AED Saver One Скачать руководство пользователя страница 9

 
    AUTOMATIC 

2

 

Safety instructions 

For a correct use of the 

Saver One defibrillator

, users must be aware of the safety factors listed below. 

Please read them carefully. 

The 

Saver  One  defibrillator

,  individually  and  in  connection  with  its  standard  and  optional  (original)  accessories, 

complies  with  the  safety  regulations  currently  in  force  and  is  in  compliance  with  the  provisions  of  the  directives  on 
medical products. 
The appliance and its accessories are to be considered safe in the case of application according to the provisions and if 
the descriptions and indications listed in this user manual are respected. 
The  following  are  the  main  precautions  to  be  taken  for  the  correct  and  safe  use  of  the  defibrillator,  divided  for  easy 
consultation between hazard indications, warning indications and disposal instructions. 
 

2.1

 

Indications of 

DANGER 

 

Use the 

Saver One   

in accordance with the prescriptions in this user manual. Carefully read these instructions for use and in particular the 

safety instructions indicated in them. 

 

In  accordance  with  IEC  standards  (section  2.4),  the  use  of  the 

Saver  One     

  device  or  its  accessories  in  the  presence  of  flammable 

substances (petrol or similar) or in an atmosphere enriched with oxygen or flammable gases / vapours is not allowed. 

 

Do not recharge the Li-SOCl

2

 battery (SAV-C0903). Explosion risk! 

 

Do not allow the batteries to come into contact with an open flame. Do not expose to fire. 

 

Do not short circuit the battery terminals. 

 

In  case  of  leakage  of  liquids  or  strange  smells  from  the  batteries,  keep  them  away  from  fire  to  prevent  any  leaked  electrolytes  from 
catching fire. 

 

Danger of electric shock. The device generates high voltages and dangerous levels of current. 

 

Do not open the 

Saver One ,

 do not remove the panels and do not attempt to repair it. The 

Saver One   

 contains no components that users 

can repair. For repair purposes, the Saver One   P must be sent to an authorized technical service centre. 

 

Do  not  apply  the  electrodes  to  the  patient's  chest  if  nitro-glycerine  patches  are  present.  Remove  the  patches  and  only  then  position  the 
electrodes. Otherwise there is a risk of causing an explosion. 

 

Do not touch the patient and prevent third parties from coming into contact with the patient during the defibrillation  shock phase. Avoid 
any contact between: 

 

parts of the patient's body 

 

conductive liquids (such as gel, blood or solution of table salt)   

 

metal  objects  in  the  surroundings  of  the  patient  (such  as  bed  frame  or  stretching  device)  that  represent  indirect  ways  for  the 
defibrillation current 

 

Before using the device ensure the patient’s safety, if necessary move them carefully and position them in a safe place as per the  
AHA / ERC 2017 guidelines 

 

Do not immerse any part of the 

Saver One,

 its parts or accessories in water or other liquids. 

 

Do not allow liquids to enter the 

Saver One its

 parts or accessories. Avoid spilling liquid on the device and its accessories. Failure to do so 

may cause damage or cause a risk of fire or electric shock. Do not sterilize the 

Saver One   

or its accessories. 

 

2.2

 

Indications of 

CAUTION

 

 

Avoid  the  formation  of  air  bubbles  between  the  skin  and  defibrillation  PADs.  The  formation  of  air  bubbles  during  defibrillation  can 
cause  severe  burns to  the  patient's  epidermis.  To  avoid the  formation  of  air  bubbles,  make  sure  that  the  electrodes  fully  adhere  to  the 
skin. Do not use electrodes whose gel has dried; check the expiration date before use. 

 

Do not delay treatment in patients with an implanted pacemaker and perform a defibrillation attempt if the patient has lost consciousness 
and  is  not  breathing  or  breathing  normally.  The 

Saver  One  is

  equipped  with  a  pacemaker  detection  system  that  allows  ignoring  the 

signal emitted by the latter; however, with some types of pacemakers, 

Saver One   

may discourage a defibrillation  shock. 

During the application of the electrodes: 
• Do not apply the electrodes directly to an implanted device. 
• Apply the electrodes at least 2.54 cm (1 inch) from any implanted device 

 

 

RF  (radio  frequency)  interference,  caused  by  devices  such  as  cellular  phones  and  two-way  radios,  can  cause  the 

Saver  One   

  to 

malfunction.  The 

Saver  One 

  must  be  kept  at  least  2  meters  away  from  these  RF  devices,  as  indicated  in  the  standards  of 

EN  61000-  4-3.  Keep  away  from  other  therapeutic  and  diagnostic  energy  sources  (e.g.  diathermy,  high-frequency  surgery,  magnetic 
tomography). 

 

Use the 

Saver One  only

 if you have achieved a BLS-D or ALS-D training course. 

 

Before using the device, make sure that there is no obvious damage. 

 

The infrared interface emits optically invisible radiation. The emission diode complies with IEC/EN 60825-1 Class 1 "Eye Save" 

 

Do  not  use  paediatric  defibrillation  PADS  (SAV-C0016)  on  adult  patients  (older  than  8  years  and  weighing  more  than  25Kg).  Using 
paediatric  defibrillation  PADS  the 

Saver  One    automatically

  switches  to paediatric  mode,  reducing  the  maximum energy  available  to 

50J. 

 

Arrange the patient cables so as to reduce the possibility of wrapping or strangling the patient. 

 

In a domestic environment, keep the defibrillator out of the reach of children and pets. 

 

Do not apply the defibrillation electrodes directly on an implanted pacemaker to avoid any errors in the interpretation of the device and 
to avoid damage to the pacemaker through the defibrillation impulse. 

 

Disconnect high-voltage pulse-sensitive equipment from the patient, i.e. that is not defibrillator-proof, before delivering the shock. 

Содержание Saver One

Страница 1: ...User Manual External AUTOMATIC Defibrillator for public access Rev 12 2...

Страница 2: ...AUTOMATIC 2 QUICK USE GUIDE...

Страница 3: ...Infractions against this prohibition not only violate our copyright but also reduce our ability to provide accurate and up to date information to the user and the operator of the device These instruct...

Страница 4: ...f the device 13 4 2 Keys icons and indicators 14 4 3 Status display 14 4 4 Standard and optional accessories of the device 15 5 Parts and accessories of the Saver One 16 5 1 Saver One Batteries 16 5 1...

Страница 5: ...8 7 Non shockable rhythm 32 8 8 CPR 32 9 Recording viewing and archiving the data 34 9 1 Data recording 34 9 2 Archiving data on PC 34 10 Maintenance 35 10 1 After each use 35 10 2 Ordinary maintenan...

Страница 6: ...with electromagnetic emission standards 46 12 1 Guidelines and manufacturer s declaration Electromagnetic emissions 46 12 2 Guidelines and manufacturer s declaration Electromagnetic immunity 46 12 3 R...

Страница 7: ...SOCl2 SAV C0903 has a guarantee of 4 four years in Stand by mode assuming a battery activation test daily self tests without turning on the AED This information refers to new batteries fully charged...

Страница 8: ...e safety of people which also involves death and damage to the device or parts thereof CAUTION Indicates an unsafe situation or practice involving serious personal injury and damage to the device or p...

Страница 9: ...move them carefully and position them in a safe place as per the AHA ERC 2017 guidelines Do not immerse any part of the Saver One its parts or accessories in water or other liquids Do not allow liquid...

Страница 10: ...able to be used only on one patient Do not reuse defibrillation pads discard after use and replace with a new pair Defibrillation PADs are not sterile or sterilizable Intense or prolonged administrati...

Страница 11: ...o maintenance is guaranteed to operate in standby mode for 4 years or carry out a high number of shocks Rechargeable battery Li ion SAV C0011 recommended for those who use the defibrillator intensivel...

Страница 12: ...007 47 CE IIb Type of protection against electric shock Internally powered Type of patient isolation BF Degree of protection against penetration of liquids IPx4 Degree of protection against dust penet...

Страница 13: ...r environmental recordings 3 Status mini display 4 Carrying handle 5 Battery compartment 6 Keyboard with buttons and light icons 7 IrDA port service only present only in the models with TFT display 8...

Страница 14: ...eck the functional status of the AED 8 Do Not Touch Indicator Icon equipped with LEDs indicating not to touch the patient during certain operations 4 ON OFF button Allows you to switch the device on o...

Страница 15: ...C1005 HU 1 Unit User guide SAV C0916 1 Unit Carry bag The following are the optional Saver One accessories that can be purchased separately Code Image Quantity Description SAV C0011 1 Unit ACC Rechar...

Страница 16: ...condensation 45 If the remaining battery level is low the Saver One informs the user via audio and visual messages The Saver One will give a low battery warning when the level is 5 WARNING and a very...

Страница 17: ...in paragraph 5 1 With a 5 battery the Saver One allows to deliver about 14 shocks or 40 days of stand by 2 ALARM Remaining capacity level of Battery at 1 This warning will be provided both in Stand by...

Страница 18: ...owing the direction of the arrow and matching it perfectly with the point highlighted by the circle Push the battery as shown in figure 7 following the direction of the arrow until you hear a click th...

Страница 19: ...harge level or the functional status of battery charger 2 Supply Input for 12V 5A power supply connector 3 Battery contacts Contacts for energy exchange between charger and battery The Battery Charger...

Страница 20: ...ates both its functional status and the battery charge level if inserted The following is a table that allows identification of the control LED coding INDICATOR RED GREEN FIXED Battery not working Bat...

Страница 21: ...he need to insert the connector during the phases of the rescue The SAV C0846 PADs are polarized type that is the positioning of the electrodes must not be reversed For more information on positioning...

Страница 22: ...ckaging of the PADs and directly on each individual pad The PADs of the Saver One are polarized type do not reverse the positioning of each single pad 1 Position Pad 1 immediately below the patient s...

Страница 23: ...to be used must be a mini USB 2 0 USB Mini USB connection To connect the mini USB cables to the Saver One follow this procedure A Detach the battery and insert the Mini USB terminal of the cable in t...

Страница 24: ...t can be viewed via a two colour LED green red and the LCD mini display The mini display and the control LED let you know at any time even when the device is switched off stand by mode the functional...

Страница 25: ...mediately turn off the Saver One and leave the battery inserted to ensure that periodic self diagnostic tests are performed see Section 6 3 6 3 AUTOMATIC Test The Saver One was designed to always be r...

Страница 26: ...eration of the device before use Each test is conducted automatically and lasts a few seconds After pressing the power button or after inserting the battery the Saver One will emit an acoustic signal...

Страница 27: ...the i button 1 After pressing the button the first time the following screen will appear with the related information 2 Pressing the button for the second time will display the following screen with t...

Страница 28: ...he Saver One defibrillator will automatically start the semi automatic defibrillation mode every time it is turned on default setting Below are the procedures to follow to use the device in this mode...

Страница 29: ...ecessary to shave the Pads positioning points 8 3 Positioning the PADs A Remove the defibrillation PADs from their packaging B Remove the protective film from each individual PAD and place it on the p...

Страница 30: ...is suffering from the following arrhythmias VF Ventricular Fibrillation Peak to peak Amplitude min 200 Volts Some rhythms with very low amplitude or low frequency VF may not be interpreted as shockabl...

Страница 31: ...the operator using the following commands Voice commands Display Shock delivered The Saver One delivers the shock using the BTE waveform with auto compensation of the patient s thoracic impedance The...

Страница 32: ...Pulmonary Resuscitation in one of the following cases A shockable rhythm was detected and a defibrillation shock was delivered A non shockable rhythm was found A shockable rhythm was found but the pat...

Страница 33: ...ovement must be from pivoting on the coxo femoral joint G After each compression release all pressure from the chest without losing contact between one s hands and the sternum repeat the manoeuvre wit...

Страница 34: ...rmed by the device with its outcomes and all the SERVICE information This type of file can be viewed on a PC using a simple reading program AEDFILE aed This file stores the rescue data such as environ...

Страница 35: ...r One defibrillator it is necessary to proceed with the following operations in order to prepare the device for the next use 1 Check the presence of the memory card and its remaining capacity see para...

Страница 36: ...alled it is advisable to keep the device with the battery always inserted to allow it to carry out periodic self diagnostic tests For easy retrieval of the device in case of emergency place it in easi...

Страница 37: ...or code In standby the control LED flashes GREEN RED alternately and a wrench appears on the control display Very low battery Level 1 The device may turn off during use see the relevant paragraph Repl...

Страница 38: ...Operating conditions 620 hPa at 1060 hPa altitude calculated min 382 mt and max 3955 mt Operating functional conditions Normal use Keep the AED device within the operating and standby ranges not the...

Страница 39: ...8 LED Red Sound Indicators Multilingual voices for instructions during use of the device Acoustic signals of warnings and dangers Speaker Pre set Volume Emissions in compliance with IEC EN 60601 2 4 p...

Страница 40: ...PADs SAV C0016 Shock protocol Children Version 200J Version 360J Fixed First and Subsequent 50J Charge control Automatic through patient analysis system Charge time from the shock notice Version 200J...

Страница 41: ...0 J Energy Tpos ms Tneg ms Umax A Set Energy J delivered Joules 25 Ohm 4 6 5 6 43 8 150 147 2 50 Ohm 6 2 4 24 9 150 146 9 75 Ohm 6 8 3 3 18 4 150 147 15 100 Ohm 7 2 3 15 150 147 2 125 Ohm 7 4 2 8 13 1...

Страница 42: ...11 5 4 6 11 4 250 241 15 Impedance Shock of 350 J Energy Tpos ms Tneg ms Umax A Set Energy J delivered Joules 25 Ohm 4 9 9 4 65 2 350 336 50 Ohm 7 2 6 36 6 350 341 75 Ohm 9 5 6 9 25 4 350 339 3 100 O...

Страница 43: ...is designed to not recommend shocks with all other rhythms including normal sinusoidal rhythm moderate ventricular fibrillation 200 Volts some slow ventricular tachycardia and asystoles 11 10 ECG Anal...

Страница 44: ...without condensation 45 11 13 Internal back up battery Category Nominal specifications Type Battery Coin Cell LiMnO2 Purpose Maintaining configuration data date time etc Voltage 3 VDC Duration Mainta...

Страница 45: ...AM thickness 1 mm Conductive gel Low impedance conductive adhesive gel Total area for pad 148 cm 75 cm Active area for pad 81 cm 31 cm Conductive material Metal foil Connection Anti shock safety conne...

Страница 46: ...n any building including those for residential use and those directly connected to the public low voltage power supply network that supplies residential buildings Harmonic Emissions IEC EN 61000 3 2 N...

Страница 47: ...MHz the higher frequency range applies NOTE 1 These guidelines may not apply in all situations Electromagnetic propagation is influenced by absorption and reflection from structures objects and people...

Страница 48: ...d at a maximum power not listed above the separation distance d in meters m can be determined using the equation applicable to the transmitter frequency where P represents the maximum power produced b...

Страница 49: ...er Do not expose to high temperatures or flames Manufacturing date Do not recharge Lot Number LOT Do not open Expiration date Do not destroy or damage it Model identifier Do not use it in puddles of w...

Страница 50: ...AUTOMATIC 50 14 Certifications 14 1 EC Certificate...

Страница 51: ...AUTOMATIC 51...

Страница 52: ...AUTOMATIC 52 14 2 IMQ Brand...

Страница 53: ...able and adequate maintenance incorrect installation replacement of parts and accessories that do not comply with the specifications provided by AMI Italia S r l any modifications made to the device a...

Страница 54: ...TIC 54 16 Product registration In order to guarantee a correct and rapid traceability of the product sold we ask you to complete the form below and send it by fax or registered letter to A M I Italia...

Страница 55: ...AUTOMATIC 55...

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