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laerdal Moyo User Manual

Fetal heart rate monitor
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Moyo
Fetal Hear t Rate Monitor
User Guide
www.laerdalglobalhealth.com

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Summary of Contents for laerdal Moyo

  • Page 1 Moyo Fetal Hear t Rate Monitor User Guide www.laerdalglobalhealth.com...
  • Page 2 Intended Use The "Moyo - Fetal Heart Rate Monitor" by Laerdal Global Health is intended for healthcare professionals to monitor fetal heart rate during labor. Moyo uses a Doppler ultrasound sensor to measure and analyze the fetal heart rate. The calculated fetal heart rate is presented on the display together with an audible (doppler) sound.

  • Page 3: Table Of Contents

    Contents 1 Overview 2 Cautions & Warnings 3 Getting Started 4 Alarms 5 Cleaning & Charging 6 Features in Detail 7 Troubleshooting 8 Technical Description...

  • Page 4: Overview

    Overview Items included: 1 Moyo main unit with ultrasound sensor, 1 neck strap, 3 reusable abdominal transducer belts, 1 charger, 1 charger cable and this User Guide. Speaker Status Light Display Maternal heart rate pads (electrodes) Power on/off button Speaker on/off button...

  • Page 5: Cautions & Warnings

    Cautions & Warnings Please ensure that following precautions are taken to ensure that Moyo functions properly during use. This product is intended for use by authorized healthcare professionals only. Read this User Guide and become familiar with the operation of the device prior to use.

  • Page 7: Getting Started

    Getting Started To start operating Moyo, you need to learn the basic functions first.
  • Page 8 Only water-based ultrasound gel should be used. If ultrasound gel is not available, water can be used for short time monitoring. You should charge Moyo's battery regularly to ensure that it is always ready for use. To learn more about how to charge Moyo, refer to page 28.
  • Page 9 Getting Started Use sequence 15:36 To start using Moyo, press and hold the power button PRACTICE OBSERVE Do you see the display turning on? Turn on Moyo. Do you hear the startup sound? If you encountered a problem, go to...
  • Page 10 Use sequence Getting Started 15:36 means that no heart rate (HR) is found by the sensor. SIMULATION NOTE You can tap on the sensor to manually simulate a HR when there is no dedicated FHR simulator available. 10 10...
  • Page 11 Getting Started To measure fetal heart rate (FHR), you first need to apply gel on the ultrasound sensor and place it on the mother’s abdomen (if possible over the fetal back). If no HR sound is heard, reposition the ultrasound sensor until you hear the rhythmic HR sound. Palpate to identify fetal position.
  • Page 12 Getting Started Moyo shows a HR number. Green color means that HR is in the normal range for a fetus. You can hear rhythmic HR sound from the speaker. Notice when FHR is shown, the status light blinks at the same rate as the FHR together with the rhythmic HR sound.
  • Page 13 Getting Started 15:36 If you are not sure that the found heart rate is the fetal, you can instruct the mother to hold the pads to measure mother’s HR. If the two numbers are similar, then the HR found by the ultrasound sensor might be the maternal HR. The ultrasound sensor might measure or be affected by mother's HR, a twin (multiples) or excessive patient movement/handling.
  • Page 14 Getting Started When you are sure that you have found the FHR, tighten the abdominal transducer belt around the mother to secure the ultrasound sensor in place. PRACTICE Keep the sensor in place using the abdominal transducer belt. 14 14...

  • Page 15: Alarms

    Alarms Moyo provides alarms if the FHR is lost or if prolonged abnormal FHR is detected. In this chapter, you will learn about the alarms. 15 15...
  • Page 16 Ox2O Lost FHR alarm 15:36 Moyo will give an alarm if the ultrasound sensor has not picked up any HR for 60 seconds. You will see the blinking, and hear an alarm sound. If you hear the alarm, press the speaker button to silence (acknowledge) the alarm.
  • Page 17 Alarms When is shown, reposition the ultrasound sensor to find the FHR. If FHR is not found after repositioning the sensor, continue monitoring according to your medical procedures, e.g. using alternative devices to obtain FHR. If you are not sure that the detected heart rate is the fetal, you can instruct the mother to hold the pads to obtain the maternal HR for comparison.
  • Page 18 Moyo is designed to monitor FHR, and provide visual and auditory alarm when abnormal FHR is present over a prolonged period. Moyo shows the number and status light in 3 different colors as shown below: More than Abnormally high FHR...
  • Page 19 Alarms 15:36 Moyo will give an alarm when the FHR has been abnormal for a prolonged time. You will see the status light and number in red color, and hear the alarm sound. If you hear the alarm you can press the speaker button to silence (acknowledge) the alarm.
  • Page 20 20 20...

  • Page 21: Cleaning & Charging

    Reprocessing In this chapter, you will learn how to clean, disinfect and inspect Moyo, and how to charge its battery so that it is ready for the next use.
  • Page 22 A toothbrush dipped in soapy water can be used to remove difficult soil from the sensor. The main unit must not be scrubbed with a brush to avoid getting water into the device. Wipe Moyo with a clean cloth dampened with clean water, then leave to dry. 22 22...
  • Page 23 Effective disinfection is not possible without first performing a thorough cleaning. Care should be taken while handling the product between cleaning and disinfection. Spray 70% ethanol on the surface of Moyo, or wet Moyo with a clean cloth dampened with 70% ethanol.
  • Page 24 Do not dry this product using heating devices such as ovens or hair dryers. Inspection Inspect Moyo main unit, the sensor and the cable after each use for cracks or damages. If there is any damage, refer to Troubleshooting section.
  • Page 25 Reprocessing Abdominal transducer belt Cleaning & Disinfecting Submerge the belt in soapy water (10-40 °C), and keep for a minimum of 10 minutes. Rinse and scrub the belt by rubbing parts of the belt against each other under running tap water (10-40 °C) for a minimum of 2 minutes.
  • Page 26 Reprocessing 0.5% NaCIO 0.5% NaCIO Submerge the belt in bleach containing 0.5% sodium hypochlorite (NaClO), and keep for a minimum of 30 minutes. Rinse the belt under running tap water (10-40 °C) for a minimum of 2 minutes.
  • Page 27 Reprocessing Let the belt air-dry. Inspect to confirm that belt is clean and dry.
  • Page 28 15:36 12.12.2014 Ox2O Open the rubber cover on Moyo and connect the power adaptor to it. During charging, Moyo shows the battery status on the display: The device cannot be used clinically during charging. Charging time can be up to 5 hours when the battery is empty.

  • Page 29: Features In Detail

    Features in Detail In this chapter, you will learn more about the features of Moyo in detail.
  • Page 30 To turn on Moyo, press and hold the "power on/off" button for at least 0.5 seconds. If Moyo is turned on using the "power on/off" button, Moyo beeps once and the LED blinks in green color to allow users to verify audio/speaker and light functionality.
  • Page 31 Features As an addition to the default display, there are two functions in Moyo that enable the user to view additional information on the display. These displays are only shown momentarily when the associated functions are enabled. 1. History Graph display The HR that has been obtained from the ultrasound sensor during the last 30 minutes can be viewed on the History Graph.
  • Page 32 Features 2. Maternal HR display 15:36 12.12.2014 CONFIGURATION Lorem Ipsum Use sequence When the pads are held by the mother, the display simultaneously shows the Ox2O HR from the ultrasound sensor and the maternal HR. See illustration below: HR detected from ultrasound sensor 15:36 Symbol for HR detected from...
  • Page 33 Features Colors FHR is communicated with 3 different colors: green, yellow, red. Green is used when FHR is normal (between 110 - 160 bpm). Yellow and red are used when FHR is abnormal (less than 110 bpm or more than 160 bpm). Yellow color turns red when abnormal FHR is present for a period of time.
  • Page 34 Together with the display, fetal heart rate is indicated with the status light. The status light on Moyo blinks with the same rate as the heart rate detected by the ultrasound sensor. The color of the light changes based on the FHR value...
  • Page 35 Features Doppler sound Moyo provides a Doppler sound, which can be silenced by pressing the speaker on/off button. The speaker status is indicated with a symbol on the display as shown below: Speaker on Speaker off When an alarm is triggered, the speaker is set to “on” automatically.
  • Page 36 Features Alarms Moyo provides two types of alarms: soft alarm and abnormal FHR alarm. Soft alarm can be triggered for different reasons whereas the abnormal FHR alarm is only triggered when there is a prolonged abnormal FHR. See below for...
  • Page 37 Features Silence/acknowledge alarm: During an alarm, alarm sounds can be silenced if the “speaker on/off” button Use sequence is pressed. The silent state of the alarm lasts until current alarm is over (i.e. not time limited). When an alarm is silenced, the alarm silenced symbol is shown on the display. This symbol will remain on the display until the alarm is over.
  • Page 38 Low battery If the battery drops to below critical level, Moyo will show the “battery empty” symbol on the display for three seconds, and then turn off automatically. See illustration below: Battery empty No other functionality is on/available when the battery is empty.
  • Page 39 Features Abnormal fetal heart rate alarm: When abnormal FHR is present over a prolonged period, the abnormal FHR alarm is activated. During abnormal FHR alarm, three fixed-pitch pulses are played every 5 seconds. The heart rate number and status light are displayed in red color.
  • Page 40 Features Neck strap The provided neck strap is designed to enable mobility of the mother during continuous FHR monitoring. Attaching the neck strap to Moyo is explained below: Inspect that the neck strap is undamaged and clean. Remove the ends of the neck strap by squeezing the tabs.
  • Page 41 Features Thread the neck strap to Moyo. Reconnect the neck strap. When needed, the neck strap can be cleaned and disinfected following the same procedure as the abdominal transducer belt (see page 25).
  • Page 42 42 42...

  • Page 43: Troubleshooting

    Troubleshooting Did you experience a problem with Moyo? Read this chapter to find the possible cause and solution to your problem.
  • Page 44 • 0x01 - Program memory checksum error Ox2O • Restart the Moyo, if the problem persists, the device is • 0x02 - Calibration memory Critical Error broken and should not be used.
  • Page 45 • Speaker is not functioning. • Continue standard procedure audible. without use of the device. • Restart the Moyo, if the problem persists, the device is broken and should not be used. • If under warranty, contact Laerdal Global Health.
  • Page 46 46 46...

  • Page 47: Technical Description

    Technical Description This chapter covers the technical descriptions of Moyo.
  • Page 48 Technical Description Symbol Glossary This product is in compliance with the essential requirements of EU Council directive 93/42/ EEC as amended by EU Council directive 2007/47/EC, and EU Council directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS). Manufacturer This product is marked according to the European directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE).
  • Page 49 Neck strap: Polyester, non-latex DIMENSIONS Size: 96 x 96 x 24 mm (W x H x D, without cable and ultrasound transducer) Weight: 300 g (main unit + ultrasound transducer) Maintenance Moyo does not have any replaceable or serviceable parts, including the battery.
  • Page 50 Technical Description Electromagnetic Conformity List of cables and battery charger with which Moyo is in compliance with the IEC 60601-1-2 EMC standard: • Charger PSB05R-050Q and USB cable, type A to mini type B, 1.5 m (Laerdal cat.no. 510-10350) Use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Laerdal as replacement parts for internal components, may result in increased electromagnetic emissions or decreased immunity of Moyo.
  • Page 51 Technical Description Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Moyo is intended for use in the electromagnetic environment specified below. The customer or the user of Moyo should assure that it is used in such an environment. IMMUNITY TEST IEC 60601 TEST...
  • Page 52 Technical Description Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Moyo is intended for use in the electromagnetic environment specified below. The customer or the user of Moyo should assure that it is used in such an environment. IMMUNITY COMPLIANCE COMPLIANCE ELECTROMAGNETIC ENVIRONMENT -...
  • Page 53 If the measured field strength in the location in which Moyo is used exceeds the applicable RF compliance level above, Moyo should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating Moyo.
  • Page 54 Technical Description Accessories and spare parts CAT. NO DESCRIPTION 510-10150 Abdominal transducer belt (package of 3) 510-10250 Neck strap (package of 3) 510-10350 Battery charger and cable (5 V USB wall adapter + USB cable, 1.5 m)
  • Page 55 Moyo contains electronic components. Dispose of it at an appropriate recycling facility in accordance with local regulations.
  • Page 56 Tel: +47 51 51 17 00 Fax: +47 51 52 35 57 Email: laerdal.norway@laerdal.no Moyo catalogue number: 510-00033 US and International patents pending. Laerdal ® is a registered trademark of Laerdal Medical AS. © 2017 Laerdal Medical AS. All rights reserved. www.laerdalglobalhealth.com...