parts. The
packaging must be large enough for all components so that there is no
strain on the seal.
Sterilization The reusable tube system can be autoclaved with steam at up to 134 °C.
Load the autoclave according to the manufacturer’s instructions for use
and start the appropriate program.
Further information on sterilization can be found in chapter 9.6.
Storage After sterilization, store the system in the sterilization packaging, first
ensuring it is dry and free of contamination.
Additional information Do not allow the tubes from the tube system to twist around or catch on
the cable bridge!
If the tubes become twisted or caught on the cable bridge, the tube
heating may be damaged and not work properly.

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7.3 Manual ventilation

9.7.2 Patient component P1

CAUTION
After each manual or automated thermal treatment, any residual water must be
removed from the patient component and the component dried. The purging can be
done using compressed air and the component can then be dried in a drying cabinet.
Alternatively, it can be sterilized with hot steam.

Do not use any rinse aids or other drying agents!


For more information about the use of cleaning agents, see chapter 9.2.

Instructions

Place of use Remove surface dirt with a disposable cloth/paper towel

Storage and transport No particular requirements

Cleaning preparations 1. Disconnect the patient component from the side panel of the
ventilator.
2. Unscrew and drain the humidifier bottle.
3. Screw the protective cap onto the patient component.
4. Remove the plug for the oxygen sensor if necessary.
5. Turn both push-and-turn buttons all the way to the left (minimum).

Cleaning: automatic 1. Connect the expiration nozzle to the injector rail of the cleaning and
disinfection equipment.
2. Position the patient component to ensure that it will be fully rinsed
and that no spots are missed. Excess water must be able to run off
freely.
3. Load the automated disinfection equipment according to the
manufacturer’s instructions for use and start the program for
anesthesia materials. Dry the disinfected parts (in a drying cabinet if
necessary), unless this happens inside the automated disinfection
equipment.
Further information on automatic cleaning can be found in chapter 9.3.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 79


9 Care and maintenance

Instructions

Cleaning: manual 1. Immerse the individual parts in ready-to-use disinfectant solution.


Disinfection All of the parts must be fully covered by the disinfectant.
Drying 2. Move the parts around in the solution several times until all air
bubbles have been removed.
3. After the dwell time, rinse off all of the disinfectant.
4. Dry the disinfected parts (in a drying cabinet if necessary).
5. After completion, check the parts for visible external residual
contamination or disinfectant. If necessary, repeat the manual
cleaning and disinfection process.
Further information on manual cleaning and disinfection can be found in
chapter 9.4.

Maintenance No maintenance required for cleaning.

Inspection and functional Check all parts for damage (cracks, breaks, hardening, etc.) after
checks disinfection and before each use.
Do not reuse damaged parts.

Packaging Standardized packaging material can be used for the packable parts. The
packaging must be large enough for all components so that there is no
strain on the seal.

Sterilization All patient component parts can be autoclaved with steam at up to


134 °C. Load the autoclave according to the manufacturer’s instructions
for use and start the appropriate program.
Further information on sterilizing the ventilation system can be found in
chapter 9.6.

Storage After sterilization, store the system in the sterilization packaging, first
ensuring it is dry and free of contamination.

Additional information Preparation: Screw the protective cap onto the patient component.

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7.3 Manual ventilation

9.7.3 Connection cable for disposable patient tube system P1

CAUTION
The connection cable P1 for disposable patient tube systems is not suitable for
automatic treatment or sterilization with hot steam.
Sterilization with hot steam leads to the destruction of the adapter!

Fig. 20: Connection cable P1 for disposable patient tube system

Instructions
Place of use Remove surface dirt with a disposable cloth/paper towel
Storage and transport No particular requirements
Cleaning preparations 1. Disconnect the connection cable plug from the ventilator
2. Remove the connection cable from the patient tube system
Cleaning: automatic Not possible
Cleaning: manual Wipe the surfaces with ready-to-use disinfectant solution (surface
Disinfection disinfectant).
Drying Further information on manual cleaning and disinfection can be found in
chapter 9.5.
Maintenance No maintenance necessary
Inspection and functional After disinfection and before each use, check all parts for damage
checks (cracks, breaks, hardening, etc.) and ensure that the connection plug
screw fitting (item 12) is tight. Tighten the screw fitting if necessary.
Do not reuse damaged parts.
Packaging No particular requirements
Sterilization Not possible
Storage Store in a dry place free from dust and frost and ensure low
microbiological contamination.
Additional information None

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9 Care and maintenance

9.7.4 Test lung with tube adapter

CAUTION

Do not use any rinse aids or other drying agents!


For more information about the use of cleaning agents, see chapter 9.2.

Instructions
Place of use Remove surface dirt with a disposable cloth/paper towel
Storage and transport No particular requirements
Cleaning preparations 1. Remove the connection tube from the test lung together with the tube
adapter and tube sleeve.
2. Remove the tube adapter and tube sleeve from the silicone tube.
Cleaning: automatic 1. Connect the silicone tube to the injector rail of the cleaning and
disinfection equipment.
2. Position the test lung to ensure that the cavity will be fully rinsed and
that no spots are missed. Excess water must be able to run off freely.
3. Place the tube sleeve in a container for small parts.
4. Load the automated disinfection equipment according to the
manufacturer’s instructions for use and start the program for
anesthesia materials.
5. Dry the disinfected parts (in a drying cabinet if necessary), unless
this happens inside the automated disinfection equipment.
Further information on automatic cleaning can be found in chapter 9.3.
Cleaning: manual 1. Immerse the individual parts in ready-to-use disinfectant solution.
Disinfection All of the parts must be fully covered by the disinfectant.
Drying 2. Move the parts around in the solution several times until all air
bubbles have been removed.
3. Clean the parts on the inside and outside with a soft brush.
4. After the dwell time, rinse off all of the disinfectant.
5. Dry the parts thoroughly.
6. After completion, check the parts for visible external residual
contamination. If necessary, repeat the manual cleaning and
disinfection process.
Further information on manual cleaning and disinfection can be found in
chapter 9.4.
Maintenance No maintenance required for cleaning. Oils can damage silicone!

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7.3 Manual ventilation

Instructions
Inspection and functional Check all parts for damage (cracks, breaks, hardening, etc.) after
checks disinfection and before each use.
Do not reuse damaged parts.
Packaging Standardized packaging material can be used for the packable parts. The
packaging must be large enough for all components so that there is no
strain on the seal.
Sterilization The test lung can be autoclaved with steam at up to 134 °C.
Load the autoclave according to the manufacturer’s instructions for use
and start the appropriate program.
Further information on sterilization can be found in chapter 9.6.
Storage After sterilization, store the system in the sterilization packaging, first
ensuring it is dry and free of contamination.
Additional information Preparing the test lung with the tube adapter:

1. Remove the connection tube from the test lung together with the tube
adapter and tube sleeve.
2. Remove the tube adapter and tube sleeve from the silicone tube.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 83


9 Care and maintenance

9.8 Treatment table

CAUTION
The processes for the treatment of the medical device described in this table are
recommendations only. Always observe the specific procedural instructions given by
the responsible hygiene officer.

WARNING

In case of infectious patients, all parts of the patient system carrying breathing gas
must also be sterilized.

System components Automated Manual Sterilization


thermal treatment
treatment

Housing, power cord, No Surfaces No


connection tubes
Patient component Yes Yes Yes

Humidifier bottle Yes Yes Yes

Patient tube system Yes Yes Yes


(reusable),
Y piece, silicone cap

Connection cable P1 for No Surfaces No


disposable patient tube
system P1
Test lung with tube Yes Yes Yes
adapter

Mobile stand, drawer set, No Surfaces No


brackets
Tab. 5: Treatment table

84 GA-015-1217V2.4-HAO-en  Fritz Stephan GmbH


®

7.3 Manual ventilation

9.9 Before next patient

Storage Store in a dry and dust-free place for subsequent use.

Preparation for use Preparation for use is described in chapter 4 from page 51.

Function test Before F 120 GT is operated, it must always be tested (see chapter 5 from
page 57).

What to do in the event If you notice any damage to the device or accessories during or after
of damage treatment, please contact your medical technology department or the
authorized customer service team immediately.
The manufacturer accepts no responsibility for damage caused by
improper handling or treatment of the device!

9.10 Servicing

WARNING
Only authorized customer service personnel is permitted to alter, modify, repair, or
open the device, or to replace the battery. This does not include the intended
dismantling of the patient component according to the operating instructions. When
servicing the device, only use original spare parts.

CAUTION

F 120 GT and all its accessories must be cleaned and disinfected prior to all servicing
activities, as well as before being returned for repair.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 85


9 Care and maintenance

9.10.1 Maintenance and inspection intervals

Interval Tasks

After every patient Check the device for external damage


Monthly Check the intake filter, replace if necessary
Every 6 months Replace the intake filter
Every 6 months Check the O-rings of the gas connection nipples and replace if necessary.
Every 6 months Check the O-ring of the humidifier bottle and replace if necessary.
Every 6 months Perform a safety check (see also chapter 9.10.2)
Every 6 months Maintenance and inspection by the authorized customer service team
Annually Replace the oxygen sensor
Every 2 years Have the internal battery replaced by the authorized customer service team
Tab. 6: Maintenance and inspection intervals

86 GA-015-1217V2.4-HAO-en  Fritz Stephan GmbH


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7.3 Manual ventilation

9.10.2 Safety checks

WARNING

If safety checks are not performed, the safety of the device may be compromised!
Safety checks must always be performed at the specified intervals.

CAUTION

Safety checks must not be used as a substitute for the maintenance and replacement of
wear parts as prescribed by the manufacturer.

Visual inspection  Overall condition


 All labeling and markings on the device are present and
legible, operating manual is available
 Condition and mechanical coding/color coding of the gas
supply elements

Electrical safety  Inspection according to DIN EN 62353

Checking the safety  Perform an automatic selftest


functions  Function of the alarm transmitter
 Function and accuracy of the operating elements
 Function of the pop-off valve
 Leakage test
 Disconnection alarm
 Stenosis alarm
 Power failure alarm

Checking the device  Function test of the FiO2 monitor


functions  Function test of the heating
 Function test of voltage switching
 Function test of the pressure measurement
 Function test of gas supply switching
 Check of the internal battery
 Check dosing valve for external oxygen supply

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 87


®

7.3 Manual ventilation

10 Electromagnetic emissions and


immunity

NOTE
Electrical medical devices are subject to special precautions regarding
electromagnetic compatibility (EMC) and must be installed and put into service
according to the EMC information provided in the accompanying documentation.

Portable and mobile RF communications equipment can affect electrical medical


devices.

10.1 Electromagnetic emissions

The F 120 GT ventilator is intended for use in the electromagnetic


environment specified below. Before using the F 120 GT ventilator, you
must ensure that it is being operated in the correct environment.

Emissions Compliance Electromagnetic environment guideline

RF emissions as defined in Group 1 The F 120 GT ventilator uses RF energy for its internal
CISPR 11 function only. Therefore, its RF emissions are very low
and are not likely to cause any interference with nearby
electronic equipment.
RF emissions as defined in Class A The F 120 GT ventilator is suitable for use in facilities
CISPR 11 other than homes and those directly connected to the
public low-voltage power supply network that also
Harmonics as defined in Class A
supplies buildings used for domestic purposes, on the
IEC 61000-3-2
condition that the following warning is observed:
Voltage fluctuations/flicker Met Warning: This device/system is to be used only by
as defined in IEC 61000-3-3 qualified medical personnel. This is a Class A
device/system according to CISPR 11. In a residential
area, this device/system may cause radio interference,
which means it may be necessary to take remedial
measures, such as changing the alignment or arrangement
of the F 120 GT ventilator, shielding the device or
filtering the connection to the site.
Tab. 7: Electromagnetic emissions (IEC 60601-1-2)

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 89


9 Care and maintenance

WARNING
Portable and mobile RF communications equipment can affect electrical medical
devices! Electrical medical devices or systems should not be used adjacent to or
stacked with other equipment. If adjacent or stacked use is necessary, the electrical
medical device or system should be monitored to verify its intended operation in the
configuration in which it will be used.

10.2 Electromagnetic immunity

The F 120 GT ventilator is intended for use in the electromagnetic


environment specified below. The customer or user of the F 120 GT
ventilator should ensure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic


environment guideline
Electrostatic +6 kV (contact) +6 kV (contact) Floors should be wood,
discharge (ESD) as +8 kV (air) +8 kV (air) concrete or ceramic tile. If
defined in IEC floors are covered with
61000-4-2 synthetic material, the
relative humidity should be
at least 30%.
Electrical fast +2 kV for power +2 kV for power The quality of the supply
transient/burst as cables cables voltage should be that of a
defined in IEC +1 kV for input and +1 kV for input and typical commercial or
61000-4-4 output cables output cables hospital environment.

Surges as defined in +1 kV +1 kV The quality of the supply


IEC 61000-4-2 Line-to-line Line-to-line voltage should be that of a
typical commercial or
+2 kV +2 kV
hospital environment.
Line-to-earth Line-to-earth
Voltage dips, short < 5% UT (> 95% dip < 5% UT (> 95% dip The quality of the supply
term interruptions in UT) for 0.5 cycles in UT) for 0.5 cycles voltage should be that of a
and fluctuations in 40% UT (60% dip in 40% UT (60% dip in typical commercial or
the supply UT) for 5 cycles UT) for 5 cycles hospital environment.
voltage as defined in The battery run time
70% UT (30% dip in 70% UT (30% dip in
IEC 61000-4-11 specified in the
UT) for 25 cycles UT) for 25 cycles
documentation must be
< 5% UT (> 95% dip < 5% UT (> 95% dip
taken into account.
in UT) for 5 seconds in UT) for 5 seconds

90 GA-015-1217V2.4-HAO-en  Fritz Stephan GmbH


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7.3 Manual ventilation

Immunity test IEC 60601 test level Compliance level Electromagnetic


environment guideline
Power frequency 3 A/m 3 A/m Power frequency magnetic
(50/60 Hz) magnetic fields should be at levels
field as defined in characteristic of a typical
IEC 61000-4-8 location in a typical
commercial or hospital
environment.
UT is the AC power voltage prior to application of the test level.

Tab. 8: Electromagnetic immunity (IEC60601-1-2)

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 91


9 Care and maintenance

Immunity test IEC 60601 test Compliance level Electromagnetic environment


level guideline
Portable and mobile RF communications
equipment should be used no closer to any part
of the F 120 GT ventilator, including the cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.

3 Veffective value 10 Veffective value Recommended separation distances:

Conducted RF 150 kHz to 80 MHz d  0,15 P


disturbances as defined in outside ISM bands a
IEC 61000-4-6
10 Veffective value 10 Veffective value

150 kHz to 80 MHz


d  1,2 P
in ISM bands a

Radiated RF 10 V/m 10 V/m

IEC 61000-4-3 80 MHz-2.5 GHz 80 MHz-800 MHz


d  1,2 P for 80 MHz to 800 MHz

3 V/m d  7,7 P for 800 MHz to 2.5 GHz


800 MHz-2.5 GHz where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,c
should be less than the compliance level in each
frequency range. d
Interference may occur in the vicinity of
equipment marked with the following symbol.

At 80 MHz and 800 MHz, the higher frequency range applies.


These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects,
and people.
a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz, 13.553 MHz to
13.567 MHz, 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are
intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought
into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance in these frequency
ranges.
Field strengths from fixed transmitters, such as base stations for mobile telephones, mobile terrestrial radio equipment, amateur radio
c
stations, AM and FM radio stations, and TV stations cannot theoretically be predicted with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location
in which the F 120 GT ventilator is used exceeds the compliance levels above, the F 120 GT ventilator should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the F 120 GT
ventilator.
Over the frequency range 150 kHz to 80 MHz, field strength is less than 10 V/m.
d

92 GA-015-1217V2.4-HAO-en  Fritz Stephan GmbH


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7.3 Manual ventilation

10.3 Recommended separation distance

The F 120 GT ventilator is intended for use in an electromagnetic


environment in which radiated RF disturbances are controlled. The
customer or user of the F 120 GT ventilator can help to prevent
electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
F 120 GT ventilator as recommended below, according to the maximum
output power of the communications equipment.

Recommended separation distances between portable and mobile RF communications equipment


and the F120 GT ventilator

Distance based on the transmitter frequency (m)

150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz – 800 MHz 800 MHz – 2.5 GHz
Maximum outside ISM bands a within ISM bands a . ………………………
transmission ____
.
power of the
transmitter (W) d  0,15 P d  1,2 P .
d  1,2 P d  7,7 P

0.01 0.015 m 0.12 m 0.12 m 0.77 m

0.1 0.04 m 0.37 m 0.37 m 2.43 m

1 0.15 m 1.2 m 1.2 m 7.7 m

10 0.47 m 3.80 m 3.80 m 24.35 m

100 1.5 m 12 m 12 m 77 m

For transmitters without a rated output listed in the table above, the distance can be determined using the equation in the corresponding column,
where P is the transmitter’s rated output in watts (W) according to the transmitter manufacturer.

1 At 80 MHz and 800 MHz, the higher frequency range applies.


2 The ISM bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz
to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz.
3 An additional factor of 10/3 has been incorporated into the formula and is used to calculate
the recommended separation distance for transmitters in the ISM frequency bands between
150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the
likelihood that mobile/portable communications equipment could cause interference if it is
inadvertently brought into patient areas.
4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

Tab. 9: Recommended separation distances (IEC 60601-1-2, Table 5)

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 93


®

7.3 Manual ventilation

11 Accessory list
Accessories/spare parts Item Description Art. no.
for F 120 GT
1 Patient component P1 100261014
2a Tube system with Y-piece, heated 100261513
2b Disposable patient tube system P1, heated 100761310
2c Adapter cable tube heating for disposable 100761072
ventilation tube P1 with uncoiled plug
3 Atmos suction pump power pack 170550056
4 O-ring 4 x 1.5 195060003
5 O-ring 34.5 x 3.5 195060023
for humidifier bottle 300 ccm
6 Teflon sleeve, long, complete for patient 100261020
component P1/P2/P3
7 Humidifier bottle 300 ccm 165040005
8 Protective cap for P1/P2/P3, complete 100261016
9 Y piece with rubber cap 170160416
Tab. 10: Accessories and spare parts for F 120 GT

F 120 GT spare parts Item Description Art. no.


for ventilator
1 Fuse link 5x20 mm 180460002
2 Connection cable 230 V 180260406
3 Connection cable 12 V 160561029
4 Connection cable for O2 measuring cell 110760008
5 O2 measuring cell for O2 monitor M15 110760009
6 Diffuser for O2 measuring cell 110760010
7 O-ring for diffuser 195060009
Tab. 11: Replacement parts for ventilation system

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 95


®

12 Warranty

12 Warranty
The manufacturer warrants the product for 24 months from the purchase
date. This assumes regular safety checks and maintenance of the device
by suitably qualified personnel authorized by the manufacturer. The
manufacturer recommends inspection and maintenance every six months.

Only the manufacturer or its authorized customer service team are


allowed to manipulate or repair the device. Non-compliance voids the
warranty.

Improper handling of the device also voids the warranty.

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 97


®

13 List of figures

13 List of figures

Fig. 1: Pneumatic diagram for F120 GT ................................................. 29


Fig. 2: Breathing patterns ........................................................................ 31
Fig. 3: Front view with patient component and tube system................... 32
Fig. 4: Control and indicators.................................................................. 33
Fig. 5: Timer for adjusting ventilation times........................................... 36
Fig. 6: Gas supply and monitoring .......................................................... 41
Fig. 7: Dual flow meter ........................................................................... 42
Fig. 8: O2/AIR table ................................................................................ 43
Fig. 9: Patient component ....................................................................... 44
Fig. 10: Patient tube system .................................................................... 47
Fig. 11: Reusable tube system for incubator ........................................... 48
Fig. 12: Disposable tube system P1 (art. no. 100761310)....................... 49
Fig. 13: Disposable patient tube system for incubator ............................ 50
Fig. 14: Side view ................................................................................... 50
Fig. 15: Rear view ................................................................................... 51
Fig. 16: F 120 GT checklist..................................................................... 59
Fig. 17: IMV ventilation ......................................................................... 65
Fig. 18: Disconnection and stenosis alarm for IMV ventilation ............. 65
Fig. 19: CPAP ventilation ....................................................................... 66
Fig. 20: Connection cable P1 for disposable patient tube system ........... 81

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 99


®

14 List of tables

14 List of tables

Tab. 1: Abbreviations and technical terms .............................................. 11


Tab. 2: Pictograms .................................................................................. 13
Tab. 3: Efficacy ranges according to EN ISO 15883-1 ........................... 73
Tab. 4: Standard procedure for steam sterilization* ............................... 76
Tab. 5: Treatment table ........................................................................... 84
Tab. 6: Maintenance and inspection intervals ......................................... 86
Tab. 7: Electromagnetic emissions (IEC 60601-1-2) .............................. 89
Tab. 8: Electromagnetic immunity (IEC60601-1-2) ............................... 91
Tab. 9: Recommended separation distances (IEC 60601-1-2, Table 5) .. 93
Tab. 10: Accessories and spare parts for F 120 GT ................................ 95
Tab. 11: Replacement parts for ventilation system ................................. 95

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 101


®

15 Notes

15 Notes

 Fritz Stephan GmbH GA-015-1217V2.4-HAO-en 103


Fritz Stephan GmbH
- Medizintechnik -
Kirchstraße 19
56412 Gackenbach

 +49 (0)6439 9125 – 0


 +49 (0)6439 9125 – 111
[email protected]
 www.stephan-gmbh.com

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