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III

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions

Mindray's obligation or liability under this warranty does not include any transportation or other charges or
liability for direct, indirect or consequential damages or delay resulting from the improper use or application of
the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray
authorized personnel.

This warranty shall not extend to:

■

Malfunction or damage caused by improper use or man-made failure.

■

Malfunction or damage caused by force majeure such as fire and earthquake.

■

Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service
people.

■

Malfunction of the instrument or part whose serial number is not legible enough.

■

Others not caused by instrument or part itself.

Company Contact

Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan,
Shenzhen 518057,P.R.China

Website:

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

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Содержание BeneHeart C Series

Страница 1: ...neHeart C2 BeneHeart C2A BeneHeart C1 Fully Automatic BeneHeart C1A Fully Automatic BeneHeart C2 Fully Automatic BeneHeart C2A Fully Automatic BeneHeart S1 BeneHeart S1A BeneHeart S2 BeneHeartS2A BeneHeart S1 Fully Automatic BeneHeart S1A Fully Automatic BeneHeart S2 Fully Automatic BeneHeart S2A Fully Automatic ...

Страница 2: ......

Страница 3: ...I Copyright 2019 Shenzhen Mindray Bio Medical Electronics Co Ltd All rights reserved Release time July 2019 Revision 2 0 ...

Страница 4: ... appear in this manual are used only for informational or editorial purposes They are the property of their respective owners Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice All information contained in this manual is believed to be correct Mindray shall not be liable for errors contained herein or for incidental or consequential damages ...

Страница 5: ...r damage caused by improper use or man made failure Malfunction or damage caused by force majeure such as fire and earthquake Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people Malfunction of the instrument or part whose serial number is not legible enough Others not caused by instrument or part itself Company Contact Manufacturer Shenzhen Mi...

Страница 6: ...your product If you have any question please contact us Intended Audience This manual is intended for persons who have been trained in equipment s operation The operator should be trained in basic life support advanced cardiac life support or other emergency medical response Illustrations All illustrations in this manual serve as examples only They may not necessarily reflect the setup or data dis...

Страница 7: ...rements 3 2 3 2 3 Connecting the Electrode Pads 3 2 3 3 Turning on the Equipment 3 3 3 4 Switching Voice Language 3 3 3 5 Turning off the Equipment 3 3 4 Using the Equipment 4 1 4 1 Operating Safety Information 4 1 4 2 Screen Display for Equipment Configured with the Screen 4 2 4 3 Responds to a Rescue 4 3 4 4 Performing CPR 4 5 4 4 1 Using the CPR Metronome 4 5 4 4 2 Using the CPR Sensor 4 5 4 5 ...

Страница 8: ...sories 9 1 9 1 Therapy Accessories 9 1 9 2 Miscellaneous 9 2 A Specifications A 1 A 1 Safety Specifications A 1 A 2 Environmental Specifications A 1 A 3 Physical Specifications A 2 A 4 Display Specifications for Equipment Configured with the Screen A 2 A 5 Audio Indicators A 2 A 6 Interface Specifications A 3 A 7 Battery Specifications A 3 A 8 Data Storage A 4 A 9 Wireless Specifications A 5 A 10 ...

Страница 9: ... General Setup D 1 D 2 AED Setup D 2 D 3 CPR Setup D 2 D 4 Test Setup D 3 D 5 WLAN Setup D 3 D 6 AED ALERT Related Setup D 4 E Voice Prompts E 1 F Symbols and Abbreviations F 1 F 1 Units F 1 F 2 Symbols F 2 F 3 Abbreviations and Acronyms F 2 G Inspection Record G 1 H Device Tracking H 1 I Declaration of Conformity I 1 ...

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Страница 11: ...ies To avoid explosion hazard do not use the equipment in the presence of oxygen rich atmospheres flammable anesthetics or other flammable agents such as gasoline Keep the equipment and the operating environment dry and clean Defibrillation current can cause operator or bystander severe injury or even death Keep distance with the patient or metal devices connected to the patient during defibrillat...

Страница 12: ... from the equipment when the wireless function is in use 1 1 3 Cautions CAUTION At the end of its service life the equipment as well as its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products to avoid contaminating the environment Magnetic and electrical fields are capable of interfering with the proper performance of the equipment For this re...

Страница 13: ...IVE IN THE EUROPEAN COMMUNITY General symbol for recovery recyclable The product bears CE mark indicating its conformity with the provisions of the Council Directive 93 42 EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive The following definition of the WEEE label applies to EU member states only This symbol indicates that this product should not be...

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Страница 15: ...R status by default Both types of models provide voice instructions that guide you through the entire defibrillation process A flashing Shock button on the semi automatic model is also presented to reinforce the voice prompts The equipment also provides real time CPR feedback including the chest compression depth rate and interruption time if it is connected with a CPR sensor Model Defibrillation ...

Страница 16: ...in public places and facilities by persons who have been trained in its operation The operator should be trained in basic life support advanced cardiac life support or other emergency medical response 2 3 Applied Parts The applied parts of the equipment are Electrode pads CPR sensor if configured 2 4 Main Unit Based on the clinical application the view that the equipment laid on the ground with li...

Страница 17: ...g on surrounding noise levels by default 6 Display screen for equipment configured with the screen 7 Pads connector connects the electrode pads 8 Pads package holder stores the electrode pads 9 Adult Child mode switch flip right or left to switch between adult and child 10 Language button press to switch between the configured languages 11 Optical sensor for equipment configured with the screen th...

Страница 18: ... connects the USB flash memory 2 micro USB connector connects the computer 3 Network connector for equipment configured with the cellular module connects the SIM card 4 Battery compartment stores the battery 1 2 3 4 1 Multifunction connector for equipment configured with the CPR sensor connects the CPR sensor 1 ...

Страница 19: ...ions whether a particular combination is hazardous for example due to summation of leakage currents consult the manufacturers or else an expert in the field to ensure the necessary safety of all devices concerned will not be impaired by the proposed combination CAUTION Make sure that the operating environment of the equipment meets the specific requirements Otherwise unexpected consequences e g da...

Страница 20: ...er condensation may occur as a result of temperature or humidity difference In this case never start the system before the condensation disappears 3 2 3 Connecting the Electrode Pads 1 Open the socket cover and plug the pads connector into the pads socket 2 Put the socket cover back Ensure the socket cover is centered and closed 3 Place the pads package into the pads package holders properly and c...

Страница 21: ...s on 3 4 Switching Voice Language You can press the Language button until the desired language is selected At most three voice languages can be configured 3 5 Turning off the Equipment Before turning off the equipment perform the following inspections 1 Confirm that the patient therapy is completed 2 Disconnect the electrode pads from the patient To turn off the equipment close the AED lid WARNING...

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Страница 23: ...electrode pads from contamination by dust or water before they are attached to the patient Otherwise incorrect or delayed analysis may result NOTE Use pediatric pads for children If pediatric pads are not available you can use adult pads press the Adult Child mode switch to the Child mode and apply the electrode pads If MR62 MR63 electrode pads are used the equipment automatically recognizes the p...

Страница 24: ... pads 4 2 Screen Display for Equipment Configured with the Screen 1 ECG rhythm displays one ECG waveform acquired from the electrode pads if ECG Display is set to On 2 Runtime area displays the equipment s operating time since powered on 3 CPR time 4 Number of delivered shocks 5 Record icon available when the sound recording function is enabled 6 Network type indicator indicates the equipment is c...

Страница 25: ...d on Stay calm Follow the instructions 3 Check Patient Category Flip the Adult Child mode switch left or right For an adult 8 years and older or over 25kg You hear Adult mode For a child under 8 years old or under 25kg You hear Child mode 4 Prepare the Patient Expose the patient s bare chest Ensure the patient s skin is clean and dry Dry the patient s chest and shave excessive hair if necessary Yo...

Страница 26: ...in the picture Red sternum pad placement place the red pad as the red area on the back middle line illustrated in the picture You hear Apply pads firmly to patient s bare chest as shown on Pads 6 Analyze Heart Rhythm Do not touch the patient waits for heart rhythm analysis You hear Do not touch the patient Analyzing heart rhythm 7 Deliver a Shock If Shock Advised For fully automatic models The equ...

Страница 27: ...t s condition Because patient status can change in a short time the patient should be assessed at all times Do not perform CPR on a patient who is responsive or is breathing normally 4 4 2 Using the CPR Sensor The equipment provides voice instructions about real time compression feedbacks if it is connected with a CPR sensor NOTE The CPR sensor is not available in the markets of UK Germany and Fra...

Страница 28: ...Retrieve the rescue data stored in the equipment For more information see 5 Data Management 2 Squeeze the pads connector and hold it back to remove the pads connector 3 Replace with the new electrode pads For more information see 3 2 3 Connecting the Electrode Pads 4 Ensure the Adult Child mode switch is available by flipping it right or left 5 Close the lid and check the Status indicator illumina...

Страница 29: ...figurations Changing configurations Restoring to the factory default configurations For more information on specific operations see AED Tool Instructions for Use Data Type Description Management Method Patient Data ECG data Heart rhythm Contact your local distributor Events AED analysis CPR operation system operations and prompts Recordings Audio recorded during a rescue Rescue data Total rescue t...

Страница 30: ...r registered equipment and rescuers giving brief statistical graphs Viewing the equipment information Monitoring equipment status and sending email or message notifications when the equipment is turned on or off Instructing a lost equipment by sending its approximate location only available for a cellular connection Sending email notifications when auto test fails no auto test detected low battery...

Страница 31: ...NOTE Battery operating time depends on the ambient temperature equipment configuration and operation Poor network quality connecting AED ALERT system will reduce the battery standby life 6 3 Battery Indications On screen battery symbols battery related voice prompts indicate the current battery status 6 3 1 Battery Power Indicators for Equipment Configured with the Screen The on screen power indic...

Страница 32: ...to the left and lift it to remove from the battery compartment 5 Align the battery pins slide the battery into the battery compartment until it clicks into place 6 Re install the battery door with the screws 7 Perform the test by referring to 8 3 1 User Test Voice Prompt Recommended Action Low Battery Please replace battery as soon as possible The battery charge is low Replace the battery with a n...

Страница 33: ...ies are stored for an extended period of time they should be placed in a cool place NOTE Storing batteries at temperature above 38 C 100 F for an extended period of time significantly shortens the battery operating time and standby life The battery storage temperature is between 5 C and 35 C Storing batteries in a cool place can slow the aging process Ideally the batteries should be stored at 15 C...

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Страница 35: ...ed cleaners WARNING The equipment manager shall carry out all cleaning and disinfection procedure specified in this chapter Be sure to shut down the system and remove the battery before cleaning the equipment CAUTION Contact your service personnel in case of spilling liquid on the equipment or accessories 7 2 Cleaning Your equipment should be cleaned on a regular basis If there is heavy pollution ...

Страница 36: ...required in your facility servicing schedule Cleaning equipment before disinfecting is recommended 7 4 Sterilization Sterilization is not recommended for the equipment unless otherwise indicated in the Instructions for Use that accompany the product ...

Страница 37: ...pment should be performed by professional servicing personnel Otherwise undue equipment failure and possible health hazards could result The service personnel must be properly qualified and thoroughly familiar with the operation of the equipment CAUTION Do not perform any functional check and maintenance if the equipment is connected to a patient otherwise the patient might be shocked If you disco...

Страница 38: ...ted corresponding prompts are provided You can also perform the user test using the AED Tool software For more information see AED Tool Instructions for Use CAUTION Frequently turning on or off the equipment during the user test will reduce the battery standby life Maintenance Item Recommended Frequency Test Item User test After installing the battery After replacing the battery After each use Per...

Страница 39: ...ted Mindray recommends you check the status indicator every day and record the result according to G Inspection Record CAUTION With the equipment powered off auto test can be performed only when the battery is installed NOTE When the equipment is placed at a temperature below 20 C the auto test cannot be carried out and incorrect status indication could result 8 3 3 Electrode Pads Check The expira...

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Страница 41: ...nd humidity ranges If accessory performance is degraded due to aging or environmental conditions contact your service personnel Check the accessories and their packages for any sign of damage Do not use them if any damage is detected Use the accessories before the expiry date if their expiry date is indicated The disposable accessories shall be disposed of according to local regulations 9 1 Therap...

Страница 42: ...9 2 9 2 Miscellaneous Description Model PN Disposable battery LM34S002A 022 000411 00 ...

Страница 43: ...ting conditions 5ºC to 50ºC at least 60 minutes of working time when the temperature reduces from room temperature to 20ºC 5 to 95 non condensing 57 0 to 106 2 kPa 381m to 4575m Short Term Storage conditions 30ºC to 70ºC 5 to 95 non condensing 57 0 to 106 2 kPa 381m to 4575m Long Term Storage conditions 15ºC to 35ºC Shock Complies with requirements of 21 102 ISO9919 Peak acceleration 1000m s2 102g...

Страница 44: ...Heart C2 BeneHeart C2A BeneHeart S2 BeneHeart S2A 2 3 0 3 kg including one battery excluding the Wi Fi and cellular modules BeneHeart C1 Fully Automatic BeneHeart C1A Fully Automatic BeneHeart S1 Fully Automatic BeneHeart S1A Fully Automatic 2 0 0 3 kg including one battery excluding the Wi Fi and cellular modules BeneHeart C2 Fully Automatic BeneHeart C2A Fully Automatic BeneHeart S2 Fully Automa...

Страница 45: ...ischarges 510 150 J discharges The equipment is powered by a new battery at 20 C 5 C of ambient temperature wireless function off voice volume set to low with three discharges every minute 400 200J discharges 200 360J discharges Equipment configured with the screen 12 hours The equipment is powered by a new battery at 20 C 5 C of ambient temperature wireless function off not performing defibrillat...

Страница 46: ...C of ambient temperature wireless function off voice volume set to low screen brightness set to indoor mode and at least 10 200J discharges with one minute of CPR between discharges At least 30 minutes operating time at 20 C 5 C of ambient temperature wireless function off voice volume set to low screen brightness set to indoor mode and at least 6 360J discharges with one minute of CPR between dis...

Страница 47: ...TE TDD Standards Meet standards of IEC 60601 2 4 Defibrillation mode BeneHeart C1 BeneHeart C1A BeneHeart C2 BeneHeart C2A BeneHeart S1 BeneHeart S1A BeneHeart S2 BeneHeart S2A semi automatic external defibrillation BeneHeart C1 Fully Automatic BeneHeart C1A Fully Automatic BeneHeart C2 Fully Automatic BeneHeart C2A Fully Automatic BeneHeart S1 Fully Automatic BeneHeart S1A Fully Automatic BeneHea...

Страница 48: ...5 J 62 J 60 J 57 J 100 J 97 J 100 J 97 J 93 J 89 J 85 J 81 J 150 J 146 J 150 J 146 J 140 J 134 J 128 J 122 J 170 J 166 J 170 J 166 J 159 J 151 J 145 J 138 J 200 J 195 J 200 J 195 J 187 J 178 J 170 J 163 J 300 J 292 J 300 J 292 J 280 J 267 J 255 J 244 J 360 J 351 J 360 J 350 J 336 J 321 J 306 J 293 J Charge time at 20 C 5 C of ambient temperature Battery status From lid opened to charge done From i...

Страница 49: ... Electrode Pads MR60 MR61 MR63 MR62 Electrode shape Oval Cable length 1 2 m preconnectable Total area 148 cm2 75 cm2 75 cm2 126 cm2 Adhesive Area 145 cm2 74 cm2 74 cm2 123 cm2 Maximum Number of Defibrillation Shocks Up to 50 shocks 360J monophasic and biphasic Shelf life with sealed package 36 months 60 months Storage Condition 0ºC to 50ºC 15ºC to 35ºC The shelf life assumes a storage temperature ...

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Страница 51: ...Database for evaluation of Mindray shockable rhythm analysis algorithm includes MIT BIH The Massachusetts Institute of Technology Beth Israel Hospital Arrhythmia Database from Holter AHA The American Heart Association Database for Evaluation of Ventricular Arrhythmia Detectors from Holter VFDB MIT BIH Malignant Ventricular Arrhythmia Database from Holter CU The Creighton University Sustained Ventr...

Страница 52: ...677 1682 b Clause 201 7 9 3 103 Essential Performance data of the Rhythm Recognition Detector and clause 201 107 Requirements for Rhythm Recognition Detector International Electrotechnical Association IEC 60601 2 4 Medical Electrical Equipment Part 2 4 Particular Requirements for the Basic Safety and Essential Performance of Cardiac Defibrillators 2010 Rhythm category Requirement Test result Shock...

Страница 53: ... to be installed and put into service according to the EMC information provided below Portable and mobile RF communications equipment may affect thisequipment This equipment is intended for use in professional healthcare facility environment or in home healthcare environment such as restaurants cafes shops stores markets schools churches libraries outdoors streets sidewalks parks domiciles residen...

Страница 54: ... used in such an environment Immunity test IEC 60601 Test level Compliance level Electromagnetic environment guidance Conduced RF IEC 61000 4 6 3 Vrms 150k to 80 MHz 3 Vrms V1 Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the tra...

Страница 55: ...in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device d Over the frequency ranges 150 kHz to 80 MHz field strengths should be less than 3V m Recommended Separation Distances between Port...

Страница 56: ... 5 24 GHz 5 745 GHz to 5 825 GHz Modulation mode DSSS and OFDM Output Power 20 dBm Operating frequency LTE FDD B1 1920 MHz to 1980 MHz 2110 MHz to 2170 MHz LTE FDD B3 1710 MHz to 1785 MHz 1805 MHz to 1880 MHz LTE FDD B7 2500 MHz to 2570 MHz 2620 MHz to 2690 MHz LTE FDD B8 880 MHz to 915 MHz 925 MHz to 960 MHz LTE FDD B20 832 MHz to 862 MHz 791 MHz to 821 MHz LTE FDD B28A 703 MHz to 733 MHz 758 MHz...

Страница 57: ...9 Language Sets the language for voice prompts At most three languages Voice Recording Selects whether the recording function is enabled On Off Off Voice Volume Sets the volume level for voice prompts Auto the equipment automatically adjusts the volume according to the ambient noise Low level if noise 30 db Hight level if noise 80 db Not specified if 80 db noise 30 db Auto High Low Auto Brightness...

Страница 58: ...0J 360 J Energy 1 Pediatric Sets the defibrillation energy level for the first shock on the children 10 15 20 30 50 70 100J 50 J Energy 2 Pediatric Energy 1 configurable value Energy 3 Energy 1 to 100 J 70 J Energy 3 Pediatric Energy 2 configurable value Energy 2 to 100 J 100 J Initial CPR Selects whether the equipment enters the CPR status directly after turned on On Off Off ECG Display Selects w...

Страница 59: ...ce Management System Site Input the IP address or domain name of AED ALERT system aed alert mindray com Device Management System Port Input the port of AED ALERT system 0 to 65535 16903 Network Name Input the network name of Wi Fi hotspot 0 to 32 characters Address Type Manual Address Type IP Address Subnet Mask are required DHCP the equipment automatically gets IP address Manual DHCP DHCP IP Addr...

Страница 60: ...w Menu Item Description Options Range Default Device Enabled Reminder Sends messages to the designated person on the AED ALERT system when the equipment is turned on turned off or out of the specified location On Off On Auto Upload Rescue Data Uploads the rescue events not including ECG waveforms automatically to the AED ALERT system after a rescue On Off On ...

Страница 61: ...ly pads as shown on Pads Prompts to remove the patient s clothing and place the electrode pads Remove clothing from patient s chest Plug in pads connector Remove pads package from lid of AED Tear open package Apply pads as shown on Pads Apply pads as shown on Pads Apply pads as shown on Pads Abnormal Pads connection Pads connection failure start CPR immediately The equipment analyzes the patient s...

Страница 62: ...it is not suitable to deliver a shock to the patient The equipment disarms itself and resumes the rhythm analysis after a discharging failure After three consecutive discharging failures the equipment automatically enters the CPR status Shock canceled Press pads firmly to patient s bare skin Shock canceled Pads must not be touching each other Rhythm change shock canceled The equipment detects a rh...

Страница 63: ...metronome pacing the speed of compressions Follow the metronome to give 30 compressions and 2 rescue breaths Prompts to prepare to provide compressions and breaths CPR Follow the metronome to give 15 compressions and 2 rescue breaths Use a CPR sensor for CPR Incomplete recoil Prompts to use more effort and release all pressure when moving hands up Compress faster Prompts to adjust the compression ...

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Страница 65: ...ere hour bpm beat per minute bps bit per second ºC centigrade cm centimeter dB decibel ºF fahrenheit h hour Hz hertz in inch J Joule kg kilogram kPa kilopascal L litre m meter min minute mm millimeter ms millisecond mV millivolt mW milliwatt rpm breaths per minute s second V volt Ω ohm ...

Страница 66: ...iation ANSI American National Standard Institute aVF left foot augmented lead aVL left arm augmented lead aVR right arm augmented lead CE Conformité Européenne CISPR International Special Committee on Radio Interference CPR Cardiopulmonary resuscitation DC direct current Defib defibrillation ECG electrocardiograph EMC electromagnetic compatibility EMI electromagnetic interference ESU electrosurgic...

Страница 67: ...ht emitting diode LL left leg MRI magnetic resonance imaging Neo neonate O2 oxygen Ped pediatric PNC pacer not captured PNP pacer not paced PVC premature ventricular complex RA right arm Rec record recording RL right leg Sync synchronization USB universal serial bus ...

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Страница 69: ... in red 4 in green in red 20 in green in red 5 in green in red 21 in green in red 6 in green in red 22 in green in red 7 in green in red 23 in green in red 8 in green in red 24 in green in red 9 in green in red 25 in green in red 10 in green in red 26 in green in red 11 in green in red 27 in green in red 12 in green in red 28 in green in red 13 in green in red 29 in green in red 14 in green in red...

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Страница 71: ...ce we are going to track our product Please contact us with the device tracking information when you have received your defibrillator monitor Please fill the information in the next page cut the table and fax it to 86 755 26582934 You can also email your information to service mindray com ...

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Страница 73: ...ng Information User Information Customer Name Department name Address City State Zip Post Code Country Contact Person Tel No Fax No Email Address Device Information Product name Serial number Model Installation Date ...

Страница 74: ......

Страница 75: ...I 1 I Declaration of Conformity ...

Страница 76: ...I 2 ...

Страница 77: ......

Страница 78: ...P N 046 012619 00 2 0 ...

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