CardiAid CT0207RS User Manual And Introduction To The Device

Semi-automatic defibrillator & fully automatic defibrillator

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User Manual and
Introduction to the Device
For Models
CT0207RS Semi-Automatic Defibrillator
&
CT0207RF Fully Automatic Defibrillator

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Summary of Contents for CardiAid CT0207RS

  • Page 1 User Manual and Introduction to the Device For Models CT0207RS Semi-Automatic Defibrillator & CT0207RF Fully Automatic Defibrillator...
  • Page 3 User Manual Introduction to the Device For Models CT0207RS Semi-Automatic Defibrillator & CT0207RF Fully Automatic Defibrillator...
  • Page 4: Table Of Contents

    Contents Overview of CardiAid CT0207RS & CT0207RF ..........3 1. Introduction to the Device ........... 6 1.1 Intended Use ..................6 1.2 User Qualification ................. 6 1.3 Description of the Functions ..............6 1.4 Indications for Use ................8 1.5 Contraindications for Use ..............8 1.6 Important Points in an Emergency ............
  • Page 5: Overview Of Cardiaid Ct0207Rs & Ct0207Rf

    Indicator Window Indicator: “Remove clothing from chest and stick on electrodes” Indicator: “Do not touch the patient from now on” Indicator: “Patient may be touched” Indicator: “Ready for Shock” (only for CT0207RS) Shock Button (only for CT0207RS) Info-Button Repair Symbol...
  • Page 6 Overview of CardiAid CT0207RS & CT0207RF CT0207RF CardiAid Emergency Kit CPR Mask Razor Scissors Gloves Alcohol Pad...
  • Page 7 The device is not ready for use, if the battery symbol is flashing or lighting. In this case, contact Cardia International or an authorized service provider of Cardia International immediately. 16. OK Symbol CardiAid is ready for use, if the OK symbol is flashing while the device is switched off.
  • Page 8: Introduction To The Device

    CardiAid is a public access defibrillator (PAD), i.e. an automated external defibrillator (AED) which is available for public use. CardiAid can be used for the resuscitation of patients older than 8 years (>25 kg) with standard electrodes and patients 1 to 8 years old (<25 kg) with special paediatric electrodes.
  • Page 9 During this time, the timer for basic life support continues in the background. Application Documentation CardiAid records ECG and incident data in its internal memory. These data may be obtained from the device as a report to be analysed by specialists to define subsequent treatment.
  • Page 10: Indications For Use

    CardiAid CA-10ES Adult Defibrillation Electrodes should be used for patients older than 8 years or weighing more than 25 kg. CardiAid CR-13P Paediatric Electrodes should be used if the patient is 1 to 8 years old or weighs less than 25 kg. Therapy should not be delayed to determine the exact age or weight of the patient.
  • Page 11: User Manual

    2.1 Description of the User Manual Please read this user manual carefully to ensure safe and effective use of CardiAid and to be prepared in case of an emergency. If you have additional questions about information in the user manual, you may contact the local distributor or Cardia International directly.
  • Page 12: Labels On The Device And Its Accessories

    High Adult 170J 270J 12V, 15Ah Pediatric Type Plate Label Battery Pack for CT0207/CT0207RS/CT0207RF Model No: CA-4BP 12V-15Ah-Alkaline Cardia International A/S, Hersegade 20, 4000 Roskilde, Denmark www.cardiaid.com Battery Life Label Battery Product Label (on battery) Electrode Product Label Do not re-use...
  • Page 13: Safety Rules

    6.2. Function Check for further details). Caution! CardiAid can be used to defibrillate a patient on either a wet or metal surface as long as the appropriate safety precautions are taken. During use of the CardiAid, please be sure that no one is touching the patient when the shock is being delivered.
  • Page 14: Defibrillation / Use

    Do not attempt to deliver electroshock if defibrillation electrodes are in contact with each other or are not connected to the patient. Danger! Be sure that the electrode cable is not wedged when closing the cover of CardiAid. It may damage the electrode cables. Caution! Charging and delivering electroshock may affect the electronic devices nearby.
  • Page 15: Electrodes

    Caution! In order to prevent faulty interpretation of ECG data, make sure that the patient is lying still, not being touched or moved while CardiAid is analysing heart rhythm. Do not perform basic life support (CPR) during rhythm analysis. Warning! Before delivering the electroshock, make sure the patient is disconnected from other medical devices which do not have defibrillation protection.
  • Page 16: Side Effects

    Do not place the electrode pad on the nipple. Caution! If there is excessive hair on chest, use the razor in the emergency kit of CardiAid (present inside the cover of the device) to clear the chest before applying electrode pads.
  • Page 17: Preparing Cardiaid For Use

    It can only be connected as required. Placing Emergency Kit CardiAid is delivered with an emergency kit placed inside the cover of the device and electrodes placed inside the package in front of the emergency kit. Always keep the device in this condition to help save time in an emergency.
  • Page 18: Operation

    Open the cover of CardiAid. Device will switch on automatically. Self-testing CardiAid immediately starts a self-test when switched on. During self-test, all indication and warning LEDs light up. When self-test is completed, indication symbols show the status of the device. Observe the status indicators before continuing to use CardiAid.
  • Page 19 • Consciousness • Normal breathing CardiAid should be used and defibrillation can be delivered only when the person is unconscious and the breathing is absent or not normal. 2. “If not breathing normally, remove clothing from chest and stick on electrodes” (This instruction can be deactivated by an authorized service provider) instruction is heard.
  • Page 20 The process by which the shock is delivered varies according to the version of CardiAid being used: • In the semi-automatic version (CT0207RS), the user is asked to press a button to release the shock. • In the full-automatic version (CT0207RF), the device warns the user not to touch the patient and then proceeds to releasing the shock automatically.
  • Page 21 CardiAid also provides metronomic signals to guide the rescuer with the correct rhythm and number for the chest compressions. After 30 signal tones, verbal instruction “Now give 2 mouth to mouth breaths”...
  • Page 22: After Using Cardiaid

    If you detect signs of life like consciousness and normal breathing during operation of the device, place the patient in recovery position (lying on one side). Do not remove electrodes. CardiAid will continue operating normally. Heart rhythm analysis will be performed regularly.
  • Page 23: Hygiene

    5. Hygien CardiAid can be cleaned by a piece of cloth which is moistened (but not saturated) with a simple disinfectant. Caution! Do not immerse CardiAid or its accessories in any liquid. Liquid ingression may cause serious damage and the device can be unusable.
  • Page 24: Function Test

    If the OK symbol is flashing in stand-by mode, CardiAid is ready for use. 2. Open the cover of CardiAid. If the following conditions are met, the device is ready to use: • All lights and status indicator symbols light simultaneously for a short period of time.
  • Page 25: Troubleshooting

    This invalidates the warranty, may cause serious injuries and/or irreversible damage on the device. Failure Messages of CardiAid Cause Action Visual Acoustic CardiAid can be used only Battery Symbol Battery is low. in emergencies. Contact and OK Symbol Signal tone in Battery can only...
  • Page 26 7. Troubleshooting Failure Messages of CardiAid Cause Action Visual Acoustic Status indicators CardiAid can be used only do not light or in emergencies. Contact flash for a period Problem with LEDs Cardia International or an None authorized service provider of time during...
  • Page 27: Disposal

    8. Disposal Do not dispose the device to common household waste. For detailed information regarding disposal of the product and its accessories, visit www.cardiaid.com For disposal of used electrical and electronic devices, refer to special collection system for these type of devices in European Union countries and other European countries.
  • Page 28: Storage

    Device cannot be used if one of the maintenances is not performed on time. Always make sure maintenances and periodical controls are performed without delay. Pay attention to the storage condition requirements of CardiAid (see Section 12. Technical Information). Excessive ambient temperature can shorten the battery life considerably.
  • Page 29: Maintenance

    TSC during 2nd and 4th year periodical maintenance. 6th Year Maintenance: In order to be able to continue using the device after 6th year, CardiAid should be subjected to a comprehensive maintenance at the end of 6th year after purchase. In addition to the periodical...
  • Page 30: Package Content

    CardiAid CT0207RS Semi-Automatic AED CardiAid CA-10ES Adult Defibrillation Electrodes CardiAid CA-4BP Battery Pack CardiAid CT0207EK Emergency kit (Containing CPR mask, shaver, scissors, gloves, and alcohol pad) CardiAid CT0207P Protection Bag User Manual for CardiAid AED Quick Reference Card for CardiAid AED...
  • Page 31: Technical Information

    12. Technical Information 12.1 Technical Specifications DEVICE Dimensions l x w x h (in mm) ..........................301 x 304 x 112 Weight with battery and electrodes..........................3,1 kg Product class according to Medical Product regulation or Regulation No. 93/42/EEC............IIb Operation Temperature limits ..............................0°C - 50°C Humidity ..................................
  • Page 32 12. Technical Information DEFIBRILLATION / ANALYSIS Operating mode ........Semi-Automatic (One-button operation) in CT0207RS, Full-automatic in CT0207RF Wave form............................Biphasic, Current controlled Delivered energy at 50 Ω (Adult Mode) ....................Low energy 170J ± 15% ................................High energy 270J ± 15% Delivered energy at 50 Ω...
  • Page 33 12. Technical Information Guidelines and manufacturer declaration – Electromagnetic emissions CardiAid is intended for operation in the electromagnetic environment specified below. The customer or user of the device or system should make sure that it is operated in such an environment.
  • Page 34 12. Technical Information...
  • Page 35 Guidelines and manufacturer declaration – Electromagnetic immunity CardiAid is intended for operation in the electromagnetic environment specified below. The customer or user of CardiAid should make sure that it is operated in such an environment. Immunity tests IEC 60601 test...
  • Page 36 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be made. If the measured field strength in the location which the CardiAid Public Access Defibrillator is used exceeds the applicable RF compliance level above, additional measures may be necessary, such as reorientation or relocating the CardiAid Public Access Defibrillator.
  • Page 37: Pulse Form

    12. Technical Information 12.2 Pulse Form The delivered shock is a biphasic current-based shock. Two different energy levels are implemented in the device, a low energy shock and a high energy shock. The current-based shock has the advantage that the delivered energy depends on the patient impedance. Myocardium damage caused by high electrical current applied to patient with low impedance is reduced considerably with this pulse form.
  • Page 38: Address Information

    13. Address Information Registered Office / Legal Manufacturing Site: Cardia International A/S Hersegade 20 4000 Roskilde Denmark info@cardiaid.com www.cardiaid.com Corporate Office / Operation Site: Cardia International B.V. Van der Burchstraat 40 2132RN Hoofddorp The Netherlands info@cardiaid.com www.cardiaid.com Notified Body: IMQ S.p.A - Istituto Italiano del Marchio di Qualità...
  • Page 40 Cardia International A/S Hersegade 20, 4000 Roskilde, Denmark www.cardiaid.com...

This manual is also suitable for:

Ct0207rf

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