Stephan GmbH

Short Term and Transport Ventilation

REANIMATOR F120 GT Operating Instructions Ver V2.3 Jan 2003

Operating Instructions

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F120 GT Neonatology Reanimator

Operating instructions

User manual

This operating instruction aims to provide you with clearly structured answers about the operation and maintenance of the pediatric Reanimator F 120 GT. 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 user manual does not contain any instructions for repairs and installation work. In the event of any problems during operation, please contact the authorized customer service of F. STEPHAN GMBH or the authorized dealer who supplied you with the device and who gave you instructions in its function and operation. The manufacturer only warrants the safety and reliability of F 120 GT when it is used in compliance with the user manual.

Cooperation

The hygienic procedures in chapter 9 of this user manual were written by: Hygiene-ArGe Joachim Höfner Gerhart-Hauptmann-Strasse 31 47058 Duisburg www.hygiene-arge.de

F. Stephan GmbH - Medizintechnik Kirchstrasse 19 56412 Gackenbach Subject to technical alterations. as of:

Januar 2007

Version:

V2.3

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1.1

Product combination

Contents Contents ...3 1

General information ...5 1.1

Product combination...5

1.2

Device name and manufacturer ...5

1.3

Intended purpose...6

1.4

Packaging and waste disposal...6

1.5

Introduction ...7

1.6

Abbreviations and definitions...8

1.7

Technical data...10

Safety instructions...13 2.1

Danger warnings...14

2.2

Warnings...15

Structure and description of functions ...19 3.1

Front view...19

3.2

Control and displays ...21 3.2.1

Ventilation forms...22

3.2.2

Heating system ...22

3.2.3

Auto test ...23

3.2.4

Alarm suppression...23

3.2.5

Alarm and monitoring displays ...23

3.2.5.1 Alarm displays ...23 3.2.5.2 Monitoring the power supply ...24 3.2.6 3.3

O2 monitor ...25

Gas supply and monitoring...26 3.3.1

Double flow meter...27

3.3.2

Oxygen supply for external devices ...28

3.4

Patient component ...29

3.5

Patient tubing system...32

3.6

Back view ...34

Preparing for operation ...35 4.1

Gas supply ...35

4.2

Power supply ...36

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1 5

Test list...39 5.1

Checklist ...39

5.2

Daily checks every time before starting the device ...40

Operation ...43 6.1

Switching on ...43

6.2

Select ventilation form...43

Forms of ventilation...45 7.1

Intermittent mandatory ventilation ...45

7.2

Spontaneous respiration with positive end-expiratory pressure (CPAP) ...47

7.3

Hand ventilation ...48

Troubleshooting ...49

Care and maintenance ...51 9.1

Disinfection and sterilization...51 9.1.1

Device housing, gas supply tubes, power cables...52

9.1.2

Patient tubing...53

9.1.3

Patient component ...54

9.1.4

Subsequent treatment ...56

9.1.5

Assembly...56

9.1.6

How to react to damage...57

9.2

Disinfection and sterilization table ...58

9.3

Safety checks ...59

9.4

Maintenance...59

Accessories list...61

Guarantee ...63

List of figures...65

List of tables...67

Notes………………….. ...69

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1.1

General information

1.1

Product combination

F. STEPHAN GMBH rules out any warranty in the event that inadmissible device combinations are used with products which have not been permitted or certified as compatible by the manufacturer.

Only use the spare parts listed in chapter 10.

Permitted product combinations

1.2

F 120 GT may be equipped with a NEOSID NOVA monitor as additional feature for monitoring the patient's heart rate and breathing activity during transport, and with an ATMOS SUCTION PUMP.

Device name and manufacturer Device name

F 120 GT

Manufacturer

F. Stephan GmbH - Medizintechnik Kirchstrasse 19 56412 Gackenbach (+)49 (6439) 9125 – 0 (+)49 (6439) 9125 – 111 [email protected] www.stephan-gmbh.com

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General information

1.3

Intended purpose Reanimator F 120 GT is a respirator for short-term ventilation of preterm, newborn babies and infants. It is used for lung insufficiency result from immaturity, in case of illness or failure of the respiratory system, and is designed as a functional component of the TI 500 GLOBE TROTTER NEONATAL TRANSPORT SYSTEM. Therapeutic scope

F 120 GT can be used for the following conventional ventilation types: Spontaneous respiration with continuous positive airway pressure (CPAP) Intermittent mandatory ventilation (IMV) Manual ventilation

Reanimator F 120 GT is not designed for ventilation in the context of long-term intensive treatment. Warning

1.4

Packaging and waste disposal

Packaging materials

The packaging used for the device consists essentially of recyclable or reusable materials. The carton packaging can be reused or disposed of with used paper. The secondary packaging consists of CFC-free padding which can be disposed of together with the foil as recyclable plastic waste.

Return / Disposal

F. STEPHAN GMBH warrants that used devices will be taken back and disposed of correctly by our company free of charge, thus making a contribution to the environment.

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1.5

Introduction

Introduction Legislation

The Medical Devices Law (MPG), the Medical Devices Operator Ordinance (MPBetreibV) and the law on technical working equipment stipulate that the operator must be informed of the following: The device must only be operated by skilled staff. Precise knowledge of the user manual is prerequisite. Only use the device for the intended purpose described in the user manual. Read the user manual carefully and comply with its instructions, because lasting safety for patient and operator is only warranted when the device is handled correctly. The user manual must be constantly available where the device is being used. Inadequate care and operating errors can cause failure of the device and accidents.

Warranty

The manufacturer does not accept any warranty claims resulting from incorrect operation, inadequate care and maintenance. The device must be inspected regularly by correspondingly trained staff. F. STEPHAN GMBH stipulates six-monthly intervals for inspection and maintenance. The manufacturer only guarantees the safety and reliability of the device when it is operated in compliance with the operating instruction.

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General information

1.6

Abbreviations and definitions

Abbreviation/term

Definition

Meaning

amp

Unit of measurement for electric current

Fig.

Figure

Alternating current

AIR

Medical compressed air

Bat

Battery

Bar Bpm

Unit of measurement for pressure breath per minute

cmH2O CPAP

Breathing rate Unit of measurement for pressure

Continuous Positive Airway Pressure

Spontaneous respiration with continued positive airway pressure

Direct current

DIN

German standardization institute

Disc.

Disconnection

Interruption (pneumatic) of a connection

European standard

ETT

Endotrachial tube

Exp.

Expiration

Breathing out

HPa

Hecto-Pascal

Unit of measurement for pressure

Flow

Flow rate

Volume flow

Unit of measurement for frequency

Insp.

Inspiration

Breathing in

KPa

Kilo Pascal

Unit of measurement for pressure

Connection

Cont.

Continuous

LED l/m

Device for storing electrical energy in the form of electrical energy

Light Emitting Diode

Light emitting diode Liters per minute

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1.6

Abbreviation/term

Definition

Mbar min.

Abbreviations and definitions

Meaning Unit of measurement for pressure

Minutes

Unit of measurement for time

MPG

Medical Devices Law

Oxygen

PEEP

Positive End Expiratory Pressure

Positive end expiratory pressure

PIP

Peak Inspiratory Pressure

Peak inspiratory pressure

Resp.

Respiration

Seconds

Unit of measurement for time

IMV

Intermittent Mandatory Ventilation

Combination of spontaneous respiration and machine ventilation

Standby

Device is ready

Temp.

Temperature

Volt

Unit of measurement for voltage

VE W

Packaging unit Watt

Unit of measurement for power

ZGA

Central gas system

Tab. 1: Abbreviations and technical terms

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General information

1.7

Technical data

Ambient conditions

Operation

Temperature

10 – 40°C

Rel. humidity

10 – 80 %

Air pressure

500 – 1060 hPa

Let the device reach room temperature before starting operation. Storage

Temperature

5 – 40 °C

Rel. humidity

10 – 80 %

Air pressure

500 – 1060 hPa

Store protected from moisture, free of dust and free of frost

General

MPG class

II b

Protection class

I type B as per DIN EN 60601-1 : March 1996

Inspection/ maintenance cycle

every six months

Dimensions (WxHxD)

120 x 300 x 210 mm plus patient component 80 mm

Weight

Forms of ventilation

24 kg

IMV

Intermittent mandatory ventilation. Combination of spontaneous respiration and machine ventilation

CPAP

Spontaneous respiration with continuous positive airway pressure.

Manual ventilation

Test

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1.7

Power supply

Mains power

Technical data

Connection

230 V AC 50 – 60 Hz (100/115/ 250 V possible on request)

Power consumption

55 VA

Device fuse

2 AT

Vehicle power supply

12 V DC external (The device tolerates a voltage range from 11 to 14 V DC) 120 VA

Battery

Rated voltage

12 V DC

Rated capacity

17 Ah

Fuse

6.3 AT

Operating time with heating:

1.5 h

Operating time without heating:

3 hours

Protection transformer: Single-phase 170 VA separating transformer

Parameters

Current consumption

70 VA

Supply lead

Earthed plug with device jack

Inspiration time

adjustable from 0.25 to 2 s

Expiration time

adjustable from 0.25 to 30 s

O2 flow

adjustable from 0 to 10 l/min

AIR flow

adjustable from 0 to 10 l/min

Oxygen concentration

adjustable from 21 to 100 % O2

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Patient component

O2 monitor

Monitoring

Positive end expiratory pressure (PEEP):

adjustable from 0 to 10 cmH2O

Inspiratory ventilation pressure (pressure plateau):

adjustable from 15 to 60 cmH2O

Heated humidifier:

12 V DC/10 W

Heated tube system:

12 V DC/10 W

Digital display:

20 to 99 % O2 of the ventilation gas

Upper O2 limit:

adjustable from 20 to 99 % O2 visible and acoustic alarm when for high level

Lower O2 limit:

adjustable from 20 to 99 % O2 visible and acoustic alarm when for low level

Manual calibration

only for 21% O2 concentration (room air/compressed air

Ventilation pressure gauge

-10 to 60 cmH2O

Breathing rate for IMV (digital)

2 to 120 breaths per minute (bpm)

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1.7

Technical data

Safety instructions Refers to instructions drawing attention to important facts.

The following safety instructions are repeated at relevant points in the user manual and must always be heeded.

Refers to dangers which, if not heeded, can result in life-threatening injuries to the patient and/or operator. Danger

Warning

Refers to warnings which, if not heeded, can result in malfunctions, damage or defects in the device, which can possibly also put the patient at danger.

Refers to precautions which, if not heeded, can result in damage to the device and its accessories. Caution

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Safety instructions

2.1

Danger warnings

Danger

The device must only be operated by authorized and well trained skilled staff. The device must be operated according to the instructions in this user manual.

The device must be inspected at regular intervals by correspondingly trained staff. F. STEPHAN GMBH specifies six-monthly inspection and maintenance by an authorized technician.

The device must always be tested before use by pressing the »Auto Test« button. Danger

The device is not certified for use in explosion-risk areas. Danger Explosion risk! Do not use flammable or anesthetic gases. Danger

Use of the device in the vicinity of MIR scanners can have a negative impact on its function and thus endanger both patient and user. Danger

Always keep an independent hand breathing bag at the ready. Danger

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2.2

Warnings

Warning

The use of antistatic or electrically conductive patient tubing can result in burns when using electrical high-frequency surgical devices at the same time. Therefore do not use any antistatic or electrically conductive patient tubing or leads.

Handle individual parts carefully to avoid mechanical damage. Warning Only use Reanimator F120 GT with original or authorized spare parts supplied by the manufacturer. Danger

Only use original patient tubing systems by F. STEPHAN GMBH. Warning Only use dry compressed air! Moisture in the gas lines can cause technical failure of the device. Warning

Warning

Short-wave therapy devices, HF diathermy devices, defibrillators etc. in the vicinity of the device can impair its operational reliability. Constant supervision of patient and device is required in this case.

Only use correctly prepared and treated parts for operating the device. Warning

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Safety instructions

Warning

In the case of a power failure, the internal battery takes over the power supply for the device for a period of 1.5 h when the heating is on and 3 h when the heating is off. To keep the battery charged up to the optimum level, the device must always be connected to the mains power supply with the power switch on when not in use. It takes at least 20 hours to recharge the flat battery, this time is reduced the higher the charge status. A protective circuit prevents the battery from being overcharged. The device cannot be operated when the battery is flat!

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

Warning

If the battery is in a state of total discharge, it may be possible that it cannot be recharged. Only the customer service authorized by F. STEPHAN GMBH is allowed to replace the battery.

Compliance is required particularly with DIN EN 60601-1 resp. VDE 0751-1 for medical technical devices with an electrical connection. Accordingly, these devices must only be repaired by the manufacturer or by an authorized representative.

The provisions of DIN EN 60601-1 must be heeded when connecting external electrical devices: all devices must be connected via a separating transformer (4 kV test voltage, available from F. STEPHAN GMBH).

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2.2

Warning

Warnings

Only the authorized customer service for F. STEPHAN GMBH is allowed to alter, modify, repair or open the device or replace the battery. This does not include dismantling the patient component in accordance with the intended purpose of the device as stipulated in the user manual.

The setting for the mechanical overpressure release valve must always be higher than the setting for peak inspiratory pressure adjusted with the inspiration valve.

Caution is required if the incubator temperature exceeds a value of 39°C. Warning

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3.1

Front view

Structure and description of functions

3.1

Front view

Fig. 1: Front view

Control and display unit

Connection for oxygen measuring cell and space connector

Double flow meter and gas supply

Patient component

NEOSID NOVA PLUS

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Structure and description of functions

NeoSID NOVA plus

As an option, F120 GT can be combined with the monitoring system NEOSID NOVA PLUS which warrants optimum, convenient monitoring of the key vital functions such as heart rate, pulse and breathing rate together with oxygen saturation (SpO2). More information about the settings and use of this device are contained in the NEOSID NOVA PLUS operazing instruction.

F. STEPHAN GMBH will gladly answer any other questions about the monitoring system NEOSID NOVA PLUS.

Connection for the oxygen measuring cell

To install the oxygen measuring cell, remove the cover over the connection and insert the measuring cell. The spare cover 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.

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3.2

Control and displays

Fig. 2: Control and displays

Button »IMV«

Button »CPAP«

10 Display for breathing rate in IMV mode (bpm)

Button »Heating«

11 Numerical switch for adjusting the inspiration time

Button »Auto test«

12 Numerical switch for adjusting the O2 minimum alarm limit

Button »Alarm suppression«

13 Numerical switch for adjusting the O2 maximum alarm limit

Ventilation pressure gauge

14 Button »O2 calibration«

»ON/OFF« switch

15 Button »O2 monitor ON/OFF«

Monitoring display

16 Oxygen concentration monitor

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Numerical switch for adjusting the expiration time

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