Система мониторинга, регистрации и анализа электрофизиологических данных с принадлежностям

Параметр изделия

Значение параметра

Регистрационный номер

РЗН 2015/3062

Дата государственной регистрации

17.09.2015

Срок действия регистрационного удостоверения

Наименование медицинского изделия

Система мониторинга, регистрации и анализа электрофизиологических данных с принадлежностямиI. 1.1. Компьютер с системным оборудованием, техническим и программным обеспечением (включая клавиатуру, манипулятор "мышь", манипулятор шаровой, накопители данных DVD+/-RW и CD RW, HDD, AGP Video, PCI Video, Auto Switching 115 VAC-240VAC Power Supply, Extended Memory, Cache, USB, PS2, Serial Port, LAN RJ45 Ethernet, Audio Line Input, Audio Line Output, Microphone Input, инструкции). 1.2. Мониторы цветные высокого разрешения: - Viewsonic CRT; - Eizo LCD. 1.3. Интерфейсы:- VGA (D sub) VIDEO SPLITTER (e.g.; for LCD-Screens); - VGA BNC Video Splitter Kit (monitor signal booster); - VGA BNC Video Switch Kit (to slave 2 monitors to 1 slave monitor). 1.4. Принтеры лазерные и цветные - HP DeskJet colour inkjet printer for LabSystem Pro, includes USB cable;- HP LaserJet printer Parrallel Printer Switch -BLACKBOX -. 1.5. Модульный усилитель STAMP Amplifier - Basic STAMP, 230V (1 chassis, 1 stim switch, 1 blank plate); - Blank Plate, STAMP. 1.6. Модули усилителя STAMP Amplifier - ECG/Pressure Plus Module; - V-Lead/Pressure Plus Module; - Advanced Intracardiac Modules; - High Level Input Isolation (HLII) Module; - Pressure Transducer Kit. 1.7. Трансформатор изолирующий Isolation Transformer, 230V. 1.8. Источник бесперебойного питания APC 1500 VAC UPS - KENTARUS -. 1.9. Бокс-стол для размещения оборудования системы Box-Table. II. Принадлежности: 2.1. Кабели компьютерные: - Null Modem Cable, F-F, 100 ft. (30 m ) (for RF Stockert generator use); - Null Modem Cable, F-F, 25 ft. (7 m) (for RF Stockert generator use); - Null Modem Cable, F-F, 50 ft. (15 m) (for RF Stockert generator use); - JRS-232 Cable, M-F, 100 ft.(30 m) (for RF generator use); - JRS-232 Cable, M-F, 25 ft. (7 m) (for RF generator use); - JRS-232 Cable, M-F, 50 ft. (15 m) (for RF generator use); - VGA (D Sub) EXTENSION CABLE 1.5M;- VGA (D Sub) EXTENSION CABLE 6.0M; - VGA (D Sub) EXTENSION CABLE 15M; - VGA (D Sub) EXTENSION CABLE 7.6M; - VGA EXTENSION CABLE 7.6M; - VGA EXTENSION CABLE 15M; - VGA 5 BNC Monitor Cable; - VGA BNC Remote Monitor Cable, 100ft. (30m);- VGA BNC Remote Monitor Cable, 50 ft. (15m); - VGA BNC Tee Connector; - Printer Interface Cable;- RTO (Real Time Output) Cable; - BNC Male to Phono Male Cable; - BNC male to male cable, 30 Ft (9.2m) (Fluoro capture); - Female to Female BNC Adaptor (five per Package); - Power Cord, 230 V. 2.2. Кабели модульного усилителя STAMP Amplifier: - 12-Lead ECG Cable, AHA color-coded, 6.1m (20 ft.) - 12-Lead ECG Cable, IEC color-coded, 3.4m (11 ft.) - 12-Lead ECG Cable, IEC color-coded, 6.1m (20 ft.) - ECG Leadwires Radiofransiucetrt (СОNMED) 48 Inches, set of ten 1,5 m; - ECG Leadwires Radiotranslucent, 36 in. (1m) (10 per package);- ECG Leadwires (CONMED) 54 inches, set of ten;- ECG Leadwires (CONMED) 72 inches, set of ten; - ECG Leadwires, AHA color-coded, 36 in. (1 m) (10 per package);- ECG Leadwires, Banana-style, IEC color-coded, 1m (36 in.) (10 per package);- ECG Leadwires, Grabber-style, IEC color-coded, 1m (36 in.) (10 per package);- Fiber Optic Cable, 10m (32.5 ft.);- Fiber Optic Cable, 15m (50 ft.);- Fiber Optic Cable, 5m (16 ft.);- Fiber Optic Cable, 65 ft. (20m);- MMJB Interconnect cable;- MM JB KIT 11 FT. (3,4m);- MM JB KIT 20FT. (6,1 m);- MM JB KIT SOFT (15m);- MM JB Octopus Stim Cable;- MM JB Rack; - ММ JB Support Bracket; - MM JB Support Bracket Clamp Multi-Module junction Box w/pacing, 11 Ft. (3,4 m); - Multi-Module junction Box w/pacing, 20 Ft. (6,1 m);- Multi-Module junction Box w/pacing, 50 Ft. (15 m); - Protected Pin Junction Box with Pacing, 11 ft. (3.4m); - Protected Pin Junction Box with Pacing, 20 ft. (6.1m); - Protected Pin Junction Box with Pacing, 30 ft. (9.2m); - Protected Pin Junction Box with Pacing, 35' (10m);- Protected Pin Junction Box with Pacing, 45 ft. (13.8m);- Protected Pin Junction Box with Pacing, 50 ft. (15m);- Protected Pin Junction Box without Pacing, 11 ft. (3.4m);- Protected Pin Junction Box without Pacing, 20 ft. (6.1m);- Protected Pin Junction Box without Pacing, 30 ft. (9.2m);- Protected Pin Junction Box without pacing, 35' (10m);- Protected Pin Junction Box without Pacing, 50 ft. (15m);- Stim Cable with Pacing, 50 ft. (15m);- Stim Cable, 11 Ft. (3,4 m);- Stim Cable, 20 Ft. (6,1 m);- Stim Cable, 50 Ft. (15m);- Stim cable, protected pins, without bypass;- 35 Ft. Stimulator input cable;- Blood Pressure Cable;- Pressure transducers (box of five) to replace 200468;- Jumper Kit (5 per case : 3 red and 2 white);- Universal Pin Adapters (18 per package);- Universal Pin Adapters (2 per package);- Equipotential Ground Cable Equipotential Junction Box Cable Power Cord, 230V (for use between LabSystem components and Isolation Transformer).2.3. Стимулятор MICROPACE EPS 320:- Complete Micropace EPS 320 Cardiac Stimulator;- 220-240 VAC - 14.5 VDC Power Supply Unit;- Stimulus Generator Unit (SGU);- Patient Connection Box (2 channels Stimulus Connection box with RF Filter);- Keyboard with EPS 320 Key Labels;- Mains Power Cord, Monoputer;- RS232 Serial Cable;- Signal Cable, 6.5 mm Phono, Terminated;- Micropace Software, 1.44 MB Diskette;- Document Kit (User's Guide, Service Guide, Test Certificate);- Stimulus Cable, Free-Ended;- Cable Tie;- Mains Power Cord, Isolation Transformer;- Accessories Kit;- Phono Plug - RCA Socket Adapter;- RCA Plug - BNC Socket Adapter;- Test LED - Red/Orange;- 2A, 240 VAC Slo-Blo Fuse;- Signal Cable, Free-Ended;- Cable Tie, Stick-On Pad;- Installation Kit;- Extention Stim cable For Stimulus Connection Box 12 m;- Micropace LCD Monitor;- Software installation kit (Disc + documents + installation details);- Software upgrade kit V 3.19 micropace;- Extended Four Channel SM Box Control cables 12 m;- Four Channel upgrade kit (Requires Soft V 3.19);- Bona Lex Light System PC computer with V 3.19;- Stimlink Cables;- Moniputer to Software 3.19 Upgrade Kit (Include Bona Computer + Flat Screen);- Micropace HP eVectra to Software 3.19 Upgrade Kit (Include Bona Computer);- 12 V Sealed Lead Acid Battery (For SGU-main backup battery);- 9V Lithium Battery For SGU (the Emergency Fixed Rate Pacing);- Micropace HP e-Vectra Computer for EPS 320.2.4. Техническое обеспечение, инструкции по эксплуатации, запасные части, дополнительное оборудование и программное обеспечение: - Contract for Electrophysiology; - Coupler kit for Fiber Optic Cable;- Customized keyboard for LabSystem Pro;- Getting Started Guide for LabSystem Pro V1.1;- Image Capture Board for LabSystem Pro;- Image Capture Cable for LabSystem Pro;- Lease Hire of Labsystem;- Mouse Intellimouse for LabSystem Pro;- Repair Electrophysiology; -STAMP Schematics Manual;- Anthro Cart 35(H) x 30(D) x 36(W) inches;- Computer Siderack for Horizontal Cart;- Custom System Cart, 230V;- DVD Data Storage Media, pkg of 5;- ECG & Pressure Simulator -BIOTEK -;- PACE-1A Stimulator;- Firm Version 3.0 Chip Set for LabSystem EP Laboratory STAMP; - Amplifier;- Horizontal Cart;H-P Optical Disk, Formatted;- Image Capture Option Hardware Kit (capture board and cable) for;- LabSystem Pro Large Drawer 2 inches deep for Anthro Carts;- Large Drawer 6 inches deep for Anthro Carts;- LCD Arm ERGOTRON;- LS Pro upgrade version 2.1 & future;- Set of Five inch castors for Anthro Carts;- STAMP Firmware Version 3.0 EPROM for LabSystem EP Laboratory;- LabSystem Administrator for Windows 95/98, V2.0;- MS Office V4.3 for OS/2 & LabSystem;- Shorting Plug for ECG Cable (5 per package);- Trigger Cable for Biotronik Stimulator;- Trigger Cable for Bloom or EP MedSystems Stimulator;- Trigger Cable for Medtronic Stimulators.

Наименование организации – заявителя

ООО "Регистрационная компания"

Место нахождения организации-заявителя

119991, Россия, г. Москва, 5-й Донской проезд, д. 15, стр. 1

Юридический адрес организации-заявителя

119991, Россия, Москва, 5-й Донской проезд, д. 21Б, стр. 1

Наименование организации-производителя или организации-изготовителя

"Бостон Сайентифик Корпорейшн"

Место нахождения организации-производителя или организации – изготовителя

, США, Дальнее зарубежье, Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA 01752, USA

Юридический адрес организации-производителя или организации – изготовителя

, США, Дальнее зарубежье, Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA 01752, USA

ОКП/ОКПД2

94 4280

Класс потенциального риска применения медицинского изделия

3

Назначение медицинского изделия, установленное производителем

Адрес места производства или изготовления медицинского изделия

1. Boston Scientific Corporation, 47215 Lakeview Boulevard, Fremont, СA 94538, USA. 2. Boston Scientific Corporation, 55 Technology Drive, Lowell, Massachusetts 01851, USA.

Контакты производителя медицинского изделия

Контакты дистрибутора в России №1

Контакты дистрибутора в России №2

Контакты дистрибутора в России №3

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Регистрационное удостоверение