FCC submission Product Manual October 21, 2004 Medic4All Ltd.
Medic4All Telemedicine Solutions Operation Manual MiniClinic™ - VMW03 Pulse, Breathing, ECG and Temperature Monitor Caution: Federal law restricts this device to sale by or on the order of a physician. Overview The MiniClinic™ is a wireless medical monitoring and distress alarm device. It measures, stores and transfers vital signs data to a medical monitoring center using the MedicGate™ or MiniGate™.
MiniClinic™ Features Medical monitoring parameters: • Pulse rate • Heart rhythm regularity • Breathing rate • One lead ECG • Body thermometer Water proof CE standard compliant under the Euro Medical Device Directive Warnings & Precautions Consult your local provider concerning any operational difficulties. Do not attempt to repair the MiniClinic™ on your own. Any modifications made to the equipment void the device warranty and service contract obligations.
The MiniClinic™ resembles an ordinary wristwatch with wrist strap. Wear it on your wrist similarly to an ordinary wristwatch. Strap the MiniClinic™ around the outer side of your right wrist, as shown in the picture. The strap should be adjusted and tightened gently for personal comfort. Do not apply excessive force as it might restrict the blood flow.
The measurement period lasts about 60 seconds. Please make sure that you sit comfortably, and minimize your movement during the measurement. Moistening the palm of your left hand, which is in contact with the two golden metal plates of the MiniClinic™, with a wet cloth will help to improve the quality of the ECG measurement. Strongly pressing the button interferes with the measurement. Pressing the button for more than 2 seconds initiates the distress function in the MiniClinic™.
Hold the probe about four centimeters from the tip. You can place the thermometer under your armpit or in your mouth. Oral temperature check: Position the tip of the thermometer in one of the two pockets under your tongue. The tip must be in good contact with the tissue. Close your mouth and breath through the nose. Axillary temperature check: Raise your other hand and place the tip at the center of your other hand armpit. Return your other hand to its natural position.
The performance of the MiniClinic™ may be degraded should the user temperature be below the ambient temperature. The thermometer is suitable exclusively for measurements of body temperature. Never boil the thermometer tip. When you are done, discard the thermal sheath and the plastic cover in accordance with the relevant national disposal regulations.
Do not allow anyone else to use your personal MiniClinic™ device. Remember: Every time you use your MiniClinic™ the results are sent to the medical monitoring center. The use of the device by another person will cause an accumulation of erroneous data in your personal file. Scheduled measurements The MiniClinic™ can be programmed for up to 24 measurement schedules. Programming is done by the monitoring center and is automatically loaded into the MiniClinic™. Every schedule contains a date and time.
Weight Classification Model Approx. 40g, Type CF VMW-03 Complies with the CE standard under the Euro Medical Device Directive. FCC Part 15 Information This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
This product warranty is void if the product has been repaired or altered in any way as to affect its use and operation as determined by the Company. This warranty is also void if the product has been subjected to abuse, misuse, negligence or accident. No warranties, whether expressed or implied, shall exist beyond the Term.