Laerdal Medical AS 801002 CPR meter User Manual 004 00031103 CPRmeter II User Guide

Laerdal Medical AS CPR meter 004 00031103 CPRmeter II User Guide

004_00031103 CPRmeter II User Guide

CPRmeter 2User GuideENwww.laerdal.com
Contents3Intended Use 4Indication for Use 4Important Information 5Items Included 6Overview 8Before Use - Insert Batteries 10Before Use - Apply Patient Adhesive 11Getting Started 12 CPRmeter 2 Placement 13Feedback Display Overview 15Compression Feedback 16 Depth 16 On Soft Surface 17 Rate 18 Compression Counter 18 Inactivity 19Debriefing 20Battery Indicator 22 Maintenance 23 After Each Use 23 Cleaning 24 Disinfection 24 Storing the CPRmeter 2 Between Use 25 Customer Service Indicator 25Specifications 26Symbol Glossary 29Regulatory Information 31
5Important Information4Intended UseThe CPRmeter 2 with Q-CPR® technology is a small, lightweight device powered by a replaceable battery. The device is intended for use by responders who have been trained in CPR and use of the CPRmeter 2.When attached to the bare chest of a suspected victim of SCA, the CPRmeter 2 provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, release, and rate of chest compressions. It also counts the number of compressions in a series, and provides notification of lack of expected CPR activity. If in doubt about the appropriateness for use, perform CPR without using the CPRmeter 2.Indication for UseThe CPRmeter 2 is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. Warning The CPRmeter 2 is not intended for use on SCA victims under 8 years old. Note CPR cannot assure survival, no matter how well it is performed. In some patients, the underlying problem causing the cardiac arrest is not survivable despite any available care.Rx Only (USA) Caution: Federal law restricts this device to sale by or on the order of a physician.
67Items Included Items Included-AAAX 2Protective SleevePatient AdhesiveAAA BatteriesCPRmeter 2
89Overview OverviewOn/OffStatus LightCompressionAreaBattery HatchDisplayAreaPlacement guidefor adhesivePlacement guidefor adhesiveMembranePor t
10 11Before Use - Insert Batteries Before Use - Apply Patient Adhesive11x 224-3132Cautions• Ensure Patient Adhesives are within their expiration date.• Adhesives should be removed from the device and disposed of after 2 years.
12 13Getting Started CPRmeter 2 Placement Note• Remove the device from its protective cover.• Ensure the patient is on a firm surface.• Remove clothing from the patient’s chest.Turn OnPlace CPRmeter 2 If needed, wipe fluids off the chest. Ensure to use the heel of your hand and apply pressure to the light grey area. Begin CPR.Provide chest compressions according to your CPR protocol.Status Light turns green for a few seconds,when CPRmeter 2 is turned on.
14 15CPRmeter 2 Placement Feedback Display OverviewCautions• If the CPRmeter 2 moves during use, re-position it to the center of the chest, as shown.• If difficulty is encountered in applying the device, do not delay initiation of CPR. Remove the device and begin compressions.• If the device's status light is orange and the CPRmeter display is dark, stop using the CPRmeter and continue CPR. Contact Laerdal for technical support after the event. Warnings• Do not use the device in conjunction with any mechanical or automated compression device.• Do not use the device on top of defibrillation pads, unless the manufacturer of the defibrillator and the defibrillation pads has explicitly stated that the device can be used in such manner.• Do not delay CPR. If you experience any problems using the device, continue CPR without it. If the device appears to be damaged, do not use. 250:23Compression Release TargetInactivity TimerCompression Depth Indicator Compression Rate IndicatorCompression Depth TargetCompression Rate TargetCompression Counter
16 17DepthReleaseOn Soft SurfaceIf the CPRmeter 2 detects a compression that exceeds 70 mm (2.75"), it will show the depth indicator below the target area. If a specific CPR event requires CPR to be performed on a patient lying on a mattress, slide a backboard under the patient and compensate for the mattress softness by ensuring that for each chest compression the area below the compression depth target lights up.WarningWhen performing CPR on a patient lying on a mattress, a backboard must be used to limit the amount of compressed depth which is absorbed by the mattress. Depending on characteristics of the mattress, backboard and patient, the depth compensation does not guarantee that the patient chest is compressed by 50 mm (2").Compression Feedback Compression FeedbackToo shallowAdequate depthAdequate releaseIncompletely release
18 19Compression Feedback Compression FeedbackRate Compression Counter When compressions are started a counter will display grey up to 25 compressions. Compression Counter19 During a cycle of 30 compressions, the counter changes to solid white between 25 and 30 compressions. Beyond 30 compressions, the counter digits flash solid white for every tenth compression.Without a compression the counter is reset after 3 seconds. Inactivity• After 3 seconds the CPRmeter 2 displays an inactivity timer which counts the seconds since the last compression. • After 20 seconds since the last compression, the inactivity timer starts flashing. • After 1 minute, the CPRmeter 2 display fades down to conserve battery power. The display is restored when a new compression is delivered.Inactivity Timer0:23Too slowAdequate rateToo fast25
20 21Debriefing DebriefingQ-CPR® Quick ReviewThe CPRmeter 2 can display CPR performance statistics for the last CPR event. When the device is turned on, press the On/Off button once to activate Q-CPR Quick Review. The statistics are shown over two displays. Press the On/Off button once to cycle to the next display.The CPRmeter 2 reverts to Compression Feedback mode if a compression is delivered.98% 70%96%24:3573%Percentage of compressions with adequate releasePercentage of compressions with adequate depthPercentage of compressions with adequate rate% of event duration where compressions have been deliveredDuration of the CPR event (minutes: seconds). Notes• The CPR event statistics are stored when the CPRmeter 2 is turned off. When turned on again, the statistics from the last stored CPR event can be reviewed. • When the CPRmeter 2 is used in a new CPR event, the Q-CPR Quick Review will display the current event’s statistics. • CPR performance statistics are only calculated if at least 10 compressions have been delivered. Wireless Data TransferThe CPRmeter 2 has Bluetooth Smart functionality for uploading complete event data to an external device, like a PC. Bluetooth can also be used to stream live CPR performance data during training. To connect a device, go to the MiniEvent Review screen by pushing the On/Off button. The status light will flash blue indicating that Bluetooth is on and available for connection. When connected to a device, the flashing blue light turns steady. The CPRmeter 2 is now ready to transfer CPR performance data. NoteEnsure Bluetooth connectivity is disabled during clinical use. 98% 70%96%
23Maintenance22Battery Indicator2222Battery MonitoringThe CPRmeter 2 continuously monitors the power of its battery. On a routine basis, particularly after periods of non-use, check the CPRmeter 2 battery status by switching on and checking if the low battery icon is displayed. If the remaining power is estimated to be less than that required for a 30 minute CPR event, the visual indicators signal that the battery should be replaced before the next use.Routine Maintenance 1. On a routine basis check the battery status (as described).2. Replace the battery at least every 2 years.3. On a routine basis, check that the CPRmeter 2 has a patient adhesive in place and that the liner remains on it. Replace the patient adhesive at least every 2 years if it is not used. A large low-battery icon appears when the CPRmeter 2 is being turned off.A small low-battery icon appears when the CPRmeter 2 is being turned on.23 Note If the remaining battery power during use becomes too low to sustain further operation, the low-battery icon is shown for 10 seconds and then the CPRmeter 2 turns itself off. WarningDo not interrupt CPR to replace the battery. Continue CPR without feedback from the CPRmeter 2.After each UseAfter use on a patient, the CPRmeter 2 may be contaminated and should be handled appropriately.1. Place the contaminated CPRmeter 2 in a plastic bag until it can be cleaned (do not insert a contaminated CPRmeter 2 into its casing).2. If it is visibly soiled, wipe the CPRmeter 2 with a soft cloth or paper towel to remove as much contamination as possible.3. Remove the Patient Adhesive from the back of the CPRmeter 2.4. Clean the CPRmeter 2 as described under Cleaning and Disinfection. Proper cleaning is required to achieve disinfection.5. Check the exterior of the CPRmeter 2 for signs of damage. Contact Laerdal to arrange for replacement if needed.6. Apply a new Patient Adhesive to the device as described in Before Use - Apply Patient Adhesive.
24 25Maintenance MaintenanceCleaningIf the CPRmeter 2 has been used in a training situation, it may be wiped using an alcohol wipe (70% ethanol solution).If the device has been used in a clinical situation, clean it as follows:1. Prepare the cleaning solution by mixing (5 ml) of mild dishwashing liquid in 4 l of warm tap water (40-50 °C)2. Submerge a small brush (e.g. toothbrush) in the cleaning solution and scrub the device for a minimum of 2 minutes.3. If the membrane port is clogged, use the brush to remove any obstruction. 4. Wipe the exterior with a soft cloth dampened in lukewarm water (22-40 °C). Disinfection1. Disinfect the exterior using a 0.55% solution of ortho-phthalaldehyde. Spray the solution on to cover all exterior surfaces, and allow to sit for a minimum of 12 minutes. An alternative disinfection agent is isopropyl alcohol (70% solution). If necessary respray to account for evaporation of isopropyl alcohol.2. Wipe the exterior with a clean soft cloth dipped in water a minimum of three times to remove all traces of disinfectant agent. Allow to dry completely. CautionDo not immerse the CPRmeter 2 in water, hold it under running water, or allow moisture to penetrate it. Do not sterilize the CPRmeter 2.Storing the CPRmeter 2 between UseStore the CPRmeter 2 in its protective cover to shield the display screen from scratches and to protect the patient adhesive from damage. Ensure that the On/Off button can not be inadvertently activated during storage.Customer Service IndicatorIf the Customer Service Indicator appears on the CPRmeter 2 at shutdown, please contact your local Laerdal representative for further instructions.
26 27Specifications Specifications26CPR TargetsCategory SpecicationCompression Depth Target > 50 mm ( 2”)Depth accuracy: ±10%Compression Release Target Force < 2.5 kg (5.5 lbs) Force accuracy: ±1.5 kg (+3.3 lbs, - 3.3 lbs)Compression Rate Target 100 to 120/min ± 3/min CPRmeter 2 [REF 801-00233]The CPRmeter 2 meets the performance requirements of IEC 60601-1, 2nd and 3rd edition. Category SpecicationDimensions 153 mm x 64 mm x 25 mm (6.0” x 2.5” x 1.0”)Weight 163 g (5.7 oz) (excluding batteries)Battery 2 x 1.5V Size AAA (LR03)Temperature Transport and Storage: -20 °C to 70 °C (-4 °F to 158 °F)Operation: 0 °C to 40 °C (32 °F to 104 °F) Sealing: Meets ISO/IEC 60529 class IP55Product temperature can reach 60 °C (140 °F)Relative Humidity Transport: 5% to 95% Storage: 5% to 75%Operation: 5% to 95%Atmospheric Pressure (Atm.p.)Transport, Storage and Operation:1014 to 572 mbar (1014 to 572 hPa)Electromagnetic CompatiblityMeets IEC 60601-1-2 and RTCA/DO-160F Section 21 Category MCPRmeter Patient Adhesives [REF 801-10850]Category SpecicationDimensions 39 mm x 90 mm (1.5” x 3.5”)Temperature Storage: -20 °C to 70 °C (-4 °F to 158 °F )Operation: 0 °C to 50 °C (32 °F to 122 °F)Relative Humidity Storage: 0% to 75%Operation: 0% to 95%Material Foam pad with biocompatible adhesive on each side.Shelf Life 2 years when applied to the CPRmeter 2 or 4 years in unopened package. Do not exceed the expiration date on the packaging.
28SpecificationsEnvironmental ConsiderationsProduct InformationCPRmeter 2 The CPRmeter 2 contains electronic components. Dispose of it at an appropriate recycling facility in accordance with local regulations.CPRmeter Patient Adhesive The used Patient Adhesive may be contaminated with body tissue, fluid, or blood. Dispose of it as infectious waste.29Symbol Glossary29Symbol DenitionThe product is in compliance with the essential requirements of Council Directive 93/42/EEC as amended by Council Directive 2007/47/EC and Council Directive 1999/5/EC.Compliance with applicable U.S. and Canadian safety standards has been certified by Canadian Standards Association. These CPRmeter 2 patient adhesives are disposable and are for single patient use only. Do not re-use. Re-use will lead to increased risk of cross contamination, and/or degradation of adhesive performance.Defibrillation protection. The CPRmeter 2 is defibrillation protected, type BF patient connection.ManufacturerDispose of in accordance with your country's requirements Reference order numberIP55 The CPRmeter meets IEC 60529 class IP55Expiration date for patient adhesivesLATEXNot made with natural rubber latexWarning/Caution symbolTemperature limitations for transport/storage of the adhesives
31Regulatory InformationA Warning identifies conditions, hazards, or unsafe practices that can result in serious personal injury or death. A Caution identifies conditions, hazards, or unsafe practices that can result in minor personal injury or damage to the CPRmeter 2. Warnings• When the CPRmeter 2 is used together with a defibrillator, make sure to follow the defibrillator manufacturer’s instructions. Stop compressions, remove hands from the CPRmeter 2 and remain clear of all patient contact during defibrillation or when otherwise required, in accordance with a proper defibrillation protocol.• The CPRmeter 2 is not intended for use in a moving environment, such as an ambulance. If used during patient transport, the device may provide inaccurate feedback. If CPR is indicated in a moving environment, do not rely on the depth feedback during such conditions. It is not necessary to remove the device from the patient. • Do not practice by using the CPRmeter 2 on a person. It may be used with a training manikin or simply on a compliant surface for practice.• Properly performed CPR may result in fracturing of the patient’s ribs.1 If rib integrity has been compromised, continue to provide CPR in accordance with your local protocol.• Properly performed CPR may result in chest injuries1 e.g. external chest wall bruising or abrasion.• Do not rely on CPRmeter 2 feedback during aircraft ascent and descent, as its accuracy is reduced in such conditions. 1 Black CJ, Busuttil A, Robertson C. Chest wall injuries following cardiopulmonary resuscitation. Resuscitation. 2004;63:339 –343. 30Symbol Glossary30= # Contains number of CPRmeter 2 patient adhesives shown as “#.”Consult Directions for UseLift here to peel off the patient adhesive liner and apply to patient’s bare chestNot for use on children under 8 years oldAustralian RCM markBluetooth symbolFederal law restricts this device to sale by or on the order of a physicianKC symbol (for Korea)
32 33Regulatory Information Regulatory Information Cautions • Do not apply the CPRmeter 2 to an open wound or recent incision site.• The device is designed to be used only with Laerdal-approved accessories and may perform improperly if non-approved accessories are used. Do not attempt to modify the device in any way.• Use only model 801-10850 Patient Adhesives with the CPRmeter 2. NoteChanges or modifications not expressly approved by Laerdal Medical could void the user’s authority to operate the equipment. RecommendationResponders should receive training, including regular refresher training, in use of the CPRmeter 2. When training with the device on a CPR manikin, disable or ignore feedback from the manikin. WEEEThis appliance is marked according to the European directive 2012/19/EU 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 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 the Laerdal representative where you purchased the product.FCC Federal Communications Commission Statement and Industry Canada StatementsThis device complies with part 15 of the FCC rules and RSS-210 of the Industry Canada rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and2. this device must accept any interference received, including interference that may cause undesired operation.Ce dispositif est conforme à la norme CNR-210 d’Industrie Canada applicable aux appareils radio exempts de licence. Son fonctionnement est sujet aux deux conditions suivantes: 1. Le dispositif ne doit pas produire de brouillage préjudiciable, et2. ce dispositif doit accepter tout brouillage reçu, y compris un brouillage susceptible de provoquer un fonctionnement indésirable.This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:• Reorient or relocate the receiving antenna.• Increase the separation between the equipment and receiver.• Consult the dealer or an experienced radio/TV technician for help.FCC ID: QHQ-801002IC ID: 20263-801002The term ”IC” before the equipment certification number only signifies that the Industry Canada technical specifications were met.
34 35Regulatory Information Regulatory InformationElectromagnetic Conformity Guidance and manufacturer’s declaration: The CPRmeter 2 is intended for use in the electromagnetic environment specified in the tables below. The user of the CPRmeter 2 should assure that it is used in such an environment.Electromagnetic EmissionsEmissions Test Compliance Electromagnetic Environment Guidance RF CISPR 11 Group 1 Class The CPRmeter 2 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.The CPRmeter 2 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Electromagnetic ImmunityImmunity Test IEC 60601Test LevelCompliance LevelElectromagneticEnvironment - GuidanceElectrostaticDischarge(ESD)IEC 61000-4-2±6 kV contact±8 kV air±6 kV contact±8 kV airThere are no specialrequirements with respect to electrostatic discharge.PowerFrequency(50/60/400 Hz)Magnetic FieldIEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial/hospital environment.There are no specialrequirements for non-commercial/non-hospitalenvironments.Radiated RFIEC 61000-4-310 V/m80 MHz to2.5 GHz10 V/m Portable and mobile RF communications equipment should be used no closer to any part of the CPRmeter 2, than is absolutely necessary. †,‡ The recommended separation distances for various transmitters and the CPRmeter 2 are shown in the following table. Interference mayoccur in the vicinity of equipment marked with the following symbol:
36 37Regulatory Information Regulatory Information† The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,660 MHz to 40,700 MHz.‡ Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CPRmeter 2 is used exceeds the applicable RF compliance level above, the CPRmeter 2 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the CPRmeter 2.Recommended separation distances between portable and mobile RF communications equipment and the CPRmeter 2The CPRmeter 2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CPRmeter 2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CPRmeter 2 as recommended below, according to the maximum output power of the communications equipment.Electromagnetic EmissionsRated maximum output power of transmitter [W]Separation distance according to frequency of transmitter [m]150 kHz to 80 MHz80 MHz to 800 MHzd=1.2√P800 MHz to 2.5 GHzd=2.3√P0.01 NA 0.12 0.230.1 NA 0.38 0.73 0,72?1 NA 1.2 2.310 NA 3.8 7.3 7,28?100 NA 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2. The ISM (industrial, scientific and medial) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13, 567 MHz; 26,957 MHz to 27,283 MHz; and 40,660 MHz to 40,700 MHz.NOTE 3. An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.NOTE 4. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and peopleNOTE 5. Transmitters/antennas of this power-level are most likely mounted on an emergency vehicle chassis. The distances cited here are for open field. For an external antenna, the separation distance is most likely shorter.
38WarrantyThe Laerdal CPRmeter 2 has a one-year limited Warranty. Refer to the Laerdal Global Warranty for terms and conditions.About this editionThe information in this applies to the model 801-00233 CPRmeter 2. This information is subject to change. The CPRmeter™ with Q-CPR® is protected by U.S. and International registered patents.The design of CPRmeter™ and its feedback symbols are protected in several jurisdictions under international design registrations.CPRmeter™ and Q-CPR® are trademarks or registered trademark of Laerdal Medical AS.
20-09504 Rev ALaerdal® is a registered trademark of Laerdal Medical AS.© 2015 Laerdal Medical AS. All rights reserved. P.O. Box 377Tanke Svilandsgate 30, 4002 Stavanger, Norway T: (+47) 51511700 Printed in Norway.www.laerdal.com

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