JOUSING iAED-S1 User Manual

Automated external defibrillator

Hide thumbs

Table Of Contents

Table of Contents

Quick Links

Download this manual

iAED-S1

Automated External Defibrillator

User Manual

Table of Contents

Troubleshooting

Need help?

Do you have a question about the iAED-S1 and is the answer not in the manual?

Questions and answers

Summary of Contents for JOUSING iAED-S1

Page 1 Automated External Defibrillator User Manual...
Page 2 No part of this publication may be reproduced by any organization or individual without the consent of the copyright holder. The software copyright of the iAED-S1 is under protection by the copyright law and the worldwide applicable international treaty provisions. Any reproduced,...
Page 3 Industrial Park District, 215021 Suzhou, PEOPLE’S REPUBLIC OF CHINA. Tel: +86-512-62995391 Fax: +86-512-62995351 Email: service@jousing.com Authorized EU representative Company name: Wellkang Ltd Address: Enterprise Hub, NW Business Complex, 1 Beraghmore Road, Derry, BT48 8SE, Northern Ireland, UK. Tel: +44(33)33031126 Email: AuthRep@CE-marking.eu...
Page 4: Table Of Contents
1.5 User Training Requirement .................... 5 2. Safety Information ........6 2.1 Warnings ........................... 6 2.2 Cautions ..........................8 3 Setting up the iAED-S1 ........ 10 3.1 Installing the Battery ...................... 10 3.2 Battery Insertion Self-Test .................... 11 3.3 Checking the Pads Connection ................... 11 3.4 (Optional) Replacing the Battery .................
Page 5 5.2 Checking the Battery Capacity ..................22 6. Maintenance and Troubleshooting ..... 23 6.1 Routine Maintenance ....................23 6.1.1 Checking the Status Indicator ................23 6.1.2 Checking the Expired Date of the Pads ............24 6.1.3 Checking the Condition of the Unit and Accessories ........24 6.2 Cleaning the Device Surface ..................
Page 6: Introduction To Iaed-S1
1. Introduction to iAED-S1 1.1 Overview The iAED-S1 is an automated External Defibrillator (AED) that is used to treat patients in sudden cardiac arrest (SCA) and designed to be portable and battery powered, for simple and reliable operation. Voice prompts and visual indicators provide a simple interface for the operator.
Page 7: Device Parts
1.2.3 Controls, Indicators and Labels The controls, indicators and labels on the iAED-S1 are shown in Figure 2 and the corresponding functions are described in Table 1.
Page 8 Figure 2 Controls and indicators on the iAED-S1 Table 1 Functions Name Function The ON/OFF Button turns on or off the iAED-S1. The light of the button turns green when the defibrillator is on. Press button to turn on the ①...
Page 9: Indications
⑩ Battery Holder Store battery. 1.3 Indications The iAED-S1 is indicated for use on victims of sudden cardiac arrest when the patients showing both of: ⚫ Unresponsive ⚫ Not breathing or not breathing normally 1.4 Contraindications The iAED-S1 should not be used if the patient shows any of the following signs: ⚫...
Page 10: User Training Requirement
1.5 User Training Requirement The iAED-S1 is intended to be used by persons who are qualified by training in basic life support (CPR/AED certification) and the use of this device.
Page 11: Safety Information
2. Safety Information This section provides important information about safely operating the defibrillator. Many of these messages are repeated elsewhere in this manual and on the iAED-S1 or accessories. DANGER：Immediate hazards that will result in serious personal injury or death.
Page 12 ⚫ An electrical shock hazard will be resulted from unauthorized repair or modification. ⚫ Do not open the iAED-S1, remove its covers, or attempt repair or modification. There are no user-serviceable components in iAED-S1. ⚫ If repair is required, contact Jousing Medical for service.
Page 13: Cautions
⚫ When the essential performance of the device is lost or degraded due to electromagnetic disturbances, please turn off the device and keep away from strong electromagnetic environment and contact Jousing Medical for service. 2.2 Cautions Device Damage If the device appears damage in any way, please contact Jousing Medical for service.
Page 14 Label Please note all cautions and warning signs on the device and the accessories. Performance The device may not in good performance if it is stored, transported or used beyond the range of environmental conditions specified in the technical specifications.
Page 15: Setting Up The Iaed-S1
3 Setting up the iAED-S1 This section describes how to set up the defibrillator for use. A few steps are required to set up the iAED-S1 before using. (The Quick Reference Guide provides illustrated instructions for set up). 3.1 Installing the Battery To make sure the defibrillator in operation, the first step is to insert the battery into the battery holder.
Page 16: Battery Insertion Self-Test
10 minutes, then reinstall the battery to eliminate equipment failure alarm. ◼ “Self-test completed, service required”. That means error is detected and user should contact Jousing Medical for service. 3.3 Checking the Pads Connection Procedure 1. Make sure the pads package is intact and within expired date. Replace the pads if it is expired or the pads package is damaged.
Page 17: Optional) Replacing The Battery
4. Warning: Use only the pads approved by Jousing Medical, the pads specified in the 1.2 Device Appearance. Figure 4 Pads Connector Insertion 3.4 (Optional) Replacing the Battery Scenarios Replace the battery when the device prompts “Replace the battery” or “Battery low”.
Page 18 Verification Step one b) Step two Figure 5 Removing the battery...
Page 19: Using The Iaed-S1
Check the patient and get the iAED-S1. 2. If you are the only rescuer, first call the emergency services, quickly get the iAED-S1 and bring it to the patient. If there is any delay in getting the defibrillator, perform cardiopulmonary resuscitation (CPR) until the iAED-S1 is available.
Page 20: Steps
4.3 Steps The iAED-S1 is designed to be easily use. Users can use it according to the following figure. To learn more about detailed steps instructions, please refer to the sections 4.3.1 Turning on the iAED-S1 to 4.3.9 Terminate Operation.
Page 21: Preparing The Patient
Verification The device turns on and performs self-test. Once it passes the self-test, it will prompt “Beep, call for help now.” Figure 7 Power on the Device 4.3.2 Preparing the Patient Procedure Lay the patient down and do the followings if necessary: ※The device prompts “Remove all clothing from patient’s chest”.
Page 22: Tearing The Pads Package
Figure 8 Removing all clothing from the patient’s chest 4.3.3 Tearing the Pads Package Procedure 1. Tear the pads package and take out the pads from the package, as shown in figure 9 and figure 10. ※ The device prompts “Tear open pads package and remove pads”. Warning: Do not tear the pads package until you need to use the pads.
Page 23: Placing The Pads To The Patient
4.3.4 Placing the Pads to the Patient Procedure Place one pad marked with heart-shape over the ribs on the patient's left side below the left breast and the other pad below the patient's right collar bone as shown in figure 11. Warning: The pads should be placed on a flat surface of the patient's skin.
Page 24: Ecg Rhythm Analysis
Analyzing heart rhythm.” At this time, the user should not touch the patient. ⚫ If the iAED-S1 has detected motion in the patient the defibrillator will stop analysis for up to 10 seconds. The defibrillator notifies the responder of the problem.
Page 25: Defibrillation Required
CPR. “Shock delivered” will be prompted after shock button been pressed. After each shock, the iAED-S1 will guide the user to perform CPR, refer to 10. After CPR, the device will restart rhythm analysis. Once it detects that the shockable rhythm still presents, it will be ready for another shock.
Page 26: No Shock Required
4.3.7 No Shock Required If the iAED-S1 determines that no shock is required, the device will prompt “No shock advised”, The user will be prompted to begin CPR, refer to 4.3.8 CPR. 4.3.8 CPR Procedure 1. Compress the patient’s chest when the device prompts “da, da” beat.
Page 27: After Using The Iaed-S1
5. After Using the iAED-S1 5.1 Replacing Pads After rescuing, press the ON/OFF button to turn the device into standby mode. Change the pads into new ones: Insert the pads plug into the pads socket( see 3.3 Checking the Pads Connection.) and put the pads package in the carrying bag.
Page 28: Maintenance And Troubleshooting
6. Maintenance and Troubleshooting The iAED-S1 is very simple to maintain. The defibrillator performs a self-test every day and its extensive automatic self-test features eliminate the need for any manual calibration. The iAED-S1 has no user-serviceable parts. 6.1 Routine Maintenance...
Page 29: Checking The Expired Date Of The Pads
Figure 12 The Status indicator 6.1.2 Checking the Expired Date of the Pads Procedure The expired date of pads is shown in the dashed box on the packing bag label, as shown in figure 13.The pads are disposable product, so they must be replaced if the package has been damaged or the pads have been used.
Page 30: Cleaning The Device Surface
⚫ Use a soft cloth dampened in the cleaning agent to clean the device surface. Do not immerse the iAED-S1 in water or allow fluids to spill onto it. ⚫ If necessary, clean the excess agents on device with water or a dry cloth.
Page 31: Transportation Environment
Dispose the pads as infectious waste. Contact Jousing Medical for consultation. 6.6 Data Management The iAED-S1 will record data of operation in the internal memory, including ECG data, event logs and self-test data. Authorized person can download the...
Page 32: Troubleshooting
CPR, etc. Device self-test data includes periodic self-test, battery Self-test Data insertion self-test The iAED-S1 keeps ECG records of the last two rescues. Each record period can be 40 minutes maximum, starting from pads attached. 6.7 Troubleshooting Table 4 Troubleshooting...
Page 33 “replace battery now” in rescue. Status indicator is solid in red, and the iAED-S1 The defibrillator needs Contact Jousing prompts “Service repair. Medical for service. required” during rescue. Make sure the pads have been removed...
Page 34 “begin CPR now” for service after this during rescue. rescue. Status indicator is solid Replace a new battery in red, and the iAED-S1 immediately after prompts “Battery low” in Battery is low. performing this rescue. battery insertion Or, replace a new self-test.
Page 35 Other phenomenon and its possible cause. Symptom Possible Cause Corrective Action Patient’s ECG converts The iAED-S1 prompts from shock to no shock “rhythm changed, shock rhythms, no shock No action needed. cancelled”. advised, the device is normal.
Page 36: Product Warranty
7. Product Warranty Manufacturer provides a limited warranty in product warranty period. Below cases are not in warranty: Violation of instructions. Operating error. Improper use or handling. Disassemble the device by unauthorized personnel. Force majeure, such as lightning, etc. Transport damage caused by improper packaging. Device has not been maintained.
Page 37: Annex
Annex A Settings Parameter Default Category Parameters Configuration Configuration System Time / Date of Time Date manufacture Discharge sequence Note: refers to Defibrillation analysis and shock up to N times before performing CPR 0- 30:2 (Pressing - CPR assist type ventilation ratio) Note: tips on how 1-Chest...
Page 38: B Symbols
B Symbols Symbol Description Manufacturer. Catalogue number. Serial number. Date of manufacture. Follow instructions for use Dust protected, protected against splashing water. IP54 Defibrillation-proof type BF applied part. General warning sign. Dangerous voltage. Do not re-use. This way up. Fragile, Handle with care.
Page 39 The range of humidity limitation from 5% to 95%. ON/OFF button. Expired dated. Authorized representative in the European Community. Non-sterile. Information button (i-button). Shock button. Dispose of in accordance with each country’s national law. Internally powered : LiMnO battery Do not expose the battery to high heat or open flame. Do not incinerate.
Page 40: C Glossary Of Terms
Pads patient’s heart rhythm and to transfer the defibrillation shock. Manufacturer Jousing Medical Co., Ltd is the manufacturer in this manual. Electrocardiogram. Cardiopulmonary Resuscitation. A technology that is to rescue cardiac arrest patients with artificial respiration and chest compression.
Page 41: D Technical Specifications
D Technical Specifications Physical Size 198mm (L)×197mm (W)×67mm (H) Weight (include ≤2kg battery and pads) Environmental Operating(with battery and pads installed) 0℃～50℃,5%～95% RH(non-condensing) Temperature Standby (with battery and pads installed) and relative 5℃～35℃,5%～95% RH(non-condensing) humidity Storage/shipping(with battery and pads ) -30℃～65℃...
Page 42 5 years from date of manufacture when stored and Shelf life maintained according to directions provided in this manual. Standby life 5 years when stored and maintained according to directions (after provided in this manual. insertion)
Page 43: E Waveform Specifications
E Waveform Specifications The iAED-S1 delivers a Biphasic Truncated Exponential waveform, with its current and duration automatically adjusted to patient’s impedance, as shown in figure E-1. Time(ms) Figure E-1 Defibrillation energy waveform Table 5 Defibrillation energy load phase 1 phase 2...
Page 44: F Ecg Analysis Algorithm
Shock Rhythm Criteria When the patient's symptoms are consistent with suggested criteria, the iAED-S1 is designed to recommend a defibrillation shock when it detects proper pad impedance and the patient's rhythm for any one of the following table: Peak-to-peak amplitude reaches at least 200 µVolts...
Page 45 Rhythm – All other 98.7% >97% >95% non-shock rhythms Jousing medical collects ECG samples from the industry recognized ECG databases, including MITDB、AHADB、CUDB、VFDB、SVDB、EDB、QTDB、 SDDB and Jousing self-built ECG database. According to the AHA recommendations and AAMI standard DF80, supraventricular is classified into nonshockable rhythm.
Page 46: G Emc Test Results
EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration-electromagnetic emission The iAED-S1 Automated External Defibrillator is intended for use in the electromagnetic environment specified below. The user of the iAED-S1 Automated External Defibrillator should assure that it is used in such environment.
Page 47 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the iAED-S1, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Page 48 5785 217 Hz...
Page 49: H Periodic Checklist
H Periodic Checklist Periodic Checklist Date Check status indicator Check pads’ expired dated Check Completeness of Parts Inspector signature...
Page 50: I Device Tracking Table
Please record device information after you receive the equipment. -Fax to +86 0512-62995391. -Send an email to service@jousing.com. If the device address or the user’s contact Information is changed, please send the updated information to us with the least delay possible.
Page 51 Device tracking table User Information User name: Company name: Address: City: Province: Zip code: Country: Contact name: Tel: Fax: Email: Device Information Product name: Serial number: REF: Installed Time: Device Location:...