FCC submission Product Manual October 21, 2004 Medic4All Ltd.
Medic4All Telemedicine Solutions Operation Manual WristClinic™ - AIO67 The all-in-one wireless remote medical monitoring revolution August 2004 Caution: Federal law restricts this device to sale by or on the order of a physician. Ref: OM-110v1 Copyright© 2003-2004, Medic4All AG, all rights reserved. No part of this material may be copied in any form without the express written approval of Medic4All AG.
User Assistance Information For assistance, contact Medic4All at: info@medic4all.
Viewing your ECG Results Measuring your ECG and Breath Rate Aborting the Measurement Viewing your ECG and Breath Rate Results Measuring your SpO2 and Heart Rate Aborting the Measurement Viewing SpO2 and Heart Rate Results Measuring your Temperature Connecting the Thermometer to the WristClinic™ Putting on the Thermal Sheath Placing the Thermometer Taking your Temperature Cleaning the Device Low Battery Indication Maintenance Replacing the Electrodes Disposal of WristClinic™ Accessories Storage Troubleshooti
General Warnings and Cautions ¥ ¥ ¥ ¥ ¥ ¥ ¥ ¥ Use of this device is not intended as a substitute for consulting with your physician. Self-diagnosis can be dangerous, and may worsen the problem. Always follow your doctor’s instructions. Do not use the Medic4All WristClinic ™ for an infant or a person who cannot express their intention. Do not disassemble or modify the Medic4All WristClinic™. Any modifications made to the equipment void warranty and service contract obligations.
1. Make sure to read this entire instruction manual before trying to operate the WristClinic™. Disposal of this product and used batteries should be carried out in accordance with the national regulations for the disposal of electronic product. Conventions The following are conventions that are used throughout this guide: Icon Description Note. Information that describes important features or instructions. Caution. Information that instructs you to be cautious.
Description of the WristClinic™ The following are the various parts of the WristClinic™. Following are various accessories included with the WristClinic™: ¥ Thermometer probe ¥ Replaceable ECG electrodes ¥ Two 1.5V AAA Batteries ¥ Storage case ¥ Medic4All WristClinic™ AIO-67 User Guide (this guide) Getting Started Before you begin taking measurements using the WristClinic™, do the following: ¥ Insert the batteries in the WristClinic™.
Inserting the Batteries To insert batteries in the WristClinic™ device: Slide the door of the battery compartment on the bottom of the WristClinic™ to the right in order to open the compartment. Insert two AAA-size batteries (1.5V each), as shown in the figure inside the battery compartment. The WristClinic™ turns on, SELF TEST appears, then CHECK MEMORY , then TEST PASSED/ FAILED and then COMM CHECK appears on the display for a few seconds, after which the WristClinic™ turns off automatically. 2.
The WristClinic™ turns on and COMM CHECK may appear in the display. This indicates that the communication between the WristClinic™ and the gateway is being checked. If there is a communication failure, such as when the gateway is shut down, COMM FAILED appears on the display, after which the first item in the WristClinic™ main menu, BLOOD PRESS., appears. 5. 6. If you are working in multi-user mode, you are first prompted for the user number.
Button Description Press to confirm selection of the current option in the display, or to abort a measurement in progress. Press to access measurements stored in memory. For more information, refer to Using the Memory Function on page 14. Setting Up the WristClinic™ To access the SETTINGS menu: Press to navigate to SETTINGS and press .
Option Description For more information… EXIT SETTIN-GS Enables you to exit the SETTINGS menu and return to the main menu Exiting SETTINGS on page 14 Setting the Temperature Units WristClinic™ enables you to set the units in which your temperature is measured, either °C (Celsius) by default or °F (Fahrenheit). To set the temperature units: 1. From the SETTINGS menu, press press . 7. 2. The current temperature units appears. Press press 8.
14. The 8. hour is set to the selected value and the minutes flashes. Press to navigate to the correct minute and press . 15. The minutes are set to the selected value and you are returned to the SET DATE & TIME option in the SETTINGS menu. Setting the User Mode WristClinic™ enables you to define if you want to work in single mode or multi-user mode. 16. When switching from multi-user mode to single mode, all measurements in memory are erased. To set the user mode: 9.
Setting the Display Language ™ enables you to set the language in which you view the information WristClinic displayed. To set the display language: 14. From the SETTINGS menu, press press . 21. The 15. Press 16. Press 22. The to navigate to LANGUAGE and current language appears. to select the desired language for the display and press again to confirm altering the language. display language is now set to the selected value. .
Tech Mode The Tech Mode is for Medic4All technicians only. 23. Exiting SETTINGS To exit the SETTINGS menu: ¥ From the SETTINGS menu, press press . 24. You to navigate to EXIT SETTINGS and are returned to the SETTINGS option in the main menu. Selecting and Changing Users When working with multiple users, the measurements you take are automatically associated with the user that appears on the lower right of the display. To select a user number: 17. Press to turn on the WristClinic™. 25.
Browsing Through Current User Measurements To browse through user measurements: 22. Press . 30. The first measurement in the memory appears, followed by the date and time for that measurement. 31. 23. If there are no measurements stored in memory, MEMORY EMPTY appears. Press to navigate through the measurements in the memory for the current user. Press to exit the memory. Clearing Memory To erase all measurements stored in memory: 24. 25. Press to navigate to SETTINGS and press 26.
35. Place the WristClinic™ cuff directly on your skin. Make sure that your clothing is not constricting your blood flow and that the electrodes on the inside of the cuff are touching your skin. To place the WristClinic™ on your wrist: 28. 29. 30. 36. 37. Remove all objects around your left wrist, leaving it bare. Place the cuff over your left wrist with your thumb facing upwards. Leave approximately 1-2 cm between the edge of the wrist cuff and the bottom of the palm.
Measuring your Blood Pressure and Heart Rate Before measuring your blood pressure: ¥ Avoid eating, smoking, and exercising 30 minutes before taking your blood pressure. ¥ Sit in a relaxed position. ¥ Remain still and do not talk while you are taking your blood pressure. 38. To measure your blood pressure correctly, make sure to wrap the cuff around your wrist correctly (refer to Wrapping the WristClinic on page 15). Obtaining the Correct Posture 39.
To take your blood pressure and heart rate: Press ¥ to navigate to BLOOD PRESS and press . 41. --- /--- HR --- appears on the display and a few seconds later the cuff begins to inflate. The measurement lasts about 30 seconds, after which the cuff deflates. Aborting the Measurement To abort the measurement: Press ¥ before the measurement is complete. 42. The measurement stops after a few seconds, and CHECK ABORTED appears on the display.
36. Place the index finger of your right hand on the ECG electrode located above . 47. The WristClinic™ detects your finger and the measurement begins. The timer counts down from 45 seconds. 48. Avoid moving your finger, and do not use excessive pressure when placing your finger on the ECG electrode. Moistening your index finger, which is in contact with the ECG electrode, with a wet cloth will help to improve the quality of the ECG measurement.
52. If you are working with more than one user, verify that the WristClinic™ is set to the correct user before taking a measurement. The user number appears on the lower right of the display. To take your ECG and Breath Rate measurement: 37. Press to navigate to ECG AND BREATH and press 53. PLACE FINGER 38. 39. . appears on the display. Place the WristClinic™ on your upper abdomen. Place the index finger of your right hand on the ECG electrode located above . 54.
Aborting the Measurement To abort the measurement: ¥ Press before the measurement is complete. 56. CHECK ABORTED appears on the display. Viewing your ECG and Breath Rate Results Your ECG and breath rate measurements are automatically transmitted to the gateway. The results are not displayed on the WristClinic™ when the measurement is complete. You can view your ECG and breath rate measurement on the MiniGate or Call Center application.
To take your SpO2 measurement with the finger clip: 40. 41. Attach the external SpO2 finger clip to the connector marked SpO2 on the side of the WristClinic™. Press to navigate to SpO2 and press . Insert a finger (preferably the index, middle, or ring finger) into the SpO2 finger clip until the end of the finger reaches the finger stop. Keep the fingernail facing the sensor top, and ensure that long fingernails do not interfere with proper sensor position. appears on the display.
64. The thumb is not recommended for use with the SpO2 finger clip. The SpO2 finger clip does not contain natural rubber latex. To take your SpO2 measurement with the internal sensor: 43. Press 65. PLACE to navigate to SpO2 and press . FINGER appears on the display. Place the index finger of your right hand on the SpO2 sensor. Make sure to cover the SpO2 sensor completely with your finger appears on the display. After a few seconds, SpO2 and HR data appear.
Measuring your Temperature To measure your temperature, perform the following steps described below: ¥ Connect the thermometer to the WristClinic™. ¥ You may place a thermal sheath on the thermometer. ¥ Position the thermometer. ¥ Take your temperature. 69. You can set the temperature display to Celsius or Fahrenheit (refer to Setting the Temperature Units on page 11). Connecting the Thermometer to the WristClinic™ ¥ Plug the thermometer into the TEMP connector on the top of the WristClinic™. 70.
Placing the Thermometer under your Armpit ¥ 73. Place the tip of the thermometer at the center of your armpit. The tip of the thermometer must be parallel to your body, as much as possible. For the most accurate measurement, make sure the temperature tip is in good contact with your armpit. Press the tip slightly against your armpit to obtain the best results. Placing the Thermometer in your Mouth ¥ Position the tip of the thermometer in one of the two pockets under your tongue.
Taking your Temperature If you are working with more than one user, verify that the WristClinic™ is set to the correct user before taking a measurement. The user number appears on the lower right of the display. 74. ¥ Press 75. The to navigate to TEMP and press . initial temperature appears on the display. Aborting the Measurement ¥ Press before the measurement is complete. 76. CHECK ABORTED appears on the display.
79. Do not wash the cuff or make it wet. No water should enter the WristClinic™ main unit. Low Battery Indication The REPLACE BATTERY indication appears when the batteries run low. When REPLACE BATTERY first appears replace the batteries as soon as possible with two new fresh LR03 (AAA) batteries. However, you can still run a few full cycle measurements. When REPLACE BATTERY is followed a BYE , the WristClinic™ will automatically shut down. 80.
46. Place the new electrode in the location of the old electrode and press down until it fits firmly into place. Disposal of WristClinic™ Accessories Disposal of the WristClinic™ and any used batteries must be done in accordance with the national regulations for the disposal of electronic products. ¥ ¥ ¥ Storage Follow the guidelines below for storing your WristClinic™: Keep the WristClinic™ device in the storage case, protected from extreme temperatures and humidity.
Error Messag e Description What to do LOW TEMP The temperature measurement was below 35 °C (95 °F). Verify that the tip is inserted fully into its socket. Make sure to position the tip correctly (refer to Placing the Thermometer on page 24.) NO FINGER REPLACE BATTERY The finger was not detected during ECG and ECG and breath measurement checks. Verify that the device is firmly attached to your wrist. Place your index finger firmly on the electrode. Indicates low battery.
Error Messag e Description What to do SENDING FAILED The measure-ments were not sent to the gateway. If you are not connected to a gateway, ignore this message. If you are connected to a call center, contact the call center. If you are connected to a MiniGate, verify that your device is allocated to your gateway, as described in the MiniGate User Guide. If you allocated your device and you are still receiving this message, contact your service provider.
¥ Spare Parts and Accessories The following accessories are available for the WristClinic™: Batteries ¥ Thermometer probe ¥ Hygienic sheaths for use with the thermometer ¥ Electrodes ¥ External finger pulse oximeter
Specifications Medical Measurements 1 lead ECG Measurement Pulse 40-200 beat/min Bandwidth 0.05-40 Hz Heart rhythm regularity detection Irregular / Regular / Not available Measureme nt time 45 sec. ECG Measureme nt time 30 sec. Input dynamic range ±5 mV 1 lead ECG and Breath Measurement Breathing 5-35 inhale-exhale/min Pulse 40-200 beat/min Heart rhythm regularity detection Irregular / Regular / Not available Measureme nt time 50 sec. ECG Bandwidth 0.
Breathing ±3 cycles/min for 67% ±6 cycles/min for 95% Thermomete r Temperature range 35.0 °C -43.0 °C, Temp<35.0 °C display “LOW TEMP” Temp>43.0 °C display “HIGH TEMP” Temperature accuracy ±0.1 °C between 35.5 and 42.0 °C ambient temperature 18°C to 28°C. The manufacturer recommends verifying the accuracy by an authorized laboratory every 2 years. Standard prEN12470-3: 1997, and ASTM-112E Measureme nt time App. 60 sec.
External Pulse Oximeter Measureme nt range SpO2: 0 – 100% Accuracy SpO2: 70 -100%± 2 digits for adults (± 1 Standard Deviation) Measureme nt time Pulse: 18 - 300 pulses/min Pulse: ± 3%± 1 digit 30 seconds, reading every 5 second cycles Internal Pulse Oximeter Measureme nt range SpO2: 70 – 99% Accuracy SpO2: +/- 3 digits Pulse: 40-250 beat/min Pulse: +/- 3% Measureme nt time 30 seconds, reading every 6 second cycles Electronics Processor TI MSP430 micro controller RF communicat ion Frequency
Max transmission power +10 dBm @ 433.92 MHz (E.R.P) +8 dBm @ 868.3 MHz (E.R.P) -1 dBm @ 915 MHz (E.I.R.P) Bandwidth 60 kHz Transmission range App. 200 m (free space) Mechanical & Environmental Operating Temperature and humidity +10°C to +40°C, 30 to 85% RH Storage Temperature and humidity -10°C to +55°C, 10 to 95% RH Power Supply/bat Power Two LR03 batteries (AAA) Maximum Internal Voltage 4.
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 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.
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. 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.