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Portable Bedside Capnograph/Pulse Oximeter

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1. Battery Pack and AC Operation 1 Connect only Microstream EtCO consumables to the monitor 2 Battery pack operation First switch the monitor on and check that the battery pack is charged in Measuring mode Portable Bedside Capnograph 25 Initial Setup check that the battery icon on the right side of the graphic display is full AC operation Connect the AC adapter to the monitor and plug the cord into the mains power supply Switch the monitor on Check that the battery icon displays a filling pattern or the plug icon appears Refer to Figure 4 Quick Guide for all button functions 3 Adjust the parameters in the Alarm Limits menu Instrument Setup menu and Alarm Silence menu to the values appropriate to the patient s condition Quick Guide The Quick Guide adhesive label is included in the monitor packaging Apply the label to the monitor as shown in Figure 4 Quick Guide on page 18 Quick Guide PowerOn Short Press Long Press Changes Displays Accesses Selects Parameters Menus e CO2Waveform Pump Off Other Modes Home Erase Trend Changes Values Contrast Quick Scroll Accesses Silence Menu Data Transfer ON OFF Figure 4 Quick Guide 26 Portable Bedside Capnograph Chapter 5 Consumables MICROSTREAM EtCO2 Consumables MICROSTREAM EtCO Consumables e FilterLine Set e FilterLine H Set e Smart CapnoLine and Smart CapnoLine Plus available with Oz delivery e CapnoLine H e
2. The Pump Off adhesive label is included in the monitor packaging Adhere the label to the monitor as shown in Figure 1 Monitor Front and Side View on page 17 Pump Off On Figure 8 Pump Off On Label 46 Portable Bedside Capnograph Chapter 7 Communication Interface Communication Interface Communication Interface The monitor can integrate data to the following devices e Communication Adapter e Printer Seiko DPU 414 e PC e Digital to Analog Converter e Nurse Call systems using the Nurse Call Interface Kit e Patient monitoring systems Philips and SpaceLabs systems only available for Microcap devices with software versions of 3 15 and up Note The monitor interfaces to the PC or Printer with the Communication Adapter Kit For interface directions to the different devices refer to the Directions for Use of the appropriate devices and or the Communication Interface Manual WARNING When connecting the monitor to another instrument verify its proper operation before clinical use Refer to the other device s manual for full instructions For further questions contact your local representative WARNING Do not connect the monitor to a printer or to a PC unless using the Communication Adapter Kit provided by the manufacturer as an optional accessory Portable Bedside Capnograph 47 Communication Interface WARNING When using the printer PC with mains line power it is recommended to
3. Operator s Manual Portable Bedside Capnograph PN 010678 A Notice Purchase of this instrument confers no express or implied license under any Oridion Medical patent to use the instrument with any accessory that is not manufactured or licensed by Oridion Medical 1987 Ltd Capnography is covered by one or more of the following United States patents 6 437 316 5 300 859 6 428 483 6 997 880 and their foreign equivalents Additional patent applications pending Oridion Microstream FilterLine Smart CapnoLine CapnoLine Smart BiteBloc NIV Line Capnostream Microcap Microcap Plus and VitalCap are trademarks or registered trademarks of Oridion Medical 1987 Ltd Exemptions Oridion s liability under this warranty does not include any transportation damage or other charges or liability for direct indirect or consequential damages or delay resulting from improper use or application of the product or the substitution upon it of parts or accessories not approved by Oridion All information in this manual is believed to be correct Oridion shall not be liable for errors contained herein with the performance or use of this manual Copyright 2006 Oridion Medical 1987 Ltd All rights reserved Table of Contents CHAPTER 1 SAFETY INFORMATION c0sesseesseeeees 7 a E E ditt dee aaah 7 SYMbOINS n aaa aat 10 CHAPTER 2 INTRODUCTION scccsssecsseseessssensesesss 11 Monitor Features 0
4. The sample line has low dead space due to its small internal diameter This provides a sharp waveform and an accurate CO reading at a high breath rate per minute The sample line is not affected by gases and anesthetic agents in the operating room environment Portable Bedside Capnograph 15 Overview FilterLine Recognition Safeguard When the FilterLine is attached to the monitor the FilterLine Recognition Safeguard FRS identifies the FilterLine and activates the monitor thus enabling measuring Airway Adapter The airway adapter design provides multiple channels for the sampled air from the airway minimizing the possibility of water infiltration or line blockage These multiple channels allow uninterrupted monitoring for all adapter orientations and in all applications The airway adapter provides optimal performance in all directions and is seldom disabled by secretions or liquids Portable Bedside Capnograph Displays Controls and Connectors Displays Controls and Connectors Figure 1 Monitor Front and Side View The numbered labels in Figure 1 Monitor Front and Side View are described below 1 On Off Switch 9 Port for AC Adapter or 2 Alarm Bar communication adapters 3 Deti Dipayornco 92s ae Silence Menu Button and Respiration Rate 11 Alarm Silence Indicator 12 Gas Outlet 4 Graphic Display 5 Contrast Value Change Button 13 Photo Resistor 6 Next Menu Button
5. Connect the FilterLine to the patient as described in the Directions for Use Portable Bedside Capnograph 23 Initial Setup Note When the monitor is used in stationary applications secure it with the clamp available as an optional accessory Initialization CAUTION If any monitor response does not seem appropriate do not use the monitor Instead contact your local representative CAUTION Immediately after power up confirm that all display segments and icons function 3 Turn on the monitor by sliding the on off switch to the on position 4 Verify that the monitor is working properly Proper working condition is verified by completing the power on Self Test described below 5 When turned on the monitor automatically performs a Self Test The Microstream HAR display and alarm functions are tested Figure 3 Initialization Screen activating the LCD alarm bar seven segment displays alarm silence indicator and buzzer In this mode all alarms are disabled The initialization screen displays for 5 seconds refer to Figure 3 Initialization Screen at right During Self Test the EtCO and Respiration Rate LEDs show dashes When the monitor is ready and the FilterLine is connected the dashes in the EtCO and Respiration Rate LEDs are replaced by numeric values If the FilterLine circuit is not connected to the monitor dashes will appear on the LEDs 24 Portable Bedside Capnograph Measur
6. 1 IEC 60601 1 sub clause 44 3 as modified by ISO 9919 clause 44 6 IEC 60601 1 sub clause 44 5 IEC 60601 1 sub clause 44 7 IEC 60601 1 sub clause 48 IEC 60601 1 sub clause 59 2 b IEC 60601 1 sub clause 6 1 6 3 and 6 4 ISO 9919 clause 6 Portable Bedside Capnograph 65 Specifications item Compliant With 66 Front panel and case labeling Button spacing Year of manufacture symbol Conductive coating and polymeric materials Operation during physical shock Operation during vibration Electromagnetic compatibility Radiated and conducted emissions Harmonic emissions Voltage fluctuations flicker emissions Electrostatic discharge immunity Radiated radio frequency electromagnetic field immunity Electrical fast transient burst immunity Surge immunity IEC 60878 EN 980 ISO 7000 EN 60417 1 EN 60417 2 ISO 7250 EN 980 UL 60601 1 clause 55 IEC 60068 2 27 at 100 g IEC 60068 2 6 and IEC 60068 2 34 IEC 60601 1 sub clause 36 IEC EN 60601 1 2 second edition EN 55011 Group 1 Class B IEC 61000 3 2 IEC 61000 3 3 EN 61000 4 2 level 3 table top equipment IEC 61000 4 3 at 3 V m IEC 610004 4 4 IEC 61000 4 5 Portable Bedside Capnograph Manufacturer s Declaration item Compliant With Conducted EMI susceptibility Power frequency magnetic fields Laser Safety Operation with line voltage variations IEC 61000 4 6 at 3 V m IEC 61000 4 8 at 3
7. 14 FilterLine Input Connector 7 Battery Pack 15 Pump Off On Adhesive Label 8 Event Home Button Portable Bedside Capnograph 17 Overview Figure 2 Monitor Rear View The numbered labels in Figure 2 Monitor Rear View are described below 1 Clamp Connector 3 Serial Number Label 2 Space for Quick Guide 4 Battery Pack Release Adhesive Label Button 5 Battery Pack 18 Portable Bedside Capnograph Chapter 4 Initial Setup Power Requirements Unpacking and Inspection Start up and Self test Measuring Mode Quick Guide Power Requirements The monitor operates on batteries or on AC power It is equipped with a rechargeable Nickel Metal Hydride battery pack When a power outlet is available use the medical grade AC adapter provided with the monitor Before using the monitor in the field ensure that the battery pack is fully charged At the Measuring mode check that the battery icon at the right side of the graphic display is full Note If the battery is not fully charged the icon may first show as full and after a short period of time will drop to indicate the real charge level A fully charged battery pack provides between four and seven operating hours depending on power management refer to Table 6 Instrument Settings Parameters Menu 1 on page 38 for a description of the power management options WARNING Use only the medical grade AC adapter provided by the manuf
8. Instrument fault Battery pack is discharged The pump is currently off Message appears when battery charge level is low approximately 40 minutes left Contact authorized service representative Replace or recharge the battery or connect to AC power Restart pump off timer by one long press fi Prepare to replace or recharge the battery or connect to AC power xxx is the remaining time in seconds until the pump turns back on 52 Portable Bedside Capnograph Silent Advisories Alarms and Messages Silent Advisories are instrument status messages indicating the operational state of the monitor or consumables Silent advisories are low priority signals and only a message appears with no exclamation marks nor any other visual or audible indicator see Table 14 Silent Advisory Messages below Table 14 Silent Advisory Messages Pump Off Clearing FilterLine FilterLine CO2 Warm up The pump is currently off FilterLine tube twisted or clogged FilterLine is not connected to the instrument Monitor automatically performs a zero point calibration CO2 module is preparing itself for operation Activate the pump by one long press f Check the FilterLine and if necessary untwist it or replace it Connect FilterLine to input connector No action required Wait for Ready message before measuring for EtCOz No action require
9. Italian Dutch Swedish Norwegian and Portuguese Portable Bedside Capnograph 11 Introduction e Displays EtCO2 and FiCO values in mmHg kPa or Vol e Provides output for printer PC and Digital to Analog Converter e Provides interface to hospital nurse call systems 12 Portable Bedside Capnograph Chapter 3 Overview Principles of Operation FilterLine Displays Controls and Connectors The monitor incorporates Oridion s Microstream capnography technology Principles of Operation The monitor uses Microstream non dispersive infrared NDIR spectroscopy to continuously measure the amount of CO during every breath the amount of CO present at the end of exhalation EtCOz and during inhalation FiCO2 and the Respiratory Rate Infrared spectroscopy is used to measure the concentration of molecules that absorb infrared light Because the absorption is proportional to the concentration of the absorbing molecule the concentration can be determined by comparing its absorption to that of a known standard The Microstream EtCO consumables deliver a sample of the inhaled and exhaled gases from the ventilator circuit or directly from the patient via an oral nasal cannula into the monitor for CO2 measurement Moisture and patient secretions are extracted from the sample while maintaining the shape of the CO waveform The 50 ml min sampling flow rate reduces liquid and secretion accumulation decreasing the ris
10. NIV Line For a description of Microstream EtCO 2 Consumables see Microstream EtCO Consumables on page 14 CAUTION Before use carefully read the Microstreaam EtCO Consumables Directions for Use CAUTION Only use Microstream EtCO Consumables to ensure the monitor functions properly CAUTION Microstream EtCO Consumables are designed for single patient use and are not to be reprocessed Do not attempt to disinfect or flush the FilterLine as the monitor can be damaged CAUTION Dispose of Microstream EtCO Consumables according to standard operating procedures or local regulations for the disposal of contaminated medical waste Portable Bedside Capnograph 27 Consumables i i l i WARNING The FilterLine may ignite in the presence of O2 when directly exposed to laser ESU devices or high heat When performing head and neck procedures involving laser electrosurgical devices or high heat use with caution to prevent flammability of the FilterLine or surrounding surgical drapes Basic Principles When choosing Microstream EtCO consumables the following should be considered Intubated versus non intubated Whether the patient is on mechanical ventilation Duration of use Patient s size and weight For further information please contact your local representative Select the appropriate FilterLine and connect it to the monitor before attaching it to the patient s airway Be sure to follow Microstream Et
11. SCreens cceeeeeeeceeeeeeeeeeeeeteeeeeeeees 32 Table 3 Factory Default Alarm Range Values 35 Table 4 Alarm Limits 35 Table 5 Alarm Silence Standby ccccesteseeeeeeees 37 Table 6 Instrument Settings Parameters Menu 1 38 Table 7 Instrument Settings Parameters Menu 2 40 Table 8 Changing Instrument Settings Menu 1 41 Table 9 Changing Instrument Settings Menu 2 42 Table 10 Institutional SettingS c ceceeceeeeeeeeeeeeees 43 Table 11 Warning Messages 50 Table 12 Caution Messages ccceeeeeeeeeteeeeeeeeeees 51 Table 13 Advisory Messages 52 Table 14 Silent Advisory Message S cseceeereeeees 53 Table 15 Troubleshooting Guide c eeeeeeeeeeeeeees 55 Table 16 Accessing the Service Mode cccccccecees 58 Table 17 CO2 Calibration Check ccceesceeeeeeeeees 60 6 Portable Bedside Capnograph Chapter 1 Safety Information Warnings Symbols To use the portable capnograph correctly and safely carefully read this operator s manual and the Directions for Use for the Microstream EtCO consumables Use of the monitor requires full understanding and strict observance of these instructions the precautionary information in boldface type and the specifications Warnings General WARNING WARNING WARNING WARNING WARNING WARNING If
12. audible alarms including No Breath message are turned off When any alarm is disabled a single caution burst can sound once every three minutes if this option is selected through Institutional Settings refer to Institutional Settings on page 43 If an alarm condition occurs when any corresponding alarm is disabled a message is generated on the monitor display If either ALL or CO audible alarms are off and the alarm silence button is pressed the screen will remove the ALL or CO message next to the alarm icon while all alarms are silenced temporarily When the time limit for alarm silence is reached the ALL or CO message returns Alarm Silence Standby Menu Table 5 Alarm Silence Standby To access the Alarm Silence Standby C menu from any measuring display long press period V4 AN Alarm Silence To change the silence Cu short COg Alarms press Standby Alarm Silence To access any gt displayed parameters short press COz Alarms Standby Portable Bedside Capnograph 37 Basic Operation Alarm Silence 1 min To change the setting NZ S N of the selected Cu short press COs2 Alarms Standby parameter To exit and return to measuring display at fa 40 mmHg any point in the Alarm long press Silence Standby Tf after 15 seconds no action is taken the display returns to Measuring mode Alarm silence limits are from 1 2 minutes Instrument Settings Menus Instrum
13. mode the monitor reverts to the Factory default of All Alarms On Note The Alarm Limits settings are not changed do not revert to defaults when moving to and from Standby mode Pump Off Mode The Pump Off mode is a selectable function designed to prevent liquids from entering and saturating the filter During Pump Off mode pump activity is suspended to facilitate drug delivery suctioning and equipment changes while avoiding the need to replace the consumable due to blockage WARNING Ifat any time the device displays the Blockage message replace the consumable 1 From the CO Waveform screen select Pump Off mode by long pressing once Figure 6 Pump Off Note During Pump Off mode the CO parameter is dashed and the SpO function operates normally Note The time range for Pump Off is 5 30 minutes The factory default time for Pump Off mode is 15 minutes To change the factory default contact a qualified service technician 2 Exit Pump Off mode by one long press fu except during the last two minutes Portable Bedside Capnograph 45 Basic Operation 3 During the last two minutes an alarm sounds indicating there are two minutes left before the device exits Pump Off mode automatically This alarm cannot Figure 7 Pump Off Additional be disabled One long press fi Time resets Pump Off mode to the default time Another long press kal will exit the Pump Off mode Pump Off On Label
14. must periodically check the charge level of the battery pack Long term storage 6 months or more The battery pack must be stored in a cool dry area Its charge decreases over time To restore the battery pack to full power charge and discharge it three times before use Long term storage without charging the battery may degrade the battery capacity Disposal Do not dispose of the battery pack in fire it may explode Be sure to follow local governing ordinances and recycling instructions regarding disposal or recycling of batteries Portable Bedside Capnograph 21 Initial Setup Unpacking and Inspection Components Remove the monitor and the accessories from the box carefully Check that the items listed on the back cover of this manual are included Inspect each component If the package is damaged or any component is missing contact your local representative Optional Accessories The following items are available for use with the monitor e Protective Boot e Carrying Case e Clamp e Rechargeable Battery Pack e Microstream Capnograph Battery Charger e Battery Pack Carrying Pouch e 12 Volt Cable e Communication Adapter Kit e Calibration Gas Kit e Service Manual e Digital to Analog D A Converter e Seiko DPU 414 Printer e Nurse Call Interface Kit e MSM Microstream Monitor Interface Kit e Vuelink Module amp Interface Kit for use with Philips patient monitoring systems e Flexport Module amp
15. pack may not be inserted properly or missing Electrical connection is faulty or the AC wall outlet has no power The battery pack is almost discharged One of the monitor subsystems is out of order Portable Bedside Capnograph Check power cable connection and check that on off switch is on Replace or recharge the battery pack or connect to AC power Be sure the battery pack is in the monitor and inserted properly Check connections and correct problem Replace or recharge battery pack or connect to AC power If previous actions are not effective contact authorized service representative 55 Troubleshooting EtCO2 values read erratically EtCO2 values are consistently higher or lower than expected EtCO2 values are consistently higher or lower than expected 56 Mechanically No action needed ventilated patient who breathes spontaneously A leak in the airway Check for connection and line leaks to patient and correct if necessary Physiological cause Check patient Ventilator malfunction Check ventilator and patient Improper calibration Check calibration See CO2 Calibration Check on page 59 BTPS setting ON or Check BTPS setting on OFF the graphic display after Note When BTPS is Power on Contact your on the correction local service lowers the EtCOz2 representative reading to compensate for Body Temperature Pressure and
16. the monitor with the consumable used at the time of malfunction and return it with the monitor for inspection Portable Bedside Capnograph 61 Maintenance Technical assistance For technical information contact Technical Services or your local representative The Service Manual includes information that is required by qualified personnel to service the monitor 62 Portable Bedside Capnograph Specifications Physical Environmental Safety Standards Compliance Manufacturer s Declaration Performance Power Specifications Electrical Components and User Interface Physical Size 206 mm H x 88 mm W x 52 5 mm D 8 11 H x 3 46 W x 2 06 D Weight 750 grams 1 66 lb including battery pack Noise Emission Maximum 45 dB A Environmental Temperature O C to 45 C 32 F to 113 F Relative Humidity 10 to 95 noncondensing F Storage 35 C to 70 C 31 F to 158 F Portable Bedside Capnograph 63 Specifications Pressure and Altitude for operating and storage Pressure 430 mmHg to 795 mmHg Altitude 380m to 4 570m 1 250 ft to 15 000 ft Transport and Storage Parameter Value Temperature For Monitor 35 C to 70 C 31 F to 158 F not in shipping container For Microstream Accessories 20 C to 70 C 4 F to 158 F in shipping container Altitude 380m to 4 570m 1 250 ft to 15 000 ft Atmospheric Pressure 50 kPa to 106 kPa 14 7 in Hg To 31 3 in Hg Rel
17. to the patient through the Communication Adapter must be distanced from the patient environment by at least 1 5 m Electro magnetic Interference This device has been tested and found to comply with the requirements for medical devices according to the standard EN60601 1 2 2001 These standards are designed to provide reasonable protection against harmful interference in a typical medical installation However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in the healthcare environments for example cellular phones mobile two way radios or electrical appliances it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device WARNING Operating high frequency electrosurgical equipment in the vicinity of the monitor can produce interference in the monitor and give incorrect measurements WARNING Do not use the monitor with nuclear spin tomography MRT NMR NMT as the function of the machine may be disturbed Portable Bedside Capnograph 9 Safety Information Symbols The following symbols appear on the monitor and monitor LCD liquid crystal display Table 1 Symbols on the Device E AN See Directions for Use Gas Outlet i Defibrillator proof Type BF R equipment patient electrically isolated Audio Alarms Off z a a Plug Icon Batter
18. uncertain about the accuracy of any measurement check the patient s vital signs by alternate means and then make sure the monitor is functioning correctly To ensure patient safety do not place the monitor in any position that might cause it to fall on the patient Carefully route patient cabling FilterLine to reduce the possibility of patient entanglement or strangulation Do not lift the monitor by the FilterLine as it could disconnect from the monitor causing the monitor to fall on the patient To ensure accurate performance and prevent device failure do not expose the monitor to extreme moisture such as rain CO readings and respiratory rate readings can be affected by certain ambient environmental conditions and certain patient conditions Portable Bedside Capnograph 7 Safety Information WARNING The monitor is a prescription device and is to be operated by qualified healthcare personnel only MRI Scanning WARNING During MRI scanning the monitor must be placed outside the MRI suite When the monitor is used outside the MRI suite EtCO monitoring can be implemented using the FilterLine XL Refer to MRI Scanning on page 44 Alarms WARNING Do not silence the audible alarm if patient safety may be compromised WARNING Always respond immediately to a system alarm since the patient may not be monitored during certain alarm conditions WARNING Before each use verify that the alarm limits are approp
19. use a medical grade power supply complying with the following standards EN60601 1 UL 60601 1 CSA C22 2 No 601 1 M90 If the power supply is not medical grade the printer PC must be placed at least 1 5 meters from the patient environment to comply with standard EN60601 1 1 48 Portable Bedside Capnograph Chapter 8 Troubleshooting Alarms and Messages Troubleshooting Guide This section lists the alarms and messages and the corresponding actions the operator should take The Troubleshooting section discusses potential problems and suggestions for resolving them If the problem persists and the message remains contact qualified service personnel or your local representative Alarms and Messages The monitor displays the following four types of alarms and messages in order of priority e Warnings e Cautions e Advisories e Silent Advisories Alarm and Message Priorities The messages in the following tables Table 11 Warning Messages Table 12 Caution Messages Table 13 Advisory Messages Table 14 Silent Advisory Messages are listed in order of priority In the event that several problems occur simultaneously the higher priority will appear first on the display After each problem is resolved the next message is displayed in order of priority Portable Bedside Capnograph 49 Troubleshooting Warnings WARNING Always respond immediately to a system alarm since the patient may not be monitored during certain ala
20. 3 Access Instrument gt Settings menu 2 long press x2 for software versions prior to 2 7 NSA AN O English Change option to start Start Check Cal An Autozero short press gt Autozero Please Wait process bagine short press Portable Bedside Capnograph Returning the Monitor Connect the Start Cal Check calibration gas via Connect Gas Cal Check process the connecting means Check the Press the gas valve measured values for 15 seconds until shown in Vol in Connect Gas _ the readings the EtCOz digital E Cal Check stabilize display Calibration is not required if the measured value is the same as the concentration of the calibration gas 0 3 Vol of readings To return to Measuring mode if fn calibration is not long press required If calibration is required contact your local service representative Returning the Monitor If it is necessary to return the monitor for repairs call Technical Services or your local representative for shipping instructions To repack the monitor disconnect the consumable from the instrument and wrap each item separately Pack it in the original shipping carton If the original carton is unavailable use a suitable box filled with the appropriate amount of packing material It is not necessary to return the Microstream EtCO consumables or power cords If the monitor malfunctions carefully package
21. 63755 D A Converter kit 1 7 ft 0 5 m 060606 12 VAC adapter cable 2 3 ft 0 7 m not extended RF emissions CISPR 11 Class B Group 1 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emission IEC 61000 3 3 Electrostatic discharge ESD IEC 61000 4 2 Electric fast transient burst IEC 61000 4 4 Surge IE 61000 4 5 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Portable Bedside Capnograph Components and User Interface Components and User Interface Displays Graphic LCD 128 x 64 dots with LED backlight dimension display 75 mm x 53 mm Two numeric fields 3 digits each using 7 segment LED dimension 22 mm x 14 mm Controls and Indicators Front Panel On Off switch Alarm Silence Alarm Silence Menu button Contrast Value change button Event Home button Next Menu button Connections Front Panel COz Input connector Side Panel Power supply Communication Adapter port Gas outlet Portable Bedside Capnograph 75
22. A m The sensor LED light output falls within Class level according to 60825 1 2001 No special safety precautions are required IEC 61000 4 11 Manufacturer s Declaration WARNING The use of accessories and cables other than those specified may result in increased emission and or decreased immunity of the equipment and or system Performance Sampling Rate CO2 Range Accuracy EtCO2 readings 50 ml min 0 99 mmHg 0 13 2 kPa and 0 13 0 Vol at sea level a From power up until steady state is reached the CO2 reading accuracy is 0 38 mmHg 4 mmHg 39 99 mmHg 412 of reading The CO2 reading reaches its steady state accuracy 20 minutes after power up 0 38 mmHg 2 mmHg 39 99 mmHg 5 of reading 0 08 for every 1 mmHg above 40mmHg Equivalent values for kPa and Vol Portable Bedside Capnograph 67 Specifications Respiration Rate 0 150 breaths min Frequency EtCO2 accuracy is maintained up to 80 Response breaths min For maintaining accuracy for respiration rate over 60 bpm use the neonatal mode From 81 to 150 bpm accuracy is 12 if the EtCOz is higher than 18 8 mmHg in neonatal mode eae Response 2 45 seconds typical 2 9 seconds maximum includes delay and rise time Reme SSS y Neonate 190 msec with low dead space endotracheal tube adapter 240 msec with FilterLine airway adapter Alarms EtCOz2 high EtCO2 low RR FiCO2 high No Breath Display Update Int
23. CO Consumables Directions for Use for proper connection Portable Bedside Capnograph Basic Operation Data Display Screens Displayed Data Options Alarm Functions Alarm Limits Menu Alarm Silence Standby Menu Instrument Settings Menus MRI Scanning Standby Pump Off Mode Pump Off On Label Data Display Screens In Measuring mode the monitor constantly measures and displays the CO waveform EtCO numerical value respiratory rate RR and FiCO user selected values Note For both neonatal and adult patients the EtCO displayed on the LED Numeric Displays represents the maximum value during the last 15 seconds updated every 5 seconds The EtCOz is displayed from the first breath The EtCO2 warning is according to the value in the 7 Segment display The respiratory rate and EtCO gt values are constantly shown in the digital displays Waveform or Trends are shown in the graphic display depending on the selected display screen Figure 5 Monitor Display Screen and LEDs below Power icons advisories warnings or cautions appear super imposed over the data display At any time during the Measuring mode the user can mark a special event by a short press of f and a short duration tone sounds The Portable Bedside Capnograph 29 Basic Operation 30 event is stored in the monitor s memory and will appear on the data printout marked by an asterisk on the tabular trend printout and as a mark on the graphic
24. CO2 Calibration Check cccccccsseeeeeeeeeeees 59 Returning the Monitor cceeeeeeeeeeeeenees 61 Technical assistance ccccceeesseeeeeeeeeeeaaees 62 CHAPTER 10 SPECIFICATIONS c1cscecesseeesseeesssaees 63 PHYSICA ie cacchtecce pena dn etc date sce cana iacdaned eogeeebaentes 63 Environmental ruriini 63 Safely Standards seccusssscccenssanecennvinccenessneacevesaneee 64 Compliance assinou iaa 64 Manufacturer s Declaration cccccccesseeeees 67 POITOPMANCe itescciisidiessndestsssandaarsacvasarannceeeraanness 67 Power Specifications ccceceeeeeeeeeeeeeeee 68 ELGG Cal i isisiitdes ceaedctianat dvvaauandddecaPadssdanateed scabies 69 Components and User Interface 005 75 Portable Bedside Capnograph List of Figures Figure 1 Monitor Front and Side View 17 Figure 2 Monitor Rear View eeen 18 Figure 3 Initialization SCree n cccecceceeeeeeeeeetteeeeeees 24 Figure 4 Quick Guide cccceceeeeeeceeeeeeeeeeeeteeeeneeeeees 26 Figure 5 Monitor Display Screen and LEDs 30 Figure 6 Pump Offf eececceececeeceeeeeeceeeaeeeceeeetesesnnneeees 45 Figure 7 Pump Off Additional Time ceeeees 46 Figure 8 Pump Off On Label ccccecetsteeeeeeeeeeees 46 Portable Bedside Capnograph List of Tables Table 1 Symbols on the Device cccceeeeeeeeeeeeees 10 Table 2 Display
25. Interface Kit for use with SpaceLabs patient monitoring systems e Profox Respiratory Software Portable Bedside Capnograph Note CAUTION Start up and Self test For information on operating the monitor with any accessory refer to the specific accessory s Directions for Use To protect the unit the manufacturer recommends using the carrying case the clamp or the protective boot depending on the type of application Start up and Self test WARNING WARNING WARNING CAUTION CAUTION CAUTION Do not lift the monitor by the FilterLine as it could disconnect from the monitor causing it to drop on the patient To ensure patient safety do not place the monitor in any position that might cause it to fall on the patient Carefully route the FilterLine cable to reduce the possibility of patient entanglement or strangulation When using the monitor with anesthetics nitrous oxide or high concentrations of oxygen connect the gas outlets to a scavenger system The monitor is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms The monitor is a prescription device and is to be operated by qualified healthcare providers only Only use Microstream EtCO consumables to ensure that the monitor functions properly Preparation Prior to start up 1 Slide open the FilterLine input connector shutter and connect the appropriate FilterLine 2
26. N The monitor will revert to its default alarm limit settings Note at power on power interruption and when changing the patient mode The user can have the factory default values of the alarm range permanently changed see Institutional Settings on page 43 For further information call your local representative The CO values in the table are shown in mmHg The values in brackets correspond to the kPa and Vol at sea level 34 Portable Bedside Capnograph Alarm Limits Menu Table 3 Factory Default Alarm Range Values Adult Neonate Maximum Minimum Default Default fecow lo fo onma oa Ro hb e e b No Breath appears in the Alarm Limits menu as No Resp See Instrument Settings Menus on page 38 for a list of parameters that are set by the user and stored in the memory Alarm Limits Menu Table 4 Alarm Limits on page 35 explains how to access the Alarm Limits menu and to change the parameters and values Note the monitor display Important No Resp will appear as No Breath on Table 4 Alarm Limits Objective To access the Alarm Limits menu from any measuring display To change the patient mode gt long press VN Cc short press Portable Bedside Capnograph Fatient Etcoz T 6h amp Fitoz T amp HoRespo z6 RR Fish 12 35 Basic Operation To access any gt displayed parameter short press V4 To change the Cc para
27. Saturation Portable Bedside Capnograph ipter 9 Maintenance Periodic Maintenance Service Cleaning Calibration CO2 Calibration Check Returning the Monitor Technical assistance Periodic Maintenance Periodic Maintenance is recommended according to operating hours The Pump and Flow System should be replaced every 7 000 operating hours The monitor should be returned to the manufacturer for periodic maintenance every 14 000 operating hours As part of routine preventative maintenance a calibration check should be performed with safety checks as outlined by hospital protocol To check the monitor s operating hours go to the information screen in the Service mode Table 16 Accessing the Service Mode on page 58 describes how to access the information screen in the Service mode The battery pack should be replaced once every two years Portable Bedside Capnograph 57 Maintenance Table 16 Accessing the Service Mode To access the During Self Test Mi vay i icrostream Service mode press and hold 2 VE simultaneously Solr Test Self Test and A Service Mode 12345 Operating Hours 5 783 Firmware z X XX Note Contact your local distributor to order spare parts calibration kits or to answer any questions regarding periodic maintenance Service The monitor requires no routine service other than any performance testing mandated by the operator s institution Troubleshooting Guide o
28. a FilterLine The calibration check must be performed with a manufacturer authorized Calibration Kit containing 5 CO gas and the connecting means A manufacturer approved Calibration Kit can be purchased from your Technical Services representative or from Scott Medical part number 0304653ORFBD The kit consists of e Calibration Gas containing 5 CO 21 O2 e Tubing Adapter e Calibration Line CAUTION Do not check CO values from the Measuring mode This mode corrects the CO value for BTPS Body Temperature Pressure Saturation which assumes that alveolar gases are saturated with water vapor The Calibration Check mode disables this correction Portable Bedside Capnograph 59 Maintenance CAUTION Note Note 60 The instrument should not be in Standby Mode before beginning the calibration check process To prevent the device from entering Standby Mode measure at least two breaths The device will then remain in normal operating mode with an active Apnea for software versions prior to 2 7 or No Breath from software version 2 7 alarm If this process is performed while a battery powers the device make sure that the battery is fully charged Prior to calibration verify that the FilterLine supplied with the Calibration Kit is firmly attached Start the process from the Setup menu as described in Table 17 CO2 Calibration Check below Table 17 CO Calibration Check Language English long press x
29. acturer If unsure about the integrity of the line connection operate the monitor from its internal battery pack WARNING To ensure patient electrical isolation connect only to other equipment with circuits that are electrically isolated Portable Bedside Capnograph 19 Initial Setup Battery and Power Usage If power is lost when the monitor is operating from AC power it automatically switches to its internal battery pack for power A plug shaped icon at the bottom right side of the graphic display is displayed when the monitor operates from an external power source and the battery pack is fully charged A battery shaped icon is displayed when the monitor operates from the battery pack The battery icon will show the battery pack s approximate charge level An advisory message Battery appears when approximately 40 minutes of battery charge remains A caution message Battery appears when approximately 15 minutes of charge time remains While the monitor is connected to AC power the battery pack can be replaced without interrupting monitoring Battery Pack Before using a new battery pack for the first time charge and discharge the battery three times to ensure full battery capacity For charging and discharging the Microstream Capnograph Battery Charger is recommended refer to the Microstream Capnograph Battery Charger Directions for Use Internal Recharge Function CAUTION Do not attempt to disassemble the b
30. ative Humidity 10 to 95 non condensing Safety Standards The monitor was designed to comply with EN60601 1 UL 60601 1 and CSA C22 2 No 601 1 M90 ISO 21647 Compliance item Equipment Safety Standards IEC 60601 1 same as classification EN60601 1 CSA 601 1 UL 60601 1 ISO 21647 and EN IEC 60601 1 2 Type of protection Class or II on AC power Internally powered on battery power Degree of protection Type BF Applied part Mode of operation Continuous 64 Portable Bedside Capnograph Compliance item Compliant With Resistant to liquid ingress Degree of safety in presence of a flammable anesthetic Applied sensor label to indicate Type BF applied part Attention symbol consult accompanying documentation External case made with non conductive plastic No holes in case top Rigid case Case mechanically strong Resistant to rough handling Tip tilt test Resistant to liquid ingress due to spills Environmental Cleaning Case surface made of non toxic materials Case resistant to heat and fire Exterior markings IEC 60601 1 sub clause 44 6 for class IPX1 Drip Proof equipment UL 60601 1 sub clause 5 5 Not suitable IEC 60601 1 Symbol 2 of Table DII of Appendix D IEC 60601 1 Symbol 14 of Table DI of Appendix D IEC 60601 1 sub clause 16 a IEC 60601 1 sub clause 16 b IEC 60601 1 sub clause 21 a IEC 60601 1 sub clause 21 b IEC 60601 1 sub clause 21 6 IEC 60601 1 sub clause 24
31. attery pack It is a sealed unit and has no serviceable parts inside When the monitor is connected to an external power source even if the monitor is turned off the battery pack charges automatically If the instrument is on during charging the battery shaped icon displays a filling pattern It takes approximately 4 5 hours to fully charge an empty battery pack Additional battery packs can be purchased from your local representative The recommended temperature for battery charging is between 5 C and 45 C 20 Portable Bedside Capnograph Power Requirements CAUTION Important The following information relates to the safe handling storage and disposal of the monitor battery pack Battery Testing The battery pack charge level should be tested before each use by observing the level on the battery icon after Self Test For a correct reading wait for the battery charge level to stabilize Replace or recharge the battery pack when the advisory message Battery appears on the graphic display screen refer to Troubleshooting on page 49 Handling Do not immerse the battery pack in water it may malfunction Only recharge the battery pack in the monitor or use the Microstream Capnograph Battery Charger provided by your local representative to avoid possible overheating burning or rupture of the battery pack Storage Short term storage one month or less The battery pack has an automatic discharge feature You
32. cccccccccecccseeeeeesseeeeseneeeees 11 CHAPTER 3 OVERVIEW 1 cescceeeceesceecceeccnescneeenees 13 Principles of Operation cceeeeeeetteteees 13 CHAPTER 4 INITIAL SETUP 20 c00cceecceeccsecceeeeneee 19 Power Requirements ccseceeceeeeeeeeeees 19 Unpacking and Inspection ccceeeee 22 Start up and Self test 0 cceeeeeceeeeeeeeeeees 23 Measuring Mode ccccccceseeseeeeeeeeeeeeeeees 25 Quick Guide 0 2 cceeeeee cece eee eeeeteeeeeeeeeaeas 26 CHAPTER 5 CONSUMABLES c11cceeeceeeceeecneeceees 27 MICROSTREAM EtCO2 Consumables 27 CHAPTER 6 BASIC OPERATION cs0ssssesssseessesenss 29 Data Display Screens ceeeeeeeeeeee eet 29 Displayed Data Options ceeeeeeeteteees 32 Alarm Functions soenen 33 Alarm Limits Menu se 35 Alarm Silence Standby Menu ccceeee 37 Instrument Settings Menus ceeee 38 CHAPTER 7 COMMUNICATION INTERFACE 47 Communication Interface ccccceeeeeeeeeeee es 47 CHAPTER 8 TROUBLESHOOTING sscscsssssesseseess 49 Alarms and Messages eeeeeeeeeeeteeeeeeeeees 49 Troubleshooting Guide 54 CHAPTER 9 MAINTENANCE 20 c00cceeeceeeceeeceeecneee 57 Periodic Maintenance cc cccceeeecceeeeeeee eens 57 SOVICE sirnaa a N eda denaaaammaseines 58 Portable Bedside Capnograph CIGAMING os 58 Calibratie nianse aaia 59
33. d Calibration Monitor requires Calibrate Unit Required calibration Portable Bedside Capnograph 53 Troubleshooting Demo User mistakenly activated Reset the monitor Demo mode by sliding the on off switch to off position and then to on position BTPS On BTPS setting is on No action required Ready COz module is operational but breath is not detected Note If BTPS is set to OFF only Ready appears FiCO 2 xx The FiCO2 value xx No action required mmHg or x x Vol or kPa Activated by user 6 sec Patient setting for Adult No action required mode or respiration rate is low Patient setting for No action required Neonate Mode or respiration rate is high Trend screen displayed No action required CO2 Trend 8 hrs and To erase trends Oe Mena Senin press and hold f until message disappears Troubleshooting Guide In Table 15 Troubleshooting Guide on page 55 are potential problems you may experience while using the monitor and suggestions for 54 Portable Bedside Capnograph Troubleshooting Guide resolving them If you are unable to correct the problem contact qualified service personnel or your local representative Table 15 Troubleshooting Guide Monitor does not turn on Monitor switches on but then switches off automatically Power cable improperly attached or disconnected or cable has faulty electrical connection Battery pack may be discharged Battery
34. d indicate that a problem has occurred requiring the operator s attention The message appears on the screen followed by the alarm bar will flash yellow and a special repetitive caution tone is heard see Table 12 Caution Messages below Check Unit Battery FilterLine Blockage Table 12 Caution Messages Instrument fault Message appears when battery charge level is very low approximately 15 minutes left FilterLine is disconnected or not securely connected to the monitor FilterLine is twisted or clogged The message appears after 30 seconds of unsuccessful clearing of the FilterLine FilterLine airway connection is clogged Portable Bedside Capnograph Contact authorized service representative Prepare to replace or recharge battery or connect monitor to AC power Connect FilterLine to COz input connector or tighten connection Check the FilterLine and if necessary replace it Check the airway adapter and if necessary replace the FilterLine 51 Troubleshooting Advisory Messages Advisories are informative messages appearing at start up before any patient input has been detected by the monitor or during operation The message appears on the screen followed by The alarm bar will light yellow and a special one time advisory tone is heard see Table 13 Advisory Messages below Table 13 Advisory Messages Check Unit Battery Empty Pump Off xxx
35. e when changing from Adult or Neonatal Mode CO Trends The trends graphs represent trend data of the last 30 minutes or 8 hours 15 second or 4 minute resolution respectively The trends are shown in the CO scale selected by the user The tabular trend data for 14 hours 5 second resolution is relevant for the print PC option only During the 14 hour tabular trend period the data of up to the last 100 patients is stored A new patient is defined each time the monitor is turned off and on or enters Standby Note In the case of the Autoscale Option the CO scale is that of the maximum range The FiCO value shows as light pixels a light area at the bottom of the trends graph When the monitor is turned on a trend data border will mark the end of the previous trend A trend data border will also appear after exiting Standby and returning to Measuring mode The trend data border is a vertical line on the graph An event will appear on the tabular trend printout marked by an asterisk and as a mark on the graphic trend printout perpendicular to the trend graph When you enter a trend display a temporary message Press gp T0 Erase appears for 3 seconds You now have the option to erase all old trends as follows Press f the message begins to flash and hold it until the message disappears This message will not appear during an alarm Portable Bedside Capnograph 31 Basic Operation The real time EtCO and resp
36. ent Settings Menu Parameters Table 6 Instrument Settings Parameters Menu 1 and Table 7 Instrument Settings Parameters Menu 2 both below explain the user defined parameters that can be set from the Instrument Settings menus Table 6 Instrument Settings Parameters Menu 1 mmHg kPa Vol Power Mgmt Full Display backlight on and 7 segment LEDs at high intensity Normal Display backlight on and 7 LEDs segments at normal intensity Low Backlight and 7 LEDs segment off Note During AC power power management appears as full 38 Portable Bedside Capnograph Instrument Settings Menus Print Screen the current display is printed Graphic Trend real time trend is printed in a graphic form Trend History stored trend is printed in graphic and tabular form Tab Trend 5s Real time trend data is printed in tabular form every 5 seconds Tab Trend 1m Real time trend data is printed in tabular form every minute Tab Trend 14H with a resolution of 5 seconds Stored trend is communicated in tabular form COz scale 0 50 mmHg 0 7 kPa or Vol 0 99 mmHg 0 14 kPa or Vol Autoscale FiCO2 On display FiCOz Off do not display FiCOz Default Off WARNING Make sure the patient type and CO scale are appropriate for each patient An error in the patient type can cause incorrect alarm limits or incorrect CO readings If the CO scale is not appropriate the waveform will be either incomplete or s
37. erval 2 seconds Power Specifications External Power Source 12V DC Medical Grade Adapter Internal Power Source Ni MH Rechargeable Battery Pack 7 2V 2 1 A h intended for continuous operation Operating Time Between 4 and 7 hours depending on power fully charged management These values reflect the performance of a new battery age and usage 68 Portable Bedside Capnograph Electrical will decrease capacity Note If the battery pack is stored for 6 months or longer you must charge and discharge it leave unit on not connected to AC power until battery is empty three times before use in order to ensure full capacity Recharging Period Approximately 4 5 hours internal recharging Electrical Instrument Rated 100 250VAC 50 60HZ 0 5A Electromagnetic Emissions The monitor is suitable for use in the specified electromagnetic environment The user of the monitor should ensure that it is used in an electromagnetic environment as described below Emissions Test Compliance Electromagnetic Environment Guidance RF emission Group 1 The monitor uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Portable Bedside Capnograph 69 Specifications Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Class B The monitor is suitable for use i
38. ging the parameter the new setting may not be saved Portable Bedside Capnograph Instrument Settings Menus Changing Instrument Settings Table 8 Changing Instrument Settings Menu 1 and Table 9 Changing Instrument Settings Menu 2 both below describe how to change the instrument settings Note If after 15 seconds no action is taken the display returns to Measuring mode Table 8 Changing Instrument Settings Menu 1 To access the Instrument Cop Uni mmMHa Settings menu 1 From Ficos OF any measuring display the Power Gent Monrial Print Screen 1st long press accesses j the Alarm Limits menu long press The 2 long press x2 accesses the Instrument Settings menu 1 To change parameter i nes setting Power Mant Normal Print Screen C Scale To access the next Fitts oH displayed parameter Power Mant Mormal Print Screen COs Scale To change the parameter Fictoz Off setting Power Mant Normal Print Screen Portable Bedside Capnograph 41 Basic Operation 42 To exit and return to the Measuring mode at any f point in the Instrument long press Settings menu Fatient To exit and return to the gt EtCO2 FiC g Alarm Limits menu long press Hokesp To access the Instrument Settings menu 2 From ee any measuring display the 1st long press accesses the Alarm Limits menu a The 2nd long press long press accesses the Instru
39. i PAP or post op pain management Also available with O delivery e NIV Line for use under oxygen CPAP Bi PAP or NPPV mask Smart products provide oral and nasal sampling H products are for long term use 14 Portable Bedside Capnograph FilterLine Special Procedure FilterLines e FilterLine XL Provides extended length so that the monitor can be used safely during MRI see MRI Scanning on page 44 Note The generic term FilterLine used in this manual is interchangeable with any of the Microstream EtCO2 consumables FilterLine The FilterLine has five active elements that work together to offer a solution to the problems that have previously posed challenges to capnography in ICU emergency and intra transport applications These elements are described below Hydrophobic filter The hydrophobic filter is located at the end of the sample line that is closest to the capnograph This filter strips the remaining water vapor from the gas sample while keeping a laminar flow of the gas This laminar flow minimizes distortion of the CO waveform This filter is made of a 0 2 u hydrophobic porous medium Drying element The drying element is a tube made of a synthetic material that is chemically stable and has high water absorption This material allows the water vapor to pass outside the tube thereby adjusting the humidity inside the FilterLine close to the level of humidity in the ambient air Sample line
40. ing Mode Measuring Mode In Measuring mode the monitor measures displays and stores event data or prints data that has been stored in its memory During measuring the monitor shows EtCO and respiration rate readings on the digital displays Waveform respiration rate and other information according to the selected screen see Basic Operation on page 29 are shown on the graphic display The monitor begins measuring EtCO after recognizing one breath after monitor power up or after exiting Standby The monitor recognizes two breath measurement ranges Valid breath values gt 7 5 mmHg for adult mode or gt 5 0 mmHg for neonatal mode Low readings breath values lt 7 5 mmHg for adult mode or lt 5 0 mmHg for neonatal mode Note If the first breath the monitor recognizes is a Low readings breath the monitor will not display nor emit warning signals and a No Breath message will not appear If the values go above 7 5 mmHg for adult mode or 5 0 mmHg for neonatal mode and then fall below these ranges the monitor will display a No Breath message and emit warning signals see Troubleshooting on page 49 EtCO readings between 3 0 7 0 mmHg adult mode or 3 0 5 0 mmHg neonatal mode appear as numerical values on the EtCO2 LEDs Readings lt 3 0 mmHg show as 0 zero on the LEDs The monitor begins measuring Respiration Rate after two valid breaths The waveform appears on the graphic display for all EtCO2 values
41. iration rate values are shown on the real time digital display Meter Mode The Meter Mode screen displays the EtCO value on the left side of the screen and the respiration rate on the right side of the screen This mode is recommended in the following cases e When the power management is Low see Table 6 Instrument Settings Parameters Menu 1 on page 38 e When the monitor display is exposed to direct sunlight affecting the digital display reading Graphic Display Screen Contrast The LCD contrast intensity can be adjusted during Measuring mode AN To adjust the contrast press on the contrast button CD press the right side for a darker contrast and the left side for a lighter contrast The photo resistor senses the ambient light intensity and accordingly switches the backlight on or off during Normal power management setting Displayed Data Options Table 2 Display Screens EtCO2 Eh min Appears CO2 waveform automatically 32 Portable Bedside Capnograph CO2 Trend 30 min CO2 Trend 8 hr Meter Mode CO2 waveform Alarm Functions 1st short press 2nd short press sa min o LEU 3rd short press EtCO2 Eh min 4th short press Ps0immbig Note To return to CO waveform Home from any screen or menu long press the button Alarm Functions WARNING Do not turn off the audible alarm if patient safety could be compromised Pressing the alarm silence button turn
42. k of obstruction in the sample pathway in humid ICU environments Once inside the Microstream CO sensor the gas sample goes through a microsample cell 15 microliters This extremely small volume is Portable Bedside Capnograph 13 Overview quickly flushed allowing for fast rise time and accurate CO readings even at high respiration rates The Microbeam IR source illuminates the microsample cell and the reference channel This proprietary IR light source generates only the specific wavelengths characteristic of the CO absorption spectrum Therefore no compensations are required when different concentrations of N20 O2 anesthetic agents and water vapor are present in the inhaled and exhaled breath The IR that passes through the microsample cell and the IR that passes through the reference channel are measured by the IR detectors The microcomputer in the monitor calculates the CO concentration by comparing the signals from both channels Microstream EtCO2 Consumables The following products comprise the Microstream EtCO consumables Sample Lines and Airway Adapter Sets for Intubated Patients e FilterLine Set for non humid environments e FilterLine H Set for humid environments Nasal and Oral Nasal Cannulas for Non intubated patients e Smart CapnoLine Plus for use in procedural sedation Also available with O delivery e CapnoLine H for patients receiving hi flow oxygen by mask on long term CPAP or B
43. mall CO Scale Autoscale When Autoscale is selected the CO scale changes as follows e From lower to higher scale after 12 consecutive breaths with EtCO values greater than low level scale limit e From higher to lower scale after 12 consecutive breaths with EtCO values less than low level scale limit Portable Bedside Capnograph 39 Basic Operation Whenever autoscale is selected the trend scale and printed graphic scale will be the high level scale limit The Factory Default CO is 0 50 mmHg The CO scale option will not return to the Factory Default after being changed by the user See User defined Parameters on page 40 Table 7 Instrument Settings Parameters Menu 2 Language English French German Spanish Italian Dutch Swedish Norwegian and Portuguese Check Cal Off Start See CO2 Calibration Check on page 59 Factory Off Start Default This option will reset the device to the factory default settings User defined Parameters Stored as Defaults The following parameters will not return to their defaults after being changed by the user These parameters are stored in the memory of the monitor until the next time they are changed by the user CO2 Scale CO2 Units CO2 Mode Patient Print Language Power Management Note When changing any of these parameters wait 40 approximately 10 seconds before turning the monitor off If you turn off the monitor immediately after chan
44. material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial and or hospital environment Mains power quality should be that of a typical commercial and or hospital environment Mains power quality should be that of a typical commercial and or hospital Portable Bedside Capnograph 71 Specifications Immunity Test IEC 60601 1 2 Test Level Compliance Level Electromagnetic Environment Guidance power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT 95 dip in UT for 5 sec 3 A m 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT 95 dip in UT for 5 sec 3 A m environment If the user of the monitor requires continued operation during power mains interruption it is recommended that the monitor be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Ur is the AC mains voltage prior to application of the test level 72 Portable Bedside Capnograph Electrical Recommended Separation Distances Recommended Separation Distances between Portable and Mobile RF Communications Eq
45. ment x3 Settings menu 1 The 3rd long press accesses the Instrument Settings menu 2 To change the Check Enalish Calibration option Check Cal To access the language Lanauase option Portable Bedside Capnograph Instrument Menus Check Cal Language Frangais press To switch languages until desired language appears Institutional Settings The factory default parameter settings in Table 10 Institutional Settings below can be changed by your local service representative Table 10 Institutional Settings Alarm Default Settings See Table 3 Factory Default Alarm Range Values on page 35 3 Min Alert to remind user that alarms are set to off BTPS body temperature pressure saturation assumed 37 C 47mmHg Calculations are made according to PCO FCO x Pb 47 Where FCO is the Fractional concentration of CO in dry gas Portable Bedside Capnograph 43 Basic Operation Where FCO CO2 100 Pb the ambient pressure PCO the partial pressure of CO at BTPS MRI Scanning WARNING Do not use the FilterLine H Set Infant Neonatal consumable during magnetic resonance imaging MRI scanning Using the FilterLine H Set Infant Neonatal during MRI scanning could harm the patient CAUTION During MRI scanning the monitor must be placed outside the MRI suite When the monitor is used outside the MRI suite EtCO2 monitoring can be implemented by using the FilterLi
46. meter s value short press long Riba tiz press To exit and return to Measuring mode at F any point in the Alarm long press Limits menu Tf after 15 seconds no action is taken the display returns to Measuring mode The Neonatal mode is recommended when a patient s breath rate is gt 50 breaths per minute Long press the value advances quickly Display does not necessarily return to the wave form shown in the Results column it returns to the screen active prior to entering the Alarm Limits menu Alarm Silence Alarms can be temporarily silenced A short press of the alarm silence button will temporarily disable the audible alarm for a pre set period of time and the alarm silence indicator will be lit The audible alarm can be reactivated with a short press of the alarm silence button The default setting is 2 minutes You can change this setting from the Alarm Silence Standby Menu Table 5 Alarm Silence Standby on page 37 From the Alarm Silence menu you can choose to permanently disable a specific audible alarm or all audible alarms Whenever an alarm is disabled indefinitely the alarm silence indicator ha will be lit on the front panel and the Alarm Silence icon will appear on the right side of the graphic display with the appropriate label 36 Portable Bedside Capnograph e ALL e CO2 Note Note Alarm Silence Standby Menu All the audible alarms are turned off CO
47. n all establishments CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Class A emissions IEC 61000 3 2 Voltage Complies fluctuations flicker emission IEC 61000 3 3 Electromagnetic Immunity The monitor is suitable for use in the specified electromagnetic environment The user of the monitor should assure that it is used in an electromagnetic environment as described below Immunity Test IEC 60601 Compliance Electromagnetic 1 2 Test Level Environment Level Guidance Electrostatic 6 kV 6 kV Floor should be discharge contact contact wood concrete or 70 Portable Bedside Capnograph Immunity Test ESD IEC 61000 4 2 Electric fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on IEC 60601 1 2 Test Level 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle Compliance Level 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle Electrical Electromagnetic Environment Guidance ceramic tile If floors are covered with synthetic
48. n page 54 discusses potential difficulties their possible causes and suggestions for resolving them Contact your local distributor for service instructions and performance tests and checks CAUTION The monitor must be returned for repair if the Check Unit message appears Cleaning To clean the monitor s surfaces dampen a cloth with a commercial nonabrasive cleaner and wipe the top bottom and front surfaces lightly CAUTION Do not spray or pour any liquid directly on the monitor accessories or consumables CAUTION Do not use caustic or abrasive cleaners 58 Portable Bedside Capnograph Calibration CAUTION Microstream EtCO consumables are designed for single patient use and are not to be reprocessed Do not attempt to disinfect or flush the FilterLine as the monitor can be damaged Calibration Calibrate after 1 400 hours of initial use After that calibration should be performed any time the monitor displays the advisory message Calibration Required Calibration should be performed annually or after 4 000 hours whichever comes first by qualified service personnel Note It is recommended that you calibrate the monitor within two weeks of the message appearing on the monitor Note The monitor is calibrated when it leaves the factory CO Calibration Check The process should be performed only after the device has been operating for at least 20 minutes in a normal operating mode and connected to
49. ne XL to provide extended length Non invasive EtCO monitoring during magnetic resonance imaging MRI can be accomplished with the monitor and a FilterLine XL as follows 1 Place the monitor outside the MRI suite There must be a hole in the wall of the suite approximately 10cm diameter Note A small hole at the base of the wall does not affect the integrity of the MRI shielding shielding of a 1 5 Tesla magnet 2 Connect the FilterLine XL to the monitor and guide the FilterLine XL through the hole in the wall of the MRI suite Attach the FilterLine XL to the patient Note Due to the extended length of the FilterLine XL there may be a slower response and a decreased frequency response time To purchase the FilterLine XL contact your local representative Standby The Standby mode is an automatic or selectable function designed to reduce power consumption and to avoid unnecessary alarms To set the monitor manually in the Standby mode choose the Standby ON option from the Alarm Silence Standby menu Table 5 Alarm 44 Portable Bedside Capnograph Pump Off Mode Silence Standby on page 37 The Standby screen appears A long press of any key restores the Measuring mode The Alarm Limits menu appears briefly before the Measuring mode but the alarms cannot be changed at this time The monitor will automatically enter Standby mode if after Power ON no signal is registered for 10 minutes Note When exiting Standby
50. riate for the patient being monitored WARNING Check the audible alarm silence duration before temporarily silencing the audible alarms Fire Hazard WARNING When using the monitor with anesthetics nitrous oxide or high concentrations of oxygen connect the gas outlets to a scavenger system WARNING The monitor is not suitable for use in the presence of flammable anesthetic mixture with air oxygen or nitrous oxide WARNING The FilterLine may ignite in the presence of O2 when directly exposed to laser ESU devices or high heat When performing head and neck procedures involving laser electrosurgical devices or high heat use with caution to prevent flammability of the FilterLine or surrounding surgical drapes 8 Portable Bedside Capnograph Warnings Electrical WARNING To protect against electric shock hazard the monitor s cover is to be removed only by qualified service personnel There are no user serviceable parts inside WARNING To ensure patient electrical isolation connect only to other equipment with circuits that are electrically isolated WARNING Use only the medical grade AC adapter provided by the manufacturer If in doubt about the integrity of the mains supply connection operate the monitor from its internal battery pack WARNING Do not connect to a printer or to a PC unless using the Communication Adapter provided by the manufacturer as an optional accessory The printer and PC when connected
51. rm conditions Warnings refer to either patient or alarm limit settings problems They are serious and require immediate operator attention The message appears on the screen followed by the numerical parameter associated with the alarm blinks the alarm bar flashes red and a special repetitive warning tone is heard If one of the following warning messages appears first check the patient then check the ventilation equipment if used and then check the alarm limits settings Table 11 Warning Messages below Table 11 Warning Messages Possible Causes No Breath xxx No valid breath has been detected for xxx seconds The EtCO2 exceeded First check the the EtCOz high alarm patient then the limit connections from EtCO2 H The EtCO gt z fell below the patient to the EtCO2 low alarm limit monitor then The RR exceeded the ventilation RR high alarm limit equipment if used and then the alarm settings refer to the Alarm Limits Menu on page 35 The RR fell below the RR low alarm limit Fico f I I xx The FiCO2 exceeded the FiCQz high alarm limit 50 Portable Bedside Capnograph Alarms and Messages XXX the number of seconds elapsed since the last valid breath has been detected The FiCO value is displayed if selected in the Instrument Settings menu Refer to Instrument Settings Menus on page 38 Cautions Caution messages appear during Measuring mode an
52. s the audio alarms OFF and turns the alarm silence icon LED indicator ON In this condition there will be no audible alarms in the event of adverse patient conditions WARNING When exiting Standby mode the monitor reverts to the Factory default of All Alarms On The monitor has four levels of alarms For full details on alarms see Troubleshooting on page 49 Portable Bedside Capnograph 33 Basic Operation Alarms Warnings are the highest level of alarms used to alert the user that the patient s condition is beyond predefined limits Alarms can be set from the Alarm Limits menu see Alarm Limits Menu on page 35 The monitor has the following alarms with adjustable level settings No Breath alerting the user when no valid breath is detected after a predetermined time EtCO high and low levels Respiration rate RR high and low levels FiCO high level The following alarms alert the user of the instrument s status or malfunction Caution messages audible and visual Advisory messages audible and visual Silent advisory messages visual Pump Off two minute warning audible and visual Factory Default Alarm Range Values Table 3 Factory Default Alarm Range Values on page 35 lists the default values of the various alarm ranges These values can be changed from the Alarm Limits menu CAUTION Make sure that the monitor default alarm settings are appropriate for the specific patient being monitored CAUTIO
53. trend printout perpendicular to the trend graph EtCO2 amp min 40 mmHg Figure 5 Monitor Display Screen and LEDs There are four data display screens Table 2 Display Screens on page 32 e CO Waveform e CO Trend 30 minutes e CO Trend 8 hours e Meter Mode CO Waveform The CO waveform screen displays a real time CO waveform The end tidal CO and Respiration Rate values are shown simultaneously on the digital displays CO Time Base The time base is the period of time captured on the display The time base default values are e 6 seconds for Adult Mode e 3 seconds for Neonatal Mode The instrument automatically changes the time base of the CO2 waveform according to the actual respiration rate as follows Current Time Time Base Change Base Condition 6 seconds gt 35 bpm for 10 seconds 3 seconds Portable Bedside Capnograph Data Display Screens 3 seconds lt 25 bpm for 10 seconds 6 seconds Any Initialization No Breath or 6 seconds blockage During periods of high respiration rates the display will automatically depict the shorter time base to avoid compression of the waveform The time base appears at the top right side of the graphic screen as a Temporary Silent Advisory and is shown for 5 seconds each time the instrument enters the CO waveform screen or after every change of the time base The instrument also automatically changes the time bas
54. uipment and the monitor IEC60601 1 2 Rated Separation distance according to maximum frequency of transmitter AON 150 kHzto80 80MHzto 800 MHz to 2 5 of transmitter wW MHz 800 MHz GHz d 1 2V P d 1 2V P d 2 3V P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the separation distance d in meters m can be estimated 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 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people These guidelines may not apply in all situations Portable Bedside Capnograph 73 Specifications 74 Electric and Communication Cables Maximum Length Complies with 791001 Power cord North America 10 ft 3 m RJ11 communication cable contained in 048127 communication adapter kit 10 ft 3 m RJ45 communication cable contained in 048127 communication adapter kit 1 7 ft 0 5 m 15 pin D type output connector cable contained in 063755 D A Converter kit 10 ft 3 m RS232 monitor cable contained in 0
55. y Icon Respiratory Rate breaths per aa min minute EtCO End tidal carbon dioxide value DC Input Refer to manual for connector RS interface and other information Pump Off On Pump Off 10 Portable Bedside Capnograph Chapter 2 Introduction Monitor Features This manual provides directions for setup and operation of the portable capnograph monitor The device is a portable capnograph that continuously monitors end tidal carbon dioxide EtCO fractional inspired carbon dioxide FiCO gt and respiratory rate RR The monitor is for monitoring only and must be used in the continuous presence of a qualified healthcare provider It is intended for use in any environment where continuous noninvasive monitoring of these parameters is desired including hospital and hospital type facilities The monitor is intended for use on adult pediatric and infant neonatal patients Monitor Features e Capnograph in a small portable lightweight monitor e Measures and displays EtCO 2 FiCO and respiration rate in one graphic and two digital displays e Displays CO waveforms and trends e Utilizes a wide range of Microstream EtCO consumables for all applications e Operates on mains line power or a rechargeable Nickel Metal Hydride battery pack e Employs audible and visual alarm warnings for monitored parameters and instrument malfunctions e Provides user selectable language options English French German Spanish

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