EN NeoBeat Newborn Heart Rate Meter User Guide NeoBeat 532-00033 NeoBeat Mini 531-00033 www.laerdalglobalhealth.com Important Information Intended Use Overview Setup Charging Use Reprocessing Connectivity Service and Warranty Troubleshooting Specifications Technical Description Contents 4 5 6 8 14 16 22 24 25 26 29 32 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. Warnings and Cautions A Warning states a condition, hazard, or unsafe practice that can result in serious personal injury or death. A Caution states a condition, hazard, or unsafe practice that can result in minor personal injury or damage to the product. Notes A Note states important information about the product or its operation. Rx Only (USA) Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. 4 Intended Use Intended medical indication:
NeoBeat and NeoBeat Mini are intended to measure the heart rate of a newborn within the first few hours after delivery. 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. Intended users:
Healthcare professionals trained in newborn resuscitation. Operating principle:
A battery powered monitor placed on the torso of a newborn to measure and present the heart rate. Dry electrodes on each arm of the device are placed on opposite sides of the patient's torso to pick up an ECG based signal. The signal is analyzed by a QRS detection algorithm, and heart rate is displayed. 5 Overview NeoBeat *
LED Display Error LED Charging LED Bluetooth LED ECG Dry Electrode ECG Dry Electrode Magnetic Charging Interface ECG Dry Electrode
* Patient Applied Part 6 Charging Stand Overview Magnetic Charging Interface Mounting Bracket Newborn Bag-Mask Holder Power Adapter with interchangeable plugs 7 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. Caution Do not mount the Charging Stand in close proximity to heat sources
(e.g. directly below an infant warmer heat lamp). 8 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. 1 2 9 Setup 1 3 5 14 6 10 7 8 Setup 11 Setup Tabletop Use 1 22 3 12 4 Setup 13 Charging To initiate the device, NeoBeat must be charged for up to 3 hours before first use. Place it on the Charging Stand to charge the battery. Low battery Battery charging Battery full Maintenance 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 one) additional Charging Stand. 14 Charging 15 Use Remove NeoBeat from the Charging Stand. NeoBeat automatically turns on when it detects motion. 1 16 Use Place NeoBeat around the newborn's torso. 2 Do not over-bend. 17 Use 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. Clear detection Heart rate is detected and there is good signal quality. 18 Use 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. When low battery is indicated, the device will have approximately 30-60 minutes remaining run time. 19 Use Warnings Decisions on when to start or end resuscitation efforts should not be made based on the output of this device alone. If an error has occurred, if the device provides no heart rate or if you do not trust the output, continue therapy without device. Handling of the newborn may cause false heart rate readings even when the patient has no heart rate (asystole). The device alone should not be used to confirm asystole/stillbirth. Cautions Excessive patient handling and movement may cause lost or erroneous heart rate readings. 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. Excessive bending may cause the device to become permanently deformed and damaged. Do not misuse the device; e.g. using it on adults or children, or exposing the device to hard surface impacts. Do not use the product if it is damaged or cracked. 20 Use 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. When excessive movement (e.g. stimulation) is detected, the device will not show a heart rate. The device detects and displays the electrical heart rate, which in some conditions (e.g. pulseless electrical activity), may not reflect presence of circulatory pulse. Another person touching the electrodes simultaneously with the patient may interfere with the heart rate measurement. The device may indicate patient contact if one of the charging pins is touched while holding one ECG electrode. If the device is placed on a conductive surface, e.g. a metal tray, it may not go to standby, thus draining the battery. The dry electrodes are intended for use on moist newborn skin, and may reduce the heart rate accuracy when used with the thicker and drier skin of e.g. an adult's fingers. 21 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 1. Clean all surfaces of NeoBeat using a cloth dampened with soapy water. To remove difficult soil, use a toothbrush dipped in lukewarm soapy water. Clean for a minimum of 2 minutes, ensuring that all soil has been removed. 2. Wipe NeoBeat with a clean cloth dampened with clean water. 3. Dry NeoBeat using a clean cloth or by air drying. Disinfection 1. Wipe all surfaces of NeoBeat with a clean cloth soaked with 70%
ethanol. 2. Spray 70% ethanol on all surfaces of NeoBeat. Ensure it remains wet for 10 minutes. Repeat spraying as necessary to account for evaporation. 3. Wipe NeoBeat with a clean cloth dampened with clean water. 4. Allow to dry completely. 22 Reprocessing Cautions Effective disinfection is not possible without first performing a thorough Care should be taken while handling the product between cleaning and Do not submerge any of the product components in liquid (including cleaning. disinfection. ethanol). 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. Charging Stand When needed, the Charging Stand can be cleaned and disinfected using the same method as above. 23 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. Data transfer, device configuration and firmware upgrade is only available during charging, using a tablet app. Refer to company website for more information. 24 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. 25 Troubleshooting Symptom Patient contact is not detected. Possible cause The skin is too dry for NeoBeat to detect patient contact. Possible solution Wet the electrodes with water and/or reposition the device. Heart rate is not detected. The device is misplaced or not in direct contact with patient. Or Stimulation/movement/
handling of patient temporarily generating too much noise. Or Heart rate is below 20 bpm. 26 Reposition the device. Moving the device closer to the heart may give a stronger signal. If the problem continues, use alternative means of measuring newborn heart rate, e.g. a stethoscope. Symptom Critical technical error. Error code is shown in the display and error light activated. Troubleshooting Error codes x01 - Program memory x02 - Calibration memory Possible solution Continue standard procedure without use of the device. Use alternative means of measuring newborn heart rate, e.g. a stethoscope. Place the device on the charging stand. If the problem persists, remove device from service. x04 - Data memory x08 - RTC crystal x10 - Display driver communication x20 - Accelerometer communication x40 - Light sensor communication x80 - ECG analog signal chain 27 Troubleshooting Symptom NeoBeat does not turn on or it turns off during use. Possible cause Battery depleted. Nonfunctional or damaged device detected during equipment inspection. 28 Possible solution Continue standard procedure without use of the device. After the procedure, reprocess and charge the device. Note: it may take up to 10 minutes before the device indicates charging if the battery is very depleted. If the problem persists, remove the device from service. Remove the device from service. Specifications Environmental Temperature Atmospheric Pressure Relative Humidity Time to cool down from the maximum storage temperature until device is ready for operation Time to warm up from the minimum storage temperature until device is ready for operation Heart Rate Meter Dimensions Weight:
Materials Operating: 0 40 C (32 104 F) Storage / shipping: -40 70 C (-40 158 F) Operating: 620 1060 hPa (up to 4000 meters above sea level) Storage / shipping: 550 1060 hPa Up to 90%, non-condensing
<5 minutes.
(Given ambient temperature of 20 C (68 F))
<5 minutes.
(Given ambient temperature of 20 C (68 F)) 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) NeoBeat: 31 g (1.1 oz) NeoBeat Mini: 27 g (1 oz) PC, TPU, stainless steel 29 Specifications Power Battery Run time Charge time Battery charger Internal rechargeable lithium-ion button cell, 3.7 V, 120 mAh Typical service life of battery: 3 6 years depending on use
>4 hours (full charge on new battery)
>3 hours (full charge at expected end of battery service life) Maximum 3 hours (full charge of empty battery) Note: device cannot be used clinically while charging Input 100 240 V AC, 50 60 Hz, 0.3 A Output 5 V DC, 1 A Caution Only use provided power supply, PSAI05R-050QL6-R, or an alternative 5 W USB power supply, 5 V DC, 1 A, that is IEC 60950-1, IEC 62368-1 or IEC 60601-1 certified. Heart Rate Measurement Display range Accuracy 20 250 bpm; unknown or outside range displayed as -?-
Short term average 10% or 5 bpm, whichever is greater IP Classification Ingress Protection Heart rate meter: IP55 All other components: IPX0 30 Specifications Data recording Parameterized data
(always on) Research storage mode
(optional) Internal data storage size Heart rate, signal quality, acceleration (three axes), acceleration energy; sampled at 1 Hz Raw ECG (not diagnostic quality; sampling rate 250 Hz) and acceleration waves (sampling rate 50 Hz) 8 MB (Up to 160 hours of parameterized data; or, if research storage mode is enabled, up to 2.5 hours of parameterized data and waves.) 31 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 users authority to operate the equipment. 32 Technical Description Federal Communications Commission (FCC) and Industry Canada (IC) Statement This device complies with part 15 of the FCC Rules and Industry Canadas licence-exempt RSSs. 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. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes:
1. Lappareil ne doit pas produire de brouillage, et 2. Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. FCC ID: QHQ-20-09917 IC: 20263-2009917 33 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). This appliance is marked according to the European directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE). Only USA IP55 IPX0 Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Protected against ingress from dust and water jet spraying Not protected against liquid ingress Meets IEC type BF applied part leakage current requirements Manufacturer Consult User Guide The products is eligible to bear the CSA Mark with adjacent indicator US for US 34 Technical Description Symbol Glossary Temperature limitation Atmospheric pressure limitation Humidity limitation Waste Handling This appliance is marked according to the European directive 2012/19/EC on Waste Electrical and Electronic Equipment (WEEE). By ensuring this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste handling of this product. The symbol on the product, or on the documents accompanying the product, indicates that this appliance may not be treated as household waste. Instead it shall be handed over to the applicable collection point for the recycling of electrical and electronic equipment. 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. 35 Technical Description Electromagnetic Conformity NeoBeat is intended for use in the following environments: Health care facilities except for near HF surgical equipment and the RF shielded room for magnetic resonance imaging. No particular actions are required to maintain safety and performance with regard to electromagnetic disturbances for the expected service life. Warnings Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 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 could result. 36 Technical Description Electromagnetic Emissions Tests Emissions Test Standard or test method RF emissions Harmonic emissions Voltage fluctuations/ flicker emissions CISPR 11 IEC 61000-3-2 IEC 61000-3-3 Electromagnetic Immunity Tests Immunity Test Standard or test method Electrostatic discharge IEC 61000-4-2 Radiated RF EM fields IEC 61000-4-3 Proximity fields from RF wireless communications equipment IEC 61000-4-3 Rated power frequency magnetic fields IEC 61000-4-8 37 Compliance Group 1 Class B Class A Complies Compliance Level and Immunity Test Level 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 3 V/m 80 MHz 2.7 GHz 80% AM at 2 Hz 380-390 MHz: 27 V/m 430-470 MHz: 28 V/m 704-787 MHz: 9 V/m 800-960 MHz: 28 V/m 1700-1990 MHz: 28 V/m 2400-2470 MHz: 28 V/m 5100-5800 MHz: 9 V/m 30 A/m 50 Hz or 60 Hz Technical Description Immunity Test Standard or test method Electrical fast transients / bursts IEC 61000-4-4 Compliance Level and Immunity Test Level 2 kV 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 0.5 kV, 1 kV, 2 kV Conducted disturbances induced by RF fields IEC 61000-4-6 3 V; 0.15 MHz 80 MHz Voltage dips IEC 61000-4-11 Voltage interruptions, IEC 61000-4-11 6 V in ISM bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz 0% UT; 0.5 cycle At 0, 45, 90, 135, 180, 225, 270 and 315 0% UT; 1 cycle and 70% UT;
25/30 cycles Single phase: at 0 0% UT; 250/300 cycle UT is the a.c. mains voltage prior to application of the test level. 38 Technical Description Bluetooth Low Energy transmitter Frequency band: 2.400 2.4835 GHz Modulation: Gaussian frequency shift modulation 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. Machine Readable UDI The GS1 DataMatrix located on the outside of the electrode arm of NeoBeat contains the UDI of the device. This barcode can be read using apps on a smart phone or tablet. 39 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, Norway Printed in Norway D v e R 4 7 3 2 4 0 0 0 www.laerdalglobalhealth.com