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User manual | 

Safety information

11

Classification and symbols

Symbol 

Standard 

Description

IEC TR 60878

Defibrillation proof insulated CF type equipment

IEC 60601-1

Follow the instructions for use

IEC 60601-1

General warning symbol

IEC 60601-1

Warning: dangerous voltage

IEC TR 60878

Terminal for equalization of potential

IEC TR 60878

Terminal for general ground

-

Disconnects the equipment

IEC TR 60878

Alternate current

IEC TR 60878

Direct current

IEC TR 60878

Non-ionizing radiation

IEC TR 60878

Input connection

ISO 780

Maintain this side upwards

ISO 780

Fragile equipment

ISO 780

Maximum stacking of 4 units

ISO 780

Maintain protected from the rain

ISO 7000  

ISO 780

Minimum and maximum temperature

ISO 7000

Minimum and maximum atmospheric pres-sure

ISO 7000

Minimum and maximum relative humidity

IEC TR 60878

Recyclable paper

Directive 2002/96/CE

Remains of electrical and electronic equipment - separate 

disposal from other objects

EN 980 

Manufacturer

EN 980 

Manufacturing date

EN 980

Serial number

Содержание APOLUS

Страница 1: ...User Manual Biphasic Defibrillator ...

Страница 2: ...technical assistance centers operation by unqualified personnel use of defective device or use of accessories and parts not supplied by the manufacturer For information about warranty or technical assistance please contact Instramed s technical support Copyright 2016 Instramed Apolus Instramed and its respective logos are trademarks of Instramed Indústria Médico Hospitalar Ltda The internal softwa...

Страница 3: ...ch is turned off Therefore whenever the device has not been connected to an electric current for more than 20 days and with the power switch at the position on it is advisable to execute a full battery charge If this procedure is not performed there is a risk of draining the battery and consequently being unable to use the Apolus in its portable configuration not connected to the electric current ...

Страница 4: ...brillation pads set adult and child Replacement parts You can call Instramed for replacements of consumable items parts and accessories Consult Instramed for prices Shipping may apply To request pieces and services please contact the representative of your region the list may be found on www instramed com br or directly Instramed by the telephone 55 51 3073 8200 IV Package contents ...

Страница 5: ...s 12 Device care 12 Connection to other equipment 12 Grounding 13 Electromagnetic compatibility 13 Disposing of the device 13 The equipment 14 Front panel 14 1 Selector switch 15 2 LCD Display 15 3 Power battery charge and QRS indications 16 4 Operation buttons 16 Side view 17 1 Connector for defibrillation electrodes pads 17 Rear pannel 18 Defibrillation operation 19 Physics principle used 19 ...

Страница 6: ...nal test 28 Step 1 28 Step 2 28 Step 3 28 Step 4 28 Step 5 28 Indication of the functional tests results 29 Care and maintenance 30 Preventive maintenance 30 Corrective maintenance 30 Cleaning and disinfection 30 Sterilization 30 Battery 31 Returning componentes 31 Precautions restrictions and warnings 31 Electromagnetic compatibility 31 Electromagnetic emissions 33 Electromagnetic immunity Genera...

Страница 7: ...II Troubleshooting 39 Accessories 40 List of basic accessories 40 List of optional accessories 40 Specifications and safety 41 General specifications 41 Environmental specifications 42 Defibrillator 42 Warranty Certificate 48 ...

Страница 8: ...in ambulances WARNING The Apolus must be used by qualified personnel on patients who need defibrillation therapy or as a complement in assessing the patient s physiological conditions The use must happen in conjunction with the patient s clinical signs and symptoms About the Manual This manual explains the functioning of the Apolus defibrillators series alerting the user to safety risks This manua...

Страница 9: ...quids or gases ELECTRICAL SHOCK HAZARD never open the device Each and every repair must be performed by Instramed s authorized technical centers ATTENTION THE PATIENT MUST BE PLACED ON NON CONDUCTIVE SURFACES DO NOT USE WET OR METALLIC SURFACES AND IF NECESSARY DRY THE PATIENT S CHEST BEFORE SHOCK DELIVERY ATTENTION DURING THE DEFIBRILLATION DO NOT TOUCH THE PATIENT THE EQUIPMENT THE ACCESSORIES N...

Страница 10: ...lusively with the biocompatibility test of the applied parts WARNING When removing the equipment from its package carefully verify if there is any abnormality or visible damage in the device or its accessories caused by impact or mishandling during transportation In case of irregularities please contact Instramed WARNING disposable accessories and any other components must be disposed according to...

Страница 11: ...8 Alternate current IEC TR 60878 Direct current IEC TR 60878 Non ionizing radiation IEC TR 60878 Input connection ISO 780 Maintain this side upwards ISO 780 Fragile equipment ISO 780 Maximum stacking of 4 units ISO 780 Maintain protected from the rain ISO 7000 ISO 780 Minimum and maximum temperature ISO 7000 Minimum and maximum atmospheric pres sure ISO 7000 Minimum and maximum relative humidity I...

Страница 12: ...of cardiac defibrillators Device care Do not place the equipment where it may fall on the patient Do not lift the equipment by its cables or connections Place cables connected to the patient in order to restrict the possibility of strangulation Keep the defibrillator in a dry environment avoiding places that allow liquids to spill over the monitor Do not use the defibrillator if it is wet or exces...

Страница 13: ...liance with the information contained in this manual see the chapter Care and Maintenance Disposing of the device According to the Brazilian environmental legislation equipments and parts that are no longer in conditions of use should be referred to the manufacturer for the final destination thus preserving the natural resources and contributing to the conservation of the environment For disposal ...

Страница 14: ... panel Selection of energy delivered Joules 50 1 2 3 4 5 1 Selector switch turns the equipment on and off selects the energy 2 LCD display 3 Power battery charge and QRS indications 4 Operation buttons 5 Transport handle 14 ...

Страница 15: ...energy delivery Joules 50 2 LCD Display The LCD screen of the Apolus shows numeric information related to the defibrillation process as well as the battery level indicator 5 levels For further information see chapter Defibrillation operation Battery charge level 5 lines 100 of charge 4 lines 80 of charge 3 lines 60 of charge 2 lines 40 of charge 1 line 20 of charge Battery status with the AC power...

Страница 16: ...eration buttons Together with the energy selector use the operation buttons to complete the defibrillation process For more information see chapter Defibrillation operation Sync used to enable the synchronized discharge When the LED is on it indicates that the function is active At the same time the QRS LED blinks according to the heartbeat Charge its activation triggers the accumulation of the in...

Страница 17: ...User manual The equipment 17 Side view 1 1 Connector for defibrillation electrodes pads Adult child external included with the equipment may be used on adults and or children Internal Used in surgeries ...

Страница 18: ...alization and general grounding connector 3 External DC socket for battery connection or external DC source in a range of 11 to 16 VDC 4 3 pin power connector input of 100 to 265 VAC with central pin for grounding 5A fuse 20mm 20AG F5A GLASS FUSE 5 Battery on off switch internal battery on off switch Used to turn off the battery when the equipment is not used for a long period ...

Страница 19: ... that may be electrically cardioverted Direct defibrillation The application of shocks without a monitor or without ECG rhythm diagnosis is called direct defibrillation it can be applied at any time with no need of sychronism with the ECG signal It is used to eliminate ventricular fibrillation Synchronized defibrillation Among the functions of the defibrillator one of the most important is the sti...

Страница 20: ... with any metallic parts Use criteria The Apolus in defibrillation mode must only be used if the following circumstances as a whole are presented 1 Unconscious victim 2 No breathing 3 No pulse Other important considerations regarding the use of the Apolus 1 Not recommended for children under one year old 2 Pacemakers may affect the device s efficiency 3 Medicines in adhesive form must be removed b...

Страница 21: ...s from their base pulling them up and out 3 Apply the conductive material to the pads electrodes 4 Place pads as shown in the image below A Sternum B Apex The electrodes must be placed in a position which will maximize the current that passes through the myocardium The standard position is A Electrode identified as STERNUM on the right second intercostal space midclavicular line B Electrode identi...

Страница 22: ...uperficial route along the thorax wall and not reach the heart 5 Check contact with the patient The STERNUM pad has a patient contact indicator The indicator goes from BAD contact red flashing LED to GOOD contact at least one green LED on Make sure to adjust the pressure and the placement of the pads to optimize Contact with the patient so that AT LEAST ONE GREEN LED remains on ...

Страница 23: ...icated on bargraph Short circuit Shock inhibited Bad contact All LEDs blinking 25 ohm Shock inhibited Bad contact All LEDs blinking 25 ohm and 300 ohm Shock delivered Wave form is adjusted according to the patient s impedance No message LEDs lit up indicating contact level 300 ohm Shock inhibited Bad contact Only the red LED is blinking Short open Shock inhibited Bad contact Only the red LED is bl...

Страница 24: ... the front of the adult external pads 2 Pull the pads base forward to remove them 3 This exposes the smaller electrode for children Adult Child The Apolus will automatically identify that it is operating in pediatric mode Energy is limited to 50 Joules in the pediatric mode 1 ...

Страница 25: ...surement of the charged energy will appear on the display The energy selected can be increased or decreased at any time just by rotating the selector switch to the new charge To cancel the shock press Disarm When the charge is complete the device sends a sound signal and displays Charge Ready on the screen Step 3 Shock After the Charge Ready warning press the Shock 3 button orange in the frontpane...

Страница 26: ...on your monitor triggers the Apolus synchronism circuit by checking for a visual QRS LED and audible QRS indication on the defibrillato In case the Apolus is unable to identify the synchronism pulse the following message will appear on the display of the device Check the connections and cable condition If this does not resolve it may be necessary to adjust the gain of the ECG input amplifier on th...

Страница 27: ...ny time whether the charge is ready or not Pantalla de desfibrilación 1 2 1 Energy selected from 5 to 360J 2 Type of defibrillation electrode adult pad internal pad adhesive pad or disconnected pad ENERGY CHARGED After selection and charging of the energy desired the following message appears on the display ...

Страница 28: ...e pads are not connected the display will show the message CONNECT THE PADS ON THE EQUIPMENT Follow the instruction Step 3 In case the pads are not positioned in the support the display will show the message CONNECT THE PADS ON THE SUPPORT Follow the instruction Step 4 The display will show the message PRESS CHARGE Press the charge key and wait until the equipment sends the charge ready signal Ste...

Страница 29: ...ent passed functional test Equipment failed functional test ATTENTION If Apolus fails the functional test contact technical support immediately NOTE the Apolus indicates failure in the functional test when the energy delivered presents an error higher than the allowed by standards ...

Страница 30: ...esenta tive otherwise this Warranty certificate may no longer be valid No internal parts are to be fixed by the user 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 Remove the equipment from the electric current before cleaning it Wipe the e...

Страница 31: ...componentes If Apolus must be returned for repair call Instramed for shipping instructions Be prepared to provide the equipment s series number If possible use the original equipment s packaging If this is not possible use an equivalent box that provides adequate protection for the monitor Precautions restrictions and warnings The Apolus is a device built according to NBR and IEC standards and the...

Страница 32: ... disturbances during the equipment s useful life are Ensure minimum distance from an RF Radio Frequency emitting source as per the table on the Electromagnetic Immunity General page Cables and accessories must also maintain this distance Do not use this product in conjunction with electric scalpels Do not use this product in conjunction with magnetic resonance apparatus The essential performance o...

Страница 33: ... its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions ABNT NBR IEC CISPR11 Class B The Apolus is suited for use in any establishment This includes residential establishments and those directly connected to the public network of distribution of low voltage electricity which supply domestic use buildings Harmonics emissions IEC 1000 3...

Страница 34: ...mode phase phase 2 KV common mode phase ground 1 KV differential mode phase phase 2 KV common mode phase ground The quality of the power supply should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Drop 0 UT for 0 5 cycles A 0 45 90 135 180 225 270 and 315 0 UT for 1 cycle and 70 UT for 25 3...

Страница 35: ... using the equation applicable to the frequency of the transmitter Advisable distance of separation 80 MHz up to 800 MHz 800 MHz up to 2 5 GHz Where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer and d is the advisable separation distance in meters m b Field strengths established by RF transmitters as determined by an electromagnetic site surv...

Страница 36: ...ent areas Therefore an additional factor of 10 3 is used in calculating the advisable separation distance for transmitters in these frequency ranges c Field strengths established by fixed transmitters such as base stations for radio telephones cell phone wireless mobile land radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with any accuracy In order...

Страница 37: ...00 35 120 12 23 For transmitters with a maximum output power not listed above the advisable separation distance d in meters m can be determined by using the equation applicable to the frequency of the transmitter where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80MHz and 800MHz the separation distance for the highest frequency ra...

Страница 38: ...8 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT Banda LTE 1 2 3 25 UMTS Pulse modulationb 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 Band LTE 7 Pulse modulationb 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulationb 217 Hz 0 2 0 3 9 5500 5785 NOTE If necessary to reach the IMMUNITY TEST LEVEL the distance between the transmitting antenna and...

Страница 39: ...t energy 50J Adult pads identification Check if the Apolus is equipped with adult pads and if adult electrodes are properly connected Does not deliver shock Impedance measuringa Check the graph bar for the patient s impedance indication Low battery autonomy Defective battery Replace battery No QRS audio indication BEEP volume Turn on BEEP s volume in the configuration menu ...

Страница 40: ...nal defibrillation pads 79001 01 Quick guide 26173 01 CD with Instramed s manuals and softwares 25277 List of optional accessories Description Code Auxiliary grounding cable 5495 External DC connection cable 79004 Set of internal pads 79013 Pair of electrodes for adult internal pads 8966 Pair of electrodes for child internal pads 8974 Synchronism cable 79138 40 ...

Страница 41: ...00 joules Time to fully charge the battery when fully depleted 8 hours Battery level indication on display Optional rechargeable battery Type Li Ion 14 8 VDC 4 4 A h Duration 3 hours fully charged battery without the printer or a minimum of 140 shocks at 360 joules or a minimum of 200 shocks at 200 joules Time to fully charge the battery when fully depleted 8 hours Consult availability Consumption...

Страница 42: ...se conditions 15 through 30 minutes will be required to stabilize the system so that functioning failures do not occur Defibrillator Waveform Biphasic truncated exponential Wave shaped parameters adjusted according to the patient s impedance Shock application By means of multifunction pads or external adult child pads Scales for adult external defibrillation 5 10 15 20 30 40 50 80 100 150 200 250 ...

Страница 43: ... charge level indicated on display Maximum charge time in maximum energy 6 seconds with 90 to 100 of the minimum specified voltage 6 seconds with a full charge 13 seconds from equipment initialization External pads size Adult 10 3 cm x 8 5 cm Area 81 9 cm Children 4 5 cm x 4 cm Area 18 cm Automatic internal discharge 30 seconds Synchronism Synchronism circuit with external signal of 1V mV of a car...

Страница 44: ...45 5 15 80 77 5 81 5 82 5 83 0 80 5 76 5 74 5 15 100 96 0 101 0 102 5 103 5 101 0 96 5 92 0 15 150 143 0 151 5 155 0 153 0 148 0 141 0 137 0 15 200 191 5 201 5 205 5 206 0 203 5 192 0 177 0 15 250 240 0 250 5 256 5 256 0 254 0 241 5 224 0 15 300 284 0 302 0 305 5 306 0 305 0 290 0 270 0 15 360 344 0 363 0 370 5 370 0 363 0 345 0 322 0 15 Patient s impedance response table Patient Impedance Shock S...

Страница 45: ...User manual Specifications and safety 45 Values on the Y axis refer to voltage volts and values on the X axis refer to time milliseconds 360J of energy at 25R impedance 360J of energy at 50R impedance ...

Страница 46: ...User manual Specifications and safety 46 360 J of energy at 75 R impedance 360 J of energy at 100 R impedance 360 J of energy at 125 R impedance ...

Страница 47: ...User manual Specifications and safety 47 360 J of energy at 150 R impedance 360 J of energy at 175 R impedance ...

Страница 48: ...n to a power source use distinct from that described in the User manual or irregular working conditions Any attempt to violate adjust or repair this equipment by individuals not authorized by Instramed Indústria Médico Hospitalar Ltda will automatically invalidate this warranty This also applies in case of alterations made to this contract the fiscal receipt or to the serial number of the equipmen...

Страница 49: ...www instramed com br 51 3073 8200 Biphasic Defibrillator ...

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