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Table of Contents
Summary of Contents for Movesense MD
- Page 1 MOVESENSE MD User Guide OP174 2020-12-14 / R78 User Guide 2020-12-14 / R78...
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Page 2: Table Of Contents
CONTENTS CONTENTS ................................. 1 INTENDED USE ..........................2 Contraindications ....................... 3 Device description ......................4 Device lifetime ........................5 SAFETY ..............................6 Explanation of the markings used on the device ......... 6 Types of safety precautions ..................7 Safety precautions ......................7 GETTING STARTED WITH HEARTRATE/ECG MEASUREMENT .... -
Page 3: Intended Use
INTENDED USE Movesense MD sensor is intended to be used as an ECG and motion signal measurement device, which sends the measured signals to other devices for analysis. Movesense MD extracts R-peaks from the recorded ECG signal with a modified Pan-Tompkins algorithm, allowing R-R interval measurement and successive heart rate calculation. -
Page 4: Contraindications
This memory can be utilized by implementing a custom OEM firmware. As an output of the Movesense MD sensor, the signals are sent by a wireless Bluetooth connection to a host device for further processing, analyzing and storing, as needed by the end application. -
Page 5: Device Description
Movesense MD sensor is a medical device accessory which records signals for analysis as defined by the medical device manufacturer. The signal can be ECG waveform or motion. Movesense MD sensor has also a non-medical temperature measurement capability, which shall not be used for medical purposes. -
Page 6: Device Lifetime
Device lifetime The maximum expected life of the Movesense MD sensor in normal home use is 7 years. Replace the sensor after this or earlier if 1) otherwise instructed or 2) the harsher than normal operating conditions have caused deterioration of the essential features or 3) if any damage to the device is observed. -
Page 7: Safety
SAFETY Explanation of the markings used on the device and in the documentation Manufacturer Date of manufacture CE marking and the notified body identity number WEEE Directive logo. Do not throw in the garbage Left side electrode connection Right side electrode connection See user guide for important information Type BF applied part Bluetooth logo. -
Page 8: Types Of Safety Precautions
TIP: is used for extra tips on how to utilize the features and functions of the device. Safety precautions WARNING: Only for intended use. WARNING: The Movesense MD sensor must not be used for purposes other than what it is intended for. User Guide 2020-12-14 / R78... - Page 9 WARNING: Stop the usage immediately if the sensor is damaged or if a change in the performance is observed. WARNING: Stop the usage immediately if an allergic reaction is observed. WARNING: Do not modify this equipment without prior written authorization of the manufacturer.
- Page 10 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Movesense MD, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
- Page 11 IEC60950 and/or EN60601-1 standards. Avoid using the sensor in the proximity of For details see www.bluetooth.org. The Bluetooth LE radio technology used in the Movesense MD is specified in the Bluetooth v4.0 specification. Suitable host devices include mobile phones, tablet computers and other devices compliant with the Bluetooth v4.0 (or above) specification and running a...
- Page 12 Do not use close to a 2.4GHz signal source, as strong signal may negatively affect the performance of the Bluetooth radio link. NOTE: The Movesense MD sensor is waterproof and can be used in wet environments. The IP68 ingress protection rating means that the sensor withstands submerging to a depth of 1m/3.3ft underwater for a duration of one...
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Page 13: Getting Started With Heartrate/Ecg Measurement
GETTING STARTED WITH HEART RATE/ECG MEASUREMENT To start using the Movesense MD sensor with a heart rate belt 1. Snap the sensor firmly into the belt connector. Make sure that the electrode connection marked with “L” is on the left side of the patient and the electrode marked with “R”... - Page 14 Pairing You need to connect (pair) your Movesense MD sensor with compatible Bluetooth ® Low Energy (BLE) devices to view the measurement data. These devices can be, for example mobile devices running respective host applications for data visualization. Pairing procedures may vary, so refer to the instructions of your mobile application for guidance.
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Page 15: Care And Support
CARE AND SUPPORT Handling guidelines Movesense MD sensor module should be rinsed clean with fresh water after each use. If more thorough cleaning is needed, the sensor may be quickly wiped with a soft cloth moistened with ethanol based disinfectant . -
Page 16: Software Updates
The Movesense MD sensor firmware can be updated over Bluetooth. Please refer to the instructions of your host application for guidance. Battery The Movesense MD sensor uses a 3-Volt lithium coin cell battery (CR 2025). To replace the battery: 1. Remove the sensor from the Movesense connector. - Page 17 NOTE: Inspect battery compartment carefully for any leakage or residue from the old battery. If residue exists, replace the sensor. The battery must be removed prior to long term storage. NOTE: Visually inspect the battery contacts, O-ring and the sealing surfaces for contamination.
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Page 18: Troubleshooting
Troubleshooting The device does not turn on Battery empty Replace the battery automatically upon becoming in according to the contact with the patient instructions ECG signal level is low or the Patient connection is dry, strap Moisten the contacts, signal quality is low is contaminated dirty wash the strap, replace the strap... -
Page 19: Indicator Led
Indicator LED Movesense MD houses a red color indicator led on the top edge of the sensor housing, visible through the plastic casing. The functionality of the indicator led is as follows: On for 2s when the The device turns on and the LED... -
Page 20: Reference
REFERENCE Technical specifications • Device name and type identifier: Movesense MD sensor module, OP174 • Weight: 9.4 g/0.33 oz (battery included) • Diameter: 36.5 mm/1.44 in • Thickness: 8 mm/0.32 in • Operating conditions: -20°C to +60°C/-5°F to +140°F, 0-99% Relative Humidity, Pressure: 300hPa to 3000hPa •... -
Page 21: Compliance
IEC60601-2-47:2012 Particular requirements for the basic safety and essential • performance of ambulatory electrocardiographic systems; taking into account the intended use and limited analysis functionality of the Movesense MD device IEC 62479:2010 Assessment of the compliance of low-power electronic and •... - Page 22 5.3.2 Other standards FCC 47 CFR Part 2. 1093 • ISED RSS -102 Issue 5:2015 FCC Rules and Regulations CFR 47, Part 15, • Subpart C (10-1-15 Edition) & ICES-003 ISSUE 6 (2016) USA FCC Part 15.247, 15.209 • CANADA RSS-247, RSS-Gen Radio Frequency Devices. Operation within the •...
- Page 23 — Reorient or relocate the receiving antenna. — Increase the separation between the equipment and receiver. — Connect the equipment into 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. RF exposure safety Product OP174 is a radio transmitter and receiver.
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Page 24: Patent Notice
This product is protected by granted patents, pending patent applications and their corresponding national rights. Trademark Movesense, its logos, and other Suunto brand trademarks and made names are registered or unregistered trademarks of Suunto Oy. All rights are reserved. Disposal of device Please dispose of the device in an appropriate way, treating it as electronic waste. - Page 25 Test signals used in the RF wireless communications equipment proximity field immunity tests, as defined in IEC 60601-1-2:2014, Table 9: Test Band (MHz) Service Modulation Maximum Distance Immunity frequency power (W) test level (MHz) (V/m) 380-390 Tetra 400 Pulse modulation 18 Hz 430-470 DMRS 460, FRS...
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