Indications - SpiderFlash

Indications and Precautions

SpiderFlash-a is a digital patient activated ECG event loop recorder intended for ambulatory recording of ECG strips triggered by the patient. The software EventScope is to be used to download, edit and print the ECG strips recorded with SpiderFlash-a.

End of life

When the SpiderFlash-a reaches the end of its life time, it should be returned to Sorin CRM for appropriate recycling.

The batteries should be recycled as appropriate. ECG cables and pouch can be thrown away, since they do not contain specific dangerous material. The SpiderFlash-a parts and accessories do not contain mercury or mercury compounds.

Conditions for use and storage of the device and the card The following table shows the conditions for use, storage and transportation of SpiderFlash-a:

Protection against very humid environments: in case of severely wet environment, a protective bag is needed. During storage the battery must be removed from the device. SpiderFlash-a is not protected from external defibrillation shocks, high-frequency currents or strong electromagnetic disturbances. The use of cellular or cordless telephones may cause signal interference.

Warnings
If a patient wearing a SpiderFlash-a recorder needs to be defibrillated, it is mandatory that the recorder’s electrodes be removed before the defibrillator is used.

The MMC and SD cards can be used up to 300,000 times. Cards resist to electrostatic discharges up to ± 4kV on contact pads and ± 8kV on non contact pad area (coupling plane discharge). MMC and SD cards will withstand an impact not exceeding 1 000 G.

SpiderFlash-a is only guaranteed to work properly if MMC or SD cards supplied by Sorin CRM are used. Furthermore, an MMC card designed for use in Sorin CRM recorders should not be used for other applications.

SpiderFlash-a shall not be used in environments with flammable aesthetic mixtures with oxygen or nitrous oxide.

The use of portable and mobile RF communication equipment (ex. cellular phones) can affect the event recorder since the recorded ECG signal may be disturbed due to electromagnetic interference.

The device shall not be used in presence of ionizing radiations (X rays, gamma rays, …) that could cancel the internal memory and the external flash card.

Tables about electromagnetic emission and immunity of the recorder are reported in the annex of that manual.

The external case and the patient cable can be cleaned with a slightly damp cloth or one wet with soapy water. Detergents, alcohol or acetone must not be used.

The SpiderFlash-a bag is disposable and should not be washed or reused.

Under no circumstances should SpiderFlash-a, patient cables or cards be sterilized. If the device fails to work properly, contact the Sorin CRM After-Sales Service or your distributor. Do not unscrew the case under any circumstances (see Warranty chapter).