User manual AUTOMATED EXTERNAL DEFIBRILLATOR WITH MANUAL FUNCTION

Manufacturer Instramed Indústria Médico Hospitalar Ltda. Industrial Unity: Beco José Paris, 339 – Pavilhão 19 Postal code: 91140-310 Porto Alegre – RS, Brazil Phone/Fax number: +55 51- 3073 8200 Email: [email protected] Website: www.instramed.com.br European representative: Obelis S.A. Bd. Général Wahis 53, 1030, Brussels - Belgium Phone: + 32.2.732.59.54 Fax: + 32.2.732.60.03 E-mail : [email protected] ATTENTION: Instramed assumes no responsibility for any damage caused to individuals or property brought by failure to use this product in accordance with the information, recommendations...

Battery use ATTENTION: Observe the battery charge maintenance instructions First use: The batteries are rechargeable Lithium-Ion (Li-ion). Before using it for the first time the device must receive a full battery charge. In order to do this, the equipment needs to be connected to an electric current for at least eight hours. To charge the battery connect the charger to the lateral connector in the device and then to the electric current. Time for full battery charge = 5 hours. The device blocks any operation on the patient when connected to the electric current. Occasional use: Even when disconnected...

Package contents Included items: When opening the package, please check whether all items below are present: • An Isis PRO automated defibrillator • A power supply for charging internal battery • A cable for connecting the power supply to the electric current • A pair of disposable adult size adhesive pads • A pair of disposable child size adhesive pads • A user manual • A first-aid Kit. • A transport bag • A USB cable • A CD with the Soft DEA management Software Replacement parts: You can ask Instramed for replacements of the following items (consult Instramed for prices. Shipping costs may...

Safety Information

Operating in manual mode

User manual | Index

Precautions, restrictions and warnings Warranty Certificate

The Isis PRO is a new generation Semi-Automated External Defibrillator (AED). Using Neural Network technology, the Isis PRO guides by voice, makes the diagnosis, considers clinical variables and applies treatment safely with the touch of only a single button. Designed for emergency care, it is compact, light, resistant and easy to use. In its PRO version, the Isis offers the flexibility of the manual mode, which allows the health care professional to select the parameters of shock delivery treatment, such as selecting charge up to 270 Joules. Through a touch screen with excellent contrast and...

User manual | Introduction Purpose The defibrillator is a device used for treating cardiac arrhythmias, situations in which the heart loses the ability of keeping steady heartbeats, blood stops being pumped and oxygen and nutrients do not get to the organs, starting a degenerative process known as biological death. Among the most common cases of cardiorespiratory arrest are ventricular fibrillation (VF) and ventricular tachycardia (VT), and the most efficient treatment for these kinds of cardiac dysrhythmia is electrical defibrillation, a technique by which electrical shocks are applied to the...

User manual | Introduction Source: Sociedade de Cardiologia do Estado de São Paulo – SOCESP, Revista Socesp V.11, no 2. Use criteria The Isis PRO, as well as any other Automated External Defibrillator, must only be used if the following circumstances, as a whole, are presented: • Unconscious victim or unresponsive to verbal or physical stimulus • Not breathing • No pulse (for professionals) Other important considerations regarding the use of the Isis PRO: • Not recommended for children under one year old. • Pacemakers may affect the device’s efficiency. • Medicines in adhesive form must be removed...

Safety Information ATTENTION The following factors may cause ECG misinterpretation: • Wrongly placed pads. • Patient’s movements. • Pacemaker (it may lessen the precision of the cardiac arrest detector). • Radio frequency interference, including mobile phones. • Excessive hair or wet skin in the application area of the electrodes. • Pieces of clothing between skin and pads. • Isis PRO ONLY works with battery. Warnings IMPORTANT: This equipment may only be operated by qualified technical personnel. Read this guide carefully before using the equipment. WARNING: THE PATIENT MUST BE PLACED ON NON...

User manual | Safety Information NOTICE: The applied parts are protected against defibrillation discharge; during discharge there may be baseline variation. NOTICE: Avoid connecting the patient to several items of equipment at the same time. The limits of current leakage may be exceeded. NOTICE: the applied parts intended to come into contact with the patient have been evaluated and comply with the directives and principles of ISO 10993-1. NOTICE: when removing the equipment from the package, carefully verify if there is any abnormality or visible damage in the device or its accessories, caused...

User manual | Safety Information Standards The Isis PRO was designed according to safety and performance standards, such as: • NBR IEC 60601-1:1997 (IEC 60601-1:1995), Medical electrical equipment – Part 1 – General Requirements for Safety. • EN 60601-1:1990, (Amendment, A1:1993, A2:1995, A13:1996) (IEC 606011:1988, A1:1991, A2:1995), Medical electrical equipment - Part 1 - General Requirements for Safety. • NBR IEC 60601-1-2:2006 (IEC 60601-1-2:2004), Medical electrical equipment – Part 1-2 - General Requirements for Safety – Collateral standard: Electromagnetic compatibility - Requirements...

User manual | Safety Information Cleaning and disinfection Instramed recommends cleaning and disinfecting the equipment and its accessories every three months, or shorter periods whenever excessive dirt or contamination is noticed. Equipment: • Disconnect the unit from the mains before cleaning. • Clean the outside of the machine with a cloth moistened with neutral soap and water or isopropyl alcohol. • Rub the surface to be cleaned for about 5 minutes. • Perform the procedure at room temperature. Important recommendations: • Never immerse the equipment in liquid. • Avoid using abrasive in the...