CPR4 Wired Inductive Programming Head USER MANUAL B10031 US CPR4 – UA10821A 1
Table of Contents 1 INTRODUCTION ................................................................................................................................................ 4 1.1 Intended purpose ............................................................................................................................................................. 4 1.2 Indication(s), target population(s) and intended user(s) ......................................................................................
9 EXPLANATION OF SYMBOLS ........................................................................................................................... 15 10 GLOSSARY .......................................................................................................................................................
1 INTRODUCTION 1.1 Intended purpose The CPR4 is the inductive programming head intended to be used with suitable MicroPort CRM programmers for the interaction with the IMDs manufactured by MicroPort CRM, or by its predecessors Sorin Group and Ela Medical. The CPR4 is functional to achieve the programmer’s intended purpose: 1.
Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or ventricular fibrillation induced at electrophysiological study. Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or LV dysfunction.
1.3 Contra-indications No known contraindications to the use of the CPR4. Any serious incident in relation to the device should be reported to MicroPort CRM and the local Competent Authority. 1.
2 WARRANTY CONDITIONS The manufacturer agrees to replace any defective material. If a technical problem occurs, please contact your company representative or the company’s service department. WARNING: Never modify the configuration of the CPR4. The CPR4 contains no internal parts that can be repaired by the user. In the event of a problem, please return the equipment to your company representative in the condition in which it was received.
1) Collimator LEDs (white) 3) USB connector 2) Locator LEDs (blue) 4.2 CONNECTION TO THE PROGRAMMER 1. 2. 3. Connect the inductive programming head CPR4 to a programmer’s USB port. The head is automatically turned on when the programmer is switched on. The programming head is functional when the related icon is displayed in the programmer’s User Interface.
The following pictures show how to use the LEDs to find the best position for the CPR4: No detection (pair of white alternating LEDs ) Partial detection (two steady white LEDs). Indication to mode the head downwards.
For the same reason, if the CPR4 does not turn on, check at first that the USB cable is properly and completely inserted into a working USB port of the programmer. Also, try changing ports. 5.3 UPGRADE OF THE PROGRAMMING HEAD’S SOFTWARE The CPR4 contains a dedicated embedded software. When a new release of this software is available, it will be included in a comprehensive upgrade of the programmer’s software (SmartView).
The medical device complies with applicable electromagnetic compatibility standards, however, the user will ensure that any electromagnetic interference does not create an additional hazard, such as radio frequency transmitters or other electronic devices. In this chapter you will find information necessary to ensure the installation and commissioning of your medical device under the best conditions in terms of electromagnetic compatibility.
7.4 Surge immunity IEC61000-4-5 Immunity to conducted disturbances, induced byradiofrequency fields IEC61000-4-6 Radiated immunity -Magnetic fields IEC61000-4-8 Voltage dips, short interruptions and voltagevariation immunity IEC 61000-4-11 Electromagnetic emissions The programmer is intended for use in the electromagnetic environment specified below. The customer or the user of the programmer should ensure that it is used in such an environment.
Voltage Interruptions (IEC 61000-4-11) 270° and 315° 0% UT for 1 cycle and 70% UT for 25 cycles, 50Hz 30 cycles, 60 Hz, Monophase: 0° 0 % UT; For 250 cycles, 50 Hz For 300 cycles, 60 Hz 270° and 315° 0% UT for 1 cycle and 70% UT for 25 cycles, 50Hz 30 cycles, 60 Hz, Monophase: 0° NA NOTE: UT is the a.c. mains voltage prior to application of the test level. 7.6 Electromagnetic Immunity, Portable Radio Frequency Equipment The CPR4 is intended for use in the electromagnetic environment specified below.
7.7 Raw materials Item Material Description Plastic parts Cycoloy C2100 HF (ABS/PC, UL 94 V-0, White RAL9016) Label Glossy white polyester B423 POLYCARBONATE ABS (ABSPC) White for outer parts and grey for the middle part POLYESTER Main cable Polyurethane (UL 94 V-2) PU Non-slip pad Polyurethane Bumpon SJ6032 Black PU 8 TECHNICAL DATA 8.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines. This equipment has very low levels of RF energy that is deemed to comply without testing of specific absorption rate(SAR). 8.3 Performances 8.3.1 PERFORMANCE CHARACTERISTICS The table below describes the performance characteristics of the programmer (including programming software) making use of a CPR4.
This electronic product is subject to disposal and recycling regulations that vary by country and region. Many countries prohibit the disposal of waste electronic equipment in standard waste receptacles. For more details, please refer to the European Directive 2012/19/EU (WEEE). The device is compliant with ACMA rules. This symbol confers the approval of the US Federal Communications Commission.
10 GLOSSARY Term Meaning AC Alternated current ACMA Australian Communication and Media Authority ANSI American National Standard Institute AAMI Association for the Advancement of Medical Instrumentation BF Type Applied part with high protection against electrical shock CISPR International Electrotechnical Commission (Comité International Spécial des Perturbations Radioélectriques) CPR4 Inductive Programming Head ECG Electrocardiogram EEC European Economic Community EMC Electromagnetic C
