EnSite X Cather Connection Cables Instructions for Use

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

LIMITED WARRANTY AND DISCLAIMER Abbott Medical hereby warrants that if any Abbott Medical product fails to perform within normal tolerances for a patient due to a defect in materials or workmanship, Abbott Medical will provide, at no charge, a replacement Abbott Medical product for the patient’s use. This limited warranty applies only if each of the following conditions are met. 1. The product was packaged and labeled by Abbott Medical. 2. The failed product must be returned to Abbott Medical and becomes the property of Abbott Medical. 3. The product has not been mishandled, reprocessed or altered in any way. 4. The product was used before the “USE BY” date marked on the packaging of the product. No representation or warranty is made that a Abbott Medical product will not fail. Abbott Medical disclaims responsibility for any medical complications, including death, resulting from the use of its products. Except as expressly provided by this limited warranty, ABBOTT MEDICAL IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE, OR MALFUNCTION OF ITS PRODUCTS, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE. Some states do not allow the exclusion or limitation of incidental or consequential damages however, so the above limitation or exclusion may not apply to you. Except as expressly provided by the limited warranty, ABBOTT MEDICAL MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. Pat. http://www.abbott.com/patents © 2020 Abbott. All Rights Reserved.

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

EN: English... 1 9 ... AR:‫اﻟﻌﺮﺑﯿﺔ‬ BG: Български ... 17 CS: Čeština ... 26 DA: Dansk ... 34 DE: Deutsch ... 42 EL: Ελληνικά ... 51 ES: Español ... 60 ET: Eesti ... 68 FI: Suomi... 76 FR: Français ... 84 HR: Hrvatski ... 92 HU: Magyar ... 100 IT: Italiano ... 108 KO: 한국어 ... 116 LT: Lietuvių... 124 LV: Latviski ... 132 MK: Македонски ... 140 NL: Nederlands ... 149 NO: Norsk ... 157 PL: Polski ... 165 PT: Português... 173 RO: Română... 181 RU: Русский ... 189 SK: Slovenčina... 199 SL: Slovenščina ... 207 SR: Cрпски ... 215 SV: Svenska... 223 TR: Türkçe ... 231 UK: Український ... 239 VI: Tiếng Việt... 248 ZF: 繁體中文 ... 256 ZH: 简体中文... 265

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

EN: English

EnSite™ X Catheter Connector Cables Instructions for Use

Description Electrophysiology cables are flexible, insulated cables constructed of metal and plastic materials. Table 1. EnSite™ X Catheter Connection Cables Model Number

Description

Compatible Catheters

D-ENS-AVSE-5-CBL

Advisor™ FL Sensor Enabled™ 12 Pin EnSite™ X Cable

Advisor™ FL Circular Mapping Catheter, Sensor Enabled™

D-ENS-AVSE-6-CBL

Advisor™ HD/VL Sensor Enabled™ 22 Pin EnSite™ X Cable

Advisor™ HD Grid Mapping Catheter, Sensor Enabled™

D-ENS-INQ-DD-CBL

Inquiry™ 20 Pin EnSite™ X Cable

Inquiry™ Electrophysiology Catheter, 12-20 pin (non-Sensor Enabled™)

D-ENS-INQ-OD-CBL

Inquiry™ 10 Pin EnSite™ X Cable

Inquiry™ Electrophysiology Catheter, 5-10 pin (non-Sensor Enabled™)

D-ENS-INQ-Q-CBL

Inquiry™ 4 Pin EnSite™ X Cable

Inquiry™ Electrophysiology Catheter, 2-4 pin (non-Sensor Enabled™)

D-ENS-L/R-BQ-CBL

Livewire™/Response™ 4 Pin EnSite™ X Cable

Livewire™ Electrophysiology Catheter, 2-4 pin (non-Sensor Enabled™)

Advisor™ VL Mapping Catheter, Sensor Enabled™

Response™ Electrophysiology Catheter, 2-4 pin (non-Sensor Enabled™) D-ENS-L/R-DDY-CBL

Livewire™/Response™ 20 Pin EnSite™ X Cable

Livewire™ Electrophysiology Catheter, 12-20 pin (non-Sensor Enabled™) Response™ Electrophysiology Catheter, 12-20 pin (non-Sensor Enabled™)

D-ENS-L/R-HOD-CBL

Livewire™/Response™ 10 Pin EnSite™ X Cable

Livewire™ Electrophysiology Catheter, 5-10 pin (non-Sensor Enabled™) Response™ Electrophysiology Catheter, 5-10 pin (non-Sensor Enabled™)

D-ENS-SUP-D-CBL

Supreme™ 10 Pin EnSite™ X Cable

Supreme™ Electrophysiology Catheter, 8-10 pin (non-Sensor Enabled™)

D-ENS-SUP-DDY-CBL

Supreme™ 20 Pin EnSite™ X Cable

Supreme™ Electrophysiology Catheter, 12-20 pin (non-Sensor Enabled™)

D-ENS-SUP-H-CBL

Supreme™ 6 Pin EnSite™ X Cable

Supreme™ Electrophysiology Catheter, 5-6 pin (non-Sensor Enabled™)

D-ENS-SUP-Q-CBL

Supreme™ 4 Pin EnSite™ X Cable

Supreme™ Electrophysiology Catheter, 2-4 pin (non-Sensor Enabled™)

A-ENS-MAGEXT-CBL

Magnetic Extension 10 Pin EnSite™ X Cable

FlexAbility™ Ablation Catheter, Sensor Enabled™ TactiCath™ Ablation Catheter, Sensor Enabled™

Intended Use The EnSite™ X catheter cables are intended to be used with the EnSite™ X EP System to connect catheters to the EnSite™ X EP System amplifier.

1

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

Indications The connector cable is intended for use with the Ensite X™ EP System and compatible electrophysiology products for electrogram recording and cardiac stimulation.

Contraindications There are no known contraindications.

Patient Target Group The intended patient population for the EnSite™ X catheter cables are patients for whom electrophysiology studies have been indicated.

Intended User The users for this system are medical professionals and Abbott field personnel trained on system functionality. There are three user segments – Electrophysiologists, EP Lab Techs, and Abbott Field Clinical Engineers (FCEs).

Warnings Inspect the catheter cable; discontinue use if there is visible evidence of tampering.

Precautions 

United States law restricts this device to sale by or on order of a physician.



Read directions prior to use.



This device should be used by or under the supervision of physicians thoroughly trained in techniques of intracardiac electrophysiology.



Inspect cables prior to reuse. Do not use cables if there is visible damage, for example cuts, bulges, loose strain reliefs, or connectors. Discard damaged cables.

Potential Adverse Events 

Electrical shock.



Infection.

Directions 1.

Inspect the cables carefully for integrity and overall condition.

2.

For Sensor Enabled™ diagnostic and non-Sensor Enabled™ diagnostic cables, use the connection with the black strain relief to connect to the catheter. For the bifurcated cables, use the red connector for pole 1-10 and the black connector for poles 11-20. For the magnetic extension cable, use the white receptacle to connect to the matching cable connector.

3.

For Sensor Enabled™ diagnostic and non-Sensor Enabled™ diagnostic cables, use the connection with the green (10-pole) or blue (20-pole) strain relief to connect to the matching amplifier input on the EnSite™ X System. For the magnetic extension cable, use the white plug to connect to the matching amplifier input on the EnSite™ X System.

4.

Ensure that the connection is secure between the cable and connecting equipment.

5.

To disconnect the Sensor Enabled™ diagnostic and non-Sensor Enabled™ diagnostic cables, twist the grey connector nut from the amplifier. To disconnect the catheter side, push the plug into the receptable and pull it out, or depress the tab to disengage the locking mechanism and disconnect the cable. To disconnect the magnetic extension cable from the amplifier, push the plug into the receptacle and pull it out, and to disconnect from the cable side, push the plug into the receptacle and pull it out.

Packaging and Storage The original packaging is designed to provide for aseptic product transfer. It is recommended that the product remain in the unopened package until time of use. Contents are sterile if package is unopened and undamaged. The expiration date is marked on the outside of the package. The product should be stored in a cool, dry location. The instructions for use is recyclable. Dispose of used product and packaging following standard solid biohazard waste procedures. Personnel handling the electrophysiology cable should wear gloves. During storage and transport, keep each connector cable in a sealed pouch in a cool, dry location away from sunlight, including UV light.

2

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

Performance Characteristics As accessories these products contribute to the realization of the intended clinical benefit of the primary, compatible Ensite X™ EP Systems for which they support.

Incident Reporting If, in the course of use of this device, you have reason to believe that a serious incident occurred, please report it to the manufacturer. For customers in the European Union, report the serious incident to your national authority as well as to the manufacturer.

Clinical Data Summary A summary of the safety and clinical performance for this device is available at https://ec.europa.eu/tools/eudamed. Search for the device using the UDI-DI provided on the outer packaging of the device.

Clinical Benefit As accessories these products contribute to the realization of the intended clinical benefit of the primary, compatible Ensite X™ EP Systems for which they support.

Cable Reuse 

Properly clean and re-sterilize cables within twenty-four (24) hours after use.



Do not submerge cables in an enzymatic detergent or water bath during transport. Avoid contact with contaminated equipment or instruments during cable transport.



Cables are intended to be reused a maximum of twenty (20) times. Discard cables that have reached this number of uses. NOTE: It is the customer’s responsibility to track the number of reuses of the cable. Customers should follow their established procedures for reuse tracking.



Inspect cables prior to reuse. Do not use cables if there is visible damage (e.g., cuts, bulges, loose strain reliefs, or connectors, etc.). Discard damaged cables. NOTE: To ensure cables are properly cleaned and externally sterile, use the specified cleaning and sterilization methods/parameters. Deviations from the specified methods/parameters may result in reduced catheter cable life or inadequate cleaning or sterilization. If alternate methods/parameters are used, it is the customer’s responsibility to ensure cables are effectively cleaned and sterilized. The sterilization and cleaning methods listed in this manual are only valid when using properly installed, maintained, calibrated and compliant cleaning and sterilization equipment. Customers are responsible for ensuring that the cleaning and sterilization methods recommended can be duplicated in their environment.

Cable Cleaning Methods NOTE: One manual cleaning method (enzymatic or alkaline) followed by manual disinfection OR one automated cleaning method (enzymatic or alkaline) with thermal disinfection is required prior to sterilization of the cable.

Manual Method Enzymatic Detergent 1.

Remove any excess soil by rinsing with cold tap water prior to starting the cleaning procedure.

2.

Soak the cable for five (5) minutes, fully submerged in diluted ENZOL‡ Enzymatic detergent (or equivalent). Dilute the detergent according to the manufacturer’s recommendations with warm 31°–43°C (88°–110°F) tap water. Remove visible soil with a soft-bristled brush.

3.

Rinse the cable with clean warm running tap water for a minimum of one (1) minute.

4.

Dry with a clean, lint-free cloth.

5.

After cleaning, visually inspect cables for any remaining soil or moisture. Repeat cleaning and/or drying if necessary. NOTE: Cable must be thoroughly dried before sterilization.

3

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

Manual Method Alkaline Detergent 1.

Remove any excess soil by rinsing with cold tap water prior to starting the cleaning procedure.

2.

Soak the cable for ten (10) minutes, fully submerged in diluted Neodisher‡ MediClean forte detergent (or equivalent). Dilute the detergent according to the manufacturer’s recommendations with warm tap water. Remove visible soil with a soft-bristled brush.

3.

Rinse the cable with clean warm running tap water for a minimum of one (1) minute.

4.

Dry with a clean, lint-free cloth.

5.

After cleaning, visually inspect cables for any remaining soil or moisture. Repeat cleaning and/or drying if necessary.

Manual Method Disinfection NOTE: Manual disinfection shall be performed after either of the two manual cleaning methods. Perform the disinfection procedure as outlined below: 1.

Prepare a bath of 70% IPA.

2.

Allow the articles to soak for 10 minutes.

3.

Remove the articles from the 70% IPA bath and rinse them by immersion in a bath of purified water for a minimum of 1 minute.

4.

Dry the articles using sterile, lint-free cloths.

Automated Method Enzymatic Detergent Preparation for Automated Cleaning Prior to putting cables in the washer/disinfector, perform the following steps to ensure that any organic matter on the cables is rehydrated. 1.

Remove any excess soil by rinsing with cold tap water prior to starting the cleaning procedure.

2.

Soak the cable for 1 minute, fully submerged in diluted ENZOL‡ Enzymatic detergent (or equivalent). Dilute the detergent according to the manufacturer’s recommendations with warm 31°–43°C (88°–110°F) tap water.

3.

Remove visible soil with a soft-bristled brush.

4.

Rinse the cable with clean, warm, running tap water for a minimum of 1 minute.

Automated Cleaning with Thermal Disinfection 1.

Load cables into a tray in a manner that is consistent with the manufacturer’s instructions. Do not place heavy objects on top of cables or place cables next to sharp objects during an automated cleaning cycle. Doing so may damage the cables.

2.

The automated washer/disinfector must be programmable to meet the settings below.

Cycle

Time

Water Temperature and Type

Detergent and Concentration

Pre-Wash

1 min

Cold tap water

N/A

Enzymatic Wash

1 min 30 sec

Hot tap water

PROLYSTICA‡ 2X Concentrate Enzymatic Presoak and Cleaner (or equivalent), diluted per manufacturer’s instructions

Wash

2 min 30 sec

Heated tap water 60°–70°C (140°–158°F)

PROLYSTICA‡ 2X Concentrate Neutral Detergent (or equivalent), diluted per manufacturer’s instructions

Rinse

1 min 30 sec

Heated tap water 60°–70°C (140°–158°F)

N/A

4

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

Cycle

Time

Water Temperature and Type

Detergent and Concentration

Disinfection Rinse

5 min

Heated RO/DI water 90°C (194°F)

N/A

Drying

1 hour

Air temperature 70°–80°C (158°–176°F)

N/A

3.

After cleaning, visually inspect cables for any remaining soil or moisture. Repeat cleaning and/or drying if necessary.

Automated Method Alkaline Detergent Preparation for Automated Cleaning Prior to putting cables in the washer/disinfector, perform the following steps to ensure that any organic matter on the cables is rehydrated. 1.

Remove any excess soil by rinsing with cold tap water prior to starting the cleaning procedure.

2.

Soak the cable for 1 minute, fully submerged in diluted Neodisher‡ MediClean forte (or equivalent). Dilute the detergent according to the manufacturer’s recommendations with warm tap water (max. 40°C/104°F).

3.

Remove visible soil with a soft-bristled brush.

4.

Rinse the cable with clean, warm, running tap water for a minimum of 1 minute.

Automated Cleaning with Thermal Disinfection 1.

Load cables into a tray in a manner that is consistent with the manufacturer’s instructions. Do not place heavy objects on top of cables or place cables next to sharp objects during an automated cleaning cycle. Doing so may damage the cables.

2.

The automated washer/disinfector must be programmable to meet the settings below.

Cycle

Time

Water Temperature and Type

Detergent and Concentration

Pre-Wash

1 min

Cold tap water

N/A

Alkaline Detergent Wash

10 min

Hot tap water

Neodisher‡ MediClean forte detergent (or equivalent), diluted per manufacturer’s instructions

Neutralizing Rinse

5 min

Tap water Approx. 43°C (109°F)

N/A

Intermediate 4 min Rinse

Heated tap water 60°-70°C (140°-158°F)

N/A

Disinfection Rinse

5 min

Heated RO/DI water 90°C (194°F)

N/A

Drying

1 hour

Air temperature 70°-80°C (158°-176°F)

N/A

3.

After cleaning, visually inspect cables for any remaining soil or moisture. Repeat cleaning and/or drying if necessary.

Sterilization Methods Ethylene Oxide Sterilization 1.

Ensure cables are thoroughly dried before loading into the EO sterilizer.

2.

Coil cable loosely and place into an appropriately-sized, breathable package suitable for EO sterilization (e.g., TYVEK‡ pouch or equivalent). Do not place labels on the breathable side of the package as this may impede sterilant penetration.

3.

Load cables into chamber and run equipment in a manner that is consistent with the EO sterilizer manufacturer’s instructions.

5

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

Abbott Medical has validated the following cycle parameters. Pre-Conditioning Chamber Ethylene Oxide (EtO) Process

Aeration

Cycle Parameters

55°C Temperature Cycle

37°C Temperature Cycle

Pre-Conditioning Time

60 min

30 min

Relative Humidity

60%-80%

50%

Exposure Time

1 hour

4 hours

Vacuum Set

1.3 psia

1.3psia

EtO Gas

100% EtO

100% EtO

EtO Concentration

725 mg/L–880 mg/L

735mg/L-880mg/L

Time

12 hours

12 hours

Steam Autoclave Sterilization 1.

Ensure cables are thoroughly dried before loading into the autoclave.

2.

Handle cables in the same manner as other reusable instruments that require packaging or wrapping during sterilization.

3.

Coil cable loosely and place in an appropriately sized package that is labeled for steam sterilization use (e.g. sterilization wrap, TYVEK‡ pouch, or equivalent).

4.

Load cables and run equipment in a manner that is consistent with the autoclave sterilizer manufacturer’s instructions.

Abbott Medical has validated the following cycle parameters. Do not place labels on the breathable side of the package as this may impede sterilant penetration. Dynamic/Pre-Vac Gravity Displacement

Cycle Parameters

Low Temperature Cycle

High Temperature Cycle

Temperature

132°C (270°F)

134°C–135°C (273°F–275°F)

Time

4 min exposure, 20 min dry time

3-5 min, 16 min dry time

Temperature

121°C (250°F)

Time

40 min exposure, 30 min dry time

NOTE: Sterilization temperatures must not exceed 135°C (275°F).

Steris V-Pro Sterilization 1.

Ensure cables are thoroughly dried before packaging.

2.

Handle cables in the same manner as other reusable instruments that require packaging or wrapping during sterilization.

3.

Coil cable loosely and place in an appropriately sized package that is labeled for V-Pro sterilization use (e.g. sterilization wrap, TYVEK‡ pouch, or equivalent).

4.

Load cables and run equipment in a manner that is consistent with the V-Pro sterilizer manufacturer’s instructions.

Abbott Medical has validated the following cycle parameters. Do not place labels on the breathable side of the package as this may impede sterilant penetration. V-PRO‡ 1 V-PRO‡ 1 Plus V-PRO‡ maX V-PRO‡ maX 2 V-PRO‡ 60 V-PRO‡ s2 Low Temperature Low Temperature Low Temperature Low Temperature Low Temperature Low Temperature Sterilization System Sterilization System Sterilization System Sterilization System Sterilization System Sterilization System Standard cycle

Lumen or non-lumen cycle

Lumen, non-lumen, or flexible cycle

6

Lumen, non-lumen, flexible, or fast non-lumen cycle

Lumen, non-lumen, or flexible cycle

Lumen, non-lumen, flexible, or fast non-lumen cycle

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

Symbols The symbols below and harmonized symbols may be found on the product or product label. For harmonized symbols, refer to the Universal Symbols Glossary at medical.abbott/manuals. Symbol

Definition Caution

Quantity

Keep dry

Keep away from sunlight

Catalog number Batch code Unique Device Identification Medical Device Length

Dispose of hardware in accordance with local law

Sterilized with Ethylene Oxide Gas. CAUTION: Federal law (U.S.) restricts this device to sale by or on the order of a physician. Manufacturer Date of Manufacture Authorized European representative

Importer

7

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

Symbol

Definition Consult instructions for use

Follow instructions for use on this website Catheter Connector Cable For use with catheters Do not use if package is damaged Use by Temperature limitations Humidity limitation Single sterile barrier system Reprocessing cycles Conformité Européenne (European Conformity). Affixed in accordance with European Council Directive 93/42/EEC (NB 2797) and 2011/65/EU. Hereby, Abbott Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive.

8

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

HR: Hrvatski

EnSite™ X Priključni kabeli katetera Upute za uporabu

Opis Elektrofiziološki kabeli fleksibilni su, izolirani kabeli izrađeni od metala i plastike. Tablica 1. Priključni kabeli katetera EnSite™ X Broj modela

Opis

Kompatibilni kateteri

D-ENS-AVSE-5-CBL

Kabel EnSite™ X s 12 kontakata za Advisor™ FL Sensor Enabled™

Kateter za kružno mapiranje Advisor™ FL, Sensor Enabled™

D-ENS-AVSE-6-CBL

Kabel EnSite™ X s 22 kontakta za Advisor™ HD/VL Sensor Enabled™

Kateter za mrežno mapiranje Advisor™ HD, Sensor Enabled™

D-ENS-INQ-DD-CBL

Kabel EnSite™ X s 20 kontakata za Inquiry™

Elektrofiziološki kateter Inquiry™, 12 - 20 kontakata (bez Sensor Enabled™)

D-ENS-INQ-OD-CBL

Kabel EnSite™ X s 10 kontakata za Inquiry™

Elektrofiziološki kateter Inquiry™, 5 - 10 kontakata (bez Sensor Enabled™)

D-ENS-INQ-Q-CBL

Kabel EnSite™ X s 4 kontakta za Inquiry™

Elektrofiziološki kateter Inquiry™, 2 - 4 kontakata (bez Sensor Enabled™)

D-ENS-L/R-BQ-CBL

Kabel EnSite™ X s 4 kontakta za Livewire™/Response™ Elektrofiziološki kateter Livewire™, 2 - 4 kontakta (bez Sensor Enabled™)

Kateter za mapiranje Advisor™ VL, Sensor Enabled™

Elektrofiziološki kateter Response™, 2 - 4 kontakta (bez Sensor Enabled™) D-ENS-L/R-DDY-CBL

Kabel EnSite™ X s 20 kontakata za Livewire™/Response™

Elektrofiziološki kateter Livewire™, 12 - 20 kontakta (bez Sensor Enabled™) Elektrofiziološki kateter Response™, 12 - 20 kontakta (bez Sensor Enabled™)

D-ENS-L/R-HOD-CBL

Kabel EnSite™ X s 10 kontakata za Livewire™/Response™

Elektrofiziološki kateter Livewire™, 5 - 10 kontakta (bez Sensor Enabled™) Elektrofiziološki kateter Response™, 5 - 10 kontakta (bez Sensor Enabled™)

D-ENS-SUP-D-CBL

Kabel EnSite™ X s 10 kontakata za Supreme™

Elektrofiziološki kateter Supreme™, 8 - 10 kontakata (bez Sensor Enabled™)

D-ENS-SUP-DDY-CBL

Kabel EnSite™ X s 20 kontakata za Supreme™

Elektrofiziološki kateter Supreme™, 12 - 20 kontakata (bez Sensor Enabled™)

D-ENS-SUP-H-CBL

Kabel EnSite™ X s 6 kontakata za Supreme™

Elektrofiziološki kateter Supreme™, 5 - 6 kontakata (bez Sensor Enabled™)

D-ENS-SUP-Q-CBL

Kabel EnSite™ X s 4 kontakta za Supreme™

Elektrofiziološki kateter Supreme™, 2 - 4 kontakata (bez Sensor Enabled™)

A-ENS-MAGEXT-CBL

Magnetski produžni kabel EnSite™ X s 10 kontakta

Kateter za ablaciju FlexAbility™, Sensor Enabled™ Kateter za ablaciju TactiCath™, Sensor Enabled™

Namjena Kabeli katetera EnSite™ X namijenjeni su za upotrebu s elektrofiziološkim (EP) sustavom EnSite™ X u svrhu spajanja katetera s pojačalom elektrofiziološkog sustava EnSite™ X.

92

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

273

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

274

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

State: Released Date: 2020.05.20 05:37 GMT Effectivity: Upon Release

Abbott Medical 5050 Nathan Lane North Plymouth, MN 55442 USA +1 855 478 5833 +1 651 756 5833

2020-04 ARTMT600102776 A

*600102776*

Abbott Medical The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11