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Primedic HeartSave Y Instructions For Use Manual

Automated external defibrillator
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Automated External Defibrillator
Instructions for use
HeartSave Y | YA
English
24335 EN
Revision: D1
Date of issue: 08/2024

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  • Page 1 Automated External Defibrillator Instructions for use HeartSave Y | YA English 24335 EN Revision: D1 Date of issue: 08/2024...
  • Page 3 Masthead Publisher Manufacturer: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Address: No.1 Baisheng Road Development Zone, Danyang, Jiangsu People’s Republic of China Tel.: 86-511-86900833 Fax: 86-511-86900851 Postal code: 212300 Web: www.yuwell.com/en Metrax GmbH Address: Rheinwaldstr. 22, D-78628 Rottweil, Germany Proprietary note The manufacturer reserves all rights to these operating instructions.

  • Page 4: Table Of Contents

    Safety notes for the protection of third parties Safety notes for protection of the device Description of device General description Device description Accessory kit of the HeartSave Y | YA Status display Preparatory measures before (initial) start-up Unpacking Inserting electrode Install the battery 6.3.1...
  • Page 5 Defibrillation Cardio-pulmonary resuscitation (CPR) 7.8.1 CPR for trained rescuers 7.8.2 CPR for lay rescuers 7.8.3 CPR configuration of the HeartSave Y | YA 7.8.4 CPR metronome function Keeping the defibrillator ready for use Data management Data storage Data output Configuration item...

  • Page 6: Glossary

    Keep these instructions for use near the device so that you consult them for any queries which might arise. If you have any questions regarding the start-up, use or maintenance of the HeartSave Y|YA, please do not hesitate to contact us.

  • Page 7: Disclaimers

    The content of this document can be changed from the manufacturer without prior notice. Disclaimers Liability claims in the event of damages to people or property are excluded if they are based on one or more of the following reasons: Using the device in a manner for which it was not intended.

  • Page 8: Pictogrammes

    Pictogrammes The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfil the essential requirements of Annex I of this directive. Dust-protected Protected against water jets. Refer to instruction manual/booklet. Environmentally friendly use Do not dispose of device in domestic refuse.
  • Page 9 Permissible air humidity range in % Permissible air pressure specification in hPa Keep away from sunlight Keep dry Maximum number of defibrillation shocks up to 50 times Latex free Do not bend or fold the electrodes Do no use if package is damaged Batch code Article number Caution...

  • Page 10: Summarized Operating Instructions

    Summarized operating instructions The brief instructions can be found on the device and helps you with the use of the HeartSave Y | YA series. 9 / 44...

  • Page 11: Intended Use

    When a patient develops ventricular fibrillation or ventricular tachycardia, the device gives a shock to the heart to restore the disordered rhythm to normal. The HeartSave Y | YA series is kept on the patient until professional assistance arrives even if the patient starts to breathe again.

  • Page 12: Safety Notes For The User

    Take care of the ambient conditions in the technical specifications when storing and operating the device. Always follow the commands issued by HeartSave Y|YA series. Do not use the HeartSave Y|YA series in the presence of flammable materials. Keep the device away from children. DANGER The device should not be used in the vicinity of flammable materials (e.g.

  • Page 13: Safety Notes To Protect The Patient

    Keep a sufficient distance away from other energy sources (e.g. microwave oven, induction stove, etc.). These devices may cause HeartSave Y|YA devices not working properly or doesn’t work. Please make sure to disconnect all other devices from the patient before defibrillation.

  • Page 14: Safety Notes For The Protection Of Third Parties

    HeartSave Y | YA series is equipped with device, defibrillation electrode and battery. You could also check chapter 5.2 for detailed information. HeartSave Y | YA series is designed to be safe and quick to use for emergency. The power supply of The HeartSave Y | YA series is powered by a non-rechargeable lithium battery.

  • Page 15: Device Description

    Device description Fig. 1 Front view with lid (1) Status display (2) Device lid (3) Open the lid as directed by the arrow Fig. 2 Back View (1) Carrying handle (2) Battery 14 / 44...
  • Page 16 (5) Child button with back-light When back-light is green: child mode activated When back-light not illuminated: adult mode (6) Shock button with red back-light (only for HeartSave Y series), flashing when ready to shock Red back-light (only for HeartSave YA series) 15 / 44...

  • Page 17: Accessory Kit Of The Heartsave Y | Ya

    Accessory kit of the HeartSave Y | YA The emergency kit is attached to the back of the HeartSave Y | YA and contains the following accessories: 1x Scissor 1x Disposable razor 1x Pair of disposable gloves 1x Resuscitation mask Fig.

  • Page 18: Preparatory Measures Before (Initial) Start-Up

    Provide them serial number and describe the damage of the device. Inserting electrode The defibrillation electrode on the HeartSave Y|YA are pre-connected at the factory and do not need to be additionally plugged in before first use. However, if defibrillation electrode were replaced or unplugged, they must be reconnected to the device with the following steps.

  • Page 19: Install The Battery

     Check the seals of defibrillation electrode pouch/cable and expiry date before use. Install the battery The power supply of the HeartSave Y|YA series comes from a non-rechargeable lithium battery. Before first use of HeartSave Y|YA, the battery transport seal must be removed and insert the battery into the device. 6.3.1...

  • Page 20: Battery Removal

    6.4.1 Self-test when switch on the device When HeartSave Y|YA is switched on by opening the lid or pressing on/off button, the device performs a quick self-test to check all key functions and signal mechanisms. When the battery is inserted into the HeartSave Y|YA, the device will perform a manual self-test.

  • Page 21: Periodic Automatic Self-Tests

    Voice prompt < Device not ready for use > – Please execute the test again. If it is not successful, please contact our service team. 6.4.2 Periodic automatic self-tests The HeartSave Y|YA carries automatic self-tests to ensure that it is always ready for operation. Type of test Test coverage Daily* Check main control module, battery, speaker, internal power module, defibrillation electrode, treatment module.

  • Page 22: Using The Heartsave

     Make sure to call emergency services. Switching on HeartSave Y|YA The HeartSave Y|YA automatically activates when the lid is opened. If the device is not switched on automatically, switch it on by pressing the on/off switch button. When device is switched on, all option buttons are selectable, except shock button (HeartSave Y only) because defibrillation function is not possible to be triggered unless the device has detected a defibrillation required rhythm.

  • Page 23: Check The Patient Category

    8 years or weigh less than 25 kg. Otherwise use the adult mode for patients. You can press child button to switch to child mode. If HeartSave Y|YA is in child mode, the indicator LED of the child button will illuminate (green).

  • Page 24: Removing Clothes From Patient

    7.5.1 Removing clothes from patient Use the supplied razor to remove chest hair from the area where the defibrillation electrode will be attached. 7.5.2 Placing electrodes WARNING Avoid damage to gel layer of defibrillation electrodes Skin burning risk  Be careful not to touch gel layer before attaching electrodes to patient ...
  • Page 25 Green : in the middle of the chest HeartSave Y|YA will give a voice prompt to guide you applying defibrillation electrode to the patient. < Apply electrodes as shown > < Remove all clothing from patient's chest, unpack defibrillation electrode and apply them to patient's bare chest as shown >...

  • Page 26: Carrying Out The Ecg Analysis

    If the device clearly identifies ventricular fibrillation (VF), it will recommend defibrillation. The device issues voice prompts: HeartSave Y series HeartSave YA series semi-automatic external defibrillator fully-automatic external defibrillator <...

  • Page 27: Cardio-Pulmonary Resuscitation (Cpr)

    < Begin CPR > Cardio-pulmonary resuscitation (CPR) As a configuration of the HeartSave Y | YA for CPR we follow the recommendations of the 2021 ERC guidelines. The 2021 ERC guidelines differentiate the approach to resuscitation for trained and lay rescuers.

  • Page 28: Cpr For Trained Rescuers

    7.8.4 CPR metronome function During chest compressions, HeartSave Y|YA also equipped with metronome function which guide you with correct frequency for chest compression. Please follow the rhythm. The last five CPR metronome tones sound slightly different to indicate a break after the compression cycle. The artificial respiration is also guided by two acoustic outputs.

  • Page 29: Keeping The Defibrillator Ready For Use

    Data output The HeartSave Y|YA support to export data from device to a storage device. This data may not be used for diagnostic purposes or therapy for the patient. Follow these steps to export data from device: ...

  • Page 30: Accessories

    Accessories The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1. WARNING Use accessories specified in this chapter. The use of other accessories may cause damage to the equipment or not meet the claimed specifications.

  • Page 31: Troubleshooting

    Troubleshooting This section explains problems you may encounter while using the HeartSave Y|YA and provides information about keeping your defibrillator in a state of readiness. Troubleshooting During Use: Problem Possible cause What to do Unable to power on The battery may not be inserted Insert battery.

  • Page 32: Servicing

     Before sending, protect the contacts of the battery with insulating adhesive tape. Where possible, use the original box. If the original box is no longer available, use suitable packaging materials make the device fixed and well wrapped to protect the HeartSave Y|YA from impact and damage.
  • Page 33 Through registration of Metrax GmbH with the responsible authorities, we ensure that the disposal and utilisation of electronics devices introduced onto the market by us is secure in accordance with the EU directive on the disposal of electronic and electrical equipment (WEEE-directive). For business customers in the European Union Please contact your dealer or supplier if you want to dispose of electrical and electronic equipment.

  • Page 34: Appendix A: Technical Data

    Appendix A: Technical Data Defibrillation Operating modes: HeartSave Y series: semi-automatic external defibrillator HeartSave YA series: fully-automatic external defibrillator Impulse shape: Biphasic truncated exponential, auto-compensation according to patient impedance. Optional output energy For adults:100 J, 150 J, 170 J, 200 J, 300 J, 360 J For children:10 J, 15 J, 20 J, 30 J, 50 J, 70 J, 100 J Refer to Chapter 8.3 for the configuration methods...
  • Page 35 Waveform parameters Charge time: Parameter for the HeartSave Y | YA for charging the first shock: 1) new battery From open device cover to charge 200 J done: no more than 7 s From open device cover to charge 360 J done: no more than 14 s...
  • Page 36 Battery life in standby mode 60 months Operating time 150 times 360 J discharge or operate 12 hours. (The equipment is powered by a new battery at 20 °C± 5 °C of ambient temperature, not performing defibrillation charges or discharges, voice volume set to low.) Remaining charge after When the remaining battery capacity is 12 %, the device will announce <...
  • Page 37 Shock test Complies with requirements of 10.1.3a), IEC 60601-1-12:2014 Vibration test Complies with requirements of 10.1.3b) IEC 60601-1-12:2014 Other Standards applied Standards (for licensing in the EU, the corresponding harmonised European standards EN were used instead of the IEC standards): IEC 60601-1:2005+AMD1:2012+AMD2:2020 IEC 60601-1-2:2014+AMD1:2020 IEC 60601-2-4:2010+AMD1:2018...

  • Page 38: Appendix B: Warranty

    Appendix B: Warranty Within 8-year warranty period, the manufacturer will remedy any defects in the device free of charge if they are based on material or manufacturing errors. The device can be reinstated to its original condition as selected by the manufacturer either by repair or replacement. A claim under warranty does not extend the original warranty period.

  • Page 39: Appendix C: Rhythm Detection System

    Appendix C: Rhythm detection system The rhythm detection system on the HeartSave Y|YA analyses the patient's ECG and detects a shockable or non-shockable rhythm. The algorithm  Filters interference and measures artefacts  Calculates several ECG signal parameters including frequency and morphological parameters - rejects implantable pacemaker artefacts ...

  • Page 40: Appendix D: Emc

    Appendix D: EMC The equipment meets the requirements of IEC 60601-1-2: 2014 DANGER  Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation.
  • Page 41 The equipment is suitable for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Emitted interference Conformance Electromagnetic environment - code of practice measurements The equipment uses RF energy only for its internal RF emissions according to function.
  • Page 42 The equipment is suitable for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Immunity to IEC 60601 test Level of conformance Compliance level interference testing level 0.15MHz~80MHz,80% AM at...

  • Page 43: Appendix E: Index Diagram

    Fig. 2 Back View Fig. 3 Bottom View Fig. 4 HeartSave Y | YA series front view Fig. 5 Accessory kit of the HeartSave Y | YA Fig. 6 Inserting defibrillation electrode Fig. 7 Insert the battery Fig. 8 Removing the battery Fig.
  • Page 44 Metrax GmbH No.1 Baisheng Road Development Zone, Danyang, Jiangsu Rheinwaldstraße 22 Postal Code: 212300 78628 Rottweil Peoples Republic of China Germany Phone: +86 511 86900833 Phone: +49 741 257 0 Fax: +86 511 86900851 E-Mail: info@primedic.com www.yuyue.com/en www.primedic.com WEEE-Reg.-No.: 73450404...

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