Operating Manual
244 Pages
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Sophie Neonatology Ventilator
Operating Manual
Preface
Operating Manual
This manual answers your questions about the operation and care of SOPHIE. The manual does not contain any information about repairs and installation. If any malfunctions occur while operating the device, please contact an authorized Customer Service of FRITZ 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
Fritz Stephan GmbH - Medizintechnik Kirchstraße 19
Equipment is subject to technical modification Status: October 2012 Version: V3.0 from software version 1.10.x
56412 Gackenbach
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GA-038-1012V3.0-HAO-en
Fritz Stephan GmbH
®
List of contents
List of contents List of contents ...3 1
2
3
General details ...9 1.1
Product combination ...9
1.2
Device name and manufacturer ...11
1.3
Intended use ...11
1.4
Packaging and waste disposal ...12
1.5
Introduction ...12
1.6
Abbreviations and definitions ...13
1.7
Technical details ...17
Safety instructions ...25 2.1
Danger warnings ...26
2.2
Warnings ...27
Structure and functional description ...32 3.1
3.2
Front view ...32 3.1.1
Voltage source display ...34
3.1.2
Function buttons ...36
Monitor unit ...40 3.2.1
Measured value display ...41
3.2.2
Main menu...43
3.2.3
Ventilation menu ...44
3.2.4
Ventilation parameter display ...45
3.2.4.1 Special functions display: ...46 3.2.5
Status, alarm and info display ...47
3.2.5.1 Alarm messages ...48 3.2.5.2 Internal battery charge condition display ...49 3.2.6 3.3
Fritz Stephan GmbH
Graphic display ...50
Side view from the right ...52 3.3.1
Patient component ...53
3.3.2
Patient hose system ...55
3.3.3
Connections panel ...57
3.3.4
Automatic refill system (optional) ...58
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List of contents 3.3.4.1 Preparation ...59 3.3.4.2 Function principle ...64 3.4
3.5 4
Rear view ...66 3.4.1
Pneumatic module ...67
3.4.2
Power supply module and interfaces ...68
Mobile stand ...69
Main menu ...71 4.1
Control concept...71
4.2
Menu structure ...74 4.2.1
Menu „Alarmlimits“ ...74
4.2.2
Menu “Curves” ...78
4.2.2.1 “2. Panel“ ...78 4.2.2.2 “Scale“ ...79 4.2.2.3 “Trend On/Off“ ...80 4.2.3
Menu “View“ ...80
4.2.3.1 “Units ON/OFF“ ...81 4.2.3.2 “Display VT“ ...81 4.2.3.3 “More Infos ON/OFF“ ...82 4.2.3.4 “Limits ON/OFF“ ...82 4.2.3.5 „Day/Night“ View...83 4.2.4
“Measure“...84
4.2.5
Menu “Heating“ ...86
4.2.6
Menu “Extra functions“ ...89
4.2.7
Menu “Options“ ...90
4.2.7.1 “PNT-A/B/C/None“ ...90 4.2.7.2 “O2 Calibration” ...91 4.2.7.3 “Trigger Press/Flow“ ...92 4.2.7.4 „Exp. Trig Ein/Aus“ ...93 4.2.7.5 “Communication“ ...94 5
Menu „Ventilation“ ...97 5.1
5.2
Control concept...97 5.1.1
Adjusting the type of ventilation after start ...99
5.1.2
Changing the type of ventilation during operation ..103
Special functions in the ventilation menu ...106 5.2.1
“Standby/Off”...106
5.2.1.1 Activation of the „Standby“-Modus...107
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List of contents 5.2.1.2 Shutting off SOPHIE ...109
5.3
5.4
5.2.2
„Break“ ...110
5.2.3
“Test“ ...111
Adjustable ventilation parameters ...114 5.3.1
Special aspects in adjusting VtLim / VtTar ...115
5.3.2
Setting up the expiration time or frequency ...116
Choosing type of ventilation ...117 5.4.1
IMV – intermittent mandatory ventilation ...118
5.4.2
S-IMV – Synchronized IMV ventilation ...119
5.4.3
S-IMV with terminated inspiration time (ITT/PSV)120
5.4.4
Ass./Co.- Assist Controlled ventilation ...121
5.4.5
Ass./co. – with terminated inspiration time (ITT/PSV)122
5.4.6
High frequency oscillation with IMV (optional) ...123
5.4.7
High frequency oscillation with CPAP (optional)...125
5.4.8
NCPAP – Non-Invasive (nasal) CPAP ...127
5.4.9
(S)NIPPV – Non-invasive positive pressure ventilation ...131
5.4.9.1 SNIPPV ...133 5.4.9.2 SNIPPV-B ...134 6
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Preparing for operation ...137 6.1
Setting up the device...137
6.2
Connecting the gas and power supply ...138 6.2.1
Gas supply ...138
6.2.2
Power supply ...138
6.2.3
Patient component ...139
6.2.4
Filling the humidifier bottle ...140
6.2.5
Patient hose system ...143
6.2.6
Tubus Adapter ...144
6.2.7
PNT A ...145
6.2.8
Expiration filter ...145
6.2.9
Connection of the external respiration sensor ...146
Test before commissioning ...147 7.1
Testing requirements ...147
7.2
Test list ...148
Operation ...149 8.1
Switching on ...149
8.2
Test mode ...149
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List of contents 8.2.1
9
8.3
Choosing the type of ventilation ...152
8.4
Non-Invasive ventilation ...153
8.5
Switching off ...154
8.6
Decommissioning the device ...154
Types of ventilation ...155 9.1
General...155
9.2
External Trigger (Optional) ...156
9.3
Pressure controlled ventilation IMV ...158
9.4
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System test...149
9.3.1
IMV with volume limitation...159
9.3.2
Pressure controlled respiration without PNT ...161
Synchronized mechanical ventilation ...162 9.4.1
Assisted controlled respiration ...163
9.4.2
S-IMV...164
9.4.3
Inspiratory Time Termination (ITT/PSV) ...165
9.5
S-IMV with ITT and Pressure Support (PS) ...167
9.6
High frequency oscillation (HFO) ...168
9.7
Noninvasive CPAP (NCPAP)...171
9.8
Synchronized Noninvasive Positive Pressure Ventilation (S)NIPPV) ...174
Patient gas humidifification ...179 10.1 Basics…………… ...179 10.2 Special features of the P7 patient system ...179 10.3 Humidity and flow ...180 10.4 Condensation in the hose system ...180 10.4.1 Air conditioned rooms ...181 10.4.2 Low incubator temperature ...182 10.4.3 Sensor positioning ...183
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Functional description ...185 11.1 Basics……………………………… ...185 11.2 Pneumatic diagram ...187
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Troubleshooting ...189 12.1 List of errors ...189 12.2 Extremely oscillating ventilation curves ...200 12.2.1 Patient valve ...200 12.2.2 Humidity in pneumotachograph ...201 12.3 Prevention of condensate in PNT and hoses ...202
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List of contents 13
Care and Maintenance...205 13.1 Disinfection and sterilization ...205 13.1.1 Automated cleaning and disinfection ...206 13.1.2 Manual cleaning and disinfection...207 13.1.3 Sterilization ...209 13.2 Carrying out the treatment ...210 13.2.1 Patient hose system ...210 13.2.2 Patient component ...211 13.2.3 Pneumotachograph ...215 13.3 Treatment table ...220 13.3.1 Before next patient ...221 13.4 Safety checks ...221 13.5 Servicing ...221
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Electromagnetic emissions and immunity to interference ...223 14.1 Electromagnetic emissions ...223 14.2 Electromagnetic interference immunity ...224 14.3 Recommended safe distances ...227
Fritz Stephan GmbH
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Accessory list ...229
16
Guarantee ...233
17
List of figures ...235
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List of tables...241
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Notes... ...243
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1.1
1
General details
1.1
Product combination
Product combination
FRITZ 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 combinations
1. Medication Nebulizer Set Manufacturer: Fritz 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: Fritz Stephan GmbH Art.No.: 1 035 60 800
Ultrasonic Nebulizer Manufacturer: Schill GmbH & Co. KG Art.No.: MN81100
3. Medication Nebulizer Set Aeroneb® Solo System Manufacturer: Inspiration Medical GmbH Art.No.: AG-AS3000-NE 4. Pneumotachograph
Fritz Stephan GmbH
Pneumotachograph Type A Manufacturer: Dr. Schaller Medizintechnik Art.No.: 1 035 61 303
Pneumotachograph Type B Manufacturer: Dr. Schaller Medizintechnik Art.No.: 1 035 61 300
Pneumotachograph Type C Manufacturer: Dr. Schaller Medizintechnik Art.No.: 1 035 61 301
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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
Pneumotachograph – Type NO with plug and silicone hoses, can be autoclaved 140°C, type B for the determination of the flow via flow box Art. No.: 1 035 61 302
Adapter for NO suction Art. No.: 1 007 53 082
6. Device for regulating the metered dosing of NO to inhaled air Name: Inovent Manufacturer: Datex Ohmeda
Connecting adapter for INO-Flow box Art. No.: 1 953 61 003
7. Respiration sensor for external trigger, (Disposable) Manufacturer: Fritz Stephan GmbH Art.Nr.: 1 035 60 103 (Only for Sophie with external respiration sensor)
Warning
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Disposal accessories do not reuse! Reconditioning may lead to deterioration of mechanical and biological properties resulting in a substantial decrease in patient safety. The reuse of disposable accessories exacerbates risk of contamination thus increasing patient risk to potentially dangerous levels.
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1.2
1.2
Device name and manufacturer
Device name and manufacturer Device name
SOPHIE
Manufacturer
Fritz Stephan GmbH - Medizintechnik Kirchstraße 19 56412 Gackenbach
1.3
(+)49 (6439) 9125 – 0 (+)49 (6439) 9125 – 111 [email protected] www.stephan-gmbh.com
Intended use SOPHIE is suitable for the invasive and non invasive 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
Fritz Stephan GmbH
SOPHIE can be used for all approved conventional types of ventilation:
Non-Invasive Ventilation with positive airway pressure (NCPAP) with or without Backup-Ventilation
Synchronized Intermitted Mandatory Ventilation (SIMV) with or without Inspiratory Time Termination (ITT)
Synchronized Intermitted Mandatory Ventilation (SIMV) with additional pressure support and spontaneous breathing
Controlled ventilation (IMV)
Assisted controlled ventilation (patient activated) with or without ITT
Controlled Non-Invasive Controlled Positive Pressure Ventilation (NIPPV)
Controlled and Synchronized Non-Invasive Positive Pressure Ventilation ((S)NIPPV)
High frequency oscillation (HFO) combined with IMV and CPAP (optional)
Controlled and Synchronized Non-Invasive Positive Pressure Ventilation ((S)NIPPV) with expiratory trigger (optional)
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General details
Contraindication
The safety instruction mentioned in chaper 2 must be observed. There are not further contraindications known. It is on the users own responsibility to select the most appropriate ventilation mode / ventilation therapy for the disease pattern of the patient. The continuous monitoring of the patient state must be assured at any time.
1.4
Packaging and waste disposal Packaging
The device packaging consists essentially of recyclable or reusable materials. The carton packaging can be reused, or disposed of as used paper. The wrapping consists of CFC-free padding which can be disposed of together with the foil as recyclable plastic waste (in Germany: yellow trash can).
Return / Disposal
1.5
FRITZ STEPHAN GMBH guarantees that used devices from our company can be returned free of charge and disposed of correctly, thus making a contribution to the environment.
Introduction Installation, commissioning, operation and maintenance of equipment by certified personnel only. All relevant national laws, guidelines and regulations are valid. Following instructions to be strictly observed:
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The device must only be operated by skilled staff that 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.
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1.6
Warranty
Abbreviations and definitions
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.
1.6
Abbreviations and definitions
Abbreviations / Technical terms
Definition
Meaning
ADC
Analog digital converter
APD
Apnea duration
Apnea
Apnea
Arb
Arbitrary Unit
Dimensionless unit of the graphical external trigger signal
Battery
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 1000 hpa = 1 bar
bpm
Breaths per minute
BTPS
Body Temperature and Ambient Pressure Saturated
cmH2O COM
Fritz Stephan GmbH
Pressure
Unit of measurement for pressure 1 cmH2O = 0,9806 hPa Serial interface
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General details
Abbreviations / Technical terms
Definition
Meaning
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:
CPAP
Continuous Positive Airway Pressure
time controlled, pressure controlled
time controlled, volume controlled
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.
Communic
Communication
Connection
Connection
Cont.
Continual
deceleration
Flow curve pattern:
Diathermia HF Diathermia
Therapy where high frequency currents heat through the tissues within the body.
High frequency diathermia
DIN
Deutsches Institut für Normung e.V.
German Institute for Standardization
Disc.
Disconnection
Interruption (pneumatic) of a connection
distal
Away from the patient
EN
European Norm
ETT
Endotracheal tube
Exp.
Expiration
Exhalation
FHFO
Frequency of High frequency oscillation
FiO2
Inspiratory oxygen fraction
Flow
Volume flow
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1.6
Abbreviations and definitions
Abbreviations / Technical terms
Definition
Meaning
hPa
Hecto-Pascal
Unit of measurement for pressure 1 hPa = 1 mbar
Hz
Hertz
Unit of measurement for frequency
IGR
Inkrementeller Geber
Turn-Push-Button
IMV
Intermittent Mandatory Ventilation
Intermittent Mandatory Ventilation
Insp
Inspiration
Inhalation
ITT LED
Inspiratory Time Termination Light emitting diode
linear MAP
Light emitting diode Pressure curve pattern:
Mean airway pressure
mbar
Mean airway pressure Unit of measurement for pressure 1 hPa = 1 mbar
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
minute
Unit of measurement for time
HP
High priority
An alarm indicating the need for prompt intervention by the user (IEC 60601-1-8).
ms
millisecond
Unit of measurement for time
NIST
Non-interchangeable screw thread
Non-interchangeable coupling
NCPAP
Noninvasive CPAP
NCPAP-B
Non Invasive (nasal) Continuous Positive Pressure Ventilation with backup ventilation
NIPPV
Non-Invasive Positive Pressure Ventilation
PEEP PMAX
Fritz Stephan GmbH
Positive End Expiratory Pressure
Positive end expiratory pressure Maximum pressure
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General details
Abbreviations / Technical terms
Definition
Meaning
PMEAN
Medium respiratory pressure
PMin
Minimum pressure
PNT
Pneumotachograph
Flow receiver
proximal
Close to the patient
resistive
Creates a pneumatic resistance
Resp.
Respiration
s
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
(S)NIPPV
Synchronized Non-Invasive Positive Pressure Ventilation
SNIPPV-B
Synchronized Non-Invasive Positive Pressure Ventilation with backup ventilation
TA
Technical alarm
VT
Tidalvolumen
Breathing volume
VTi
Inspiratorisches Tidalvolumen
Inspiratory breathing volume
VTe
Exspiratorisches Tidalvolumen
Expiratory breathing volume
Vo
Oszillatorisches Tidalvolumen
Oscillatory breathing volume
V
Volume
V´
Flow
WB CGU
Water bath
Moistener bottle with water filling Central gas unit
Tab. 1: Abbreviations and technical terms
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1.7
1.7
Technical details
Technical details
Ambient conditions
Operation
Temperature
15 -40 °C
Rel. humidity
10 – 80 %
Air pressure
500 – 1060 hPa
Bring to room temperature before starting to operate the device. Storage
Temperature
5 - 40 °C
Rel. humidity
10 – 80 %
Air pressure
500 – 1060 hPa
Store in a protected, dust-free place protected from Humidity and frost General
Power supply
Fritz Stephan GmbH
Class according to 93/42 ECC
II b
Protection class
IP X4
UMDNS-Code
14-361
Inspection / maintenance cycle
six-monthly (customer service company authorized by FRITZ STEPHAN GMBH)
Dimensions
470 x 342 x 332 mm
(WxHxD)
Weight
Device
23 kg
Trolley
16,2 kg
Mains
Connection
100 – 240 V AC 50 – 60 Hz
Protection class
I Typ B according IEC 60601-1 Supply line
Safety plug with device socket
Power consumption
210 VA
Cos φ
0,93
Current compensation
2,1 – 0,87 A
Fuses
2x T3,15 AH/250V DIN 41571
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General details
Battery
Typ
Lithium metal oxide
Nominal voltage
24 V DC
Nominal capacity
3,2 Ah
Operating time (new battery,
minimum 30 min
100% fully charged)
Gas supply
Supply pressure
Gas consumption
Charge time
At least 6h for 100%
AIR
3 – 6 + 0,5 bar
O2
3 – 6 + 0,5 bar
Conventional
min. 4 l/min*
HFO
min. 18 l/min*
HFO-Transport
min. 14 l/min*
Aerosol
ca. 9 l/min
* + MV (max. 25l/min) System pressures
System pre-pressure
max. 150 cmH2O
Active expiration
max. -30 cmH2O
Pneumatic medication nebulizer
1,5 bar
The gas must be dry and free of oil and dust.
Operating modes
Pressure regulation
Pressure pattern
linear sinus rectangle
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1.7
Types of ventilation
Parameter
Fritz Stephan GmbH
Technical details
NCPAP
Spontaneous breathing with non-invasive patient interface (Prong / Nasal masc) at continuous positive airway pressure
NCPAP B
Non Invasive (nasal) Continuous Positive Pressure Ventilation with backup ventilation
SIMV
Synchronized intermittent mandatory ventilation
Ass./Co.
Assisted controlled mandatory ventilation
IMV (contr.)
Controlled mandatory ventilation
ITT
Inspiratory Time Termination as addition to SIMV and Ass./Co. For SIMV with additional Pressure Support
VG
Volume Guarantee in addition to all conventional forms of ventilation
HFO
High frequency oscillation
NIPPV
Non-Invasive Positive Pressure Ventilation
(S)NIPPV
Synchronized Non-Invasive Positive Pressure Ventilation
(S)NIPPV
Synchronized Non-Invasive Positive Pressure Ventilation with backup ventilation
Operating unit
Tidal volume
2 – 150 ml
Pmax
5 – 60 cmH2O
PPSV%
0 – 100 %
Pmin
1 – 59 cmH2O
Vtlim
2 – 150 ml/OFF
VtTar
2 – 150 ml/OFF
PEEP
0 – 30 cmH2O
MAP
0 – 30 cmH2O
MaxV‘
6 – 20 l/min /OFF
CPAP-L
0 – 30 cmH2O
Temperature
30 – 40 °C
Humidity
-4 – +6
Inspiration time
0,1 – 2 s
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General details
High frequency oscillation
Patient component
Expiration time
0,1 – 60 s*
Frequency
1 – 300 /min*
FiO2
21 – 100 %
Trigger
0,1 – 2,9 l/min 0,1 – 2,9 mbar/OFF 0,1 – 2,9 Arb /OFF
Inspiration proportion
33 – 50 %
Frequency
5 – 15 Hz (300 – 900 /min)
Amplitude
0 – 100%
FlowLimitLine
0,1 – 10 l/min /OFF
Oscillatory Volume VTosc
max. 24 ml
Safety pressure
40 – 70 cmH2O
Humidifier bottle
350 ml 21 – 100%
Preoxygenation
* Depending on the customer’s wishes, Sophie can be supplied with either selectable expiration time or selectable breathing frequency. The inspiration time setup value is not affected by these selections.
Monitoring
Display
10,4“ color – TFT
Pressure
Pmax
-20 – 99 cmH2O
Pmean
-20 – 99 cmH2O
PEEP
-20 – 99 cmH2O
POSC
-20 – 99 cmH2O
Accuracy: Volume
20
P=
(2 % P + 1 cmH2O + 1 digit)
MV
0 – 999 l/min
VTe
0 -999 ml
VTi
0 – 999 ml
Vleak
0 – 999 ml
MVo
0 – 999 l/min
Vo
0 – 999 l/min
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1.7
Volume measuring:
BTPS
Accuracy:
V=
Breathing rate
0 – 999 /min
Inspiration proportion
0.1 – 100 %
FiO2
0 – 100 % Accuracy:
Technical details
(10 % V + 1 ml + 1 digit)
5 Vol %
Respiratory gas temperature
12 - 60 °C
Resistance
0 – 999 cmH2O/l/s
Compliance
0 – 999 ml/cmH2O
Curve representation
P(t), V(t), V’(t), E(t) V(P), V’(V), V’(P)
Supervision
Parameter
Unit
Lower limit
Upper limit
Resolution
PMAX
cmH2O
1 – 60
2 – 70
1
POSC
cmH2O
0 – 149
1 – 150
1
PMEAN
cmH2O
0 – 40
1 – 60
1
PEEP
cmH2O
–
0 – 30
1
MV, MVo
l/min
OFF – 0,10
–
0,01
0,10 – 9,90
–
0,05
–
0,2 – 19,9
0,1
0 – 10
0 – 10
0,5
10 – 50
10 – 50
2
50 – 150
50 – 225
5
VTE, Vo
ml
FIO2
%
18 – 99
21 – 100
1
TEMP
°C
29 – 40
36 – 41
1
Tab. 2: Alarm limits
Fritz Stephan GmbH
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