16
⑤
Store the device referring to the following considerations.
•
You must store the defibrillator according to the storage conditions specified in [Section 6.1:
Device Storage].
•
Store the defibrillator in an easy-to-access location where its technical alarms can be easily
heard (e.g. alarm on low battery or other device problems).
•
Store the accessories along with the device in the device’s carrying case for easy and quick
access.
Electromagnetic interference may affect the performance of the device.
While the device is in
use, it should be kept away from devices that cause electromagnetic interference. Devices
that may cause such interference include motors, X-ray equipment, radio transmitters, and cell
phones. Please refer to [Appendix D: Electromagnetic Compatibility] of these Instructions for
Use for more information.
The use of accessories or cables other than those referred to in these Instructions for Use
may increase electromagnetic radiation from the device or reduce the device’s
electromagnetic immunity. Only accessories and cables that are authorized by the
manufacturer should be used with the i-PAD CU-SP2.
When the product is used for asynchronous defibrillation treatment in Manual mode, do not
use it on patients who show any of the following symptoms:
- responsiveness, normal movement, normal breathing and detectable pulse.
There is a possibility of explosion or fire if the product is used in the presence of flammable
agents or in an OXYGEN enriched atmosphere due to the arc discharged caused by electric
shock.
Do not deliver an electric shock when the patient's ECG signal is in the asystole state. It may
lead to a failure to restore cardiac pacemaker functions in the heart, meaning the cardiac
function will not be restored.
This product must not be applied on patients implanted with the implantable pacemaker. If
patients show all of the symptoms including no response, and abnormal breathing, use the
product in the following ways:
- Attach the pad at least 3cm away from the implantable pacemaker attached to the patient.
- Do not attach the pad right on the area implanted with the implantable pacemaker.