Inovytec SALI D Operator's Manual
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Inovytec SALI D Operator's Manual

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

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Summary of Contents for Inovytec SALI D

  • Page 1 EMPOWERING EMERGENCY CARE INV-IFU-2001, Rev. 09, Last update September 2021 Page 1 of 48...
  • Page 2 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.
  • Page 3 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.

  • Page 4: Table Of Contents

    TABLE OF CONTENTS ABOUT THIS USER MANUAL ................7 TYPES OF WARNINGS, CAUTIONS AND NOTES ..........7 ................8 LOSSARY AND BBREVIATIONS OVERVIEW OF SYSTEM ................... 9 ..................9 ESCRIPTION OF EVICE CONDITIONS FOR USE .................. 10 ..................10 NDICATIONS FOR ..................
  • Page 5 10.4 ................40 OPERATIONAL SPECIFICATIONS 10.5 S .............. 41 TANDARDS AND AFETY EQUIREMENTS 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.
  • Page 6 Inovytec, you may contact Inovytec at info@Inovytec.com. 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.

  • Page 7: About This User Manual

    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.

  • Page 8: Glossary And Abbreviations

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

  • Page 9: Overview Of System

    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 •...

  • Page 10: Conditions For Use

    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.

  • Page 11: Limitations Of Use

    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 •...

  • Page 12: Safety

    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 •...

  • Page 13: Immunity

    4.2.2 IMMUNITY Electromagnetic Immunity Immunity Test Compliance Level Electromagnetic Environment – Guidance Floors should be wood, concrete or ceramic Electrostatic ± 8kV contact tile. If floors are covered with synthetic discharge (ESD) ±6 kV air material, the relative humidity should be at IEC 61000-4-2 least 30 %.
  • Page 14 Conducted RF 10 V/m IEC 61000-4-3 The SALI-D is suitable for use in typical commercial or hospital environments. Radiated RF IEC 10 Vrms 61000-4-6 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: Safety Instructions

    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.
  • Page 16 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.
  • Page 17 Warnings Improperly placed pads may produce incorrect analysis and an inappropriate "shock" or "no shock" decision by the AED. Page 17 of 48...
  • Page 18 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.
  • Page 19 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.
  • Page 20 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.

  • Page 21: Symbols

    5. SYMBOLS The following table explains the meaning of each symbol on the label. Symbol Meaning Consult instructions for use Manufacturer European approval mark Authorized representative in the European Community Serial Number Catalogue Number Batch code Date of Manufacturing Direct current Alternating current Do not dispose of, contact for recycling Caution: Law prohibits dispensing without...
  • Page 22 Symbol Meaning Oxygen Cylinder Use by date Do not expose to rain Do not expose to the sun Product is non- sterile Product contains Phthalate’s type DEHP Product is Latex Free Page 22 of 48...

  • Page 23: System Components

    SYSTEM COMPONENTS SALI-D – MAIN COMPONENTS (1) Patient Head Rest, (2) display, (3) Keyboard, (4) Defibrillator Pads, (5) ECG Wrist Electrode stickers, (6) SpO Sensor, (7) Face Mask Page 23 of 48...
  • Page 24 (8) Battery and SIM compartment, (9) O Cylinder compartment, (10) Docking Station charging points Page 24 of 48...

  • Page 25: Connecting The Sali-D

    7. CONNECTING THE SALI-D EXTERNAL CONNECTIONS 1 ON/OFF Switch 2 Auxiliary 9 -36 VDC Connector 3 Auxiliary O2 Connector 7.2 INTERNAL CONNECTIONS 1 Face Mask Connectors 2 SpO Connector (Blue) 3 ECG Connector (Black) 4 Defibrillator Connectors Page 25 of 48...

  • Page 26: Sali-D Installation

    Charging of the batteries is performed by RF (radio frequency) and is isolated from the system. The installation of the device Wall Mount shall be performed only by an approved Inovytec Representative and according to Wall Mount Installation Instructions . 8.1 TURNING THE SYSTEM ON...

  • Page 27: Sali-D Operation

    9. SALI-D OPERATION 9.1 GENERAL SYSTEM OPERATION The SALI-D is a safe and easy to use device. Once the SALI-D is removed from its control station it immediately informs the Medical Emergency Center that it is now in operation. When the Operator arrives to the patient, he opens the SALI-D door. With the door open, the SALI-D immediately becomes fully operational, instructing the operator as to how to respond to a conscious or unconscious patient and to place the patient’s head on the head rest.

  • Page 28: Defibrillator Operation

    a) If there is no heart no heart rate is detected. b) If ventricular fibrillation (VF) or ventricular tachycardia (VT) is detected. 9.2 DEFIBRILLATOR OPERATION The defibrillator recognizes ventricular fibrillation and ventricular tachycardia. When properly connected to a patient who is unconscious, the defibrillator analyzes the patient's heart rhythm to determine if a shockable rhythm exists and if defibrillation is necessary.
  • Page 29 Normal heart rhythm is detected: If a normal heart rhythm is detected, the defibrillator will start an internal discharging. Discharging Procedure When the charging procedure of the defibrillator is finished, the defibrillator will enter the discharging procedure and give voice prompts to the operator. Warning: During the discharging procedure the following instruction will appear "Don't touch patient, rhythm analysis"...
  • Page 30 An emergency cancellation If any unpredictable situation occurs, the operator can use ON/OFF button at the rear of the device to make an emergency cancellation. Waveform details The table below provides details of the biphasic truncated exponential waveform delivered by the AED (set to 200J) when connected to resistive loads of 25 through 175 Ohms.
  • Page 31 Rhythm Recognition Performance The AED algorithm exceeds the requirements of ANSI/AAMI DF39-1993, section 3.3.18 and the sensitivity and specificity levels recommended by the AHA - Automatic External Defibrillators for Public Access Use: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance.

  • Page 32: Getting Started

    9.3 GETTING STARTED 1. Lay the SALI-D down flat beside the patient so that it is resting on its bottom legs 2. Open the SALI-D Door. This will provide access to the required accessories. 3. Place the patient's head on the head rest. 4.

  • Page 33: Accessories Placement

    For Professional Medical staff Only: 1. If required, switch to Advance Mode by pressing the ADV button. This will allow you to see on the display all the vital signs and historical major events that have taken place. 2. SALI-D can be connected to external auxiliary devices through the auxiliary panel on the device.

  • Page 34: Face Mask

    9.4.2 FACE MASK The Face Mask should be correctly placed over the patient’s face. Before placing the Face Mask, the following procedures must be done: 1. Remove the Face Mask from its storage compartment. 2. Before placing the Mask on the patient, check that there are no secretions or vomiting present around the mouth.

  • Page 35: Spo 2 Sensor

    9.4.4 SpO SENSOR The SpO Finger Probe should be correctly placed on the patient’s index finger. Before placing the probe, the following procedures must be done: 1. Remove the Finger Probe from its storage compartment. 2. Wipe off any water, grease or any grime that may be present on the finger.
  • Page 36 Remove clothes from patient’s chest to expose the skin Take the pads and remove protective material Place the pads Advise whether a shock is required Perform CPR: Page 36 of 48...
  • Page 37 Hand placement Compression rhythm Stop Responsive Patient: Place Mask on face Place ECG electrodes Page 37 of 48...
  • Page 38 Place SpO sensor Page 38 of 48...

  • Page 39: Specifications

    10. SPECIFICATIONS 10.1 DIMENSIONS AND WEIGHT Dimension Measurement Width 420 mm Length 390 mm Height 120 mm Weight 10 kg with oxygen 10.2 ENVIRONMENTAL SPECIFICATIONS Operating Temperature -18 °C to 40 °C (0°F to 122 °F) Storage Temperature -40 °C to 70 °C (-40 °F to 158 °F) Relative Humidity 10% to 90% Water and Dust...

  • Page 40: Operational Specifications

    10.4 OPERATIONAL SPECIFICATIONS Oxygen Supply Cylinder Flow 5 or 10 lpm Duration 20 min. at 10 lpm ECG 3-Lead Measure range -2.0mV - 2.0mV ± 0.02mV or 10% whichever is greater Indication Suspected VF/VT SPO2 saturation Measuring Range 0 – 100 % ± 1% Accuracy 70 % –...

  • Page 41: Standards And Safety Requirements

    10.5 STANDARDS AND SAFETY REQUIREMENTS The Ventway Sparrow meets the requirements of the following international standards: IEC 60601-1 Medical electrical equipment — Part 1: General require- ments for basic safety and essential performance IEC 60601-1-2 Medical electrical equipment — Part 1-2: General re- quirements for basic safety and essential performance —...
  • Page 42 ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment EN ISO 10524-1 Pressure regulators for use with medical gases -- Part 1: Pressure regulators and pressure regulators with flow- metering devices EN ISO 10524-3 Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves...

  • Page 43: Alarms And Indications

    11. ALARMS AND INDICATIONS This section provides information about alarms and system indicators. Low Battery Low Oxygen Indication LED will light red: System not operational Stop CPR Do Not Touch Patient Page 43 of 48...

  • Page 44: Service And Maintenance

    Service Center. If the Service Center obtains a malfunction indication, the Service Center will automatically alert the Client that Service is required. Service should only be provided by an authorized Inovytec Medical Solutions Ltd. representative. 12.1 CLEANING AND ROUTINE MAINTENANCE...

  • Page 45: Parts And Accessories

    Battery Pack All equipment and accessories are available directly from Inovytec Medical Solutions Ltd. or from an authorized local distributor. For a Inovytec Medical Solutions Ltd. local distributor please contact Inovytec email as specified below. Note: Consumables may be available in pre-prepared kits, please contact Inovytec Medical Solutions Ltd.
  • Page 46 Fax: +972 9 965 64 79 E-mail: Info@Inovytec.com; Web Site: http://www.Inovytec.com Page 46 of 48...

  • Page 47: Regulatory

    14. REGULATORY Manufacturer: Inovytec Medical Solutions Ltd. 5 HaTidhar St., Raanana 4366507, Israel Tel: +972 9 965 64 70 Fax: +972 9 965 64 79 E-mail: Info@Inovytec.com Web Site: http://www.Inovytec.com Européen Agent Information: OBELIS S.A. Bd Général Wahis, 53 B-1030 Brussels...

  • Page 48: Warranty

    If shipping the device is required, pack the device and its accessories carefully to prevent shipping damage. Duration Inovytec Medical Solutions Ltd. will repair or replace, at its sole discretion, the product or any defective part, provided it is returned to Inovytec Medical Solutions Ltd. service within 30 days.

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