Saadat SHOOKA User Manual
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Saadat SHOOKA User Manual

Electroshock
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SAADAT Co.
User Manual
SHOOKA
Electroshock
D00983-V7
1

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Summary of Contents for Saadat SHOOKA

  • Page 1 SAADAT Co. User Manual SHOOKA Electroshock D00983-V7...
  • Page 2 POOYANDEGAN RAH SAADAT CO. No. 4, 1st East St., Ettehad Blvd., Damavand St., TEHRAN, IRAN. Post box: 1658916599 Tel: +98 21 77960719, +98 21 77962181 Fax: +98 21 77964239 Customer Services: Tel: +98 21 73098000, +98 21 77798910 Cell: +98 912 1977157...
  • Page 3 It also describes all adjustable and measurable parameters by the system, defined maneuvers, alarms and briefly all capabilities of the SHOOKA AED. Observance of this manual is a prerequisite for proper operation and assures patient and operator’s safety.

  • Page 4: Table Of Contents

    ARNINGS AND SAFETY INFORMATION 1-4 D ............................ 7 EVICE ABELS AND YMBOLS 1-5 G ..........................8 UARANTEE AND RESPONSIBILITIES OVERVIEW OF SHOOKA AED ..........................9 2-1 D ..............................9 EFIBRILLATION 2-2 D ................................. 9 EVICE VIEWS ACCESSORIES ..............................12 3-1 B ................................

  • Page 5: Introduction

    SHOOKA is manufactured based on CPR guideline of AHA revised in 2010. SHOOKA provides an internal automated self-test and indicates the device is ready to use or not. SHOOKA operates with disposable battery and detects low battery condition and produces related prompts for battery exchanging.

  • Page 6: Warnings And Safety Information

    ➢ Make sure there is no direct contact between user and patient during shock. ➢ Do not use SHOOKA AED in the presence of flammable gases or anesthetics. Turn off gas source or move source away from patient during defibrillation. Do not defibrillate in an oxygen-enriched atmosphere.

  • Page 7: Device Labels And Symbols

    Device Labels and Symbols Table 1: Symbols Waste equipment is disposed of in compliance with environmental requirements Compliance with CE standard requirements Under 12.5 mm diameter protection from particles and vertically dripping water have IP22 no harmful effect when the enclosure is tilted at an angle up to 15°...

  • Page 8: Guarantee And Responsibilities

    BF-type applied parts European representative Dangerous voltage Guarantee and responsibilities The manufacturer will not take any responsibility if operator: • Misuses the device • Fails to follow operating instructions • Disregards any warning or technical information • Modifies the device in any way •...

  • Page 9: Overview Of Shooka Aed

    SHOOKA provides two operation modes: 1- Rescue mode: This is default operation mode of the device when it turns ON. In this mode AED provides rescue measures. SHOOKA could be configured as fully automated or semi-automated which could be decided by customer requirement.
  • Page 10 Back view Top View Pad Storage Area USB Port Speaker Battery Pack Table 3: Controls Title Description Status indicator Indicate the last self-test status ON/OFF key Used for turning device on or off Child key This button set AED for child mode. In semi-automatic versions, this button is used to deliver shock to patient after hearing appropriate voice alarm.
  • Page 11 In management mode, touch screen provides required control menu for configuration of the device. PAD connector PAD connection Battery placement Battery placement USB Connector USB connection for export data...

  • Page 12: Accessories

    Table 4: Accessories Manufacturer Part Accessory Manufacturer Number Adult PAD FIAB F7958W Child PAD FIAB F7958P Battery Pack SAADAT P41021 Battery SHOOKA uses non-chargeable lithium-ion manganese Dioxide battery (LiMnO2) pack for operation. Install battery pack according to below steps:...
  • Page 13 Warning ➢ Lithium manganese dioxide battery packs are non-rechargeable. Do not attempt to recharge the battery pack, it may result in fire or explosion. ➢ Do not immerse battery pack in water or other liquids It may result in fire or explosion.

  • Page 14: Pads

    Pads SKOOKA AED always has a connected pad. If the pad is not compatible with patient (Adult/child) change the pad with suitable pad according to below steps: • Adult Connect adult pad as picture below: Figure 2: Adult pad placement •...
  • Page 15 Warning ➢ To prevent possible cross-contamination and inappropriate shock delivery, single-use accessories (such as pads) should not be reused. ➢ Pay attention to expiration date of the accessories and avoid using outdated accessories. ➢ When using Child pad, the Child mode will be selected automatically. ➢...

  • Page 16: Operation

    ➢ The AED must be operated by trained rescuers. ➢ Be sure battery is installed and pad’s cable is connected. When SHOOKA is turned on in rescue mode, operators should follow below sequences: Table 5: AED mode user prompts Step...
  • Page 17 Step Action Result (Audio prompt will be repeated after 4 seconds) AED determines that patient has a shockable rhythm or not: If rhythm is shockable plays: After ANALYZING, AED SHOCK ADVISED decides whether a shock is needed DON’T TOUCH PATIENT If rhythm is not shockable Plays: SHOCK NOT ADVISED According to previous step:...
  • Page 18 Step Action Result Perform CPR (Audio prompt will be repeated each 30 seconds) CPR Remaining Time MINUTE: SECOND After 30 Pushes, Give Two Breaths (Visual prompt GIVE 2 RESCUE BREATHS ANALYZING HEART RHYTHM, DON’T TOUCH PATIENT Wait until AED determines (Audio prompt) next step AED determine next action according to...
  • Page 19 ➢ Do not move the AED during analysis. Moving the AED during analysis may affect the ECG signal resulting in an inappropriate shock or no shock advised decision. Do not touch the patient or the AED during analysis. ➢ Before using this defibrillator, disconnect all equipment that is not defibrillator- protected from the patient.

  • Page 20: Aed Management Mode

    5 AED Management Mode SHOOKA provides management mode for device configuration, self-test, data transferring and updates. Warning ➢ Approved supplier must change the AED setting. ➢ In case the cross symbol is pressed in management mode, the device will autosave the data and changes and AED will be turn off.
  • Page 21 Figure 5: Date/Time page Following changes can be done in this page: • Calendar: Solar or Christian calendars can be selected • Date: date can be adjusted by arrow buttons • Time: time can be adjusted by arrow buttons Language: English or Persian language can be selected AED Mode: Semi or Full mode can be selected.

  • Page 22: Maintenance And Troubleshooting

    • Verify case has no physical problem (broken...) • Verify additional accessories are available SELF-Test SHOOKA provides self-test in order to verify device is ready to use or not. These tests verify the following features: • Self-test include: 1- Battery charge...

  • Page 23: Troubleshooting

    Troubleshooting In the following table, issues which could be happen to SHOOKA AED and relative actions are described: Table 6: Troubleshooting Issue Action Status indicator shows X when AED is OFF: Turn on the AED and wait until automated self-test is completed.

  • Page 24: Periodic Inspection

    Periodic inspection There is a periodic inspection procedure for the AED which is done every 1 years after sale by the company. All critical components are tested in this procedure and malfunctioning ones will be replaced. Warning Do not open unit, remove casing or attempt to repair. Dangerous high voltages and ➢...

  • Page 25: Cleaning And Disinfecting

    Thus, there is no need for cleaning and disinfecting, • Do not sterilize the SHOOKA AED and its accessories. • Do not wipe the display with dry cloth. It might cause scratch.

  • Page 26: Technical Specifications

    8 Technical Specifications Table 8: Specifications Disposable Battery Chemistry LiMnO2 voltage Battery 5Ah, 200 defibrillator discharges at maximum energy (200J) or 5 hours of capacity continuous ECG Monitoring Shelf-life 5 years Environment Operating 0° to 50° C Temperature Storage -30° to 70° C Temperature Humidity 10 to 95% relative humidity...
  • Page 27 Defibrillator Electrode ECG Protected Circuitry Analyzing Time < 10s UART Communication with Mother Board Communication UART Communication with HV Board Time required for device to get ready at maximum energy from Less than 40s Power ON for all battery conditions Time required for device to get ready at maximum energy from Less than 30s...

  • Page 28: Appendix 1_ Rectilinear Biphasic Waveform

    Appendix 1_ Rectilinear Biphasic Waveform SHOOKA uses rectilinear biphasic waveform which reduces peak current of the shock. Below table shows the energy characteristics for different energy and loads. Table 8: Delivered energy for different loads Selected Energy Load Child Adult...
  • Page 29 Figure 7: 200J Shock Current waveform Figure 8: 150J Shock Current waveform Figure 9: 120J Shock Current waveform...
  • Page 30 Figure 10: 85J Shock Current waveform Figure 11: 70J Shock Current waveform Figure 12: 50J Shock Current waveform...

  • Page 31: Appendix 2_ Ecg Analysis Algorithm Accuracy

    SA for each ECG waveform segment was compared to the databases reference annotations or treatment recommendation by similar device. The main ECG database used to verify the performance of the SHOOKA automatic external defibrillator for SA is named the PhysioNet Test Set. In addition, the ECG database named Simulator Test Set was used to provide shockable and Non-shockable ECG segments for verification purposes.
  • Page 32 Performance Report is provided in accordance with AHA recommendations and IEC requirements for reporting performance data for a rhythm recognition detector. A. Acquisition and Annotation Methodology This section includes recording methods, rhythm source, rhythm selection criteria, annotation methods, and annotation criteria for the databases. PhysioNet Test Set The PhysioNet Test Set includes 5891 ECG segments gathered from a variety of sources.
  • Page 33 Also included rhythms with pacemaker pulses. C. Shock Algorithm Performance Report The results of tests with the Simulator and PhysioNet Test Sets in the SHOOKA automatic external defibrillator are shown below in the context of requirements from IEC 60601-2-4 and the recommendations from the American Heart Association.
  • Page 34 Non-Shockable 300 total 5270 total >99% (Specificity) >96% 4123 >95% (Specificity) >97% Other QRS 1118 >95% (Specificity) >92% Asystole Intermediate Report Only Same as Zoll Fine VF Report Only AED Pro Other VT...

  • Page 35: Appendix 3_Emc

    ➢ It is suggested to use another sensitive device in distance with the AED. Guidance and manufacturer's declaration – SHOOKA emissions The SHOOKA is intended for use in the electromagnetic environment specified below. The customer or the user of the SHOOKA, should assure that it is used in such an environment.
  • Page 36 Guidance and manufacturer's declaration – electromagnetic immunity The SHOOKA is intended for use in the electromagnetic environment specified below. The customer or the user of the SHOOKA should assures that it is used in such an environment.
  • Page 37 Pulse LTE Band 13, 704- 787 modulation 217 Hz GSM 800/900, TETRA 800, Pulse 800- 960 iDEN 820, modulation CDMA 850, 18 Hz LTE Band 5 GSM 1800; 1720 CDMA 1900; Pulse GSM 1900; 1845 1700- 1990 modulation DECT; LTE 217 Hz Band 1, 3, 4 25;...

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