SMART SPOT™ KC861 USER'S MANUAL USA with mobile communication
TABLE OF CONTENTS 1. INTRODUCTION ................................................................................................................................ 3 2. INDICATION ....................................................................................................................................... 3 3. USER PROFILE ................................................................................................................................. 3 4. WARNINGS AND PRECAUTIONS ............
ABOUT THIS MANUAL 4.2. SAFETY PRECAUTIONS Your doctor should be your first source of information regarding your health. Alteration – Your Smart Spot and supplied parts shall not be modified, altered, or changed in any way without signed written permission from MicroPort. Unauthorized modification may void the equipment authorization from the FCC and will void the MicroPort warranty. Use only MicroPort supplied parts.
Wireless communication – The Smart Spot is designed for use with a mobile phone network. It is intended to transmit your personal data using a mobile phone operator. The operator and number to call are pre-configured, there is nothing to set up. 5.2. DESCRIPTION OF CONTENTS Check button – Do not press the Check button on the bottom of the Smart Spot unless requested to do so by our MicroPort technical assistance. Interference – Using Smart Spot may potentially disturb your TV.
4. Plug the power supply block into the mains. Constant green You should observe the following: OFF The status light turns steady amber for around 45 seconds and then turns green as shown below. Constant green Your Smart Spot is currently transferring your data to your doctor. DO NOT TOUCH THE Smart Spot. Constant green OFF OFF 8. The transmission is successful once the PIT button turns OFF. Constant green Your Smart Spot is now ready to operate. 5.
again, then proceed to transmission. OFF 2 Constant Green Constant RED Meaning: The implanted device is not compatible with the Smart Spot. It cannot be interrogated. Action: Contact MicroPort technical assistance for guidance. 8. SMART SPOT BASIC CARE Your Smart Spot has been designed to successfully pass the safety and regulatory standards. To maintain your Smart Spot in proper working order, prevent it from being splashed with any kind of liquid.
Power supply AC input: 100-240V ~ 50-60Hz 600 mA (to wall socket) Class II Telemetry head Type BF applied part on the lower side of telemetry head (applied part temperature can reach a maximum of 45°C/113°F) Radio Equipment Transmitter Frequency Bands/ Maximal Power Receiver Frequency Bands Modem 2G/3G/4G Class 4 (33dBm ± 2dB) for GSM 850 B2: 1900 MHz Quectel EG25-G Class 1 (33dBm ± 2dB) for GSM 1900 Operating conditions from 0°C to +35°C (32 °F to 95 °F) from 5% to 93% RH non condensing Trans
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 interference 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 into an outlet on circuit different from that to which the receiver is connected.
14.2. ELECTROMAGNETIC EMISSIONS The Smart Spot is intended for use in the electromagnetic environment specified below. The customer or the user of the Smart Spot should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance Electromagnetic radiation disturbance (radiated EMISSIONS) CISPR 11 Group 1 The Smart Spot uses RF energy only for its internal function.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Voltage Interruptions (IEC 61000-4-11) 0 % UT ; 0 % UT ; For 250 cycles, 50 Hz For 250 cycles, 50 Hz Mains power quality should be that of a Home health care environment or Professional health care establishment For 300 cycles, 60 Hz For 300 cycles, 60 Hz If operation of the system requires continued use during power cuts, it is recommended that the medical device be powered by a separate power source (UPS
14.5. RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE SMART SPOT The Smart Spot is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
17. EXPLANATION OF SYMBOLS Symbols Symbols Explanation of symbols Humidity limits for storage and transportation. Explanation of symbols 1 Protected against solid foreign objects of 12.5 mm diameter and greater Protected against vertically falling water drops Follow instructions for use. +70°C (+158°F) Temperature limits for storage and transportation. -15°C (+5°F) Atmospheric pressure limits for storage and transportation. Follow instructions for use.
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MicroPort CRM S.r.l. Via Crescentino S.N. 13040 Saluggia (VC) Italy Tel: +39 0161 487095 www.crm.microport.
