CapnoTrue User Manual Ver EN 3.1 Released March 2010

CapnoTrue® User Manual Version: EN 3.1 Released: 03/2010 The information in this document is subject to change without notice. Copyright © 2010 bluepoint MEDICAL GmbH & Co. KG. All Rights Reserved. This document contains proprietary information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced or translated to another language without prior written consent of bluepoint MEDICAL GmbH & Co. KG. Contact information bluepoint MEDICAL GmbH & Co. KG An der Trave 15 23923 Selmsdorf Germany Phone: +49 (38823) 548 8000 Fax: +49 (38823) 548 8029 E-mail: [email protected] www.bluepoint-medical.com

CapnoTrue®AMP and CapnoTrue®ASP User Manual | bluepoint MEDICAL GmbH & Co. KG 2010

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Declaration of Conformity 0482 This product meets the requirements of the 93/42/ EWG guidelines for medical products. Liability bluepoint MEDICAL GmbH & Co. KG shall in no event be liable for any direct, indirect, special or consequential damages including without limitation damages for loss of business profits, loss of income, business interruption, loss of business information, loss of use or other related exposures, however caused, arising from the faulty or incorrect use of the product.

or altered or modified or used without following the instructions in the user manual, will void this guarantee. Patents PHASEIN AB holds the following patents regarding products described in this manual: SE519766; SE519779; SE523461; SE524086. Other patents pending Trademarks bluepoint MEDICAL GmbH & Co. KG owns the following registered trademarks: CapnoTrue®, SoftFlap®, SoftCap® and SoftWrap®. PHASEIN IRMA™, PHASEIN XTP™, ISA™ and LEGI™ are trademarks of PHASEIN AB.

Bluepoint MEDICAL GmbH & Co. KG guarantees that the product delivered has been thoroughly tested to ensure that it meets its published specifications. Warranty bluepoint MEDICAL GmbH & Co. KG warrants the products manufactured or distributed by them to be free from faulty materials and workmanship for a period of 24 months from date of original shipment to first end user except for disposable products or products which have a stated guarantee longer or shorter than 24 months. bluepoint MEDICAL GmbH & Co. KG will perform warranty service at its factory. The obligations for bluepoint MEDICAL GmbH & Co. KG under this guarantee shall be limited to repair, or at bluepoint MEDICAL GmbH & Co. KG's discretion, replacement of necessary parts or assemblies and shall not include shipping costs or other incidental damages. Claims for damages during shipment must be filed promptly with the transportation company. All correspondence concerning the products must specify both the name of the product and its serial number as written on the label on the product. Use of the equipment for other than its intended use, or if it has been repaired by anyone except bluepoint MEDICAL GmbH & Co. KG or a bluepoint MEDICAL GmbH & Co. KG authorized service centre, CapnoTrue®AMP and CapnoTrue®ASP User Manual | bluepoint MEDICAL GmbH & Co. KG 2010

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Table of Contents 1 1.1 1.2 1.3 1.4 1.5 1.6

Introduction Intended Use Warnings Cautions Symbol Description Terms and Definitions User Requirements

6 6 6 9 10 10 11

2 2.1 2.2

Theory of operation CO2 measurement SpO2 measurement

12 12 13

3 3.1 3.2 3.2.1 3.2.2 3.3 3.3.1 3.3.2 3.4

Product overview 13 Available models 13 Mainstream Capnography Accessories 14 IRMA CO2 analyzer 14 IRMA airway adapter 14 Sidestream Capnography Accessories 15 Nomo Adapter 15 Sidestream sampling line, airway adapter and other patient interfaces 16 SpO2 Sensors 16

4 4.1 4.2

Exterior View, Controls and Connectors 17 Mainstream Capnograph/Pulse Oximeter - CapnoTrue®AMP 17 Sidestream Capnograph/Pulse Oximeter - CapnoTrue®ASP 18

5 5.1 5.1.1 5.1.2 5.2 5.2.1 5.2.2 5.2.3 5.3 5.4 5.5 5.5.1 5.5.2

Preparation for Use Selecting Power Supply Power Supply Rechargeable Li-ion Battery or AA Alkaline Batteries Connecting Sensors/Sampling Line Configurations to the CapnoTrue® IRMA™ CO2 Analyzer (mainstream) Nomo technology sampling line configuration (sidestream) SpO2 Sensor Visual Check Switching on the Device Connecting Sensors/Sampling Line Configurations to the Patient IRMA™ CO2 Analyzer (mainstream) Nomo Technology sampling line configuration (sidestream)

19 19 19 19 20 20 20 21 21 21 21 21 22

5.5.3 5.6 5.7

SpO2 Sensor Commencing Monitoring Switching off the Device

22 23 23

6 6.1 6.2 6.3

Display Modes and Displayed Data Toggling Between Display Modes Symbols and Indicators Pulse Tone

24 24 25 25

7 7.1 7.2 7.3 7.4 7.5 7.6

Alarms Alarm Priority and Appearance Audible Alarm Volume Default Alarm Limits Limit Alarm Alarm Messages Resetting of Alarm Signals

26 26 26 26 27 27 28

8 Menu Structure 8.1 Main Menu 8.1.1 Submenu: Alarm Settings 8.1.2 Submenu: Data Management 8.1.2.1 Recording Data 8.1.2.2 Data Management 8.1.3 Submenu: Setup 8.1.3.1 General Information 8.1.3.2 Parameters 8.1.4 Submenu: Patient ID 8.1.5 Default Start Settings 8.2 Other 8.2.1 Volume Control Shortcut 8.2.2 Brightness Control Shortcut 8.2.3 Power-Save Mode

28 28 28 29 29 29 30 30 31 34 34 34 34 34 34

9 9.1 9.1.1 9.1.2 9.2

Adverse affects on performance CO2 measurements Humidity or Condensation Interfering gases or vapours SpO2 Measurement

34 34 34 35 35

10 10.1 10.2 10.3 10.4

Troubleshooting guide 36 Error Message – Cause – Corrective Action 36 Failure – Cause – Corrective Action 37 IRMA™ LED Status and LEGI™ Status 38 Problems with EMI (Electromagnetic Interference) 38

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11 Maintenance 11.1 Maintenance 11.2 Cleaning 11.3 Testing 11.4 Zeroing the Capnograph 11.4.1 Mainstream CapnoTrue®AMP 11.4.2 Sidestream CapnoTrue®ASP

38 38 38 39 39 39 39

12

CapnoTrue® PC-Software

40

13

Technical Specifications

41

14 14.1 14.2 14.3 14.4

Component Lists and Ordering Packing List Order Number Accessories Replacement Parts

43 43 44 44 45

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1 Introduction 1.1 Intended Use The CapnoTrue® CO2 /SpO2 Monitor is intended to provide continuous monitoring of end-tidal CO2 concentration (EtCO2), inspired CO2 concentration (FiCO2), functional arterial oxygen saturation (SpO2), respiration rate (RR) and pulse rate (PR) of adult, paediatric infant and neonatal patients. The CO2 measurement can be performed either with the mainstream method using the CapnoTrue®AMP or with the sidestream method using the CapnoTrue®ASP. It may be used in hospital, hospital type facilities, operating suites, intensive care units, emergency medicine/emergency transport as well as in the home care environment. The CapnoTrue® CO2 /SpO2 Monitor is not intended to be used as the only means of monitoring a patient. It shall always be used in combination with other vital sign monitoring devices and/or professional human judgments of a patient’s condition. The CapnoTrue® is intended to be used by trained and authorized health care professionals only. 1.2 Warnings Adhere to the following warnings for safe operation of the CapnoTrue®AMP mainstream CO2 /SpO2 Monitor and the CapnoTrue®ASP sidestream CO2 /SpO2 Monitor. For CapnoTrue® in General: Warning: The monitor is to be operated only by trained personnel and is for attended monitoring only. Warning: Do not make any clinical judgments based solely on the CapnoTrue®. The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. The interpretation of the measurement values should be done only by trained health care professionals. Warning: The monitor should only be used for the purpose and in the manner described in this manual. Warning: Explosion hazard. Do not use the monitor in the presence of flammable anaesthetic mixtures with air, oxygen, or nitrous oxide.

Warning: Routinely monitor the patient to make sure that the CapnoTrue® is functioning correctly and the SpO2 sensor, the mainstream IRMA™ CO2 analyzer and the CO2 sidestream sampling configuration are correctly placed. Warning: Do not place the monitor in any position that might cause it to fall on to the patient. Warning: Certain environmental and physiological conditions, medical procedures, sensor application errors and external agents may interfere with the monitor‘s ability to detect and display accurate measurements. (Chapter 9 provides information on possible interferences) Warning: For the SpO2 measurement, the monitor uses red and infrared light with specific fixed wavelengths. Consider that these wavelengths might influence diagnostic parameters of other optical applications. The specifications of the wavelengths used are listed in the ‘Instructions for Use’ of the specific sensor. Warning: The monitor detects respiratory effort via changes in CO2 concentration of exhaled air; therefore, the CO2 measurement can be used to detect apnoea. The device however is unable to discriminate between a patient not breathing and a sensor that is disconnected from the patient circuit. Always monitor and set alarms for SpO2 when using the CapnoTrue® to monitor respiratory function. Warning: If you are uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate means; then make sure the monitor is functioning correctly. Warning: The use of accessories, sensors, and cables other than those specified may result in increased electromagnetic emission and/or create invalid readings of the monitor. Warning: In high ambient light conditions it is required to shield the SpO2 sensor application site with opaque material. Too much ambient light may result in inaccurate measurements. Warning: Check all alarm settings and auditory alarm before use of the monitor. Warning: Do not silence the audible alarm function, or decrease the audible alarm volume if patient safety could be compromised.

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Warning: No modifications of the monitor are allowed without authorization of the manufacturer.

Additional warnings regarding the mainstream device - CapnoTrue®AMP:

Warning: Measurements can be affected by mobile and RF communications equipment. Make sure that the monitor is used in the electromagnetic environment specified in this manual .

Warning: Disposable IRMA™ airway adapters shall not be reused. Used airway adapters shall be disposed of in accordance with local regulations for medical waste.

Warning: Disconnect the monitor and probes from the patient during computed tomography (CT).

Warning: Do not use the IRMA™ airway adapter (adult/paediatric) with infants as the adapter adds 6ml dead space to the patient circuit.

Warning: Disconnect the monitor and probes from the patient during magnetic resonance imaging (MRI) scanning. An induced current could potentially cause burns. Additional warnings regarding the power supply system: To prevent the possibility of the Li-ion battery CT-2500 from leaking, heating or explosion, observe the following precautions.

Warning: Do not use the IRMA™ airway adapter (infant) with adults or paediatric as this may cause excessive flow resistance. Warning: Do not place the IRMA™ airway adapter between the endotracheal tube and an elbow as this may allow patient secretions to block the adapter windows and result in incorrect operation.

Warning: Do not immerse the battery in water or seawater. Store it in a cool and dry environment if not used. Warning: Do not discard, store or use the battery near a heat source (e.g. a fire or heater). Warning: Only charge the Li-ion battery CT-2500 while inserted in the CapnoTrue® monitor using the provided power supply FW 7660M/06. Warning: Do not connect the positive and negative terminal with metal objects such as wire and do not transport or store the battery together with metal objects such as necklaces or hairpins as this may short-circuit the battery. Warning: Do not strike, throw or trample the battery or pierce it with a nail or other sharp object. Warning: Only use the Li-ion battery Model No. CT-2500 provided with the monitor. Contact the manufacturer for replacements. Warning: Only use the power supply Model No. FW 7660M/06 provided with the monitor. The use of a power supply other than this may result in hazardous situation and effect patient’s safety. Warning: Do not use rechargeable AA sized batteries instead of alkaline AA sized batteries to operate the device, as this may affect the function of the device.

Warning: To keep secretions and moisture from pooling on the windows, always position the IRMA™ CO2 analyzer in a vertical position.

Warning: Do not use the IRMA™ CO2 analyzer with metered dose inhalers or nebulised medication as this may affect the light transmission of the airway adapter windows. Warning: A successful zeroing requires the presence of ambient air (21% O2 and 0% CO2) in the IRMA™ airway adapter during zeroing. Incorrect zeroing of the IRMA™ CO2 analyzer will result in false gas readings. Warning: Replace the IRMA™ airway adapter if condensation occurs inside the adapter.

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Additional warnings regarding the sidestream device – CapnoTrue®ASP: Warning: Do not use the CapnoTrue®ASP to analyse gasses (e.g. anaesthetics like nitrous oxide etc.) that need to be returned to the patient circuit or a scavenging system. The gas outlet of the sidestream device is not designed to return the exhaust gases to the patient circuit or a scavenging system.

Warning: The Nomo Adapter is reusable. It only needs to be replaced if occluded. Replace the Nomo Adapter if “Sampling system occlusion !” is displayed by the monitor whilst only the Nomo Adapter is connected.

Warning: Excessive positive or negative pressure in the patient circuit might cause incorrect readings and internal damage of the monitor. Warning: Carefully route the sampling line to reduce the risk of patient entanglement or strangulation. Warning: Do not lift the CapnoTrue®ASP by the sampling line as this could disconnect from the monitor, causing the monitor to fall on the patient. Warning: Do not use adult or paediatric type sampling line configurations with infants or neonates, as this may add dead space to the patient circuit. Warning: Do not use infant or neonatal type sampling line configurations with adults or children, as this may result in excessive flow resistance. Warning: Do not use the CapnoTrue®ASP with metered dose inhalers or nebulised medication as this may block the bacteria filter integrated in the Nomo Adapter. Warning: Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2  ) in the device, ensure that the CapnoTrue®ASP is placed in a well ventilated environment. Avoid breathing near the monitor before or during the zeroing procedure. Incorrect zeroing of the integrated ISA™ CO2 analyzer will result in false gas readings. Warning: Replace the blocked part of the sampling line configuration if a sampling system occlusion message is displayed by the monitor. Warning: Do not re-use the disposable sampling lines and airway adapters. Warning: Used disposable sampling lines shall be disposed of in accordance with local regulations for medical waste.

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1.3 Cautions Adhere to the following recommendations to avoid damage or malfunction of the CapnoTrue®AMP mainstream CO2 /SpO2 Monitor and CapnoTrue®ASP sidestream CO2 /SpO2 Monitor. For CapnoTrue® in General: Caution: Do not spray, pour, or spill any liquid on the monitor, its accessories, connectors, switches, or openings in the enclosure as this may damage it. Caution: Do not immerse the monitor or its accessories in liquid. Caution: Do not autoclave or steam sterilize the monitor or its accessories. Caution: Refer to the specific ‘Instructions for Use’ of the used SpO2 sensor for correct cleaning and/or sterilization. Caution: Do not apply excessive tension to any of the monitor cables. Caution: Do not operate the monitor outside the specified operating temperature environment. Caution: The monitor requires no routine calibration. A basic maintenance plan conducted by qualified service personnel is recommended. Please refer to the Service Manual for detailed information. Caution: There are no user-serviceable parts inside the CapnoTrue®. The cover should only be removed by qualified service personnel. Additional cautions regarding the power supply system: Caution: Do not use or store the Li-ion battery at very high temperature conditions e.g. strong direct sunlight or in a heated vehicle. Under these conditions the battery can overheat, causing it to burn or its performance will degenerate and its service life will be decreased.

Caution: If the Li-ion battery leaks and the electrolyte gets into the eyes, immediately rinse the eyes with clean running water and seek medical assistance to prevent injury of the eyes. Caution: If the Li-ion battery gives off an odour, generates heat, becomes discoloured or deformed, or in any way appears abnormal during use, recharging or storage, immediately remove it from the device and stop using it. Caution: If the Li-ion battery terminals are dirty, clean the terminals with a dry cloth before use, otherwise a power failure or charging failure may occur due to poor connection with the device. Caution: Discharged batteries may cause fire; tape the terminals to isolate them. Caution: Remove the batteries if the device is to be stored or not used for a longer period of time. Additional cautions regarding the mainstream device - CapnoTrue®AMP: Caution: Do not immerse the IRMA™ CO2 analyzer in liquid. Caution: The IRMA™ CO2 analyzer and the IRMA™ airway adapters are non-sterile devices. To avoid damage, do not autoclave these components. Caution: Use only PHASEIN manufactured IRMA™ airway adapters. Additional cautions regarding the sidestream device - CapnoTrue®ASP: Caution: The Nomo Adapter, the sampling lines and their patient interfaces are non-sterile devices. To avoid damage, do not autoclave these components. Caution: Use only Nomo Adapters manufactured by bluepoint MEDICAL.

Caution: Do not use the Li-ion battery in an electromagnetic environment other then specified in this manual, as this may damage the safety features of the battery and result in unforeseen danger. CapnoTrue®AMP and CapnoTrue®ASP User Manual | bluepoint MEDICAL GmbH & Co. KG 2010

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1.4 Symbol Description Accompanied with “Warning: Supplementary text.” within this document. Warnings indicate potential harmful conditions that may lead to injury or death. Accompanied with “Caution: Supplementary text.” within this document. Cautions indicate conditions that may lead to damage to or malfunction of the device.

Note

Denoted as “Note: Supplementary text.” within this document. Notes inform the user to relevant facts and conditions in connection with the device.

European Union approval (complies with 93/42/EEC Medical Device Directive) IPXY

IP Code (International Protection Rating)

1.5 Terms and Definitions BTPS

Body Temperature and Pressure Saturated

CapnoTrue®

Handheld CO2 / SpO2 monitor developed by bluepoint MEDICAL. Available as mainstream (CapnoTrue®AMP) or sidestream (CapnoTrue®ASP) version.

CO2

Carbon dioxide

EtCO2

End-tidal expired CO2 gas concentration

FiCO2

Inspired CO2 gas concentration

Hb

Deoxygenated haemoglobin

Manufacturer

HbO2

Oxygenated haemoglobin

Date of manufacture

HME

Heat Moisture Exchanger

IR

Infrared

Consult User Manual for detailed operating information. Consult accompanying documents for important safety-related information

Type BF applied part REF

Catalogue number

SN

Serial number

P/N

Part number

LOT

Batch code Use by [YYYY-MM-DD] (indicates that the device should not be put into service after the date accompanying the symbol) Temperature limitation

IRMA™

Infrared mainstream CO2 analyzer.

ISA™

Infrared sidestream CO2 analyzer

LEGI™

Light Emitting Gas Inlet: Status indicator integrated in the gas sample inlet port.

Li-ion battery

Lithium-ion rechargeable battery

MDD

Medical Device Directive

MRI

Magnetic Resonance Imaging

N/A

Not applicable. Data does not apply to the configuration.

Nomo Adapter

Adapter that is connected between the sidestream CapnoTrue®ASP and the selected sampling line. The Nomo Adapter removes water and water vapour from the sampling line and has a hydrophobic bacterial filter to reduce the potential for water intrusion and cross contamination.

Do not re-use Fragile, handle with care Do not dispose in the consumer waste. Electrical and electronic equipment shall be collected and recycled in accordance with (Directive 2002/96/EC)

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Nomo technology

Unique technology to remove water vapour and aspired or condensed water from the sidestream CO2 gas sample through a membrane-like surface into the surrounding air. (Nomo stands for “no-moisture”)

PR

Pulse rate

RF

Radio frequency

RH

Relative humidity

Rise time

RR

Sampling line config.

1.6 User Requirements The user(s) of the monitor shall have an in-depth knowledge of gas analyzing and non-invasive monitoring of functional arterial oxygen saturation.

Time required to achieve an increase from 10% to 90% of final value when step function change in concentration occurs at the sampling site. Respiration rate A sampling line configuration consists of a Nomo Adapter connected to a sampling line with an appropriate patient interface for sampling gas, e.g. a nasal cannula, respiratory mask or the Y-piece of an intubated patient.

SpO2

Functional arterial oxygen saturation

TBD

To Be Determined. Value or property not yet decided; further investigations may be necessary.

Time from a step function change in gas level at the sampling site to Total system the achievement of 90% of the final response gas reading of the capnograph. time Total system response time = Delay time + Rise time USB

Universal Serial Bus

Zeroing

Ambient gas reference measurement used to establish zero concentration level for CO2. Zeroing needs to be performed ONLY when an offset in gas measurement values is observed, or when an unspecified accuracy message is displayed.

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2 Theory of operation 2.1 CO2 measurement Principle The measurement of CO2 in gas mixtures with the CapnoTrue® is based on the fact that different gases absorb infrared light at specific wavelengths. The absorption spectra for CO2, N2O and different anaesthetic agents are shown in Figure 1. The CO2 analyzer of the CapnoTrue® uses the absorption peak at 4.2μm to determine the CO2 concentration in the gas. Two additional wavelengths beside this absorption peak are used as reference. To measure the absorption of light at these wavelengths, a broadband infrared radiation source is

Capnogram A capnogram is a graph representing the CO2 concentration in respiratory gasses plotted against time. The capnogram waveform is typically divided into 4 phases (Bhavani-Shankar & Philip, 2000). In the waveform below the inspiration (phase 0) is plotted in blue and the expiration (phase I - III) in red.

Figure 2: Normal capnogram waveform

100,0 % 90,0 % 80,0 %

N2O

Absorbtion

70,0 % 60,0 %

Agents 50,0 % 40,0 % 30,0 %

CO2

20,0 % 10,0 % 0,0 %

3,5

4,5

Figure 1: Gas absorption spectra

5,5

6,5

7,5

8,5

9,5

10,5

wavelength (µm)

used. The light transmitted from the infrared source passes through the gas sample and is then filtered using a set of narrow optical band pass filters. The individual filters are mounted in a rapidly rotating filter wheel that intersects the light path before the light reaches the infrared detector. The infrared detector detects the portion of the light that is not absorbed by the gas. The amplitude of the detector output is an inverse function of the gas concentration. Thus, at a concentration of zero, the amplitude is at its maximum.

Phase I: Baseline (FiCO2) Phase II: Positive expiration slope (alveolar gas) Phase III: Alveolar plateau (EtCO2) Phase 0: Inspiration A capnogram provides valuable information regarding the health situation of patients in respiratory distress. Measurement methods Determining the CO2 concentration of respiratory gases is done either using the mainstream method or

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the sidestream method. In both cases the measurement principle is very similar (infrared spectroscopy) the position of the sensor in the measurement setup however differs. In mainstream capnography an airway adapter is, for example, inserted between the endotracheal tube and the Y-piece of the breathing circuit. The airway adapter has an optical window over which the infrared mainstream CO2 sensor is positioned. The respiratory CO2 measurements are obtained by continuously measuring the infrared light absorption, in the gas flow, through the optical windows. For sidestream capnography a sampling line is connected to an endotracheal tube with the help of a sidestream airway adapter or directly from the nose via a nasal prong. Gas samples are continuously taken from the patient at a constant flow rate (CapnoTrue®ASP has a suction rate of 50ml/min) and transferred to the infrared CO2 sensor incorporated in the capnograph. The CO2 measurement is taken within the device and after measurement the waste gas is exhausted through the gas outlet. Typically water traps and bacteria filters are positioned between the sampling line and the device inlet to avoid damage to the device. 2.2 SpO2 measurement SpO2 measurement is performed in transmission mode. The SpO2 sensor consists of emitters which pass red and infrared light through peripheral sites such as a finger, toe or ear to a light-sensitive detector. For both wavelengths the change in absorption is continuously measured. In this way the pulsatile signal due to the arterial blood alone is extracted, excluding the offset due to absorption by venous blood, skin, bone, muscle and fat. This signal is used to determine the functional arterial oxygen saturation (SpO2) based on the fact that the amount of absorbed infrared light and red light is different for oxygenated haemoglobin (HbO2) and deoxygenated haemoglobin (Hb). The amount of red and infrared light received is compared and the percent of haemoglobin molecules bound with oxygen molecules calculated:

SPO2=

HbO2 HbO2 + Hb

These measurement values are continuously displayed as a waveform (plethysmogram) and also used to determine the pulse rate. Note that the pulse oximeter equipment is calibrated to display the functional oxygen saturation. Certain physiological conditions, medical procedures, and external agents may interfere with the monitor’s ability to detect and display accurate SpO2 measurements (see chapter 9.2 for detailed information). 3 Product overview 3.1 Available models Mainstream Capnograph/Pulse Oximeter – CapnoTrue®AMP The CapnoTrue®AMP is used together with an IRMA™ CO2 analyzer, an IRMA™ airway adapter and an application appropriate SpO2 sensor. Power is delivered via either the provided power supply, a rechargeable Li-ion battery or 4 x AA batteries. Mainstream CO2 monitoring is performed with the IRMA™ CO2 analyzer. This key technology sets new standards in CO2 mainstream measurement and provides reliable, safe and easy CO2 monitoring. Key features of CapnoTrue®AMP: • Warm-up time < 10s • Direct measurement without time delay • Small, light-weight and shock-resistant: IRMA™ CO2 analyzer weighs less than 30 g • Adult/paediatric and infant IRMA™ airway adapters available • Easy plug and measure technology • IRMA™ airway adapter with XTP™ non-condensing light transmission window • Maintenance and calibration-free technology • Wide range of high-quality SpO2 sensors available • 2 years warranty

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Sidestream Capnograph/Pulse Oximeter – CapnoTrue®ASP The CapnoTrue®ASP monitor is used together with a Nomo Adapter, a suitable sampling line configuration (e.g. sampling line, airway adapter, nasal/oral sampling) and an application appropriate SpO2 sensor. Power is delivered via either the provided power supply, a rechargeable Li-ion battery or 4 x AA batteries. Sidestream CO2 monitoring is performed with the ISA™ CO2 analyzer incorporated in the CapnoTrue®ASP. Together with the Nomo technology that removes water from the sampled gas, the ISA™ CO2 analyzer with integrated sampling pump delivers highest performance in ultra-compact format. Key features of CapnoTrue®ASP: • Warm-up time < 10s • Specially designed for all applications using low flow sampling (50 ml/min); from adults to neonates • For intubated and non-intubated patients • Nomo technology incorporated in the Nomo Adapter to remove water and water vapour from the sampling line. • Hydrophobic bacterial filter incorporated in the Nomo Adapter to reduce the potential for water intrusion and cross contamination. • Maintenance and calibration-free technology • Wide range of high-quality SpO2 sensors available • 2 years warranty 3.2 Mainstream Capnography Accessories 3.2.1 IRMA™ CO2 analyzer The IRMA™ CO2 analyzer is an ultra compact measurement device for mainstream CO2 measurement with the CapnoTrue®AMP. As all necessary calibration constants are stored within each IRMA™ CO2 analyzer, the analyzer can be replaced without the need for recalibration.

Figure 3: IRMA™ CO2 analyzer with airway adapter

To perform gas measurements, the IRMA™ CO2 analyzer requires an airway adapter. The IRMA™ CO2 analyzer connects in place on top of the IRMA™ airway adapter. This airway adapter is, for example, inserted between the endotracheal tube and the Y-piece of the breathing circuit. Respiratory CO2 measurements are obtained by continuously measuring the infrared light absorption, through optical XTP™ windows, in the gas flow through the adapter. 3.2.2 IRMA™ airway adapter The IRMA™ airway adapter is designed as a singlepatient-use disposable product and is available as: • IRMA™ airway adapter (adult/paediatric) for patients over 1 year of age or 10kg in weight. • IRMA™ airway adapter (infant) for patients up to 1 year of age or 10kg in weight. The IRMA™ airway adapter (infant) has specially designed connectors for minimizing the dead space and can be used on very small patients.

The analyzer has a rugged mechanical design providing reliable shock resistance.

XTP™ window

XTP™ window

Figure 4: IRMA™ airway adapters: Infant (left) and Adult/Paediatric (right)

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As the airway adapter is positioned directly in the airway, its performance can be affected by water vapour, patient secretions or nebulised medications that can accumulate on the adapter’s windows.

The Nomo Adapter contains an unique water separation section and a hydrophobic bacterial filter to protect the ISA™ CO2 analyzer against water intrusion and cross contamination.

The water vapour can condense on the surface of the adapter windows in the format of small discrete water droplets. This condensation can affect light absorption through the windows, thus affecting the precision of the measurement. The XTP™ windows of the IRMA™ airway adapter therefore have special features that prevent a decrease in performance when vapour is present. Using the latest advances in material technology they are designed to provide a window minimizing the impact of water vapour on light transmission. For optimal results, the airway adapter shall not be placed between an endotracheal tube and an elbow, as this may allow patients secretions to block the adapter window. 3.3 Sidestream Capnography Accessories Sidestream CO2 measurement is performed by continuously removing a gas sample at a flow of 50ml/min from the respiratory circuit and analyzing it within the sidestream ISA™ CO2 analyzer incorporated in the CapnoTrue®ASP. To transport the gas sample from the patient to the device, a sampling line configuration is required. A sampling line configuration consists of a Nomo Adapter connected to a sampling line with an appropriate patient interface for sampling gas, e.g. a nasal cannula, respiratory mask or the Y-piece of an intubated patient. 3.3.1 Nomo Adapter The gas sample coming from the sampling line is fed through the Nomo Adapter to the CapnoTrue®ASP. The Nomo Adapter is specifically designed for 50ml/ min low sampling flow applications. It has a very low dead space that results in an ultra-fast rise time, making CO2 measurement possible, even at high respiratory rates. The CapnoTrue®ASP application therefore ranges from neonates to adults.

Figure 5: Nomo Adapter

No condensing water: Because of condensing water within the connected sampling line, droplets can potentially result in occlusion of the sampling system and interfere with the CO2 measurement. To prevent this situation the Nomo Adapter incorporates a unique water separation section, the NOMO section. This section is made of a special polymer and a hydrophobic bacteria filter and removes water vapour and aspired or condensed water. Water and water vapour passes through the membrane-like surface of the sampling line and evaporates into the surrounding air, while leaving CO2 unaffected. Bacterial filter: To protect the sidestream ISA™ CO2 analyzer against cross contamination, the Nomo Adapter includes a filter with bacterial filter efficiency of ≥99.9980%. It is important to be aware that secretion and nebulised medication may be absorbed by the surface of the bacteria filter, and may block the Nomo Adapter. Replacement of Nomo Adapter: The Nomo Adapter is reusable as the Nomo technology allows up to two weeks of continuous monitoring with high moisture containing breathing gases. Warning: The Nomo Adapter is reusable. It only needs to be replaced if occluded. Replace the Nomo Adapter if “Sampling system occlusion !” is displayed by the CapnoTrue®ASP whilst only the Nomo Adapter is connected.

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3.3.2 Sidestream sampling line, airway adapter and other patient interfaces Sampling with intubated patient Sampling with intubated patients is typically performed with an appropriate sidestream airway adapter connected to the Nomo Adapter with a disposable sampling line. The sidestream airway adapter is designed as a single-patient-use disposable product and is available in different sizes ranging from adults through to neonates.

Sampling with non-intubated patient Sampling with non-intubated patients is typically performed with a nasal or oral sampling configuration. This sampling assembly is directly connected to the nose or mouth with a cannula. For further instructions, warnings and precautions refer to the ‘Instructions for Use’ provided with the selected sampling system assembly. Note: Our sampling line configurations are continuously updated; please contact bluepoint MEDICAL for detailed information. Specific patient sampling line configurations and interfaces are available upon request. 3.4 SpO2 Sensors Bluepoint MEDICAL supplies a large variety of disposable and reusable SpO2 sensors for use with the CapnoTrue®.

1

Depending on the sensor type and model, their application ranges from adults to neonates, providing application specific features and design. The SoftCap® Sensor is typically used for adult applications and the SoftWrap® Sensor for infant and neonatal applications (see figure 7). Other sensors are available upon request.

2

Figure 7: SpO2 sensor SoftCap® (left) and SoftWrap® (right)

3 Figure 6: Typical sampling line assembly for intubated patients: 1. Disposable sampling line, 2. Sidestream airway adapter (adult/paediatric), 3. Sidestream airway adapter (infant/neonatal)

All sensors operate in transmission mode. The light source emits red and infrared light with wavelengths of 660nm and 905nm respectively at a typical radiant power of 3.5mW. The SpO2 sensor is applied to peripheral areas of the body such as finger tips and toes for adults, and paediatrics, and the foot or palms for infants and neonates.

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4 Exterior View, Controls and Connectors 4.1 Mainstream Capnograph/Pulse Oximeter - CapnoTrue®AMP

Capno True AMP

42

EtCO2 mmHg

40 20 0

45 38

FiCO2 mmHg

17:35

07 10 /min

15

99 120

SpO2 %

99

30

7

03

/min

140

85

45

8

9

1 2

4

5 6

3

Top View

1

Front view

No.

Symbol

Side view

Rear view is the same as for CapnoTrue®ASP but without gas outlet (see Chapter 4.2)

Feature/Button

Function

1

Arrow buttons (up/down)

Multifunction buttons used for: 1. Scrolling through menu items 2. Increasing/decreasing parameters 3. Shortcuts to volume/brightness control during monitoring

2

Display mode

Toggles between various display modes. Shortcut to return to display mode during menu mode.

3

Alarm silenced/reset

1. The audible alarm can be silenced for a maximum period of two minutes. Optical alarm remains activated. 2. To reset alarms press and hold the button for approx. 3 seconds.

4

Menu

Menu selection. Shortcut to return to the previous menu level during menu mode.

5

On/Off and ENTER button

1. To turn on the device: press and hold the button briefly. 2. To turn off the device: press and hold the button for approx. 3 seconds. 3. To confirms selection at the device: press and hold the button briefly while the device is switched on.

6

Pulse tone

Turns pulse tone on/off

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7

USB

USB 2.0 interface

8

SpO2 Sensor port

Port to connect the SpO2 sensor

9

CO2 Mainstream port

Port to connect the IRMA™ CO2 analyzer

4.2 Sidestream Capnograph/Pulse Oximeter - CapnoTrue®ASP

11

10

12

13

Top View

Front and side views are the same as for CapnoTrue®AMP (see Chapter 4.1)

Rear view

No.

Symbol

Feature/Button

Function

10

Power input

Port to connect the external power supply (100-240V AC / 50-60Hz, Model No. FW 7660M/06)

11

Gas outlet port

Gas outlet of the sidestream module (not applicable for mainstream)

12

SpO2 sensor port

Port to connect the SpO2 sensor

13

CO2 Sidestream gas inlet port

Port with Light Emitting Gas Inlet (LEGI™) to connect the Nomo Adapter

CapnoTrue®AMP and CapnoTrue®ASP User Manual | bluepoint MEDICAL GmbH & Co. KG 2010

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5 Preparation for Use 5.1 Selecting Power Supply

5.1.2 Rechargeable Li-ion Battery or AA Alkaline Batteries

Power is supplied to the monitor either via external power supply, rechargeable Li-ion battery, or 4 x AA alkaline batteries.

For convenient monitoring in emergency medicine or during patient transport the monitor can be powered by the rechargeable Li-ion battery (3.7 V / 2500 mAh, Model No. CT-2500) or with 4 x AA alkaline batteries.

5.1.1 Power Supply The external power supply (100-240V AC / 50-60Hz, Model No. FW 7660M/06) is used for continuous operation of the monitor and to charge the Li-ion battery. Connecting the power supply (see figure 8): 1. To operate by mains, connect the power supply cable into the power input socket located at the back of the device. 2. Ensure that the correct power supply plug is connected to the power supply. It can be exchanged by pressing the release button (2.1) on the power supply. As standard the device is supplied with a European and United Kingdom plug. Additional plugs are available upon request. 3. Connect the power supply to an AC outlet.

3.

When the device is connected to an AC outlet the Liion battery will begin recharging. This is represented by the three segments of the battery level indicator illuminating in sequence. When the Li-ion battery is completely recharged the three segments of the battery level indicator will be displayed fully. Note: The charging function is not available at the battery contacts of the 4 x AA alkaline batteries. Battery Installation (see figure 9): 1. Slide down the cover of the battery compartment on the rear panel of the device. 2. Insert four alkaline batteries (1.5V, AA), ensuring the correct orientation in accordance with the polarity markings. 3. Alternatively, insert the rechargeable Li-ion battery (Model No. CT-2500), orientated according to the guiding grooves. 4. Slide the battery-compartment cover back into its initial position to close. 2.

2. 2.1

3.

1.

1./4.

Figure 8: Connect the power supply

Warning: Only use the power supply Model No. FW 7660M/06 provided with the monitor. The use of a power supply other than this may result in hazardous situation and effect patient’s safety.

Figure 9: Insert a Li-ion battery or 4 x AA alkali batteries

Warning: Only charge the Li-ion battery CT-2500 while inserted in the CapnoTrue® monitor using the provided power supply FW 7660M/06.

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Caution: Do not dispose the Li-ion battery or the alkaline batteries in the consumer waste, if they are empty or can no longer be recharged. Batteries may contain substances which are harmful to the environment and to the health. Please dispose the batteries at the available battery collecting sites or the recycling yards of the municipalities. Please only dispose discharged batteries into the designated containers. Tape the terminals of the Li-ion batteries at the poles before disposing. Caution: Remove the batteries if the device is to be stored or not used for a longer period of time. 5.2

Connecting Sensors / Sampling Line Configurations to the CapnoTrue® 5.2.1 IRMA™ CO2 Analyzer (mainstream)

5.2.2 Nomo technology sampling line configuration (sidestream) For CO2 sidestream capnography with the CapnoTrue®ASP inspect the Nomo Adapter and the selected sampling line assembly for any external damage. a) Insert the Nomo Adapter head into the CO2 sidestream inlet port (LEGI™) located on the top edge of the CapnoTrue®ASP. b) Now connect the selected sampling line assembly to the female Luer Lock connection at the Nomo Adapter. A typical sampling line assembly for intubated patients consists of a sampling line and a sidestream airway adapter. For non-intubated patients, a sampling line configuration with nasal and/or oral sampling is typical.

For CO2 mainstream capnography with CapnoTrue®AMP inspect the IRMA™ CO2 analyzer and connector cables for any external damage. 1.

Insert the connector of the IRMA™ CO2 analyzer into the CO2 Mainstream port located on the top edge of CapnoTrue®AMP. Secure the IRMA™ CO2 analyzer on top of the IRMA™ airway adapter. It will click into place when correctly seated.

2.

3.

1. Reusable Nomo Adapter 2. Disposable sampling line 3. Sidestream airway adapter

Figure 10: Nomo Adapter with sampling line configuration for intubated patients

Warning: Do not use the IRMA™ airway adapter (adult/paediatric) with infants as the adapter adds 6ml dead space to the patient circuit. Warning: Do not use the IRMA™ airway adapter (infant) with adults or paediatric as this may cause excessive flow resistance. Caution: Use only PHASEIN manufactured IRMA™ airway adapters.

Warning: The Nomo Adapter is reusable. It only needs to be replaced if occluded. Replace the Nomo Adapter if “Sampling system occlusion !” is displayed by the CapnoTrue®ASP whilst only the Nomo Adapter is connected. Warning: Do not re-use disposable sampling lines and airway adapters. Warning: Used disposable sampling lines and airway adapters shall be disposed of in accordance with local regulations for medical waste. Caution: Use only Nomo Adapters manufactured by bluepoint MEDICAL.

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