Stephan GmbH
EVE IN Operating Manual Ver 3.2 July 2021
Operating Manual
274 Pages
Preview
Page 1
EVEIN ICU Ventilator
Operating manual
Preface This manual aims to provide clear answers to your questions about the operation and care of the EVEIN. This manual does not contain any information about repairs or installation or about hazards that are clearly observable by the user or caused by the non-intended use of or nonauthorized modifications to the device. If any malfunctions occur while operating the device, please contact the 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 only guarantees the safety and reliability of the EVEIN when it is operated according to the manual.
NOTE For information about the maintenance and care of the EVE, please see the service manual. This also contains detailed information about the device design and function as well as its individual components.
NOTE Fritz Stephan GmbH offers training on the safe and efficient use of the EVE ventilator. Training material can also be requested. Please contact info@stephan-gmbh.com for more information.
Fritz Stephan GmbH - Medizintechnik Kirchstraße 19 56412 Gackenbach
Equipment is subject to technical modification. Valid as of:
July 2021
Version:
V3.2
From software version: V2.7
Germany Art. no.: 107090001
2
GA-070I-0721V3.2-HAO-EN
© Fritz Stephan GmbH
®
Table of contents
Table of contents Table of contents ...3 1
General information ...11 1.1
Product combination ...12
1.2
Optional components ...15 1.2.1
2
3
Software components ...15
1.3
Device name and manufacturer ...15
1.4
Intended use ...16
1.5
Contraindications ...17
1.6
Disposal ...17
1.7
Introduction ...18
1.8
Abbreviations, definitions, and pictograms ...19
1.9
Specifications...25
Safety instructions...41 2.1
Danger ...42
2.2
Warning ...43
Design and functional description...47 3.1
3.2
Front view ...47 3.1.1
Alarm indicator ...48
3.1.2
Control panel ...49
3.1.3
Function buttons ...52
Touchscreen monitor ...55 3.2.1
General information about touchscreen navigation ...56 Selecting a function field ...56 Setting options and parameters ...57 Functions in the System Settings menu ...58
3.2.2
Measured value display ...60
3.2.3
Function fields ...63 Measured value indicator switch...63 Values ...63 Alarms ...65 Maneuver ...71 Graph...72
© Fritz Stephan GmbH
GA-070I-0721V3.2-HAO-EN
3
Table of contents Parameter ...73 3.2.4
Parameter display ...74
3.2.5
Ventilation mode display ...75
3.2.6
“Energy supply” indicator ...76
3.2.7
System settings ...77
3.2.8
Status, alarm, and info display ...78
3.2.9
Graphic display ...79 Configuring the measurement curves...80 Configuration of loops and trends ...81
3.3
Left side view ...84
3.4
Right side view ...85
3.5
Bottom view ...86
3.6
Rear view ...87
3.7
Docking station ...88
3.8 4
3.7.1
Docking station standard ...88
3.7.2
Mobile stand light...90
3.7.3
COM interface (RS232) ...91
Mobile stand ...91
System Settings ...93 4.1
4.2
System ...94 4.1.1
Info ...94
4.1.2
Display ...95
4.1.3
Time and Date ...95
4.1.4
Function...96
Sensor ...97 4.2.1
Pulse oximetry ...98 Settings ...98 Parameter ...99 SpO2 ...100 SpHb ...101
4.3
4.2.2
Capnometry ...102
4.2.3
Flow...103
4.2.4
FiO2 ...105
Display ...106 4.3.1
4
Measured values ...106
GA-070I-0721V3.2-HAO-EN
© Fritz Stephan GmbH
®
Table of contents 4.4
Setup ...107 4.4.1
Oxygen configuration ...108
4.4.2
I:E/Tinsp ...110
4.4.3
Language ...111
4.4.4
Touchscreen calibration ...112
4.4.5
Factory Settings ...112
4.4.6
Service Software ...112
4.4.7
Deep Sleep mode...112
4.4.8
Sound...113
4.4.9
Logbook ...114
4.4.10 License ...114 4.4.11 Protocol ...114 4.4.12 Pressure units...115 4.4.13 Patient Configuration ...115 4.4.14 Tinsp max. PSV...118 5
Preparation for use ...119 5.1
5.2
Connecting the oxygen supply...119 5.1.1
Connecting the oxygen cylinder ...120
5.1.2
Sample calculation: O2 oxygen consumption ...122
5.1.3
Changing the oxygen cylinder ...124
5.1.4
Connection to the central gas supply ...125
5.1.5
Connecting to an oxygen concentrator ...125
Energy supply connection...125 5.2.1
Mains power supply ...125
5.2.2
Internal energy supply ...126
5.2.3
Charging the external battery ...128
5.3
Connecting the nurse call...129
5.4
Connecting the patient tube system ...129 5.4.1
Single-use tube system S180DL-A ...130
5.4.2
Single-use tube system S180CL-P ...131
5.4.3
Disposable tube system with humidifier chamber...131 Standard configuration ...132 Configuration for use of the EasyFlow nCPAP system ...133 Configuration for use of the HighFlow system ...134 Helmet single-use tube system ...134
© Fritz Stephan GmbH
GA-070I-0721V3.2-HAO-EN
5
Table of contents
5.5
5.4.4
Dual hose system with combination valve ...135
5.4.5
Dual hose system with combination valve and humidification...135
Installing the expiration valve ...136 5.5.1
Connecting the distal expiration valve ...136
5.6
Installing the flow sensor ...136
5.7
Connecting the E-Flow sensor ...138
5.8
Installing the patient filter...139
5.9
Installing the SpO2 sensor ...139
5.10 Aerosol nebulization ...140 6
Operation ...143 6.1
Test before every start-up ...143 6.1.1
Testing requirements ...143
6.1.2
Checklist ...144
6.2
Switching the device on/off ...145
6.3
Selftest ...145 6.3.1
Selftest passed ...145
6.3.2
Selftest failed ...146
6.4
Standby mode ...147
6.5
Using fast tracking keys ...148
6.6
New Patient...148 6.6.1
6.7
6.8 7
Default factory ventilation parameters ...149
Mode Settings ...150 6.7.1
Monitoring...152
6.7.2
Selecting the ventilation mode ...152
Ending ventilation...154
Ventilation modes ...155 7.1
Invasive and non-invasive ventilation modes ...155
7.2
Trigger functionality ...158
7.3
7.2.1
Flow trigger ...158
7.2.2
Internal flow trigger ...159
Mandatory ventilation...160 7.3.1
Volume-controlled ventilation ...161 Volume-controlled continuous mandatory ventilation (VC-CMV) ...161 Volume-controlled synchronized intermittent mandatory ventilation (VC-SIMV) ...163
6
GA-070I-0721V3.2-HAO-EN
© Fritz Stephan GmbH
®
Table of contents 7.3.2
Pressure-controlled ventilation modes ...165 Pressure-controlled continuous mandatory ventilation (PC-CMV)...165 Non-invasive pressure-controlled mandatory ventilation (nPC-CMV)...167 Pressure-controlled synchronized intermittent mandatory ventilation (PC-SIMV)...168 Non-invasive pressure-controlled synchronized intermittent mandatory ventilation (nPC-SIMV) (optional) ...171 Pressure-controlled assist/control ventilation (PC-ACV) ...172 Non-invasive pressure-controlled assist/control ventilation (nPC-ACV) ...173 Pressure-controlled assist/control ventilation plus (PC-ACV+) ...174 Non-invasive pressure-controlled assist/control ventilation plus (nPC-ACV+) ...174 DUOPAP...175 Non-invasive DUOPAP (nDUOPAP)...178
7.3.3
Spontaneous breathing ...179 CPAP...179 nCPAP...181
7.3.4 7.4
8
Additional options for ventilation modes ...183 7.4.1
Pressure-regulated and volume-controlled ventilation (PRVC) ...183
7.4.2
Pressure support ventilation (PSV) ...185
7.4.3
Tube compensation ...187
CO2 measurement (optional) ...189 8.1
© Fritz Stephan GmbH
High flow O2 therapy ...182
Measurement using the mainstream technique ...190 8.1.1
Intended use...190
8.1.2
Specifications ...191
8.1.3
Warnings ...191
8.1.4
Installing the CO2 measuring probe ...194
8.1.5
Running zero calibration ...197
8.1.6
Probe status indicator ...198
8.1.7
Cleaning the probe ...198
GA-070I-0721V3.2-HAO-EN
7
Table of contents 8.2
Measurement using the sidestream technique ...199 8.2.1
Intended use...199
8.2.2
Specifications ...200
8.2.3
Warnings ...200
8.2.4
Installing the ISA™ CO2 analyzer ...204
8.2.5
Running zero calibration ...206
8.2.6
Status indicator of the analysis adapter ...207
8.2.7
Cleaning the CO2 analyzer ...207
9
Functional description...209
10
Troubleshooting ...211 10.1 List of errors ...211 10.2 Selftest error ...227 10.3 Moisture in the flow sensor ...228
11
Care and maintenance ...229 11.1 Disinfection and sterilization ...229 11.2 Information about cleaning agents and disinfectants...230 11.3 Automated cleaning and disinfection ...231 11.4 Manual cleaning and disinfection ...233 11.5 Cleaning and disinfection of device surfaces ...234 11.6 Sterilization...235 11.7 Carrying out the treatment ...236 11.7.1 Type B Pneumotachograph (flow sensor) ...236 Preparing the PNT B ...238 Post-treatment ...239 11.7.2 Test lung Neo with tube adapter...242 11.8 Treatment table ...244 11.9 Safety checks ...245 11.10 Maintenance...246 11.11 Servicing ...247 11.11.1 Procedure...249 Replacing the coarse filter ...249 Replacing the HEPA filter ...250 Replacing the fan filter ...250 Replacing the external battery ...251 Replacing the O2 sensor...252
8
GA-070I-0721V3.2-HAO-EN
© Fritz Stephan GmbH
®
Table of contents 12
Electromagnetic emissions and immunity ...253 12.1 Electromagnetic emissions ...253 12.2 Electromagnetic immunity...255 12.3 Recommended separation distance ...258
© Fritz Stephan GmbH
13
Accessory list ...259
14
List of figures ...265
15
List of tables...271
16
Notes ...273
GA-070I-0721V3.2-HAO-EN
9
®
1
1
General information
General information FRITZ STEPHAN GMBH disclaims any warranty with respect to the operation of unauthorized device combinations with products not approved by the manufacturer or without certified compatibility.
ATTENTION Do not reuse disposable accessories! The necessary reconditioning may lead to the deterioration of mechanical and biological product properties, posing a significant risk to the patient. In addition, reusing such accessories dangerously 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.
NOTE The applied parts of the EVE (CO2 sensor, SpO2 sensor, E-Flow sensor and ventilator breathing system (VBS)) are protected against defibrillation. For the SpO2 and CO2 module, the recovery time is under 5 seconds.
© Fritz Stephan GmbH
GA-070I-0721V3.2-HAO-EN
11
1
General information
1.1
Product combination FRITZ STEPHAN GMBH disclaims any warranty with respect to the operation of unauthorized device combinations with products not approved by the manufacturer or without certified compatibility. Certified product combinations
1. Medication nebulizer •
Pneumatic medication nebulizer 22m/22f Manufacturer: GaleMed
2. Flow sensors •
Flow sensor, adults Manufacturer: Fritz Stephan GmbH
•
Flow sensor, children Manufacturer: Fritz Stephan GmbH
•
Flow sensor for Neo Manufacturer: Fritz Stephan GmbH
•
Electronic flow sensor for Neo type SFM 3400 D Manufacturer: Fritz Stephan GmbH
•
Electronic flow sensor for Adults type SFM 3300 D Manufacturer: Fritz Stephan GmbH
•
Pneumotachograph for Adults type D for ventilator EVE Manufacturer: Fritz Stephan GmbH
•
Pneumotachograph, preterm infants and newborns, type B for ventilator EVE Manufacturer: Fritz Stephan GmbH
•
Pressure measuring adapter nCPAP Manufacturer: Fritz Stephan GmbH
3. Disposable patient tube systems
12
•
S180SL-A (Adult ICU single-use tube system, length: 180 cm) Manufacturer: Fritz Stephan GmbH
•
S240SL-A (Adult emergency single-use tube system, length: 240 cm) Manufacturer: Fritz Stephan GmbH
•
S300SL-A (Adult emergency single-use tube system, length: 300 cm) Manufacturer: Fritz Stephan GmbH
•
S440SL-A (Adult emergency single-use tube system, length: 440 cm) Manufacturer: Fritz Stephan GmbH
GA-070I-0721V3.2-HAO-EN
© Fritz Stephan GmbH
®
1
General information
•
S180DL-A (Adult emergency single-use tube system, length: 180 cm) Manufacturer: Fritz Stephan GmbH
•
S180CL-P (Pediatric single-use tube system, length: 180 cm) Manufacturer: Fritz Stephan GmbH
•
S180DL-N (NEO single-use tube system, length: 180 cm) Manufacturer: Fritz Stephan GmbH
•
S180DLF-N (NEO single-use tube system with flow measurement, length: 180 cm) Manufacturer: Fritz Stephan GmbH
•
Patient tube system, 10 mm, newborn, heated Manufacturer: WILAmed
•
Patient tube system, 15 mm, child, heated Manufacturer: WILAmed
•
Patient tube system, 22 mm, adult, heated Manufacturer: WILAmed
•
Patient tube system 950A80, adult, heated Manufacturer: Fisher & Paykel
•
Patient tube system 950N80, adult, heated Manufacturer: Fisher & Paykel
•
Patient tube system RT 265, child, heated Manufacturer: Fisher & Paykel
•
Patient tube system RT 380, adult, heated Manufacturer: Fisher & Paykel
•
Patient tube system RT330 Optiflow Junior, heated Manufacturer: Fisher & Paykel
•
Ventilation tube RT024 Manufacturer: Fisher & Paykel
4. NCPAP patient interfaces •
EasyFlow nCPAP system Manufacturer: Fritz Stephan GmbH
5. Expiration valve Manufacturer: Fritz Stephan GmbH 6. CO2 sensor Manufacturer:
Masimo
7. Masimo rainbow Set® Manufacturer: Masimo
© Fritz Stephan GmbH
GA-070I-0721V3.2-HAO-EN
13
1
General information 8. Respiratory gas humidifier •
AirCon Gen2® Manufacturer: WILAmed
•
MR 850 Manufacturer: Fisher & Paykel
•
MR 950 Manufacturer: Fisher & Paykel
9. NO delivery system •
INOmax® DSIR Manufacturer: IKARIA Inc.
10. NOxBOXi® Manufacturer:
NOxBOX Ltd.
11. Nasal cannulas •
Optiflow Junior Nasal Cannula Manufacturer: Fisher & Paykel
•
Optiflow + Nasal Cannula Manufacturer: Fisher & Paykel
•
Hi-Flow Star System MP05601 Manufacturer: Dräger
•
Hi-Flow Star nasal cannula Adult S/M/L Manufacturer: Dräger
NOTE Further information on the accessories for the ventilator can be found in chapter 13.
14
GA-070I-0721V3.2-HAO-EN
© Fritz Stephan GmbH
®
1
1.2
General information
Optional components
1.2.1 Software components On customer request, EVEIN can also be equipped with the following software components: •
License graphic (loops & trends), art. no.: 107061451
•
License Neo mode, art. no.: 107061460
•
License Niv/Duopap, art. no.: 107061450
•
License ACV+/nACV+, art. no.: 107061452
1.2.2 Hardware components EVEIN can optionally be equipped with a CO2 measurement using the mainstream or sidestream technique (see chapter 8) as well as a pulse oximeter for measuring the Masimo Rainbow® parameters Pulse, PVI, PI, SpMet, SpCO, and SpOC (see supplemental pulse oximetry manual).
1.3
Device name and manufacturer Device name
EVEIN
Manufacturer
Fritz Stephan GmbH - Medizintechnik Kirchstraße 19 56412 Gackenbach Germany
© Fritz Stephan GmbH
(+)49 (6439) 9125–0 (+)49 (6439) 9125–111 info@stephan-gmbh.com www.stephan-gmbh.com
GA-070I-0721V3.2-HAO-EN
15
1
General information
1.4
Intended use The EVEIN is used for invasive and non-invasive ventilation in an ICU setting, as well as for HighFlow O2 therapy, and is suitable for long-term ventilation. The EVEIN is used as an ICU ventilator and can be used for transport within the hospital. The EVEIN is suitable for the ventilation of children and adults weighing up to 200 kg. It is also possible to ventilate preterm infants and newborns. The EVEIN supports the following types of ventilation:
Therapeutic scope
Ventilation mode
Standard
Optional
PC-CMV
X
-
PC-SIMV
X
-
PC-ACV
X
-
PC-ACV+
-
License ACV+/nACV+ required
CPAP
X
-
VC-CMV
X
-
VC-SIMV
X
-
High flow O2 therapy
-
License Neo mode or NIV-DUOPAP required
DUOPAP
-
License Neo mode or NIV-DUOPAP required
nPCMV
-
License Neo mode required
nPC-SIMV
-
License Neo mode required
nPC-ACV
-
License Neo mode required
nPC-ACV+
-
License ACV+/nACV+ required
nDUOPAP
-
License Neo mode required
nCPAP
-
License Neo mode required
Tab. 1: Therapeutic scope
16
GA-070I-0721V3.2-HAO-EN
© Fritz Stephan GmbH
®
1
1.5
General information
Contraindications The safety instructions provided in chapter 2 must be observed. No additional contraindications exist. It is the sole responsibility of the user to select the most appropriate mode of ventilation based on the patient’s medical condition. The continuous monitoring of the patient’s condition must be assured at all times. Non-invasive ventilation is contraindicated in the following cases:
1.6
▪
No spontaneous breathing
▪
Fixed or functional airway obstruction
▪
Gastrointestinal bleeding or ileus
Disposal Disposal of the packaging
Disposal of the device and the battery
The device packaging largely consists of recyclable or reusable materials. The cardboard packaging can be reused or disposed of as used paper. FRITZ STEPHAN GMBH will accept the return of any used devices from our company free of charge and dispose of these correctly, thus making a contribution to the environment. Used batteries and the device itself must not be disposed of as domestic 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!
© Fritz Stephan GmbH
GA-070I-0721V3.2-HAO-EN
17
1
General information
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!
1.7
Introduction Device setup, operation, and maintenance is only permitted by trained personnel. 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.
NOTE The EVEIN 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 manufacturer guarantees the safety and reliability of the device only when it is operated in compliance with operating instructions.
18
GA-070I-0721V3.2-HAO-EN
© Fritz Stephan GmbH
®
1
1.8
General information
Abbreviations, definitions, and pictograms
Abbreviation/ Term technical term
Meaning
Bat.
Device for storing electrical energy in the form of chemical energy
Battery
Apnea
Respiratory arrest
BTPS
Body Temperature Pressure Saturated
Measuring condition at body temperature, current ambient pressure, and saturated gas
CPAP
Continuous positive airway pressure
Spontaneous breathing with continuous positive airway pressure. When breathing under CPAP, the device keeps the pressure constant on the endotracheal tube’s connection piece.
Distal
Away from the patient
DUOPAP
Ventilation support at two different pressure levels
ETT
Endotracheal tube
Exp
Expiration (exhalation)
Time period from the onset of the expiration flow until the onset of the inspiration flow
HEPA
High Efficiency Particulate Air Filter
High-performance particle filter
Flow limit
Flow limitation
Limitation of the flow for non-invasive ventilation in NEO mode Heat and moisture exchanger
HME HP
An alarm indicating the need for prompt intervention by the user (IEC 60601-1-8).
High priority
HW
Notification
IGR
Incremental encoder
Push and turn knob for device operation
Insp
Inspiration (inhalation)
Time period from the onset of the inspiration flow until the onset of the expiration flow
MP
Medium priority
An alarm indicating the need for prompt intervention by the user (IEC 60601-1-8).
© Fritz Stephan GmbH
GA-070I-0721V3.2-HAO-EN
19
1
General information
Abbreviation/ Term technical term
Meaning
nCPAP
Non-invasive spontaneous breathing with continuous positive airway pressure. When breathing under CPAP, the device keeps the pressure constant on the endotracheal tube’s connection piece.
Non-invasive continuous positive airway pressure
nPC-CMV
Non-invasive pressure-controlled mandatory ventilation
nPC-SIMV
Non-invasive pressure-controlled synchronized intermittent mandatory ventilation
nPC-ACV
Non-invasive pressure-controlled assist/control ventilation
nPC-ACV+
Non-invasive pressure-controlled assist/control ventilation with expiration trigger
nDUOPAP
Non-invasive ventilation support at two different pressure levels
NIST
Non-interchangeable screw thread
O2
Oxygen level
PC-CMV
Pressure-controlled continuous mandatory ventilation
PC-SIMV
Pressure-controlled synchronized intermittent mandatory ventilation
PC-ACV+
Pressure-controlled assist/control ventilation with expiration trigger
PC-ACV
Pressure-controlled assist/control ventilation
PI
Perfusion index
PRVC
Pressure regulated volume control Pressure-controlled and volume-regulated ventilation Pressure support ventilation
PSV PVI™
Pleth Variability Index
Plethysmographic variability index
PEEP
Positive end expiratory pressure
Pinsp
Inspiratory pressure
PAW
Airway pressure
Pmean
Mean airway pressure
20
GA-070I-0721V3.2-HAO-EN
© Fritz Stephan GmbH
®
1
Abbreviation/ Term technical term
Meaning
PNT
Flow sensor
Pneumotachograph
General information
Proximal
Close to the patient
Resistive
Creates a pneumatic resistance
SIMV
Synchronized intermittent mandatory ventilation
SpCO®
Carboxyhemoglobin measurement Index for CO level in arterial blood
SpMet™
Methemoglobin measurement
Index for methemoglobin level in arterial blood
SpHb®
Hemoglobin measurement
Index for hemoglobin level in arterial blood
SpOC®
Oxygen level measurement
Index for oxygen level in arterial blood
SpO2®
Measurement of oxygen saturation
Index for oxygen saturation
Standby STPD
Form of ventilation synchronized to the patient
The device is ready for use Standard temperature, pressure, dry
Measuring condition at standard temperature (20°C), standard pressure (1013 mbar absolute), dry
TA
Technical alarm
TC
Tube compensation
V´
Flow
Volume flow
VC-CMV
Volume-controlled continuous mandatory ventilation
VC-SIMV
Volume-controlled synchronized intermittent mechanical ventilation
PU
Packaging unit
VT
Tidal volume
Breathing volume
VTe
Expiratory breathing volume
Expiratory tidal volume
CGS
Central gas supply
V
Volume Tab. 2: Abbreviations and technical terms
© Fritz Stephan GmbH
GA-070I-0721V3.2-HAO-EN
21