Справочник
Система мониторинга, регистрации и анализа электрофизиологических данных с принадлежностями (см. Приложение на 7 листах)
ФС № 2005/1390
Параметры изделия
- Уникальный номер реестровой записи
- 54011
- Статус
- Внесено изменение
- Регистрационный номер медицинского изделия
- ФС № 2005/1390
- Дата государственной регистрации медицинского изделия
- 2005-09-27
- Срок действия регистрационного удостоверения
- 2015-09-17
- Наименование медицинского изделия
- Система мониторинга, регистрации и анализа электрофизиологических данных с принадлежностями (см. Приложение на 7 листах). I. Система мониторинга, регистрации и анализа электрофизиологических данных: 
 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
 MM 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 "Центр биомедицинской инженерии "ВИМЕД""
- Производитель медицинского изделия
- C.R. Bard GmbH (завод Bard Electrophysiology (BEP), США)
- Страна производителя
- 3185883715783890671
- Адрес производителя
- ФРГ