laerdal NeoBeat User Manual Download

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NeoBeat

Newborn Heart Rate Meter

User Guide

www.laerdalglobalhealth.com

NeoBeat 532-00033

NeoBeat Mini 531-00033

Summary of Contents for NeoBeat

Page 1: ...NeoBeat Newborn Heart Rate Meter User Guide EN www laerdalglobalhealth com NeoBeat 532 00033 NeoBeat Mini 531 00033 ...

Page 2: ......

Page 3: ...ontents Important Information 4 Intended Use 5 Overview 6 Setup 8 Charging 14 Use 16 Reprocessing 22 Connectivity 24 Service and Warranty 25 Troubleshooting 26 Specifications 29 Technical Description 32 ...

Page 4: ...ing 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...

Page 5: ...Beat 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 bas...

Page 6: ...Charging LED Error LED Bluetooth LED ECG Dry Electrode ECG Dry Electrode Overview 6 ECG Dry Electrode Magnetic Charging Interface LED Display NeoBeat Patient Applied Part ...

Page 7: ...Mounting Bracket Charging Stand Newborn Bag Mask Holder Power Adapter with interchangeable plugs Overview 7 Magnetic Charging Interface ...

Page 8: ...d 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 Setup 8 ...

Page 9: ...1 2 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 Setup 9 ...

Page 10: ...1 5 6 3 1 4 10 Setup ...

Page 11: ...7 8 11 Setup ...

Page 12: ...1 2 2 3 12 Setup Tabletop Use ...

Page 13: ...4 13 Setup ...

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 one additional Charging Stand Low battery Battery charging Battery full ...

Page 15: ...15 Charging ...

Page 16: ...1 Use 16 Remove NeoBeat from the Charging Stand NeoBeat automatically turns on when it detects motion ...

Page 17: ...2 Use 17 Place NeoBeat around the newborn s torso Do not over bend ...

Page 18: ...ntact 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 ...

Page 19: ...indicated the device will have approximately 30 60 minutes remaining run time 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 ...

Page 20: ...e 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 becom...

Page 21: ...ical 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...

Page 22: ...othbrush 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 ...

Page 23: ...in liquid including 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 me...

Page 24: ...nfiguration 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 ...

Page 25: ...NeoBeat does not have any replaceable or serviceable parts NeoBeat has a one year limited warranty Refer to company website for terms and conditions Service and Warranty 25 ...

Page 26: ...n 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 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 ...

Page 27: ... memory x04 Data memory x08 RTC crystal x10 Display driver communication x20 Accelerometer communication x40 Light sensor communication x80 ECG analog signal chain 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 ...

Page 28: ...d 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 Nonfunctional or damaged device detected during equipment inspection Remove the device from service ...

Page 29: ...n from the maximum storage temperature until device is ready for operation 5 minutes Given ambient temperature of 20 C 68 F Time to warm up from the minimum storage temperature until device is ready for operation 5 minutes Given ambient temperature of 20 C 68 F 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 NeoB...

Page 30: ... be used clinically while charging Battery charger Input 100 240V AC 50 60 Hz 0 3 A Output 5V 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 20 250 bpm unknown or outside range displayed as Accuracy Short term average 10 or 5 bpm whichever ...

Page 31: ...celeration energy sampled at 1 Hz Research storage mode optional Raw ECG not diagnostic quality sampling rate 250 Hz and acceleration waves sampling rate 50 Hz Internal data storage size 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 ...

Page 32: ...ription 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: ... interference received including interference that may cause undesired operation Le présent appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio exempts de licence L exploitation est autorisée aux deux conditions suivantes 1 L appareil ne doit pas produire de brouillage et 2 L appareil doit accepter tout brouillage radioélectrique subi même si le brouillage est suscepti...

Page 34: ...RoHS This appliance is marked according to the European directive 2012 19 EU on Waste Electrical and Electronic Equipment WEEE Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner IP55 Protected against ingress from dust and water jet spraying IPX0 Not protected against liquid ingress Meets IEC type BF applied part leakage current requirements ...

Page 35: ...r 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 recycl...

Page 36: ...oper 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...

Page 37: ...est Standard or test method Compliance Level and Immunity Test Level Electrostatic discharge IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air Radiated RF EM fields IEC 61000 4 3 3V m 80 MHz 2 7 GHz 80 AM at 2 Hz Proximity fields from RF wireless communications equipment IEC 61000 4 3 380 390 MHz 27V m 430 470 MHz 28V m 704 787 MHz 9V m 800 960 MHz 28V m 1700 1990 MHz 28V m 2400 2470 MHz 28V m 5...

Page 38: ...s Line to ground IEC 61000 4 5 0 5 kV 1 kV 2 kV Conducted disturbances induced by RF fields IEC 61000 4 6 3V 0 15 MHz 80 MHz 6V in ISM bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz Voltage dips IEC 61000 4 11 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 Voltage interruptions IEC 61000 4 11 0 UT 250 300 cycle UT is the a c mains voltage ...

Page 39: ... 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 ta...

Page 40: ...hts 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 ...

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