User's Manual

CPR4 – UA10821A

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.

1.4 Intended Clinical benefits

By using the CPR4, clinicians can improve the patient’s treatment in several ways, including changing the implanted

device’s settings, fine-tuning or adapting the therapy to suit patients’ needs, and detecting issues with the implanted

device or the lead(s) that may result in a required re-intervention (repositioning, replacement…).

1.5 Warnings and precautions

 Same as the programmer system, the CPR4 is Magnetic Resonance (MR) unsafe. Don’t bring the CPR4 into

MRI site Zone 3 or 4 as defined by the Guidance Document for Safe MR Practices published by the American

College of Radiology

 The equipment must be operated by qualified personnel only: physicians, nurses, technical members of

hospital staff, company representatives. All of them being trained and having a comprehensive or partial

knowledge of cardiac rhythm management, in keeping with their assigned task: surgery, follow-up,

servicing, etc. For additional information please contact your company representative.

 To avoid damage or hazards, NEVER make any changes or modifications to the equipment. For

maintenance services and support, please contact your company representative.

 Do not use the CPR4 should there be any sign of visible damage.

 Shocks or rough handling could damage the device's housing. Mishandling may affect the CPR4’s operation.

Even if the device appears to be operating well after the impact, damage that is not immediately detectable

may arise.

 When designing and manufacturing the device, every precaution is taken to minimize the risks of infiltration.

However, any liquid penetration shall alter its operation.

 Prolonged storage in a high-humidity location may alter the device's operation. For detailed information

about the storage humidity constraints please refer to section 8.6.

 The CPR4 must be stored in a secure and locked room when not in use.

 The CPR4 inductive programming head must come into contact with intact skin only.

1.6 Residual risk and undesirable effects

The potential hazards related to the use of the CPR4 have been carefully evaluated by the manufacturer’s risk

management team. This evaluation concludes that the residual risk is at the lowest possible level.

This assessment is based on the assumption that the CPR4 is used according to its intended purpose and all of the

prescriptions contained in this User Manual are carefully followed.

Based on the literature and on inductive wands’ use experience, possible adverse events are:

 Prolonged follow-up programming/real life test sessions

 Non optimal patient management (related to the programming or the diagnosis)

Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007