laerdal NeoNatalie Resuscitator User Manual

laerdal NeoNatalie Resuscitator User Manual Manual pdf 1 page image

EN7546231User GuideNeoNatalieResuscitatorNEWBORN BAG-MASKREUSABLE - AUTOCLAVABLECat. no. 846040 QTY 1 eachCLINICAL INDICATIONSDevice DescriptionThe NeoNatalie Resuscitator (NNR) is a self-inflating manualresuscitator that is intended for patients requiring total orintermittent ventilatory support.Indication for UseThe NNR is intended for patients requiring total or intermittent ventilatorysupport. Ventilation is possible with or without supplemental oxygen.Intended UseThe NNR provides positive pressure ventilation and allows spontaneousbreathing with a face mask or an artificial airway.It is intended for newborns and infants up to 5 kg.Intended UsersThe NNR is intended to be used by healthcare professionals trained indelivering ventilatory support and in the use of manual resuscitators.Clinical BenefitsPositive impact on clinical outcome, by respiratory support that reducesprobability of adverse outcomes, such as morbidity and mortality caused byhypoxia.Clinical OutcomeDesired outcome of ventilation is oxygenation of the patient, oftenevaluated using SpO2, EtCO2, blood gas analysis or other method ofanalysis.Known Side EffectsGastric InsufflationOxygen ToxicityContraindicationsNo known contraindications for use.IMPORTANT INFORMATIONRead this User Guide and become familiar with the operation andmaintenance of the product prior to use. Use the product only as describedin this User Guide.Warnings and CautionsA Warning states a condition, hazard, or unsafe practice that can result inserious personal injury or death.A Caution states a condition, hazard, or unsafe practice that can result inminor personal injury or damage to the product.NotesImportant information about the product or its operation.Warnings• This resuscitator should only be used by persons who have received sufficienttraining in its use. Incorrect operation of the resuscitator can be hazardous.• This resuscitator should not be used in poisonous or hazardous atmospheres.© 2022 Laerdal Medical AS, All rights reserved.Manufactured in China for:Laerdal Medical ASP.O. Box 377, Tanke Svilandsgate 304002 Stavanger, NorwayTel : +47 51 51 17 00NeoNatalie Resuscitator; Newborn - Reusable,the Laerdal Logo, and “helping save lives” are alltrademarks of Laerdal Medical AS.Laerdal® is a trademark or registeredtrademark of Laerdal Medical AS.76Oxygen kit846141ACCESSORIESCat. no Description846141 Oxygen kit (NeoNatalie): Oxygen Reservoir Bag,Valve, Tubing and User Guide850500 Expiration Diverter (OD 30 mm)SPARE PARTSCat. no Description846130 Oxygen Reservoir Bag and Tubing (NeoNatalie)846145 Valves/Membranes, Complete set (NeoNatalie)846136 Silicone Mask no. 0 (NeoNatalie) Qty. 10*846137 Silicone Mask no. 1 (NeoNatalie) Qty. 10*540103 LSR Lip Valve*Masks are bulk packed: 10 masks in 1 polybag.20-19669 Rev A• Do not use the resuscitator if you have any reason to be concerned about itsfunctionality.• Care should be taken when using the NNR on patients with severe pulmonarydisease or severely immature lungs. Applied pressure should be adjusted andmonitored according to the patient's condition.• Care should be taken when using the NNR on patients with severe patientanomalies or when applying other medical devices which may conflict withthe mask as mask leakage may occur. If mask face sealing is not possible toachieve consider using alternative airway device.• Care should be taken when applying pressure to the mask to avoid facialdamage.• Care should be taken when using the NNR on patients with severely congestedairways. Consider removing congestion from the oropharyngeal airway. Use ofthe NNR on patients with severely congested airways may result in a reductionin expected oxygenation.• The NNR is not intended for use with advanced airways.Cautions• Use only NeoNatalie Resuscitator parts from a Laerdal authorized source withthis resuscitator. Use of other parts may affect safety and/or performance.• The resuscitator may be reused provided proper cleaning and sterilizationprocedures are performed between each patient use.• The resuscitator components must be cleaned and disinfected before firstpatient use.• This resuscitator can provide supplemental oxygen only when used with theOxygen Kit. The NeoNatalie Resuscitator is not supplied with the Oxygen Kitand its User Guide (sold separately).• The resuscitator is not intended for use in an ambulance.• The hard plastic components of the resuscitator are incompatible with polarsolvents such as ethanol and isopropyl alcohol.• The NNR and masks should only be used by persons who have receivedadequate training in the use of resuscitators.• Resuscitators should not be used with supplemental oxygen where smoking ispermitted or when fire, flame, oil or grease is in close proximity.• Resuscitators should not be used in toxic or hazardous atmospheres.• The use of third party products with the NNR may affect performance.• Please consult with the manufacturer of the third party products to verifycompatibility with the NNR and obtain information on possible performancechanges.• An oxygen blender is recommended if more precise oxygen concentrations arerequired, for example for pre-terms.• The use of a PEEP valve (not provided by Laerdal) is recommended in thecase that PEEP is indicated for the patient. Note that it is necessary to use theExpiration diverter to attach a PEEP valve.• The NNR and masks are not intended for use in delivery of medications, suchas anaesthetic gases.Notes• Note that the patient port connector does not have a swivel function which canreduce the flexibility of the user to reposition the resuscitator when connectedto an advanced airway.• Should any serious malfunction, undesirable incident with, or deterioration in thefunctionality or performance of the device occur, contact Laerdal promptly. Thecompetent authority where the incident took place and/or the device was usedshould also be notified.CLINICAL USETo Use1. Connect a suitable face mask.2. Connect to external O2 source, if applicable.3. Place mask over face and check for seal.4. Squeeze the Ventilation Bag in accordance to clinical protocol.5. Observe patient chest rise during ventilation.6. Allow patient to exhale.7. Stop ventilation as required by clinical protocol.Pressure Release Valve:The resuscitator has a pressure release (pop-off) valve which releases airwhen pressure to the patient exceeds 30-40 cm H2O. A hissing soundcan be heard when the valve opens. This valve may be overridden if morepressure to the patient is needed.To override: press downwards on the Pressure Release Valve with your indexfinger.For ventilation training with the NeoNatalie Newborn Simulator, use thelargest mask (no.1). For ventilation of a real patient, use the mask size thatprovides the best seal to the patient’s face.If the Patient Valve becomes contaminated with vomit, remove from patientand shake free any contaminant and squeeze the ventilation bag several timesto expel the contaminant. If contaminant does not clear; disassemble thePatient Valve and rinse. If any components are loose, tighten or reassemblethe device and test in accordance.The resuscitator may be fitted with the Laerdal LSR Expiration Diverter.Attach firmly to the Patient Port. Attach a suited PEEP valve if PEEP isindicated for the patient.Check PEEP levels regularly with a manometer.www.laerdal.comSPECIFICATIONSConditionsOperating Conditions Temperature: -18 ˚C to 50 ˚C (-0.4 ˚F to 122 ˚F)Humidity: 15% to 95% RHStorage Conditions Temperature: -40 ˚C to 60 ˚C (-40 ˚F to 140 ˚F)Humidity: 15% to 95% RHInspiratory resistance <0.5 cm H2O at 5 LPMExpiratory resistance <2.5 cm H2O at 5 LPMPatient Connector(conical) 15 mm inner diameter, 22 mm outer diameterExternal dimensions(with Mask)Approx. 220 mm x 70 mm x 120 mm(8.66 x 2.76 x 4.72 inches)Mass (with Mask size 1) Approximately 170 grams (6 ounces)Lifetime ParametersShelf-life 5 yearsExpected Service Life 50 cycles of reprocessingDelivered volume range:Tidal volume 161 ml* +/- 15 ml (standard deviation) at room temperature* In sub-zero temperatures, the tidal volume may be approx. 20% less.Material ChartHard plastic components Polysulfone (PSU)Soft plastic components Silicone rubber (SI)Spring Stainless steelREGULATORYMeets ISO 10651-4:2002/EN ISO 10651-4:2009,Lung ventilators – Particular requirements for operator–poweredresuscitators.Symbol GlossaryMedical DeviceThis medical device complies with the general safety and performancerequirements of Regulation (EU) 2017/745 for medical devices.Not made with natural rubber latexWarrantyRefer to the Laerdal Global Warranty for terms and conditions.For more information visit www.laerdal.com.PEEP valveExpiration diverter

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