Related Manuals for laerdal NeoBeat
Summary of Contents for laerdal NeoBeat
- Page 1 NeoBeat Newborn Heart Rate Meter User Guide NeoBeat 532-00033 NeoBeat Mini 531-00033 www.laerdalglobalhealth.com...
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Page 3: Table Of Contents
Contents Important Information Intended Use Overview Setup Charging Reprocessing Connectivity Service and Warranty Troubleshooting Specifications Technical Description... -
Page 4: Important Information
Important Information The information in this User Guide applies to both NeoBeat and NeoBeat Mini. Prior to first use, read the User Guide completely to become familiar with the operation and maintenance of NeoBeat. Read all Cautions and Warnings before using NeoBeat. -
Page 5: Intended Use
NeoBeat is intended for use on newborns approximately 1.5 – 5 kg (3.3 – 11 lb) and NeoBeat Mini for newborns 0.8 – 2 kg (1.7 – 4.4 lb). NeoBeat and NeoBeat Mini are intended to be in contact with the intact skin of the newborn's torso. -
Page 6: Overview
Overview NeoBeat * LED Display Charging LED Error LED Bluetooth ® ECG Dry Electrode ECG Dry Electrode Magnetic Charging Interface ECG Dry Electrode * Patient Applied Part... - Page 7 Overview Charging Stand Magnetic Charging Interface Mounting Bracket Newborn Bag-Mask Holder Power Adapter with interchangeable plugs...
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Page 8: Setup
Setup NeoBeat Charging Stand can be mounted vertically to a wall, rail or post, or placed on a tabletop. When mounted vertically, the Newborn Bag-Mask Holder is optional. When used on a tabletop, the Newborn Bag-Mask Holder functions as a stand. - Page 9 Setup Vertical Mount • Multiple mounting screw hole patterns: 9 x 9 mm, 21 x 21 mm, 75 x 75 mm. • Use screws or double sided foam tape (not included) to mount the Mounting Bracket.
- Page 10 Setup...
- Page 11 Setup...
- Page 12 Setup Tabletop Use...
- Page 13 Setup...
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Page 14: Charging
Recharge NeoBeat monthly if not stored on the Charging Stand. Notes • NeoBeat is activated by motion, which in turn uses battery life. When not in use, store it on the Charging Stand to avoid unnecessary battery use. • The USB port on the Charging Stand can be used to connect one (and only... - Page 15 Charging...
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Page 16: Use
Remove NeoBeat from the Charging Stand. NeoBeat automatically turns on when it detects motion. - Page 17 Place NeoBeat around the newborn's torso. Do not over-bend.
- Page 18 Displays Activated NeoBeat is activated, but there is no or inadequate patient contact. If no patient contact, the device will return to standby automatically after 10 seconds. Heart rate unknown Heart rate cannot be detected. This can be due to poor positioning of the ECG electrodes, or lack of detectable heart rate despite having good contact.
- Page 19 Questionable detection Heart rate is detected, but there is questionable signal quality. This may be due to poor positioning of the device, skin is too dry or motion. Undetectable due to motion There is too much motion to detect heart rate. Low battery Battery level is low and the device should be recharged before next use.
- Page 20 • Heart rate may not be detected correctly in the case of severe arrhythmia. • Use of NeoBeat in a moving environment may reduce the device accuracy. • Do not bend the device more than necessary for application to the newborn.
- Page 21 Notes • Skin contact is necessary to measure heart rate. • If the patient skin is not moist (i.e. too dry), add a drop of water under the electrodes to improve performance of the device. • Reposition device if no heart rate can be obtained. Moving the device closer to the heart may give a stronger signal.
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Page 22: Reprocessing
Clean and disinfect NeoBeat after each patient use to minimize the risk of cross-contamination. Warning Do not place a used NeoBeat back onto the charging stand before it has been cleaned and disinfected. Cleaning Clean all surfaces of NeoBeat using a cloth dampened with soapy water. - Page 23 • Do not use sodium hypochlorite (bleach) to disinfect Inspection After reprocessing, inspect NeoBeat for cracks and damage with particular attention to the highlighted areas. If there is any damage, remove the device from service. Otherwise, put the device back onto the Charging Stand.
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Page 24: Connectivity
Connectivity NeoBeat allows wireless connectivity using a Bluetooth® Low Energy wireless technology. Possible uses are: • Device configuration (e.g. storage mode, internal date and time). • Firmware upgrade. • Transfer of stored data episodes. • Live streaming of heart rate data during clinical use. Disabled by default. -
Page 25: Service And Warranty
Service and Warranty NeoBeat does not have any replaceable or serviceable parts. NeoBeat has a one-year limited warranty. Refer to company website for terms and conditions. -
Page 26: Troubleshooting
Troubleshooting Symptom Possible cause Possible solution Patient contact is The skin is too dry for NeoBeat to Wet the electrodes not detected. detect patient contact. with water and/or reposition the device. Heart rate is not The device is misplaced or not in Reposition the detected. - Page 27 Troubleshooting Symptom Error codes Possible solution Critical technical x01 - Program memory Continue standard error. Error code procedure without use of x02 - Calibration memory is shown in the the device. display and error x04 - Data memory light activated. Use alternative means of measuring newborn heart x08 - RTC crystal...
- Page 28 Troubleshooting Symptom Possible cause Possible solution NeoBeat does not Battery depleted. Continue standard turn on or it turns off procedure without use of during use. the device. After the procedure, reprocess and charge the device. Note: it may take up to 10...
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Page 29: Specifications
Heart Rate Meter Dimensions NeoBeat: 83 x 87 x 40 mm (3.2 x 3.4 x 1.6 inches) NeoBeat Mini: 70 x 70 x 40 mm (2.8 x 2.8 x 1.6 inches) Weight: NeoBeat: 31 g (1.1 oz) NeoBeat Mini: 27 g (1 oz) - Page 30 Specifications Power Battery Internal rechargeable lithium-ion button cell, 3.7 V, 120 mAh Typical service life of battery: 3 – 6 years depending on use Run time >4 hours (full charge on new battery) >3 hours (full charge at expected end of battery service life) Charge time Maximum 3 hours (full charge of empty battery) Note: device cannot be used clinically while charging...
- Page 31 Specifications Data recording Parameterized data Heart rate, signal quality, acceleration (three axes), (always on) acceleration energy; sampled at 1 Hz Research storage mode Raw ECG (not diagnostic quality; sampling rate 250 Hz) (optional) and acceleration waves (sampling rate 50 Hz) Internal data storage 8 MB (Up to 160 hours of parameterized data;...
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Page 32: Technical Description
Technical Description Warning Do not modify this equipment without authorization of the manufacturer. Caution Changes or modifications not expressly approved by Laerdal Medical could void the user’s authority to operate the equipment. - Page 33 Technical Description Federal Communications Commission (FCC) and Industry Canada (IC) Statement This device complies with part 15 of the FCC Rules and Industry Canada’s licence-exempt RSSs. Operation is subject to the following two conditions: This device may not cause harmful interference, and this device must accept any interference received, including interference that may cause undesired operation.
- Page 34 Technical Description Symbol Glossary The product is in compliance with the essential requirements of Council Directive 93/42/EEC as amended by Council Directive 2007/47/EC, Council Directive 2014/53/EU on Radio Equipment (RED) and Council Directive 2011/65/EU on restriction of the use of certain hazardous substances (RoHS).
- Page 35 Disposal must be carried out in accordance with local environmental regulations for waste disposal. For more detailed information about treatment, recovery and recycling of this product, please contact your local city office, your household waste disposal service or Laerdal representative.
- Page 36 • 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 NeoBeat, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment...
- Page 37 Technical Description Electromagnetic Emissions Tests Emissions Test Standard or test method Compliance RF emissions CISPR 11 Group 1 Class B Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker IEC 61000-3-3 Complies emissions Electromagnetic Immunity Tests Immunity Test Standard or test method Compliance Level and Immunity Test Level Electrostatic discharge...
- Page 38 Technical Description Immunity Test Standard or test method Compliance Level and Immunity Test Level Electrical fast IEC 61000-4-4 ± 2 kV transients / bursts 100 kHz repetition frequency Surges: Line-to-line IEC 61000-4-5 ± 0.5 kV, ± 1 kV Surges: Line-to-ground IEC 61000-4-5 ±...
- Page 39 Maximum radio-frequency power transmitted: 1 mW Effective radiated power: 0 dBm Information Available Electronically Hold NeoBeat upside down and double tap firmly on the charging pin side to display the unique device identification (UDI), FCC ID, IC certification number and software version.
- Page 40 © 2018 Laerdal Medical AS. All rights reserved. US and International patents pending. US and international design registration pending. Laerdal® and Neobeat® are registered trademarks of Laerdal Medical AS. Manufactured by: Laerdal Medical AS, P.O. Box 377 Tanke Svilandsgate 30, 4002 Stavanger,...