7
•
Electronic monitoring equipment such as ECG monitors and ECG
alarms may not operate properly when Inspirstar IS02 PMS is in use.
•
Simultaneous connection of a patient to a high frequency surgical
medical equipment may result in burns at the site of the IS02 PMS
electrodes and possible damage to the IS02 PMS.
•
Operation in close proximity (e.g. 1 m) to a shortwave or microwave
therapy medical equipment may produce instability in the IS02 PMS
output.
1.3
Adverse Effects
Please consult your doctor about possible adverse effects which may arise
from the therapy protocols your doctor is using. A common issue is about
skin reaction at the electrode sites. Skin irritation and electrode burns are
potential adverse reactions. Cleaning and hydrating the skin are usually valid
methods to reduce the skin irritation or electrode burns. If gloves or cloth or
garment are used as electrodes, these gloves or cloth or garment should be
wet or damp. If electrode pads are used, sometimes conductive gel on pads
can be helpful to increase the conductivity and reduce the skin reaction.
1.4
Precautions and Safety Notices
Isolated cases of skin irritation may occur at the site of conductive materials
following long-term application. The effectiveness of the MEND Professional
TM
device is highly dependent upon patient selection by a practitioner qualified in the
management of pain. Electrode placement and stimulation settings should be based
on the guidance of the prescribing practitioner. Patients should not use the device
while under the influence of alcohol, controlled substances or narcotic drugs,
directly on the eyeball, or over a vessel that may contain a blood clot.
Caution should be used for persons with suspected or diagnosed epilepsy.
CAUTION
Federal Law (USA) restricts this device to sale by or
on the order of a licensed health care practitioner.