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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:

[email protected]

Web Site:

http://www.Inovytec.com

Européen Agent Information:

OBELIS S.A.

Bd Général Wahis, 53

B-1030 Brussels

Belgium

Tel3227325954

Fax: +3227326003

E-mail:

[email protected]

Website

www.obelis.net

2797

Содержание SALI D

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

Страница 2: ...nder 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 M...

Страница 3: ...ovytec 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 wr...

Страница 4: ...AFETY 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...

Страница 5: ...ONAL 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 REGU...

Страница 6: ...em 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 purchase...

Страница 7: ...act 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 war...

Страница 8: ...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 R...

Страница 9: ...y 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 me...

Страница 10: ...spected 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...

Страница 11: ...terfere 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 wi...

Страница 12: ...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...

Страница 13: ...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 in...

Страница 14: ...0 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 c...

Страница 15: ...etic 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 use...

Страница 16: ...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 C...

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

Страница 18: ...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 hav...

Страница 19: ...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 warr...

Страница 20: ...cal 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 p...

Страница 21: ...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 Cau...

Страница 22: ...Page 22 of 48 Symbol Meaning AED 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...

Страница 23: ...Page 23 of 48 6 SYSTEM COMPONENTS 6 1 SALI D MAIN COMPONENTS 1 Patient Head Rest 2 display 3 Keyboard 4 Defibrillator Pads 5 ECG Wrist Electrode stickers 6 SpO2 Sensor 7 Face Mask 1 2 3 4 5 6 7...

Страница 24: ...Page 24 of 48 8 Battery and SIM compartment 9 O2 Cylinder compartment 10 Docking Station charging points 8 9 10...

Страница 25: ...I D 7 1 EXTERNAL CONNECTIONS 7 2 INTERNAL CONNECTIONS 1 ON OFF Switch 2 Auxiliary 9 36 VDC Connector 3 Auxiliary O2 Connector 1 2 3 2 3 4 1 1 Face Mask Connectors 2 SpO2 Connector Blue 3 ECG Connector...

Страница 26: ...intenance The Wall Mount Cabinet requires connection to a 100 240 AC power source Charging of the batteries is performed by RF radio frequency and is isolated from the system The installation of the d...

Страница 27: ...d audio instruction to guide the operator through the process of administering treatment to the patient The SALI D will determine if defibrillation is needed shockable rhythm and if appropriate will g...

Страница 28: ...e touched or moved during this process as it may lead to an incorrect analyzing result The defibrillator delivers the defibrillation shock through two self adhesive pre gelled low impedance electrode...

Страница 29: ...eriod of charging if the defibrillators detects that the shockable rhythm has changed to a normal one the defibrillator will stop the current procedure and switch to CPR procedure Warning During the d...

Страница 30: ...to 200J when connected to resistive loads of 25 through 175 Ohms The waveforms are characterized by typical values for peak current Ip duration of the first output phase and duration of the second ou...

Страница 31: ...ricular tachycardia at a rate greater than 160 BPM Non shockable rhythms include various sinus rhythms including supraventricular tachycardia atrial fibrillation atrial flutter sinus rhythm with PVC s...

Страница 32: ...Conscious Patients 6 1 Place Face Mask as described in section Face mask 6 2 Place ECG electrodes as described in section ECG electrodes 6 3 Place SpO2 Sensor as described in section SpO2 sensor The...

Страница 33: ...er source 9 4 ACCESSORIES PLACEMENT 9 4 1 AED PADS The AED pads must be correctly placed on the patient Before placing the pads the following procedures must be done 1 Remove the AED pads from the com...

Страница 34: ...the chest and slip the head strap around the back of the head 4 Secure the Face Mask by pulling the two straps 5 Observe that the patient is breathing properly 9 4 3 ECG ELECTRODES The ECG electrode s...

Страница 35: ...ve the Finger Probe from its storage compartment 2 Wipe off any water grease or any grime that may be present on the finger 3 Place the Finger Probe on the patient s index finger 9 5 STEP BY STEP SYST...

Страница 36: ...Page 36 of 48 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 Or Perform CPR...

Страница 37: ...Page 37 of 48 Hand placement Compression rhythm Stop Responsive Patient Place Mask on face Place ECG electrodes...

Страница 38: ...Page 38 of 48 Place SpO2 sensor...

Страница 39: ...to 90 Water and Dust Resistance IP55 Note First digit relates to object size protection 1 mm Second digit indicates protection from water jets from any direction Atmospheric Pressure 101 hPa to 619 hP...

Страница 40: ...on Measuring Range 0 100 1 Accuracy 70 100 2 69 not specified Indication Below 94 Respiration Range 6 40 BPM 1 BPM Resolution 1 BPM Indications Above 35 BPM below 6 BPM AED Energy Sequence Adult 150 J...

Страница 41: ...t 1 11 General Requirements For Basic Safety And Essential Performance Collateral Standard Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Envi...

Страница 42: ...ulse 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 f...

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

Страница 44: ...wing maintenance activities are required to be performed after each use of the SALI D Part Procedure Comments SALI D Spray entire surface with 70 Alcohol Wait for 1 min Wipe device with pharma wipes 7...

Страница 45: ...y 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 m...

Страница 46: ...Page 46 of 48 Fax 972 9 965 64 79 E mail Info Inovytec com Web Site http www Inovytec com...

Страница 47: ...aanana 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 Europ en Agent Information OBELIS S A Bd G n ral Wahis 53 B 1030 Brussels Belgium...

Страница 48: ...al Solutions Ltd service department or your local distributor If shipping the device is required pack the device and its accessories carefully to prevent shipping damage Duration Inovytec Medical Solu...

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