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3.2

LASSIFICATIONS

The

Saver One P

defibrillator is classified as follows:

UMDNS

code

11132

GMDN

code

17882

CND

code

Z12030502

RDM

[(It.) Medical Device Register] number

114299 / 1536326

CIVAB

[Biomedical Equipment Information and Assessment

Centre] code

DEF02

Class in accordance with Directive

2007/47/EC

IIb

Type of protection from electric shock

Powered Internally

Type of patient insulation

BF
CF (only for ECG cable)

Protection rating against penetration by liquids

IPx4

Protection rating against penetration by dust

IP5x

Degree of safety in the presence of inflammable anaesthetic
mixtures with air, oxygen or nitrous oxide

Not protected

Sterilisation or disinfection method suggested by the supplier

See Paragraph 12.3

Operation mode

Continuous operation

Содержание Saver One P

Страница 1: ...USER MANUAL DUAL MODE DEFIBRILLATOR SEMIAUTOMATIC MANUAL Rev 12 4...

Страница 2: ...2 QUICK START GUIDE...

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

Страница 4: ...4 5 Standard and optional accessories of the device 18 5 Parts and accessories of the Saver One P 20 5 1 Batteries 20 5 1 1 Non rechargeable batteries SAV C0903 Li SOCl2 and SAV C0904 Li MnO2 20 5 1...

Страница 5: ...Heartbeat analysis 41 8 5 Shockable rhythm 42 8 6 Non shockable rhythm 43 8 7 Change of rhythm 43 8 8 CPR 44 9 MANUAL defibrillation 46 9 1 Starting manual mode 46 9 1 1 Asynchronous defibrillation 47...

Страница 6: ...ECG Monitoring 68 13 13 Display 69 13 14 Non rechargeable battery 69 13 15 Rechargeable battery 69 13 16 Internal back up battery 70 13 17 Battery charger 70 13 18 Thermal printer 70 13 19 Defibrilla...

Страница 7: ...and or property In that case A M I Italia S r l hereby disclaims all liability 1 3 WARRANTY The device Saver One P has a guarantee of 6 six years The SAV C0903 and SAV C0904 non rechargeable batteries...

Страница 8: ...ION DESCRIPTION HAZARD Indicates an immediate risk to the safety of people which also involves death and damage to the device or parts thereof WARNING Indicates an unsafe situation or practice which l...

Страница 9: ...ch the patient and prevent third parties from coming into contact with the patient during the defibrillation shock Avoid all contact between parts of the patient s body conducting liquids such as gel...

Страница 10: ...by the device may lead to a wrong or untimely diagnosis Reduce movements to a minimum while the heartbeat is being analysed If the device is used in a moving ambulance stop the vehicle and only start...

Страница 11: ...s in this manual for their application Take care not to let the conductive parts of the electrodes come into contact with other conductive parts including the earth As a precaution if there is a defib...

Страница 12: ...ossible harm to the environment or to persons health caused by incorrect disposal of waste recycle this product responsibly also to promote a sustainable use of resources In order to discard the used...

Страница 13: ...Q Maximum deliverable energy 360J Q CPR opt Saver One P 200J SVD B0006 U Q Max deliverable energy 200J Univer Face to Face PADs and Q CPR opt Saver One P 360J SVP B0007 U Q Max deliverable energy 360J...

Страница 14: ...th Directive 2007 47 EC IIb Type of protection from electric shock Powered Internally Type of patient insulation BF CF only for ECG cable Protection rating against penetration by liquids IPx4 Protecti...

Страница 15: ...e 2 Microphone for environmental recordings 3 Mini status display 4 Carry handle 5 Battery removable 6 TFT colour display 7 IrDA port service only 8 Keypad with buttons 9 Speaker No Description 10 USB...

Страница 16: ...gy to be delivered in manual mode 4 Control LEDs LED red green to check the functional status of the device 9 Charge Button To carry out charging of the device in manual mode 5 ON OFF button To switch...

Страница 17: ...r 15 2 11 Indicates not to touch the patient in certain operations 3 Indicates the patient s heart rate 12 Indicates peak R detection for shock delivery in Manual Synchronous mode 4 Indicates the pati...

Страница 18: ...r 360J Saver One P 200J SVP B0007 SVP B0007 U SVP B0007 Q SVP B0007 U Q Saver One P 360J SAV C0846 1 Unit Pre connected Adult PADs for standard models only without U option SAV C0904 1 Unit Non rechar...

Страница 19: ...CCS1 Charger SAV C0013 1 Unit GS40A15 P1J Power supply SAV C0014 1Unit Contains 3 items 01 CBACCS1 Charger 01 P66A 3P2JA Power supply unit 01 Power supply cable SAV C0016 1 Unit Children PADs for stan...

Страница 20: ...0J and CPR Saver One P Power 360J 160 complete rescue cycles shocks at 360J and CPR If the remaining battery level is low the Saver One P informs the user via audio and visual messages The Saver One P...

Страница 21: ...One P makes it possible to administer about 14 shocks or 40 days of stand by ALARM Battery residual capacity level at 1 This warning will be issued both in Stand by and in operating mode as indicated...

Страница 22: ...rly inserted Follow the instructions below to remove the battery from the device Position the device as shown in figure 9 Hold the device firmly with your left hand as shown in figure 9 Using two fing...

Страница 23: ...r outlet C The LED on the charger will flash green indicating that it is ready to charge D Insert the battery to be charged into the battery charger as shown in figure 15 The recharging station rechar...

Страница 24: ...e replaced even if not used The SAV C0846 PADs are characterized by the cable and the PAD connector outside the sealed package This solution has been adopted in order to further speed up the placement...

Страница 25: ...kage This solution has been adopted in order to further speed up the placement of the PADs avoiding the need to insert the connector during the rescue When the connector is inserted into the appropria...

Страница 26: ...LD With the SAV C0599 Universal PADs the following discharges can be delivered after patient selection Adults energy up to 200J SVP B0006 U SVP B0006 U Q up to 360J SVP B0007 U SVP B0007 U Q Children...

Страница 27: ...h of the compressions and by an acoustic signal as reference for the rhythm of the compressions For the external accessory module for Q CPR Ref SMT C14034 in conjunction with compatible defibrillator...

Страница 28: ...can only be used if the Saver One P is set in ECG MONITORING operating mode see Chapter 10 The ECG SAV C0017 cable is classified as type CF 5 5 1 Placement of the electrodes The SAV C0017 ECG cable el...

Страница 29: ...of the Saver ONE P can be downloaded via the USB port on the back of the device figure 21 The USB cable to be used must be a mini USB 2 0 USB Mini USB connection To connect the mini USB cables to the...

Страница 30: ...ttery AC DC battery charger PC interface cable Thermal paper roll 57mm 30 All information on the thermal printer can be found in the specific user manual of Martel MCP7830 Before using the printer car...

Страница 31: ...turned on the model name and operating status of the device will be shown on the display After that for models with universal pads only U option the following image will appear from which the operator...

Страница 32: ...e desired operating mode 2 Setting To access the settings submenu 3 System information To access the device information submenu 4 Print To access the print submenu only if using Martel MCP7830 printer...

Страница 33: ...ed for voice and text prompts default 1 language up to 5 selectable languages on request English 6 CPR time Allows the paediatric CPR protocol to be modified according to international guidelines Note...

Страница 34: ...version Indicates the software version installed on the device Axx xxxxMxx xxxx 4 Shock Indicates the shock protocol used 5 Power supply To access to the power supply sub menu 6 Output To exit the Se...

Страница 35: ...ity 0 100 3 No of recharges Indicates how many times the rechargeable battery has been recharged Note This item is only displayed when the rechargeable battery is inserted 0 XX 4 Voltage Indicates bat...

Страница 36: ...D 2 1 3 Indicates the selected rescue and the total amount of recorded rescues 1 X 3 2011 02 12 13 22 Indicates the date and time of the selected rescue dd m year hh mm 4 37 kB Indicates the size of t...

Страница 37: ...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 status of...

Страница 38: ...e blinking red button The shock button will start blinking The operator will have a maximum of 60 seconds to push the shock button Push the shock button to launch the ACTIVATION test If the shock butt...

Страница 39: ...basic daily in depth monthly complete half yearly The result of the automatic self test can be verified with the LED and the mini control Display located on the device keypad Refer to the tables for L...

Страница 40: ...cal responsibility 8 1 SWITCHING ON THE SAVER ONE P The Saver One P defibrillator will automatically start the semi automatic defibrillation mode every time it is turned on default setting The procedu...

Страница 41: ...ch the patient Heartbeat analysis in progress Heartbeat analysis During the heartbeat analysis the patient s body must not be touched and it must not be subject to vibrations or movements The Saver On...

Страница 42: ...bar Once the charging phase is completed the Saver One P is ready to shock This information is highlighted by voice audio and visual colour display prompts shown in the table in addition the shock but...

Страница 43: ...uired to position the PADs The shock protocol is pre set cannot be modified by the user and is reset at each power up It can only be modified by A M I Italia S r l at the express request of the custom...

Страница 44: ...suscitation is about 2 minutes If resuscitation is carried out by a single operator the compressions insufflations ratio must be 30 2 for 2 minutes 5 cycles for both adult and child patients If the re...

Страница 45: ...t of the torso the oscillating movement must be centred around the hip joint G After each compression release all pressure on the chest without losing contact between your hands and the sternum repeat...

Страница 46: ...led in this mode Given the possibility of the Saver One P to be used by paramedics in semi automatic mode the manual mode is protected by a password which must only be used by medical personnel 9 1 ST...

Страница 47: ...MANUAL Defibrillation Mode Password UP DOWN UP DOWN Enter the password following the sequence above As you enter the sequence the dashes next to Enter password will turn into asterisks Once the sequen...

Страница 48: ...on this method makes it possible to identify the QRS complex of the patients often referred to speaking of cardioversion as R wave The Defibrillator searches for the R wave on the basis of certain cri...

Страница 49: ...menu from which the operator can select the energy they believe should be delivered After selecting the energy to be delivered the Saver One P automatically exits the menu and returns to the main scre...

Страница 50: ...the CHARGE button in order to arm the device and then be able to shock This information is highlighted by voice audio and visual colour display prompts as shown in the following table Voice prompts T...

Страница 51: ...e shock is delivered press and hold If the shock button is pressed the Saver One P defibrillator will guide the operator through CPR If CPR guidance has been enabled in the settings menu the device wi...

Страница 52: ...started it requires entering a security password see the following paragraphs for more information In this mode the defibrillator does not allow charging and does not allow defibrillation This mode i...

Страница 53: ...ion errors by personnel not authorised to use this mode The password must only be used by medical personnel This password consists of a sequence of 4 characters the arrows and on the defibrillator key...

Страница 54: ...around it to move along the MENU use the and buttons To press the selected button use the button In particular Pressing button 5 resets the alarms Pressing button 6 disables alarm detection for 30 se...

Страница 55: ...of fast ventricular tachycardia In this case the patient should undergo a defibrillation shock HIGH 5 sec 5 Cardiac High frequency Detection of an accelerated sinus rhythm In this case the patient sho...

Страница 56: ...is file stores all the automatic self tests performed by the device with their outcomes and all the SERVICE information This type of file can be viewed on a PC via a simple reading program AEDFILE aed...

Страница 57: ...30 Printer Installation For more information on the Martel MCP7830 SAV C1070 portable printer refer to its user manual 1 Preparation for printing o Make sure the printer battery is charged and working...

Страница 58: ...the procedure below 1 Enter the Saver One P menu and select the PRINT item 2 Make sure the Saver One P defibrillator has correctly detected the printer If the Saver One P does not detect the printer t...

Страница 59: ...back to the previous menu The print slip contains all the rescue events the data relating to the device and the ECG tracing of the patient It will also be possible to note down some personal data rela...

Страница 60: ...Saver One P defibrillator the following operations must be performed in order to prepare the device for the next use 1 Check for the memory card and its remaining capacity 2 Check that the control LED...

Страница 61: ...lled it is advisable to keep the device with the battery always inserted to allow it to carry out the periodic self diagnostic tests For easy retrieval of the device in case of a rescue place it in an...

Страница 62: ...mode the voice prompt Low battery is provided Battery low Battery level 5 It is possible to use the device but the battery level is low see the relevant paragraph Purchase a new battery and replace i...

Страница 63: ...r vapour up to 50hPa from 35 C to 70 C Atmospheric pressure Operating conditions 620 hPa at 1060 hPa calculated altitude min 382 and max 3955 m Operating conditions Normal use Keep the AED device with...

Страница 64: ...frequency Alarm icon and cause indication Monitoring HIGH Asystole Alarm icon and cause indication Monitoring HIGH Fibrillation Detected Alarm icon and cause indication Monitoring HIGH Tachycardia De...

Страница 65: ...Subsequent 350J Energy delivered max Children Version 200J Version 360J 50J nominal when using defibrillation PADs SAV C0016 Shock protocol Children Semi automatic Version 200J Version 360J Fixed Fir...

Страница 66: ...Energy Tpos ms Tneg ms Umax A Energy set 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 13 150...

Страница 67: ...1 5 4 6 11 4 250 241 15 Impedance Shocks at 350 J Energy Tpos ms Tneg ms Umax A Energy set 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 Oh...

Страница 68: ...rhythm moderate ventricular fibrillation 200 Volts some slow ventricular tachycardias and asystoles 13 11 ECG ANALYSIS OPERATION ECG rhythm Dimension Test sample Objective Value detected Rhythm to be...

Страница 69: ...rgeable Voltage Capacity 25 2 VDC 3500 mAh 24 VDC 3000 mAh Performance Version 200J 250 complete rescue cycles shocks at 200J and CPR Version 360J 160 complete rescue cycles shocks at 360J and CPR Mon...

Страница 70: ...e relevant paragraph Power supply Input 15Vdc 2 67A 12Vdc 5 5A Output 26VDC 1 5A Absorption 40W 66W AC DC Adapter Model MeanWell GS40A15 P1J Identification code SAV C0013 Input 100 240VAC 50 60Hz 1 5A...

Страница 71: ...poles with CLIP terminals button Coding International IEC EN Model CF 13 21 CHARGE TIME Charging time performance in accordance with IEC EN 60601 2 4 201 101 Requirement In Semiautomatic mode the maxi...

Страница 72: ...n any building including residential buildings and buildings directly connected to the public low voltage electricity network that supplies residential buildings Harmonic Emissions IEC EN 61000 3 2 No...

Страница 73: ...erval applies at 80 MHz and 800 MHz NOTE 1 These guidelines may not apply to all situations Electromagnetic propagation is affected by absorption and reflected from structures objects and people a The...

Страница 74: ...m 23 m For transmitters whose estimated maximum power is not listed above the separation distance d in metres m can be determined using the equation that applies to the transmitter s frequency where P...

Страница 75: ...high temperatures or flames Manufacture Date Do not recharge Lot Number LOT Do Not Open Expiry Date Do not destroy or damage Model identification number Do not use in water puddles Manufacturer Name...

Страница 76: ...76 16 CERTIFICATIONS 16 1CE CERTIFICATE...

Страница 77: ...77...

Страница 78: ...78 16 2IMQ MARK...

Страница 79: ...nts modifications misuse non compliance with the procedures or hazards or warnings or cautions described in the user manual failure to perform reasonable and adequate maintenance incorrect installatio...

Страница 80: ...rder to guarantee correct and rapid traceability of the product sold we kindly ask you to complete the form below and send it by fax or registered letter to A M I Italia S r l or register on the AMIIT...

Страница 81: ......

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