Misinterpretation Of Data; Incorrect Force Measurements; Electrical Hazards; Conformance To Standards - Boston Scientific Rhythmia Hdx Intellanav Stablepoint Mode D'emploi

Misinterpretation of Data

Localization
Poor catheter localization may lead to clinical data misinterpretation and the potential of
resultant patient injury. To ensure correct clinical decisions, the physician must use fluoroscopy,
ultrasound, pace mapping or other visualization techniques to verify 3-D mapping results and
catheter position.

Incorrect Force Measurements

Incorrect force measurement displayed or misinterpretation of the force displayed may lead
to the user to apply more force than desired during mapping or ablating. User must observe
any system messages displayed. If User Operator applies more force than desired during
mapping or ablating, myocardial perforation, myocardial contusion, or myocardial injury
could result.

Electrical Hazards

With any electrical system there is a potential risk of electrical shock to the user, patient, and
service representative.

CONFORMANCE TO STANDARDS

The device meets the following standards:
• IEC 60601-1:2005 + A1:2012
• IEC 60601-1-2:2014
• IEC 60601-1-6:2010 + A1:2013
• IEC 60601-2-27:2011 CORR 1:2012
• IEC 62366:2007 + A1:2014
• EN 55011:2009 + A1:2010, Group 1, Class A
• CISPR 11:2009 + A1:2010, Group 1, Class A

HOW SUPPLIED

The device is packaged and supplied in a shipping carton handled by common carrier.
Do not use if package is damaged or unintentionally opened before use. Do not use if labeling
is incomplete or illegible. Only Boston Scientific representatives should open the sealed
product packaging.

Handling and Storage

Environmental Operating Conditions
Temperature: 10 °C (50 °F) to 30 °C (86 °F)
Humidity: 30% to 75% non-condensing
Atmospheric pressure: 580 mmHg to 760
mmHg
Prior to use, maintain the device within the labeled operating environmental conditions.

OPERATIONAL INSTRUCTIONS

The RHYTHMIA HDx Ablation Connection Box enables use of the RF generator and IntellaNav
StablePoint Ablation Catheter with the mapping system.
The ablation connection box, Figure 1, connects to the
a. RF generator through the tethered cabled labeled "RF GENERATOR".
b. Ablation input port on the mapping system through the tethered cable labeled "SIGNAL
STATION."
c. IntellaNav StablePoint Ablation Catheter through the ablation catheter cable.
Black (K) ∆E ≤5.0
Equipment Storage and Transport
Temperature: -29 °C to 60 °C
Humidity: 10% to 90% non-condensing
Figure 1. Ablation connection box

CLEANING GUIDELINES

Routine Cleaning and Disinfecting

Observe facility cleaning protocol while following the instructions below:
• Unplug the device from all equipment connected to a power supply.
• Wipe the external device with a cloth slightly dampened with a mild cleaning solution. Do
not allow any amount of cleaning solution or moisture to come in contact with the cable
connection ports and do not spray water or other liquids onto device.
• The device does not require sterilization or disinfection.
• Allow the cleaned surfaces to air dry prior to reconnecting or using the device.

Decontaminating the Equipment Before Shipping

To comply with United States postal and transportation laws, equipment returned to Boston
Scientific must be properly decontaminated with chemical germicide that is approved for use
as a hospital disinfectant. If equipment is received without having been decontaminated,
Boston Scientific will charge a cleaning surcharge. Any equipment return to Boston Scientific
without having been properly decontaminated must have an appropriate biohazard warning.

Disposal

All external and accessible surfaces of this system should be cleaned and disinfected per the
disinfection instructions above. Include any cables. Do not dispose of by incineration, burial
or placement into common waste stream. System should be safely disposed of in accordance
with hospital, administrative, and/or local government policy.
4