Lowenstein Medical elisa 300 User manual

LEON MRI
Proven, intuitive, stable.
Specially developed for use in a cardiac cathlabs or MRI ƒ
For all patient groups
Azeer Anesthesia
Workstation
Azeer Intinsive Care
Ventilators Elisa Family

elisa 300
elisa 500
Instructions for Use Compendium
Basic Manual
Supplement A
Supplement B
Supplement C
Supplement D
Supplement E
Supplement F

elisa 300
elisa 500
Instructions for Use
Basic Manual

The device operates according to the accompanying documentation and the equip-
ment labelling, provided that it is assembled, operated, maintained and repaired
according to the accompanying documentation.The device must be inspected at
regular intervals.The device must not be used if found to be defective. Damaged,
missing, clearly worn out, warped or contaminated parts must be replaced im-
mediately. If a repair is necessary, the manufacturer and distributor recommend
requesting advice via telephone or in writing from the nearest regional service
centre. Maintenance and repairs must only be carried out at the service centre
or by specialists authorised by the manufacturer.The user of the device shall have
sole responsibility for any malfunction or damage which is due to improper use,
poor maintenance, improper service, improper repairs or modications carried
out by unauthorised persons.
Each device has either a serial number or a UDI (Unique Device Identication).
Serial number system:
The coding system contains the code for the product group (03 or 05), the year
of manufacture (YY) and a 4-digit numeric code (ZZZZ) for unique identication.
elisa 300 03YYZZZZ
elisa 500 05YYZZZZ
UDI system:
The coding system contains the Global Trade Identication Number (GTIN), the
code for the product group (03 or 05), the year of manufacture (YY) and a 4-digit
numeric code (ZZZZ) for unique identication. The system complies with the
requirements for the GS1 standard.
elisa 300 (01)04260192090319(21)03YYZZZZ
elisa 500 (01)04260192090326(21)05YYZZZZ

Contents | 0
Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11 3
0Contents
1 About this manual 9
1.1 About this manual 10
1.2 Safety information in these instructions for use 10
2 Use 13
2.1 Intended use 14
2.2 Areas of application 14
2.3 Differences between elisa 300 and elisa 500 15
3 General safety instructions 17
3.1 General safety instructions 18
3.1.1 Safety standards 22
3.1.2 Safety functions 23
3.1.3 Work carried out on the device 25
4 Components and assembly 27
4.1 System overview 28
4.2 Main components and views 29
4.2.1 Front view 29
4.2.2 Back 30
4.2.3 Side view 31
4.2.4 Valve bar 32
4.2.4.1 Valve bar modules 32
4.2.4.2 Removing the valve bar 34
4.2.4.3 Installing the valve bar 34
4.2.5 Battery 34
4.3 Cart (option) 35
4.4 Breathing circuit 36
4.5 Tube hanger 37

4 Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11
0 | Contents
4.6 Respiratory gas humidication 37
4.6.1 Connection with an active respiratory gas humidier 38
4.6.2 Connection with a passive HME lter 39
5 General information 41
5.1 General description of the equipment functions 42
5.1.1 Layout of the ventilation screen 43
5.1.2 General operations 44
5.1.2.1 Open/close windows 44
5.1.2.2 Conrmation (Enter) 44
5.1.2.3 Edit parameters 44
5.1.2.4 Selector 44
5.1.2.5 Views 46
5.1.2.6 Stop graphs 46
5.1.2.7 Home 46
5.1.2.8 Symbols / Functions 47
5.1.2.9 Help function 47
5.1.3 Adjust the ventilation screen 48
5.2 Conguration 50
5.3 Symbols 50
5.4 Abbreviations and terms used in the instructions for use and in the user guid-
ance 52
6 Preparing the system for use 61
6.1 Power supply 62
6.1.1 Mains supply 62
6.1.2 Internal power supply (rechargeable battery) 62
6.2 Gas supply 64
6.3 Switching power on and off 65
6.3.1 Automatic patient detection APD 65
6.4 Power up test 65
6.5 System test 67
6.5.1 Select the patient category 67
6.5.2 Performing a system test 68
6.6 Leakage test 70
7 Operation 71
7.1 Standby mode 73
7.1.1 Battery symbol 75
7.1.2 Patient symbol 75
7.1.3 Select patient interface 75
7.1.3.1 Tube compensation 76
7.1.4 Dynamic view of the lung 78
7.1.5 Shortcuts: Toolbox 78
7.1.5.1 Help function 79
7.1.5.2 Screenshot 79
7.1.6 Home 79

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Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11 5
7.1.7 Status 80
7.1.8 Trend view 1 80
7.1.8.1 Search function to dene a time window 81
7.1.8.2 Graphic trend of selected measurements (congurable) 81
7.1.8.3 Parameters (congurable) 82
7.1.8.4 Tabular trend (congurable) 82
7.1.8.5 Trend update 83
7.1.9 Trend view 2 83
7.2 Selection “Same Patient” / “New Patient” 84
7.2.1 Default ventilation 85
7.3 Ventilation 86
7.3.1 Set ventilation mode 87
7.3.2 Change ventilation mode 87
7.3.3 Set ventilation parameters 88
7.3.4 Trigger 89
7.3.5 Backup ventilation 89
7.3.6 Set alarm limits 90
7.3.7 Overview of alarm limits 91
7.3.7.1 Ventilation alarms 91
7.3.7.2 Gas 91
7.3.7.3 Other alarms 92
7.3.7.4 Alarm limits for non-invasive ventilation 92
7.3.8 Drug nebulization 93
7.3.9 Start ventilation / Stop ventilation 93
7.3.10 Conguration options on the ventilation screen (end user) 94
7.3.10.1 Curve display (unit of measurement as congured) 94
7.3.10.2 Trend graphs / compressed trend graphs 95
7.3.10.3 Data table / short data table 95
7.3.10.4 Loops 95
7.3.10.5 Fastwean / Fastprotect 95
7.4 Settings under “System” 96
7.4.1 Reset to defaults 96
7.4.2 Lock and unlock the screen 96
7.4.3 Battery 96
7.4.4 System test 97
7.4.5 Settings 97
7.4.5.1 Date / Time 97
7.4.5.2 Display brightness 97
7.4.5.3 Alarm volume / brightness 98
7.4.5.4 Extras 99
7.5 Service 99
8 Measurements and graphics 101
8.1 Curve presentation 102
8.2 Instant View window 103

6 Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11
0 | Contents
8.3 Loop view 104
8.4 Data table or short data table 105
8.5 Fastwean 106
8.6 Fastprotect 107
9 Errors, alarms and troubleshooting 109
9.1 Problems – causes – corrective measures 110
9.2 Alarm system 111
9.2.1 Alarm messages 111
9.2.2 Alarm pause 112
9.2.3 Verication of the signalling devices 113
9.2.4 Alarm verication in the presence of a blocked breathing circuit
113
9.2.5 Alarm verication in the presence of a partially blocked breathing circuit
113
9.3 Alarm priorities 114
9.4 Alarm messages during operation 114
9.5 Error messages during power up test 161
9.6 Error messages during system test 164
10 Cleaning, disinfection and sterilisation, disposal 169
10.1 General information 170
10.1.1 Initial operation 170
10.2 Cleaning and disinfection 171
10.2.1 Intensive care ventilator 171
10.2.2 Valve bar 172
10.3 Disposal of elisa 300 / elisa 500 177
11 Maintenance 179
11.1 General 180
11.2 Oxygen measurement (O2) 180
11.2.1 Calibration of the paramagnetic O2sensor 181
11.3 Air lter cassette for turbine 181
11.3.1 Exchanging the air lter cassette 182
11.4 Maintenance intervals 183
11.4.1 Annual maintenance 183
11.4.2 Maintenance every 6 years 183
11.4.3 Maintenance every 12 years 183
11.5 Additional maintenance and repair information 184
12 Technical specications 185
12.1 Function chart of the elisa 300 / elisa 500 ventilator 186
12.2 General 186
12.3 Supply 189
12.4 Technical data 190
12.5 Control unit 191
12.6 Default parameters 192

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Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11 7
12.7 Increments and maximum performance range 192
12.8 Instant View window / data table(s) 196
12.9 Data transmission with terminal devices 200
12.10 Guidance and manufacturer's declaration 202
13 Default parameters 207
13.1 Default parameters (factory settings) 208
13.1.1 Default parameters 208
13.1.2 Adjustment ranges 209
13.1.3 Default alarm limits 209
13.1.3.1 Default alarm limits of the ALPV mode 211
13.1.3.2 Default alarm limits of the WOBOV mode 211
13.1.3.3 Default alarm limits of the CPR mode 212

8 Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11
0 | Contents
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About this manual | 1
Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11 9
1.1 About this manual 10
1.2 Safety information in these instructions for use 10
1 About this manual

1 | About this manual
10 Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11
1.1 About this manual
These instructions for use describe the intended use and the operation of the
following products:
elisa 300 |Intensive care ventilator |Software version 2.09.x
elisa 500 |Intensive care ventilator |Software version 2.09.x
The software version installed in your device is displayed on the standby screen.
The present document “Basic Instructions for Use” describes the intensive care
ventilators mentioned above.
The following supplements to these instructions for use are available
as separate documents:
Title For devices Content
IFU Supplement A elisa 600, elisa 800 /
elisa 300, elisa 500
Manoeuvres, Functions,Venti-
lation Modes
IFU Supplement B elisa 300 to elisa 800VIT LeoCap
IFU Supplement C elisa 300 to elisa 800VIT LeoLyzer
IFU Supplement D elisa 300 to elisa 800VIT Pulse oximetry and LeoClac
IFU Supplement E elisa 300 to elisa 800VIT External interfaces
IFU Supplement F elisa 300 to elisa 800VIT elisa@megs
The manufacturer reserves the right to further develop the device and/or carry
out changes in terms of technical progress.
The manufacturer's and distributor's contact details are stated on the back cover.
1.2 Safety information in these instructions for use
All warnings and precautions must be read and observed!
The symbols below identify dangerous situations which may occur when users fail
to observe these instructions for use:
Refers to dangerous situations which may occur when failing to
observe the present instructions for use.

About this manual | 1
Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11 11
Warning
“Warning” refers to a situation which may cause injuries to the
user or the patient.
Caution
“Caution” refers to a situation which may cause damage to the
equipment.

1 | About this manual
12 Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11
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Use | 2
Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11 13
2.1 Intended use 14
2.2 Areas of application 14
2.3 Differences between elisa 300 and elisa 500 15
2 Use

2 | Use
14 Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11
2.1 Intended use
elisa 300 / elisa 500 ventilators are designed for adult and paediatric patients
requiring ventilation support.The range of application covers invasive and non-in-
vasive ventilation as well as HFOT (high-ow oxygen therapy).
Patient category Weight
Adults 30–500 kg
Children 8 - 150 kg
There are no known contraindications. It is the user's responsibility to select
appropriate settings in consideration of the clinical situation of the ventilated
patient, periodically review these settings and adapt them when necessary.
When combined with an application system for volatile anaesthetic agents, elisa
300 / elisa 500 can also be used as an anaesthesia workstation. For more details,
please refer to the separate document “Instructions for Use – Supplement A –
Manoeuvres, Functions,Ventilation Modes”.
For a description of the device functions, please refer to chapter “5.1 General
description of the equipment functions”.
2.2 Areas of application
elisa 300 / elisa 500 is approved for stationary use and patient transport within
health care facilities.
Warning
The ventilator must not be used:
• in close proximity to nuclear magnetic resonance equipment
(MRI, NMR DEVICES)
• in close proximity to electrosurgical devices
• simultaneously with a debrillator
• in potentially explosive areas
• in the presence of ammable anaesthetics or highly amma-
ble substances
• in hyperbaric chambers
• during out-of-hospital transport of patients
• in EMS settings and ambulances
• in aircrafts or helicopters

Use | 2
Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11 15
2.3 Differences between elisa 300 and elisa 500
Hardware options elisa 300 elisa 500
Screen diagonal 12.1 " 15 "
BF interfaces 2 x BF interface 4 x BF interface
Software options elisa 300 elisa 500
Cuffscout function not available standard
Peso function not available standard
IAP function not available standard

2 | Use
16 Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11
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General safety instructions | 3
Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11 17
3.1 General safety instructions 18
3.1.1 Safety standards 22
3.1.2 Safety functions 23
3.1.3 Work carried out on the device 25
3 General safety instructions

3 | General safety instructions
18 Basic Instructions for Use elisa 300-500 | SW 2.09.x |Rev. 11
3.1 General safety instructions
Reference
These basic instructions for use describe the products:
elisa 300 |Intensive care ventilator |Software version 2.09.x
elisa 500 |Intensive care ventilator |Software version 2.09.x
Safe operation
In order to guarantee the safe operation of elisa 300 / elisa 500, the system must
only be used as described. Before putting the system into operation, users must
familiarise themselves with these instructions for use and with Supplement A
(Manoeuvres, Functions, Ventilation Modes).
Depending on the functions used, users must also familiarise themselves with the
relevant supplements (see section 1.1).
As a matter of principle, all guidelines in these instructions for use as well as ap-
plicable legal provisions for the use of a ventilator must be observed.
Users must be trained in the use of the equipment to ensure safe operation.
Please contact your sales organization to receive the required training.
Secure positioning
Verify the secure positioning of the device which must not be tilted or set up at
an angle.
Moving the cart with the device
Check that the device is securely fastened on the cart. Release the locking brakes
on the cart wheels.
When moving the cart over thresholds or when entering a lift, for example, slight-
ly lift the cart.
Warning
Always manoeuvre the device using the handles on the sides, do
not apply force to the device or the control unit – risk of tipping
over!
Patient safety
elisa 300 / elisa 500 may only be operated by qualied medical staff (physicians,
certied nursing staff, nursing staff specializing in intensive care medicine, respira-
tory therapists) in order to guarantee an adequate intervention in the event of a
device malfunction.
Patients connected to the device require continuous surveillance by specialist
staff. If a patient is connected to the system, make sure that the alarm limits are
adapted to the patient condition and the alarms are activated.