Medic4All MiniClinic VMW03 User manual

FCC submission

Product Manual

October 21, 2004

Medic4All Ltd.

POB 4222 Petach Tikva,

Israel 49000

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™.

Please read this booklet carefully in order to achieve best performance of this medical monitoring device

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.

Keep the MiniClinic™ away from electro-magnetic emitting devices.

Do not store the MiniClinic™ in direct sunlight, at a high temperature, or in a location with excessive

humidity.

Avoid any mechanical shock to the MiniClinic™ such as a harsh drop.

Use of this device is not intended as a substitute for consulting with your physician, since additional

measurements to those supplied by the MiniClinic™ may be necessary.

Disposal of this product and used batteries should be carried out in accordance with the relevant national

regulations.

Part Identification

Wearing the MiniClinic™

Golden Metal Plates

Wrist Strap

Operation Button

Temperature Probe

LED Indicator

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.

Operating the MiniClinic™ - ECG, Heart Rate and Breathing Rate Monitoring

To initiate a heart rate and breathing rate monitoring session, please do the following:

Sit comfortably on a chair with both feet placed on the floor. Do not cross your legs.

Make sure the MiniClinic™ is well strapped onto your wrist.

Place your right hand (wearing the MiniClinic™) on top of your abdomen, as shown below.

While the MiniClinic™ is placed on middle abdominal line, use your left hand to press the operation

button lightly (less than 1 second) – the unit should sound a short beep and the Green LED will start

blinking once every second.

Quickly place your left hand over the right hand as seen in the picture below. Make sure that the palm of

your left hand is in contact with the two golden metal plates of the MiniClinic™.

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™.

Make sure not to press the button for more than 2 seconds.

While the measurement reading is in progress (approx. 60 seconds) the green LED should blink once

every second.

At the end of the reading, the MiniClinic™ will beep three times and the green LED will turn off. Once

the LED is off, you no longer have to sit still.

The MiniClinic™ will transmit the data automatically.

Operating the MiniClinic™ - Temperature Measurement

To initiate a temperature measurement session, please do the following:

Take off the MiniClinic™ from your wrist.

Expose the temperature probe from the wrist strap. If desired, place a hygiene thermal sheath over the

temperature tip. Put away the protective plastic that covers of the thermal sheath.

Press the operation button lightly (less than 1 second) – the unit should sound a short beep and the green

LED will blink once every second. Press the operation button again – the unit should sound a short

beep and the green LED will blink twice every second.

Important!

For accurate measurement to

take place, sit calmly and try to

keep still.

Avoid talking or moving until the

measurement period is over.

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.

Keep still through the whole measurement

While measuring the MiniClinic™ green LED will blink twice every second.

The measurement lasts about 60 seconds.

At the end of the measurement, the MiniClinic will beep three times and the green LED will turn off. Once the

LED is off, you no longer have to sit still.

The MiniClinic™ will transmit the data automatically.

Insert the temperature probe back to the wrist strap.

Pressing the button for more than 2 seconds, initiates the distress function in the MiniClinic™. Make sure

not to press the button for more than 2 seconds.

Medic4All recommends verifying the temperature accuracy by an authorized laboratory every 2 years.

Important!

For accurate measurement to

take place, make sure the

temperature tip is in good contact

with your armpit.

Press the tip slightly against the

armpit to gain best results.

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.

Cleaning the MiniClinic™

To clean the MiniClinic™ thermometer tip wash the area extending about 2" from the tip of the thermometer

with warm (not hot) soapy water before and after each use; be sure to dry thermometer thoroughly.

You may also wipe the area described above with 70% isopropyl alcohol before and after each use. Even if

you use a thermal sheath, follow either of the above two cleaning procedures as an extra precaution.

To clean the MiniClinic™ other parts you may wipe them with 70% isopropyl alcohol.

Distress Alarm and Contacting the Monitoring Center

When in distress, the MiniClinic™ can function as a distress alarm device. Operating in that mode will cause

the MedicGate™ to immediately contact the medical monitoring center and start an audio session.

Press the MiniClinic™ button for more than 2 seconds.

A prolonged beep is sounded and the green LED will light on. The center will answer your call shortly

afterwards.

In case of communication disruption, the red LED will light. In that case repeat pressing the button.

In case of distress – you can also operate the distress mode by pressing directly the red oval button on the top

of the MedicGate™.

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.

Scheduled measurements operate similar to an alarm clock: at the time of the measurement the MiniClinic™ will

sound an alarm, indicating that you need to take a measurement. When you hear the alarm indication, sit

comfortably on a chair and perform a measurement as described in Operating the MiniClinic™ section.

(*) For more information regarding the MedicGate™ and MiniGate™ please refer to their operation manuals.

Specifications

Medical measurement

Pulse 40-200 beat/min

Respiration 5-35 inhale-exhale/min

Measurement time 60 sec.

ECG parameters

Bandwidth 0.05-40 Hz

Measurement time 30 Sec.

Input dynamic range 10 mV p-p

Thermometer

Temperature range 35.5-43.0 °C

Temperature accuracy ±0.1 °C between 35.5 and 43.0 °C ambient

temperature 18°C to 28°C.

Measurement time About 60 sec.

Radio Frequency communication

Frequency 433.92 MHz (EU)

866.3 MHz (EU)

915 MHz (USA)

Max transmission power 10 dbm (EIRP) at 433.92 MHz and 866.3 MHz.

-1 dbm (EIRP) at 915 MHz

Bandwidth 60 kHz max.

Transmission range 200 m (free space)

Environment

Operating condition +10˚C to +40˚C / 30% RH to 85% RH

Storage condition -10˚C to +60˚C / 30% RH to 85% RH

Dimensions Approx. 300[W] x 20[H] x 45 [D] mm

Weight Approx. 40g,

Classification Type CF

Model VMW-03

Complies with the CE standard under the Euro Medical Device Directive.

FCC Part 15 Information

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to

Part 15 of the Federal Communication Commission (FCC) Rules. These limits are designed to provide

reasonable protection against harmful interference in a residential installation.

This equipment generates, uses, and can radiate radio frequency energy and if not installed and used in

accordance with the instructions, may cause harmful interference to radio communications. However, there is

no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful

interference to radio or television reception, which can be determined by turning the equipment off and on,

the user is encouraged to try to correct the inference by one or more of the following measures:

•Reorient or relocate the receiving antenna.

•Increase the separation between the equipment and receiver.

•Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.

•Consult the dealer or an experienced radio/TV technician for help.

Specifications are subject to change without prior notice.

Manufacturer: Medic4All, Israel

Email: [email protected]

www.medic4all.com

Local provider Details:

Contents

1. Operation Manual

2. MiniClinic™

Warranty

This product is warranted against defects in material and workmanship beginning from the date of shipment

for a period of one year (the “Term”).

Under the Term, the obligation of Telcomed Advanced Industries Ltd (the “Company”) will be limited to

repair or replacement of the product (not including batteries, cables and spendable parts), according to the

Company’s discretion. Such repair or replacement will be made only after the Company’s examination

determines that said product is defective in material and/or workmanship.

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.

0483

MiniClinic VMW03

Tested To Comply

With FCC standards

FOR HOME OR OFFICE USE

Under no circumstances shall the Company be responsible for any loss of data or income or any special,

incidental, consequential or indirect damages, arising from the product or its operation, howsoever caused.

Under no circumstances the Company will be liable for any claim arising from the product or its operation in

excess of the total price paid for this product.

The Company reserves the right to make changes and improvements to the product without prior notice.

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