Inovytec SALI D User manual

Page 1 of 48
EMPOWERING
EMERGENCY CARE
INV-IFU-2001, Rev. 09, Last update September 2021

Page 2 of 48
Important
This User Manual is subject to periodic review, update and revision.
Do not use a defective product. Do not repair this product or any of its parts. If
this device does not perform properly, contact an Inovytec representative.
The user of this product has sole responsibility for any malfunction that results
from improper use, faulty maintenance, improper repair, unauthorized service,
damage, or alteration by anyone other than Inovytec Medical Solutions Ltd.
The safety, reliability, and performance of this device can be assured only under
the following conditions:
•The device has been used according to the accompanying operating
instructions.
•All fittings, extensions, readjustments, changes, or repairs have been carried
out by Inovytec Medical Solutions Ltd.'s authorized representatives.
No part of this publication may be reproduced, stored in a retrieval system or
transmitted in any form by any means, electronic, mechanical, photo
reproductive, recording or otherwise without the express prior written
permission of Inovytec Medical Solutions Ltd.
Inovytec Medical Solutions Ltd. reserves the right to change or improve its
products and accompanying technical literature without specific notice of
changes or improvements.
This product is protected by patents listed on the Inovytec website.

Page 3 of 48
Contact Information:
Inovytec Medical Solutions Ltd.
5 HaTidhar St.,
Raanana 4366507, Israel
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]
Web Site: http://www.Inovytec.com
Disclaimer
Information provided by Inovytec Medical Solutions Ltd. is believed to be
accurate and reliable. However, Inovytec assumes no responsibility for the use
of such information, nor for any infringements of patents or other rights of third
parties, that may result from its use.
FDA Tracking Requirements
U.S. Federal Law (21 CFR 821) requires the tracking of AEDs. Under this law,
owners of this AED must notify Inovytec Medical Solutions Ltd. if this product is
received; lost, stolen, or destroyed; donated or resold; or otherwise distributed
to a different organization. If any such event occurs, contact Inovytec in writing
with the following information:
•Originator's organization – Company name, address, contact name, and
contact phone number.
•Model number, and serial number of the ventilator
•Disposition of the ventilator (for example, received, lost, stolen, destroyed,
distributed to another organization), new location and/or organization (if
known and different from originator’s organization) – company name,
address, contact name, and contact phone number.
•Date when the change took effect.
Please address this information to Inovytec Medical Solutions Ltd. at the address
given above.
PLEASE READ THIS USER MANUAL BEFORE OPERATING THE SYSTEM.

Page 4 of 48
TABLE OF CONTENTS
1. ABOUT THIS USER MANUAL ...........................................................................7
1.1 TYPES OF WARNINGS, CAUTIONS AND NOTES...............................................7
1.2 GLOSSARY AND ABBREVIATIONS ............................................................................8
2. OVERVIEW OF SYSTEM................................................................................... 9
2.1 DESCRIPTION OF DEVICE ......................................................................................9
3. CONDITIONS FOR USE .................................................................................. 10
3.1 INDICATIONS FOR USE .......................................................................................10
3.2 CONTRAINDICATIONS ........................................................................................10
3.3 LIMITATIONS OF USE .........................................................................................11
4. SAFETY ......................................................................................................... 12
4.1 ELECTRICAL SAFETY ...........................................................................................12
4.2 EMC COMPLIANCE...........................................................................................12
4.2.1 EMISSIONS .............................................................................................12
4.2.2 IMMUNITY .............................................................................................13
4.3 SAFETY INSTRUCTIONS .......................................................................................15
5. SYMBOLS ..................................................................................................... 21
6. SYSTEM COMPONENTS ................................................................................ 23
6.1 SALI-D –MAIN COMPONENTS .....................................................................23
7. CONNECTING THE SALI-D ............................................................................. 25
7.1 EXTERNAL CONNECTIONS ...................................................................................25
7.2 INTERNAL CONNECTIONS....................................................................................25
8. SALI-D INSTALLATION................................................................................... 26
8.1 TURNING THE SYSTEM ON...................................................................................26
9. SALI-D OPERATION....................................................................................... 27
9.1 GENERAL SYSTEM OPERATION..............................................................................27
9.2 DEFIBRILLATOR OPERATION .................................................................................28
9.3 GETTING STARTED .............................................................................................32
9.4 ACCESSORIES PLACEMENT...................................................................................33
9.4.1 AED Pads................................................................................................33
9.4.2 Face mask ..............................................................................................34
9.4.3 ecg electrodes ........................................................................................34
9.4.4 spo2sensor .............................................................................................35
9.5 STEP-BY-STEP SYSTEM GUIDANCE .........................................................................35
10. SPECIFICATIONS ........................................................................................... 39
10.1 DIMENSIONS AND WEIGHT.................................................................................39
10.2 ENVIRONMENTAL SPECIFICATIONS .......................................................................39
10.3 POWER SUPPLY ................................................................................................39

Page 5 of 48
10.4 OPERATIONAL SPECIFICATIONS.............................................................................40
10.5 STANDARDS AND SAFETY REQUIREMENTS..............................................................41
11. ALARMS AND INDICATIONS ......................................................................... 43
12. SERVICE AND MAINTENANCE....................................................................... 44
12.1 CLEANING AND ROUTINE MAINTENANCE ...................................................44
13. PARTS AND ACCESSORIES ............................................................................ 45
14. REGULATORY ............................................................................................... 47
15. WARRANTY .................................................................................................. 48

Page 6 of 48
Obtaining Help
If you have a problem that you cannot solve, and the product was purchased
directly from Inovytec,you may contact Inovytec at [e-mail].
If you have a problem that you cannot solve, and the product was purchased
from an authorized Inovytec distributor, please contact your distributor directly
to report the problem.
Note: If this product has not been purchased directly from
Inovytec, please ensure that it has been purchased from an
authorized distributor of Inovytec. To obtain a list of authorized
distributors, contact Inovytec at [e-mail].

Page 7 of 48
1. ABOUT THIS USER MANUAL
This User Manual provides the information necessary to operate and maintain
the SALI-D system.
PLEASE READ THIS USER MANUAL BEFORE OPERATING THE SYSTEM. If any part
of this User Manual is not clear, contact Customer Support for assistance.
PLEASE RETAIN THIS USER MANUAL FOR FUTURE REFERENCE.
1.1 TYPES OF WARNINGS, CAUTIONS AND NOTES
Three types of special message appear in this User Manual:
Warning: A warning indicates precautions to avoid the possibility of
personal injury or death.
Caution: A caution indicates a condition that may lead to damage to
equipment, or a lower quality of treatment.
Note: A note provides other important information.

Page 8 of 48
1.2 GLOSSARY AND ABBREVIATIONS
Term
Description
AED
Automated External Defibrillator
BPM
Breaths Per Minute
LPM
Liter Per Minute
SPO2
Blood Saturation Levels (Percentage)
ECG
Electrocardiogram
HR
Heart Rate Per Minute

Page 9 of 48
2. OVERVIEW OF SYSTEM
2.1 DESCRIPTION OF DEVICE
SALI-D is a new-breed solution for medical emergencies. It is a full critical aid
system that creates a virtual hospital environment at the scene to significantly
increases the effectiveness of the medical first aid treatment. The SALI-D offers
the following features:
•Automated Oxygen Therapy
•Defibrillation
•Airway Management - SpO2 (oxygen saturation) measurement
•Lead ECG / Heart Rate measurement
•Breath Rate measurement
The device is fully self-contained for administering critical first aid in the field.
The User is instructed through easy to follow, visual and audible walk-through
instructions on how to use the device.
Each parameter measured is displayed and the data is transmitted to a web-
based server, allowing a remote healthcare provider to interact with the user.
The SALI-D is equipped with GPRS communication for off-site communication
with an Emergency Care Center.
The SALI-D also provides offsite communication to a Service Center when it is
stowed in its sleep mode to ensure it is continuously maintained in a state of
readiness.
Do not use the SALI-D in MR environment, as safety in MR environment has not
been tested.

Page 10 of 48
3. CONDITIONS FOR USE
3.1 INDICATIONS FOR USE
The SALI-D is intended for use in medical emergencies on patients weighing at
least 25 kg showing signs of physical distress. This may include:
•Respiratory distress (such as shortness of breath)
Note: in cases of upper airway foreign body obstruction, the
obstruction must be addressed first before the SALI-D is used.
•Sudden Cardiac Arrest (SCA) - the patient will be unconscious, not
breathing without a pulse
•Suspected Coronary Artery Disease (CAD) - the patient will be
conscious, showing signs of chest pain and respiratory distress as well
as an elevated or irregular heart rate.
The SALI-D is intended for use by persons who are trained to use the system.
Note: The laws and regulations for the use of AEDs differ from country
to country. Some countries allow laypersons to use AEDs without any
special training. In those countries, the SALI can be used by any
layperson. Please check your national regulations regarding any
restrictions on the use of AEDs.
3.2 CONTRAINDICATIONS
•Treatment or alleviation of disease.
•Suspected spinal injury where the patient should remain immobile.

Page 11 of 48
3.3 LIMITATIONS OF USE
Clinical situations potentially affecting accuracy or performance:
•Controlling the flow in the presence of difficult airways, such as severe
lung blockage and asymmetric air entrance to the lung.
•Low compliance of the airways.
•Laryngospasm and or water in the upper and lower air way as well as
edema may interfere with the device ability to monitor the patient
breath rate.
•Hypothermia can cause vasoconstriction which will interfere with the
SPO2 measurements.
•Drug abuse may cause vasoconstriction which will interfere with the
SPO2 measurements.
•When treating COPD patients, the targeted SpO2measurement is 88-
92% this may affect the oxygen administration as the SALI-D algorithm
stipulate an increase of O2flow to 10 LPM as such, in cases where the
saturation levels are below 90, the increase in O2flow may potentially
decrease respiration rate.

Page 12 of 48
4. SAFETY
4.1 ELECTRICAL SAFETY
The device complies with requirements of IEC/EN 60601-1 for general
requirements for safety of medical electrical equipment:
•Class I Equipment BF type applied part
•Mode of operation: Continuous measurement
•Degree of mobility: Portable
4.2 EMC COMPLIANCE
The SALI-D is suitable for the electromagnetic environment of typical commercial
or hospital settings.
During the immunity testing described below, the SALI-D continued to provide
uninterrupted delivery of data within the device specifications.
4.2.1 EMISSIONS
Electromagnetic Emissions
The SALI-D is intended for use in the electromagnetic environment of commercial
and hospitals. The user should assure that it is used in such an environment.
Emission Tests
Compliance
Electromagnetic Environment – Guidance
RF emissions
CISPR 11 Group 1
The SALI-D uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
The SALI-D is suitable for use in hospitals,
pre-hospital (transport) and field
environments.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations
/ flicker emissions
IEC 61000-3-3
Class D

Page 13 of 48
4.2.2 IMMUNITY
Electromagnetic Immunity
Immunity Test
Compliance Level
Electromagnetic Environment – Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8kV contact
±6 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with
synthetic
material, the relative humidity should be
at
least 30 %.
Electrical fast
transient / burst
IEC 61000-4-4
± 1 kV for signal
ports
± 2 kV for power
supply lines
Mains power quality should be that of a
typical commercial or hospital
environments.
Surge IEC
61000-4-5
± 1 kV differential
mode
± 2 kV common
mode
Mains power quality should be that of a
typical commercial or hospital
environments.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
Reduction of
>95%/ dip 0.5 cycle
60%/dip 5 cycles.
30%/dip 25 cycles.
>95%/ dip 5sec.
Mains power quality should be that of a
typical commercial or hospital
environments.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
10 A/m
Main power quality should be that of a
typical
commercial or hospital environment.
If a dip or an interruption of mains power
occurs, the current of the display series may
be dropped off from normal level, and it may
be necessary to use uninterruptible power
supply or a battery

Page 14 of 48
Conducted RF
IEC 61000-4-3
Radiated RF IEC
61000-4-6
10 V/m
10 Vrms
The SALI-D is suitable for use in typical
commercial or hospital environments.
Portable and mobile RF communications
equipment should be used no closer to any
part of the SALI, including cables, then the
recommended separation distance of 800
MHz to 2.5 GHz.

Page 15 of 48
4.3 SAFETY INSTRUCTIONS
Warnings
DO NOT USE BEFORE READING THIS USER MANUAL.
Product must be used by personnel trained in the use of the device.
DO NOT use the device on pediatric patients less than 25 Kg.
DO NOT use this device for any purpose other than specified in this
manual without written consent and approval from Inovytec Medical
Solutions Ltd.
DO NOT use the device or any device part should it show any signs of
damage. The device should always be maintained in a ready to use
state.
Use of accessories, other than those specified or provided by the
manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity
of this equipment and result in improper operation.
In case of failure or incorrect operation of the device is detected, the
device should not be used. The User should disconnect the patient
and apply additional treatment such as CPR until professional help
arrives.
DO NOT touch the patient during the defibrillator charging and
discharging period.
DO NOT use the defibrillation pads on a wet patient or if the pads are
wet.
Defibrillation current can cause injury. DO NOT touch the patient
during defibrillation.
DO NOT touch equipment connected to or metal objects in contact
with the patient during defibrillation. Conductive parts should not
contact other conductive parts including the earth grounding.
Remove excessive body hair, which may cause skin burns or
ineffective energy transfer.

Page 16 of 48
Warnings
Do not use alcohol, iodine or other skin preparations.
Before defibrillating, disconnect other electrical equipment which
has no DEFIBRILLATION-PROOF applied parts from the patient.
DO NOT allow defibrillation pads to touch each other, or to touch
other electrodes, lead wires, dressings, transdermal patches, etc.
During defibrillation, the operator and all other people must stand
clear of the patient, bed, and all conductive surfaces in contact with
the patient.
The Defibrillator contains an automatic disarm of the stored energy.
If the operator has not delivered the energy to a patient or a test
load, an internal timer will disarm the stored energy. This stored
electrical energy can potentially cause death or injury if discharged
improperly. Follow all instructions in this User’s Manual.
DO NOT move patient. Handling or transporting the patient during
ECG analysis can cause incorrect or delayed diagnosis
Cardiac pacemakers may affect rhythm analysis. Patient pacemakers
may reduce the sensitivity of device analysis and errors in detecting
shockable rhythms.
Radio frequency (RF) interference. Do not operate the defibrillator in
conjunction with electrocautery or diathermy equipment. Any
equipment that emits strong radio frequency signals can cause
electrical interference and distort the analysis signal to cause
inaccurate interpretation of rhythm.
Possible explosion and fire hazard if used in areas where flammable
agents are used.
DO NOT immerse or clean pads with alcohol or solvents
DO NOT perform chest compressions (CPR) through pads. These
actions may damage the electrode pads and cause the Jump Start to
function improperly.

Page 17 of 48
Warnings
Improperly placed pads may produce incorrect analysis and an
inappropriate "shock" or "no shock" decision by the AED.

Page 18 of 48
Cautions
If the device packaging is not intact, do not use the device.
If the device does not turn on, or is not working correctly, discontinue
use. Refer servicing or replacement to qualified service personnel.
Do not disassemble any part of the system components. This system is
not user-serviceable.
Do not use the equipment if it is not working properly or if it has
suffered any damage, for example, by dropping the equipment or
splashing water on it.
Use only Medical Grade Oxygen when refilling the Oxygen Cylinder.
The Oxygen cylinder, if not used, should be replaced once a year
Handle the device with care. Hold the device by its handle when
carrying the system.
Properly store the device in its assigned control station when not in
use.
The ECG Electrodes, AED Pads and Face Mask are single use only. If it
is not removed from a new container, it may have already been used
and should not be used.
Confirm that the expiration date, found on the ECG Electrodes and the
AED Pads packaging, has not been reached.
Repairs should be undertaken only by personnel trained or authorized
by Inovytec Medical Solutions Ltd. Do not modify this equipment
without authorization from Inovytec Medical Solutions Ltd.
The device may not operate correctly if used or stored outside the
relevant temperature or humidity ranges, as described in the per-
formance specifications.
Strictly follow the warning instructions in this manual.
This instrument is fragile. To prevent damage, please handle with care,
including while packing and unpacking.

Page 19 of 48
Cautions
User is prohibited from changing, adding, removing or disassembling
any system parts. Warranty shall not apply to any defects, failure or
damage caused by improper use and/or improper or inadequate
maintenance and care.
The device is not intended for use in the presence of flammable sub-
stances.
The device is not intended for use in the rain and when exposed to
water or other liquids.
To prevent damage, avoid liquid spillage while cleaning.
It is strongly recommended that all SALI-D parts be replaced with parts
purchased from Inovytec Medical Solutions Ltd. or an authorized
distributor. Use of other parts may damage the unit and void the
warranty.
Discarded used or unused ECG Electrodes, AED Pads and Face Mask
are classified as clinical waste. As such, the user is responsible for
complying with all local and national regulations regarding discarding
of clinical waste.
Notes
Dispose of this device and its accessories in accordance with local
regulations.
Use the equipment only for the purpose described in these instructions
for use.
The contents of this manual are subject to change without prior notice.

Page 20 of 48
Notes
The user or any technical personnel who are not formally authorized by
Inovytec Medical Solutions Ltd. should not open the device under any
circumstances. Opening the device could damage the unit and will void
the warranty provided by Inovytec Medical Solutions Ltd.