Stephan GmbH

Sophie Neonatal Ventilator Systems

Sophie Service Manual Ver 1.2 March 2009

Service Manual

100 Pages

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File Size: 1.42 MB

File Name: sophie_service_manual_ver_1-2_march_2009.pdf

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Sophie Neonatology – Ventilator

Service manual

Vorwort

Service manual

This service manual aims to provide you with clearly structured answers about the service and maintenance of the neonatology ventilator SOPHIE. Please carefully read each step of the procedure that is to be carried out before beginning the servicing of the unit. Always use the correct tools and the indicated measuring instruments. Any noncompliance with the instructions and/or recommendation found in this technical documentation can lead to a malfunctioning of the equipment or damage to it. Use only original replacement parts as supplied by F. STEPHAN GMBH If any malfunctions occur while operating the device, please contact an authorized Customer Service of F. STEPHAN GMBH or the authorized specialist dealer who supplied the device and who familiarized you with its function and operation. The manufacturer only guarantees the safety and reliability of SOPHIE when it is operated according to the manual

This service manual is not to be used in place of the operating manual. Each operation and handling of the equipment requires exact knowledge and observance of the operating instructions. This equipment is only to be used for the stipulated application.

The hygienicall processing in chapter 7 of the is service manual was carried out by: Hygiene-ArGe Joachim Höfner Gerhart-Hauptmann-Strasse 31 47058 Duisburg www.hygiene-arge.de

F. Stephan GmbH - Medizintechnik Kirchstrasse 19

Equipment is subject to technical modification Status: März 2009 Version: V1.2

56412 Gackenbach

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List of contents

List of contents List of contents...3 1

General details ...5 1.1

Product combination...5

1.2

Device name and manufacturer ...6

1.3

Proper use ...7

1.4

Introduction ...8

1.5

Abbreviations and definitions...9

1.6

Technical details ...12

Safety instructions...17 2.1

Danger warnings...17

2.2

Warnings...20

Structure and functional description ...23 3.1

Front view...23

3.2

Side view from the right ...24

3.3

3.4 4

3.2.1

Patient component ...25

3.2.2

Patient hose system ...27

3.2.3

Connections panel ...28

Rear view...29 3.3.1

Pneumatic module ...30

3.3.2

Power supply module and interfaces...31

Mobile stand ...32

Inspection and maintenance ...33 4.1

Implementation...33

4.2

Inspection and maintenance test protocol...47

4.3

Test protocol safety check ...51

Test before commissioning ...57 5.1

Testing requirements ...57

5.2

Test list ...58

Troubleshooting ...59 6.1

List of errors ...59

S Extremely oscillating ventilation curves...69 6.1.1

Patient valve ...69

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List of contents 6.1.2 7

Humidity in the pneumotachograph ...70

Care and Maintenance...73 7.1

Disinfection and sterilization...73 7.1.1

Housing, gas supply hoses, electric cables...74

7.1.2

Patient hose system ...75

7.1.3

Patient component ...77

7.1.3.1 Preparing the patient component...77 7.1.3.2 Preparing to lubricate the patient valve...78 7.1.3.3 Preparing to replace the humidifier fleece ...80 7.1.3.4 Method ...81

7.2

7.1.4

Pneumotachograph ...82

7.1.5

Assembly...85

Disinfection and sterilization table ...86

Accessory list ...87

Maintenance sets...89 9.1

Maintenance Set Sophie, yearly (Art.Nr.: 103861800) ...89

9.2

Maintenance Set Sophie, half-yearly (Art.Nr.: 103861801).90

9.3

Sealing Set for Double Valve, P7, half-yearly (Art.Nr.: 100761028)...90

9.4

Maintenance Set for Patient Component P7, 1/2 yeary (Art.Nr.: 103561321)...91

Pneumatic circuit diagram ...93

List of illustrations ...95

List of tables...97

Notes ...99

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1.1

Product combination

1 General details 1.1

Product combination F. STEPHAN GMBH rules out any warranty in the event that any inacceptable combination of devices is used which has not been approved by the manufacturer or with products without compatibility certification.. Certified product 1. Medication Nebulizer Set combinations Manufacturer: F. Stephan GmbH Art.No.: 1 710 60 120 The following accessories must be used: Pneumatic Medication Nebulizer Manufacturer: Dräger AG Lübeck Art.No.: 8405000 2. Medication Nebulizer Set Manufacturer: F. Stephan GmbH Art.No.: 1 035 60 800 Ultrasonic Nebulizer Manufacturer: Schill GmbH & Co. KG Art.No.: MN81100 3. Pneumotachograph Manufacturer: F. Stephan GmbH Pneumotachograph typee B Manufacturer: Dr. Schaller Medizintechnik Art.No.: 1 035 61 300 Pneumotachograph typee C Manufacturer: Dr. Schaller Medizintechnik Art.No.: 1 035 61 301 4. CPAP Nasal tube Manufacturer

F. Stephan GmbH

CPAP Nasal tube Manufacturer Dr. Schaller Medizintechnik

Size A

Art.No.:

1 701 60 040

Size B

Art.No.:

1 701 60 045

Size C

Art.No.:

1 701 60 050

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General details

5. Device for regulating the metered dosing of NO to inhaled air Name: Pulmonox mini Manufacturer: Messer, Austria Marketed by: Mallinckrodt – Nellcor – Puritan – Benett The following accessories must be used: Flow box for measuring and dosing NO for connecting to the patient component with RS 232 to reduce dead space including PNT Art. No.: 1 705 61 000 NO-Dosing adapter Art. No.: 1 035 60 067 NO-Analysis adapter Art. No.: 1 035 61 314 Neonatology pneumotachograph – SOPHIE with plug and silicone hoses, can be autoclaved 140°C, type B for NO operation Art. No.: 1 035 61 302 Adapter for NO suction Art. No.: 1 007 61 022 6. Device for regulating the metered dosing of NO to inhaled air Name: Inovent Manufacturer: Datex Ohmeda 7. Refilling system with liquid filling control Name: Auto Fill Manufacturer: F. Stephan GmbH Art.No.: N.N.

1.2

Device name and manufacturer Device name

SOPHIE

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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1.3

Proper use

Proper use SOPHIE is suitable for the ventilation of preterm infants, infants and small children up to 25 kg, but especially for the ventilation of immature preterm infants with very low birth weight. Therapeutic scope

SOPHIE can be used for all approved conventional types of ventilation: Spontaneous breathing with positive airway pressure (CPAP) Synchronized intermittent mandatory ventilation (SIMV) Controlled ventilation Assisted controlled ventilation (patient activated) High frequency oscillation (HFO) combined with all types of ventilation.

Contraindication

SOPHIE is not suitable if the patient's symptoms mean that positive pressure ventilation must not be carried out (e.g. bronchopulmonary dysplasia.

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General details

1.4

Introduction

German legislation

The Medical Devices Law (MPG), the Medical Devices Operator Ordinance (MPBetriebV) and the Law on Technical Working Equipment stipulate that the owner's attention must be drawn to the following: The device must only be operated by skilled staff who must have an exact knowledge of the operating manual. Only use the device for the intended purpose described in the operating manual. Read the operating manual carefully and comply with its instructions, because lasting safety for patient and user is only warranted when the device is operated correctly. The operating manual must be kept constantly available at the place of use. Inadequate care and incorrect operation can cause work stoppages and accidents.

Warranty

The manufacturer does not accept any warranty claims resulting from incorrect operation or inadequate care and maintenance. The manufacturer only guarantees the safety and reliability of the device if it is operated in compliance with the operating manual.

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1.5

Abbreviations and definitions

Abbreviations / Technical terms

Definition

Meaning

ADC

Analog digital converter

APD

Apnea time

Apnea

Battery

Device for storing electrical energy in the form of chemical energy

aqua dest.

aqua destilata (lat.)

Distilled, demineralized water

ass. / contr.

assisted controlled (patient activated)

With this ventilation mode, the device always delivers a mandatory breath when the inspiratory volume flow exceeds the preset trigger threshold.

bar

Unit of measurement for pressure

bpm

Breaths per minute

BUD

Backup time

BTPS

Body Temperature and Ambient Pressure Saturated

cmH2O

Unit of measurement for pressure

COM

Serial interface

contr.

controlled

With this type of ventilation, the device controls the ventilation pressure on the Y piece and the periodic process for the cyclic changes of this pressure. Forms of controlled respiration: time controlled, pressure controlled time controlled, volume controlled

CPAP

Continuous Positive Airway Pressure

Spontaneous breathing with continuous positive airway pressure. When breathing under CPAP, the device keeps the pressure constant on the connection piece of the endotracheal tube.

CPAP-L

CPAP level

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General details

Abbreviations / Technical terms

Definition

Meaning

Communic

Communication

Connection

Cont.

Continual

deceleration

Flow curve pattern:

Diathermia HF Diathermia

High frequency diathermia

Therapy where high frequency currents heat through the tissues within the body.

DIN

Deutsches Institut für Normung e.V.

German Institute for Standardization

Disc.

Disconnection

Interruption (pneumatic) of a connection

distal

Away from the patient

European Norm

ETT

Endotracheal tube

Exp.

Expiration

Exhalation

FHFO

High frequency oscillation

FiO2

Inspiratory oxygen fraction

Flow

Volume flow

Unit of measurement for frequency

IMV

Intermittent Mandatory Ventilation

Insp

Inspiration

Inhalation

ITT

Inspiratory Time Termination

kilo volt

Unit of measurement for voltage

LED

Light emitting diode

linear

Pressure curve pattern:

Lower priority

An alarm indicating the need for the user's attention

MAP

Mean airway pressure

mbar

Unit of measurement for pressure

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1.5

Abbreviations and definitions

Abbreviations / Technical terms

Definition

Meaning

MHP

Alarm that is at least a medium priority.

An alarm of at least medium priority (MP) is evaluated as such when an alarm occurs, before becoming high priority (HP) after 30 seconds.

min MP

Unit of measurement for time Medium priority

An alarm indicating the need for prompt intervention by the user (DIN EN 475). Unit of measurement for time

NIST

Non-interchangeable screw thread

Non-interchangeable coupling

PEEP

Positive End Expiratory Pressure

Positive end expiratory pressure

PMAX

Maximum pressure

PMEAN

Medium respiratory pressure

PMin

Minimum pressure

PNT

Pneumotachograph

Flow sesor

proximal

Close to the patient

resistive

Creates a pneumatic resistance

Resp.

Respiration

Unit of measurement for time

SIMV

Synchronized Intermittent Mandatory Ventilation

Form of ventilation synchronized to the patient

sinus

Flow curve pattern

square

Flow or pressure curve pattern:

Standby

The device is ready for use

Vent.

Ventilation

Tidalvolume

Watch dog WB CGU

Breathing volume Time monitoring switching

Water bath

Moistener bottle with water filling Central gas unit

Tab. 1: Abbreviations and technical terms © F. Stephan GmbH

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General details

1.6

Technical details

Ambient conditions

Operation

Temperature

15 -40 °C

Rel. humidity

10 – 95 %

Air pressure

500 – 1060 hPa

Bring to room temperature before starting to operating the device. Storage

Temperature

-10 -60 °C

Rel. humidity

10 – 100 %

Air pressure

500 – 1060 hPa

Store in a protected, dust-free place protected from Humidity and frost

General

MPG – Class

II b

Protection class

I type B nach DIN EN 60601-1 : July 2007

Inspection / maintenance cycle

six-monthly

Dimensions (WxHxD)

370* x 360 x 430 mm

(customer service company authorized by F. STEPHAN GMBH)

*plus patient component 90 mm

Weight

23 kg

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1.6

Power supply

Mains

Battery

Technical details

Connection

90 – 264 V AC 50 – 60 Hz

Supply line

Safety plug with device socket

Power consumption

150 VA

Cos φ

0,96

Current compensation

0,65 A

Hardware protection

3,15 AT DIN 41571

Nominal voltage

1 St.

Nominal capacity

Gas supply

Supply pressure

Gas consumption

24 V DC 3,2 Ah

Operating time

minimum 30 min

AIR

3 – 6 + 0,5 bar

Controlling

approx. 4 l/min

Aerosol

approx. 3 l/min

Ventilation

approx. 4 l/min + AMV (max. 25 l/min)

The gas must be dry and free of oil and dust.

Operating modes

Pressure regulation

Pressure pattern

linear sinus rectangle

Pmax

typees of ventilation

5 -60 cmH2O

CPAP

Spontaneous breathing with positive airway pressure

SIMV

Synchronized intermittent mandatory ventilation

ass. contr.

assisted controlled mandatory ventilation

IMV (contr.)

controlled mandatory ventilation

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General details

Parameter

Operating unit

High frequency oscillation

Patient component

Tidal volume

2 – 150 ml

Pmax

5 – 60 cmH2O

Pmin

1 – 59 cmH2O

Vtlim

2 – 150 cmH2O

Vtmin

0 – 40 cmH2O

PEEP

0 – 30 cmH2O

MAP

0 – 30 mbar

CPAP-L

0 – 30 mbar

Temperature

30 – 40 °C

Inspiration time

0,1 – 2 s

Expiration time

0,1 – 60 s

FiO2

21 – 100 %

Trigger

0,1 – 2,9 l/min 0,1 – 2,9 cmH2O

Inspiration proportion

33 – 50 %

Frequency

5 – 15 Hz (300 – 900 /min)

Amplitude

0 – 100%

Safety pressure

40 – 70 cmH2O

Humidifier bottle

350 ml

Preoxygenation

Monitoring

21 – 100%

Display

10,4“ color – TFT

Pressure

Pmax

-20 – 99 cmH2O

Pmean

-20 – 99 cmH2O

PEEP

-20 – 99 cmH2O

POSZ

-20 – 99 cmH2O

Accuracy:

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ΔP = ± (2 % ⋅ P + 1 cmH2O + 1 digit)

1.6 Volume

Technical details

0 – 999 l/min

VTe

0 -999 ml

Volume measuring:

BTPS

Accuracy:

ΔV = ± (10 % ⋅ V + 1 ml + 1 digit)

Breathing rate

0 – 999 /min

Inspiration proportion

0.1 – 100 %

FiO2

0 – 100 % Accuracy:

± 5 Vol %

Respiratory gas temperature

0 -50 °C

Resistance

0 – 999 cmH2O/l/s

Compliance

0 – 999 ml/cmH2O

Curve representation

P(t), V(t), V’(t) V(P), V’(V), V’(P) Scaling Measurement function

Supervision

Parameter

Unit

Lower limit

Upper limit

Resolution

PMAX

cmH2O

1 – 60

2 – 70

POSZ

cmH2O

0 – 149

1 – 150

PMIT

cmH2O

0 – 40

1 – 60

PEEP

cmH2O

–

0 – 35

l/min

OFF – 0,10

–

0,01

0,10 – 9,90

–

0,05

–

0,2 – 19,9

0,1

0 – 10

–

0,5

10 – 50

–

50 – 150

–

VTE

FIO2

18 – 99

21 – 100

TEMP

°C

29 – 40

36 – 41

Tab. 2: Alarm limits

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General details

It is not possible to exceed the lower and upper setting limits

Alarms

Data outputs

Sensors

visual, acoustic, plain text message

RS232 Flow / Volume

Pneumotachograph PNT B

up to 10 l/min dead space: 0.6 ml

PNT C

up to 22 l/min dead space: 0.9 ml

FiO2

Electrochemical oxygen sensor

Temperature

Temperature sensor

proximal distal

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2.1

Danger warnings

2 Safety instructions Refers to instructions drawing attention to important facts

The following safety instructions are repeated at relevant position in the operating 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

2.1

Danger warnings

Danger

The device must only be operated by authorized and skilled qualified staff. The device must be operated according to the instructions in this operating manual.

The device is not certified for use in explosion-risk areas. Danger

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Safety instructions

Danger of explosion! Do not use any combustible or anesthetic gases. Danger

Danger

Use of the device in the field of magnetic resonance tomography may have a negative impact on functions which can possibly put the patient and operator at danger.

Never close the ventilation outlet behind the silencer. This results in a malfunction of the device and therefore may put the patient at high risk! Danger

Danger

Never unscrew the humidifier bottle during operation! The respiratory gas moisturizer is pressurized at 150 cmH2O! When refilling the water with a syringe, utmost care must be taken that the pressure does not force the syringe plunger out of the syringe. Always keep a separate manual breathing bag ready.

Danger When medicine is applied using an aerosol nebulizer, an expiration filter must be placed on the end support of the expiration hose! Danger

Make sure that the pressure measurement hose is connected correctly! Danger Check that no condensation water accumulates near the Y piece of the inspiration hose which could leak into the pneumotachograph. Danger

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2.1

Danger warnings

Make sure that there are no drops of water in the pressure measurement hose. Danger

Danger

After preparing the pneumotachograph correctly, check that appropriate vortex bodies (type B or type C) which fit on both sides are used to avoid any measurement errors during volume measurement.

Every time before using on a patient, check that the correct pneumotachograph head has been selected for the patient and that the differential pressure measurement hoses are attached properly. Incorrect attachment will result in a negative flow curve during inspiration. Check that the hose connections on the pneumotachograph point upwards to rule out any risk of water droplets leaking into the measurement hose.

Test the device every time before it is started up. Danger After using under special conditions of suppressed alarms, make sure that the alarm is reactivated before leaving the child Danger

Danger

F. STEPHAN GMBH recommends that the ventilator is not operated with a run down battery (capacity <10%), because the device will then switch off immediately in case of a power failure.

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Safety instructions

2.2

Warnings

Warning

Burns may be caused by antistatic or electroconductive patient hoses when using electrical high frequency surgery devices at the same time. Therefore do not use antistatic or electroconductive patient hoses or lines.

Treat the individual parts carefully to avoid mechanical damage. Warning Only use original patient hose systems by F. STEPHAN GMBH. Warning Only use dry compressed air! Humidity in the gas line can lead to technical malfunctions of the device. Warning

Warning

Short wave therapy devices, HF diathermy devices, defibrillators and similar equipment near to the device may influence the functionality of this device. In these cases, the patient must be checked constantly.

When the device trolley is moved, care must be taken to ensure that the wheel brake is released, and reactivated again when fixing the device. Warning Carefully clean the pneumotachograph under running water. Do not use a dishwasher! Warning

Only use correctly prepared parts to operate the device. Warning

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