Impulse Dynamics OPTIMIZER Smart Mini Instructions For Use Manual page 149

APPENDIX III
Security of the Intelio Programmer Unit
How the Programmer Promotes Security
All installed software in the Intelio Programmer Unit has been approved by Impulse
Dynamics.
It is not possible to install general-purpose software on the programmer.
Controlling installed software minimizes the potential for vulnerabilities.
Internal software that runs the programmer is locked from change. Every time the
programmer is started, a clean version of the installed software is used.
The disk drive is encrypted.
What Hospitals and Clinics Can Do To Promote the Security of Programmers
It is very important to maintain good physical controls over the Intelio Programmer. Having a
secure physical environment prevents access to the internals of the Programmer and its
components. USB devices connected to the Programmer should be strictly controlled to limit
the potential introduction of malware.
Information regarding programmed IPGs and programming sessions may be stored in the
Intelio Programmer, and thus appropriate precautions should be taken to secure the
Programmer from unauthorized access.
APPENDIX IV
Procedure for IPG-ICD Interaction Testing
Patients with a concomitantly-implanted defibrillator (ICD) require additional testing at the end of
the implant procedure to ensure the appropriate function of both the OPTIMIZER Smart Mini IPG
and the concomitant device. The steps of the required testing procedure are as follows:
1. Program the ICD so that it does not deliver antitachycardic therapy during this test.
2. Enable CCM therapy and program the sensing windows of the OPTIMIZER Smart Mini
IPG to consistently deliver CCM therapy in the presence of the concomitant device.
3. Extend the CCM Train Delay by a minimum of 40 ms up to 50 ms beyond the chronic
CCM Train Delay setting repeatedly and observe the real-time intracardiac electrograms
(ICD-EGM) to determine the maximum amount of CCM Train Delay allowed before the
ICD begins to inappropriately sense the CCM therapy pulses as R waves.
4. Document the maximum CCM Train Delay and enter the information as part of the
Implant data.
5. Reprogram the CCM Train Delay to the pre-test value.
6. Document reprogramming of the CCM Train Delay with a parameter printout of the IPG
setting.
7. Reprogram the ICD so that it is able to deliver antitachycardic therapy.
8. Obtain the minimum R-R interval ICD VT zone from the ICD programmer or printout and
enter the information as part of the Implant data.
9. Document reactivation of the antitachycardic therapy with a parameter printout of the ICD
setting.
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