OPERATOR`S MANUAL NPB-70 Handheld Capnograph MANUAL
Contents
1. esee 69 TECHNICAL ASSISTANCE sse 69 SPECIFICATIONS rares n docu anoo ge ee DNA Sk Ge EG ME 71 PHYSIGAL ID 71 AR EE EE OE HE EE 71 Weight including battery pack iese ee ee ee 71 Noise Emission aanraai ee ee ke ee Re ee ee de ee ee 71 ENVIRONMENTAL wince 1i ee Tec eee 71 Temperature rene 71 Relative Humidity ett ete 71 Pressure and Altitude for operating and storage 71 SAFETY STANDARDS iere entente 72 PERFORMANCE ees ede ee see ee ese ee ee ke de ee ee ee ede nnne nnne 72 POWER SPECIFICATIONS eese 73 External Power Source sees ee ee ee Re Re ee ee 73 Internal Power Source ees ee ke Re ee Re ee 73 COMPONENTS AND USER INTERFACE sss 73 Displays edet NE ER He cei EE 73 Controls and Indicators essen 74 GConnectiof18 iie e eel Perte EE rere dut esae ee e TR 74 Table of Contents vi List of Figures Figure 1 Monitor Front and Side View 12 Figure 2 Monitor Rear View eeeeeeeeeene 13 Figure 3 Initialization Screen sees ees ee ee Ee 21 Figure 4 Quick Guide Adhesive Label 23 Figure 5 Monitor Display Screen and LEDs 27 Figure 6 Tabular Trend PrinNtOU sees ee ee ee 43 Figure 7 Graphic Trend Printout 44 Figure 8 Trend History Printout2. sesesssssss 46 List of Tables Table 1 Packaged monitor seeen 18 Table 2 Display ScreenS eek ee ee Re ee 30 Table 3 Factory Default Alarm Range Values 32 Table 4 Alarm LimitS iese ee RR nsere 33 Table 5 Alarm Silence Standby 35 Table 6 Instrument Settings Menu Parameters 36 Table 7 Changing Instrument Settings 38 Table 8 Institutional Settings ss 39 Table 9 Print OptiOnS see ees RA ke ee 42 Table 10 Monitor Setup esse ee ee Re ee Re ee 48 Table 11 Dip Switch Settings 0 0 0 ee ee ee 50 Table 12 Start Stop Printing Options 52 Table 13 COM Property Settings sssse 53 Table 14 Troubleshooting Examples 54 Table 15 Warning Messages eee 58 Table 16 Caution Messages ssseene 59 Table 17 Advisory Messages ees ee se ee ee ee 60 Table 18 Silent Advisory Messages 61 Table 19 Troubleshooting Guide 63 Table 20 Accessing the Service Mode 65 Table 21 CO Calibration Check 67 SAFETY INFORMATION Warnings Symbols To use the monitor correctly and safely carefully read this operator s manual and the Directions for Use for the Microstream EtCO circuits
3. Power Mamt Normal STE pices TREE Tab Trend OP Language English Check Cal Off Return to any Measuring B sec Mode ji 40 mmHg long press i Print Refer to Table 12 to start stop communication to the printer PC for each option f after 15 seconds no action is taken the display returns to the last measuring mode 48 Communication Interface COMMUNICATION INTERFACE TO A PRINTER Important For printing monitor data only use the Seiko DPU 414 printer For further information regarding use of the Seiko DPU 414 printer refer to its Operation Manual WARNING When using the printer with main line power it is recommended to use a medical grade power supply complying with the following standards EN60601 1 UL 2601 1 CSA C22 2 No 601 1 M90 If the power supply is not medical grade the printer must be placed at least 1 5 meters from the patient environment complying with standard EN60601 1 1 The monitor and the Seiko DPU 414 printer must be configured properly before printing will be successful Set or check the printer settings DIP SW when Using the printer for the first time Unsure of the settings Configuration has been changed Note There are three DIP SW and each has 8 parameters to set Printer Setup To set the printer settings 1 On the printer slide the power switch to OFF 2 While pressing the ON LINE button slide the printer s power switch to ON Releas
4. 8 OFF U S A 100 DIP SW setting complete Continue Push On line SW Write Push Paper feed SW To continue to DIP SW 3 push ON LINE ON ON ON OFF OFF ON ON ON 1 2 3 4 5 6 7 8 Continue Push On line SW Write Push Paper feed SW Push ON LINE Data Length 8 bits Parity Setting No Parity Condition Odd Busy Control XON XOFF Baud Rate Select 9600 bps After receiving the prompt DIP SW setting complete the printer is ready to receive information from the monitor The printer retains DIP SW settings when turned off 51 Communication Interface PRINTING 1 Check all cables are properly connected 2 Turn the printer ON and ensure the printer s ON LINE green light is on before printing Note If the printer is not connected to the monitor and or OFF the Printer Off Line message is displayed on the monitor for 15 seconds 3 Start and Stop printing as described in Table 12 below Table 12 Start Stop Printing Options Print Option Start Print Stop Print Screen Simultaneously Automatically stops long press after printing is finished Kall and gt Tab Trend 5s Simultaneously Automatically stops long press after printing is Tab Trend 1m a finished Graphic Trend fr and gt or After simultaneously long pressing aa Trend History Tab Trend
5. e Mode of ventilation if ventilated Duration of use Patient s weight For further information please contact your local representative Select the appropriate Microstream ECO FilterLine and or Airway Adapter and connect it to the monitor before attaching it to the patient s airway Be sure to follow Microstream EtCO Circuits Directions for Use for proper connection 25 BASIC OPERATION Data Display Screens Displayed Data Options Alarm Functions Alarm Limits Menu Alarm Silence Standby Menu Instrument Settings Menu Standby sIBu DATA DISPLAY SCREENS In Measuring Mode the monitor constantly measures and displays the CO waveform EtCO and respiratory rate bpm 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 EtCO is displayed from the first breath The ECO warning is according to the 7 Segment value The respiratory rate and EtCO values are constantly shown in the LEDs Waveform or Trends are shown in the graphic display depending on the selected display screen see Figure 5 and Table 2 Power icons advisories warnings or cautions appear superimposed over the data display At any time during the measuring mode the user can mark a special event by a short press of Hana a short duration tone sounds The event is stored in the monitor s memory and w
6. Data Transfer ON OFF 12 Overview Figure 2 Monitor Rear View The numbered labels in Figure 2 are described below 1 Clamp Adapter 3 Serial Number Label 2 Space for Ouick Guide 4 Battery Pack Release Button Adhesive Label 5 Battery Pack 13 INITIAL SETUP Power Requirements Unpacking amp Inspection Start up and Self Test Measuring Mode Handheld Capnograph 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 three to six operating hours depending on power management refer to Table 6 for a description of the power management options 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 To ensure patient electrical isolation connect
7. OPERATOR S MANUAL NPB 70 Handheld Capnograph MANUEL DE L UTILISATEUR NPB 70 Capnograph Portatif GEBRAUCHSANWEISUNG NPB 70 Tragbarer Kapnograph MANUAL DEL OPERADOR NPB 70 Capn grafo port til MANUAL PER L UTENTE NPB 70 Capnografo Palmare WAALLINCKRODT Caution U S Federal law restricts this device to sale by or on the order of a physician To contact Mallinckrodt Inc representative In the United States call 1 800 635 5267 outside the United States call your local Mallinckrodt representative C 1999 Mallinckrodt Inc All rights reserved 061233A 0899 0123 Mallinckrodt Inc 675 McDonnell Boulevard PO Box 5840 St Louis MO 63134 Tel 314 654 2000 Toll Free 1 800 635 5267 Mallinckrodt Europe BV Hambakenwetering 1 5231 DD s Hertogenbosch The Netherlands Tel 31 73 6485200 Nellcor Puritan Bennett 4280 Hacienda Drive Pleasanton CA 94588 Nellcor Puritan Bennett Inc is a wholly owned subsidiary of Mallinckrodt Inc Nellcor and Nellcor Puritan Bennett are trademarks of Mallinckrodt Inc To obtain information about a warranty if any for this product contact Mallinckrodt Technical Services or your local Mallinckrodt representative Microstream and FilterLine are trademarks of Oridion Medical Ltd Capnography covered by one or more of the following U S Patents and foreign equivalents 4 755 675 5 063 275 5 300 859 5 657 750 OPERATOR S MANUAL Handheld Capnograph
8. Alarms Warnings are the highest level of alarms to alert the user that the patient s condition is beyond predefined limits Alarms can be set from the Alarm Limits menu see Table 4 The monitor has the following alarms with adjustable level settings EtCO high and low levels e FiCOe high level Apnea is a message alerting the user when no valid breath is detected after a predetermined time depending on the patient mode 15 seconds for infant neonatal patients and 30 seconds for adult patients The APNEA message appears only after warm up and the monitor measures one valid breath The apnea alarm stops after the monitor recognizes one valid breath The following alarms alert the user of the instrument s status or malfunction Caution messages audio and visual Advisory messages audio and visual e Silent advisory messages visual Factory Default Alarm Range Values Table 3 lists the default values of the various alarm ranges These values can be changed from the Alarm Limits menu 31 Basic Operation Caution The monitor will revert to its default alarm limit settings at power on power interruption and when changing the patient mode Note The user can have the factory default values of the alarm range permanently changed see Institutional Settings For further information call your local distributor The CO values in the table are shown in mmHg The values in parentheses correspond to the kPa a
9. 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 Ltd The following are trademarks of Oridion Medical Ltd Microstream and FilterLine Capnography covered by one or more of the following U S patents and foreign equivalents 4 755 675 5 063 275 5 300 859 5 657 750 Cl04561D TABLE OF CONTENTS Contents List of Figures List of Tables CONTENTS SAFETY INFORMATION esse sesse ee ee ee ee EE 1 WARNINGS ee ke RA AR RA Re Re nennen aok ee ee 1 General EE 9 1 MRI Scanning ee Re RA Re RA Re RA ke ee 2 DAI 2 Fire Hazard ice EE EG SE EE ie eG REDE 3 Electrical EE ia 3 Electro Magnetic Interference sesse ee ee ee ee de ee 4 SYMBOLS ET 4 INTRODUCTION reta sin ee se in Ge daran EE AN GES 7 MONITOR FEATURES sese 7 OVERVIEW sb ees ee teo ee ee GE ee oe ee 9 PRINCIPLES OF OPERATION eee 9 Microstream ECO Circuits eeessesesssseess 10 DISPLAYS CONTROLS AND CONNECTORS 12 INITIAL SETUP ii ida Rr entr aua Ee RR NE GE GE AR 15 POWER REQUIREMENTS seen 15 Battery and Power USage sesse ee ee ee de Re ee 16 Battery ae SE OE OE EO N 16 UNPACKING AND INSPECTION esee 18 Components EE EE aie endian 18 Optional Accessories
10. Re Re Re ke Re ee 19 START UP AND SELF TEST eee 20 Preparations OE OE RE EE 20 TES eli E 21 MEASURING MODE ees ee ese eke ee ee ke ke Re ee ee 22 HANDHELD CAPNOGRAPH QUICK GUIDE 23 CIRCUIT pm NE EE 25 MICROSTREAM EtCO CIRCUITS sss 25 Basic Principles 25 lii Table of Contents BASIC OPERATION Eens oes seek Lau suat Ns ende AE 27 DATA DISPLAY SCREENS ese esse seen 27 CO Waveform sie EE ee tet eae lal rt re rud 28 COs Trends ER OR nir 28 Meter Mode eue e eate tt io e dee 29 Graphic Display Screen Contrast eee 29 DISPLAYED DATA OPTIONS essen 30 ALARM FUNCTIONS ee ese ee ee ee RA ke ke ee 31 Alarms EG ED Catia EE EE iii 31 ALARM LIMITS MENU ees esse ee ee ee ese ee ee eed de ee eke ee 33 Alarm Silence is ree cosas erre dere ep een Pede ge ds 34 ALARM SILENCE STANDBY MENU eene 35 INSTRUMENT SETTINGS MENU see 36 Instrument Settings Menu Parameters 36 User defined Parameters sse 37 Changing Instrument Settings essusssss 38 Institutional Settings onare eine iaa Re ee ee ee 39 STANDBY une aeo UG ee a eA 39 COMMUNICATION INTERFACE eren nnn 41 COMMUNICATION ADAPTER eene 41 COMMUNICATION OPTIONS TO A PRINTER AND PC 42 Nera eina
11. Use of the monitor requires full understanding and strict observation of these instructions precautionary information in boldface type and specifications WARNINGS General WARNING If 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 To ensure patient safety do not place the monitor in any position that might cause it to fall on the patient WARNING Carefully route patient cabling FilterLine to reduce the possibility of patient entanglement or strangulation WARNING Do not lift the monitor by the FilterLine as it could disconnect from the monitor causing the monitor to fall on the patient WARNING To ensure accurate performance and prevent device failure do not expose the monitor to extreme moisture such as rain Safety Information WARNING CO readings and respiratory rate readings can be affected by certain ambient environmental conditions and certain patient conditions Caution The monitor is a prescription device and to be operated by qualified healthcare personnel only Caution Connect the gas outlet to a scavenging system when using the monitor with N O or other anesthetic agents MRI Scanning WARNING Do not use the monitor during magnetic resonance imaging MRI scanning Alarms WARNING Do not silence the audible alarm if patient safety may be com
12. 14 hr 52 Communication Interface COMMUNICATION INTERFACE TO A PC Connect the monitor to the PC via the Communication Adapter Kit using the interface cables provided For further information refer to the Communication Adapter Kit Directions for Use Transferring the Data to the PC For transferring data to a PC use any communication software program i e HyperTerminal Refer to your local distributor to recommend software application options The COM property settings should be set as follows refer to Table 13 below Table 13 COM Property Settings Field Name Setting Bits per second 9600 Data bits 8 Parity None Flow Control Xon Xoff Downloading the Data To download 1 Check all the cables are properly connected 2 Turn the PC ON Note If the printer is not connected to the monitor and or OFF the Printer Off Line message is displayed on the monitor for 15 seconds 3 Follow the directions of the communication software program being used 53 Communication Interface TROUBLESHOOTING Table 14 below lists potential problems and suggestions for resolving them If the problem persists contact your local distributor Table 14 Troubleshooting Examples Problem Printer Off Line message is displayed on the monitor after the print buttons are pressed Solution Check cables to download device Make sure they are plugged in correctly and t
13. 42 Tabular Trend 5s 1m ee ee ke Re ias 43 Graphic Trend EE ieee 44 Trend HIStory RE RE OE EE N tex 45 Tabular Trend 14 Hr sees esse ee ee ee ee a 47 Monitor Setup for Printer PC Communication 48 COMMUNICATION INTERFACE TO A PRINTER 49 ES nie e eser e erbe id 49 PRINTING ER EE PO teda cies 52 COMMUNICATION INTERFACE TO A PC ss 53 Transferring the Data to the PC ueser 53 Downloading the Data sees ee ee Re ee Re ee 53 TROUBLESHOOTING setiap ee ees ee ese aa aiia kaki 54 ADDITIONAL INFORMATION ee ee ee ke ke Re ee 55 Ordering the Seiko DPU 414 Printer s e 55 Technical Support for the Monitor ssss 55 Technical Support for the Seiko Printer 55 Table of Contents TROUBLESHOOTING seen enarrare prin ks ese oe ke ee 57 ALARMS AND MESSAGES sss 57 Alarm and Message Priorities seesssssss 57 WarminGS RE ER OE OO EE in 57 Cautions tvs SEE ES RE SR EL EE ee serie e ee ek e eta 59 Advisory MessageS ese ee ee Re een 60 Silent Advisori S outre bt roe SKEL Se NE Ve gese as 61 TROUBLESHOOTING GUIDE esee 63 MAINTENANCE 5 eo Se GEE Ge Ge Re See De Ee SE nia 65 PERIODIC MAINTENANCE esee 65 SERVICE MA EA Rete ast e ie o seta 66 CLEANING er eer ree ttn rne 66 CO CALIBRATION CHECK sese 66 RETURNING THE MONITOR
14. are required when different 9 Overview concentrations of N O O anesthetic agents and water vapor are present in the inhaled and exhaled breath The radiation that passes through the microsample cell and the radiation 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 EtCO Circuits 10 Microstream FilterLine The Microstream FilterLine has four active elements that work together to offer a solution to the problems that have previously posed challenges to capnography in ICU emergency and transport applications These elements are described below x 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 0 45u hydrophobic porous media that reduces biological contaminants 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 Overview Sample line The sample line has
15. for periodic maintenance every 14 000 operating hours To check the monitor s operating hours go to the information screen in the service mode Table 20 describes how to access the information screen in the service mode Table 20 Accessing the Service Mode Objective Action Result During self test press and hold simultaneously To access the Service Mode Microstream and C Service Mode 12345 Operating Hours 5 783 Firmware y X XX A calibration check is recommended once a year It is recommended that the battery pack be replaced once every two years 65 Maintenance Note Contact your local distributor to order spare parts calibration kits or to answer any questions regarding periodic maintenance SERVICE The monitor reguires no routine service other than any performance testing mandated by the operator s institution The Troubleshooting section discusses potential difficulties their possible causes and suggestions for resolving them Contact your local distributor for service instructions and performance tests and checks 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 or its circuits Caution Do not use caustic or abrasive cleaners Caution Do not clean the Microstream EtCO Circuits as they are not designe
16. intensity can be adjusted during Measuring VA Mode To adjust the contrast press the contrast button D 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 29 Basic Operation DISPLAYED DATA OPTIONS Table 2 Display Screens To View CO waveform 30 min CO Trend Press Appears automatically 13 short press Result EtCO2 aa vin 40 mmHg EtCO2 aa min 2n UW Go Leu 8 hr CO Trend me 2 d short press EtCO2 a min Ul a GEU Meter Mode gt 3 short press EtCO2 a fmin 2n tw oO EEU EtCO mmHg fA MIN i CO waveform 4th short press EtCO2 aa imin un jn La Lou 6 sec 40 mmHg To return to CO waveform Home from any screen or menu Long press the ef button 30 Basic Operation ALARM FUNCTIONS WARNING Do not turn off the audible alarm if patient safety could be compromised Pressing the alarm silence button turns 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 The monitor has four levels of alarms For full details on alarms see the Troubleshooting section of this manual
17. low dead space due to its small internal diameter This provides a sharp waveform and an accurate CO reading at high breath rate per minute The sample line is not affected by gases and anesthetic agents in the operating room environment 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 it to take a measurement Microstream Airway Adapter The Microstream 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 Microstream airway adapter provides optimal performance in all directions and is seldom disabled by secretions or liquids 11 Overview DISPLAYS CONTROLS AND CONNECTORS Figure 1 Monitor Front and Side View The numbered labels in Figure 1 are described below 1 ON OFF Switch 8 Event Home Button 2 Alarm Bar 9 Power Supply Communication 3 Digital Display of EtCO Adapter Port and Respiration Rate 10 Alarm Silence Alarm Silence 4 Graphic Display Menu Button 5 Contrast Changes Value 11 Alarm Silence Indicator Button 12 Gas Outlet 6 Next Menu Button 13 Photo Resistor 7 Battery Pack 14 FilterLine Input Connector 6 8
18. mode 38 Basic Operation Institutional Settings The factory default parameter settings in Table 8 can be changed by the manufacturer s service representative or by referring to the Handheld Capnograph Service Manual Table 8 Institutional Settings Parameter Factory Default Setting Alarm Default Settings See Table 3 Default Alarm Range Values 3 Min Alert OFF to remind user that alarms are set to off BTPS body temperature ON 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 Where Fco CO 100 Pb the ambient pressure Pco the partial pressure of CO at BTPS 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 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 mode the monitor reverts to the Factory default of All Alarms On Note The Alarm Limits settings are not changed d
19. put in Standby Mode or the unit is turned OFF ON Alarms are not printed e FiCO values appear as white marks at the bottom of the CO graph Events are marked with an asterisk beside the time in the tabular trend and with a horizontal line beside the time in the graph 45 Communication Interface See skerp uu Mn EN LL S S o L Noon E texte bus D mie H au b FeO values tin Tees C2 m v I tse Trendi N ome 5 Scat eel ien Time EtCO2 M FACOD M KR 38 tren ed UE j 0 ag x 1 0 20 45 Je i j 73 79 30 49 EN 39 4 i EN s 29 et 2 qu 3 22 Crore Wart 27 30 39 3 2l R 27 1 JH 1 19 7 41 16 45 a J UR 6 47 y 20 New P Ela a 26 15 40 2 2 5 Now Patient 00 15 0 0 Teer ee d ar d bre zoe B be Tabar Trond EtCO MF LOO Mi RR 81 6 9 8 3 D p La 2 22 Jg 2 97 New Pattont cure B D p 00 04 B 3 a Figure 8 Trend History Printout 46 Communication Interface Tabular Trend 14 Hr During the 14 hour tabular trend period the data of up to the last 100 patients are stored A new patient is defined each time the monitor is turned OFF ON or enters Standby The Tabular Trend 14 Hr option prints at a 5 second resolution the contents of the stored trend data for the last 14 hours the EtCO FiCO and Respiratory Rate values Note The stored trend data for the last 14 hours c
20. the monitor in any position that might cause it to fall on the patient As with all medical equipment carefully route the FilterLine cable to reduce the possibility of patient entanglement or strangulation Caution The monitor is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms Caution The monitor is a prescription device and is to be operated by qualified healthcare providers only Caution Only use Microstream ECO circuits to ensure that the monitor functions properly Caution Connect the gas outlet to a scavenging system when using the monitor with N O or other anesthetic agents Preparation Prior to start up 1 Slide open the input connector s shutter and connect the appropriate Microstream ECO circuit Connect the appropriate Microstream EtCO circuit to the patient as described in the Directions for Use Note When the monitor is handheld it is recommended to use it with its carrying case available as an optional accessory 20 Initial Setup When the monitor is used in stationary applications it is recommended to 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 distributor Caution Immediately after power up confirm that all display segments and icons function 1 Turn on the
21. 3 0 Vol at sea level The CO reading reaches its steady state accuracy 20 minutes after power up 0 38 mmHg 2 mmHg 39 76 mmHg 45 of reading 77 99 mmHg 8 of reading From power up until steady state is reached the CO reading accuracy is 0 38 mmHg 4 mmHg 39 76 mmHg 412 of reading 77 99 mmHg 412 of reading Equivalent values for kPa and Vol 0 150 breaths min 30 seconds typical EtCO accuracy is maintained up to 80 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 EtCO is higher than 18 8 mmHg in neonatal mode 2 45 seconds typical 2 9 seconds maximum 190 msec with low dead space endotracheal tube adapter 240 msce with Microstream airway adapter 72 Specifications Ambient Pressure Compensated internally automatic Alarms EtCO high ECO low FiCO high Apnea message The accuracy of the these alarms is the same as the accuracy of the EtCO readings 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 3 and 6 hours depending on power fully charged management These values reflect the performance of a new battery age and usage will decrease capacity Note If the battery pack is stored for 6 mon
22. NCIPLES OF OPERATION The monitor uses Microstream non dispersive infrared IR spectroscopy to continuously measure the amount of CO during every breath the amounts of CO present at the end of exhalation EtCO and during inhalation FiCO 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 ECO circuits deliver a sample of the inhaled and exhaled gases from the ventilator circuit or directly from the patient into the monitor for CO measurement Moisture and patient secretions are extracted from the sample while maintaining the shape of the CO waveform The 50 ml min low sampling flow rate reduces liquid and secretion accumulation thus the sample flow is not obstructed even 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 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
23. Scale B Sa To access any displayed mal Patient Neonatal parameter shortpress BEER EK FiCc a T 8 COe Scale B Sa To change the VN parameter s value To exit and return to Measuring Mode at any point in the Alarm Limits menu CD short press long press long press um Neonatal i 15 T 8 4 56 Patient EtC a FiCO2 COe Scale 40 mmHg x measuring mode Kk If after 15 seconds no action is taken the display returns to The neonatal mode is recommended when a patient s breath rate is gt 50 breaths per minute Neonates often have a respiration rate gt 50 breaths per minute Long press the value skips by multiples of 5 except for FiCO 33 Basic Operation 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 small Alarm Silence Alarms can be temporarily silenced A short press of the alarm silence button C 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 From the Alarm Silence menu
24. age Priorities The messages in the following tables Tables 15 18 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 Warnings WARNING Always respond immediately to an alarm since the patient may not be monitored during certain alarm conditions 57 Troubleshooting 58 Warnings refer to either patient or alarm limit settings problems They are serious and reguire 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 15 Table 15 Warning Messages Message Possible Causes Action Apnea xxx No valid breath has been detected for xxx seconds EtCO f The EtCO exceeded the First check the ECO high alarm limit patient the connections from patient to the monitor then ventilation equipment if used and then the alarm settings refer to the Alarm Limits Menu section EtCO The EtCO fell below the EtCO low alarm limit FiCO 51 I The FiCO exceeded the FiCO high alarm limit xxx the
25. an be downloaded to a PC and a printer It is not recommended to download 14 hour trend history to a printer due to the large volume of data and the amount of paper that would be required In order to shorten download time disconnect the monitor from the patient put the monitor in Standby mode and start the download process The following data is communicated Patient data shows the last 14 hours with a 5 second resolution of trend history in tabular form Alarms are not shown Events are marked with an asterisk beside the time The CO value units are according to the units selected in the Instrument settings menu and are indicated in the header of the table M mmHg K kPa V Vol New Patient appears when the unit is put in Standby Mode or the unit is turned OFF ON 47 Communication Interface Monitor Setup for Printer PC Communication To access and select the monitor functions for communication interface to the Printer or PC refer to Table 10 below Table 10 Monitor Setup Objective Action Result Access the Instrument Cas Unit x LL2 Units Mol Settings menu from any i oe Power Mart Normal measuring display ong press x2 i Screen English oH Select Print from the i Vo1X Instrument Settings menu Power Mowt Narmal short press x2 Ida Language Enalish Check Cal i Change the selected value vv N CDe Units Mol to the desired print option
26. and the amount of paper that would be required Screen The Screen option prints the current data display screen Wave form CO Trend 30 minutes CO Trend 8 hours and Meter Mode 42 Communication Interface Tabular Trend 5s 1m The Tabular Trend prints EtCO FiCO and Respiration Rate in either 1 minute or 5 second resolutions depending on the print option selected After turning the unit off the printed time is reset to Zero The printout includes the following data refer to Figure 6 Tabular Trend Printout Patient data e Alarms Only warning messages print Apnea EtCO high EtCO low FiCO high If two or more alarms occur simultaneously only the alarm with the highest priority will appear on the printout refer to the Handheld Capnograph s Operator s Manual for alarm priorities Events are marked with an asterisk beside the time The CO units print according to the units selected in the Instrument Settings menu and are indicated in the header of the table as M mmHg K kPa V Vol Patient Data Table Header Event Mark Alarm message Figure 6 Tabular Trend Printout 43 Communication Interface Graphic Trend The Graphic Trend data prints in graphic form EtCO FiCO and Respiration Rate values The printout includes the following data refer to Figure 7 Graphic Trend Printout Patient data prints every 2 minutes e Alarms Onl
27. d for reuse These items are for single patient use only CO CALIBRATION CHECK 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 In order to ensure measurement accuracy a CO calibration check needs to be done once a year Calibration gas available as an optional accessory and a FilterLine are needed for this procedure refer to the Initial Setup section Start the process from the Setup menu as follows in Table 21 Note Be sure to attach a FilterLine to the monitor before starting Calibration Check 66 Maintenance Table 21 CO Calibration Check Objective Action Result m Access Instrument gt 7 Settings menu long press x2 Horn Screen Eralizh Select Check Cal gt Volt Power Hard Hornal short press X4 Print Screen Lanausae Erralizh Change option to buses Cis Units Power Fart start Es oue short press Start Check Cal gt When choosing short press Autozero Check Cal An Please Wait Autozero process NEE automatically occurs Prepare for Cal Before connecting the EtCO2 amp min Check calibration gas wait 20 minutes x Note If the monitor Connect Gas has been continuously measuring ECO for mal check 20 minu
28. displays a filling pattern or the plug icon shows Refer to Figure 4 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 osu PowerOn Short Press Long Press p Changes Displays Accesses Selects Parameters Menus Home Erase Trend e Event Mark Changes Values Contrast vAN Accesses amp Sound ON OFF Pus M a Data Transfer d t ON OFF Quick Scroll Figure 4 Quick Guide Adhesive Label 23 CIRCUITS Microstream EtCO Circuits SIBu MICROSTREAM EtCO CIRCUITS FilterLines sampling lines and Airway Adapters comprise the Microstream EtCO family of circuits for ECO monitoring Basic Principles Caution Before use carefully read the Microstream ECO Circuits Directions for Use Caution Only use Microstream ECO Circuits to ensure the monitor functions properly Caution Do not reuse sterilize or clean Microstream EtCO Circuits as they are designed for single patient use Caution Dispose of Microstream EtCO Circuits according to standard operating procedures or local regulations for the disposal of contaminated medical waste When choosing Microstream EtCO Circuits the following should be considered Patient s breathing situation intubated or non intubated
29. e the ON LINE button after a list of the current settings starts printing out and the following prompt is printed Continue Push On line SW Write Push Paper feed SW 49 Communication Interface 3 To change the DIP SW settings press the ON LINE button To save and exit press the PAPER FEED button 4 Refer to Table 11 below for the parameter settings for DIP SW 1 DIP SW 2 and DIP SW 3 To set the setting to ON press the ON LINE button once To set the setting to OFF press the FEED button once Note If you make an error for one of the settings turn the printer OFF when you reach the prompt Continue Push On line SW Write Push Paper feed SW Turn the printer ON and restart the process Table 11 Dip Switch Settings 50 Feedback Input Serial Printing Speed High Auto Loading ON Auto LF OFF Setting Command Enable Printing Density 100 DIP SW Setting s Continue Push On line SW Write Push Paper feed SW To continue to DIP SW 2 push ON LINE Communication Interface Table 11 Dip Switch Settings Continued DIP SW Parameter Setting Feedback 2 VI ON Printing Columns 40 2 ON User Font Back up ON 3 ON Character Select Normal 4 ON Zero Normal 5 ON International 6 ON Character 7 ON set
30. ected Note If BTPS is set to OFF only Ready appears 6 sec Patient setting for Adult No action required Mode or respiration rate is low 61 Troubleshooting Table 18 Silent Advisory Messages Continued Message Possible Causes Action 3 sec Patient setting for Adult No action reguired Mode or respiration rate is high Press Fro Trend screen displayed No action required Erase CO Trend 8 hrs and CO Trend 30 min 62 Troubleshooting TROUBLESHOOTING GUIDE In Table 19 are potential problems you may experience while using the monitor and suggestions for resolving them If you are unable to correct the problem contact gualified service personnel or your local distributor Table 19 Troubleshooting Guide Problem Monitor does not turn on Cause Power cable improperly attached or disconnected or cable has faulty electrical connection Battery pack s charge may be empty the battery pack may not be inserted properly or missing Action Check power cable connection and check that power 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 Monitor switches on but then switches off automatically Electrical connection is faulty or the AC wall outlet has no power The battery pack is almost discharged One of the monitor s subsy
31. es 35 Basic Operation INSTRUMENT SETTINGS MENU Instrument Settings Menu Parameters Table 6 explains the user defined parameters that can be set from the Instrument Settings menu Table 6 Instrument Settings Menu Parameters Parameter CO units Power Mgmt Management mmHg Vol kPa 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 the monitor backlight is on all the time but the power management mode setting will continue to display the current selection full normal or low 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 Language English French German Spanish Check Cal See the Maintenance section CO Calibration Check Table 21 36 Basic Operation User defined Parameters The following parameters will not return to their defaults after being changed by the user These parameters are stored in the memory of t
32. he correct cables are being used Ensure the printer is turned on 54 Unit will not print and no error message is displayed Turn off both the printer and the monitor and then turn them back on again There may have been a data overflow event Check DIP switch settings on the printer When downloading to a PC verify that the correct COM port and property settings are selected Communication Interface ADDITIONAL INFORMATION Ordering the Seiko DPU 414 Printer To order Seiko DPU 414 Printer contact your local distributor Technical Support for the Monitor For technical support for the monitor and monitor accessories including the Communication Adapter Kit please call your local distributor Technical Support for the Seiko Printer For technical support for the Seiko DPU 414 printer refer to the Seiko printer s Operation Manual 55 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 distributor 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 Mess
33. he monitor until the next time they are changed by the user Note When changing any parameter below wait approximately 10 seconds before turning the monitor off If you turn off the monitor immediately after changing the parameter the new setting may not be saved e CO Waveform Scale e CO Waveform Units e CO Mode Patient e Print Option Language e Power Management Option 37 Basic Operation Changing Instrument Settings Use this menu Table 7 to change the instrument settings Table 7 Changing Instrument Settings Objective Action To access the Instrument Settings menu first access gt the Alarm Limits menu from any measuring display by one long press and then the Instrument Settings with the 2 long press long press x2 Result Power Hart Mormal Print Screen Language English Check Cal Off To change the CO scale VN option NEM short press To access any displayed parameter short press Mormal Screen Enalish Off Screen English Off To change the parameter s setting Exit and return to the Measuring Mode at any point in the Instrument Settings menu long press Exit and return to the p long press Alarm Limits menu Screen Language English Check Cal OFF 40 mmHg Patient Adult EtCO2 T 58 Xx E FicO2z T 8 COe Scale 6 56 If after 15 seconds no action is taken the display returns to measuring
34. ill appear on the data printout marked by an on the tabular trend printout and a vertical line on the graphic trend printout EtCO2 sa nin n n HG eu B sec 40 mmHg L Figure 5 Monitor Display Screen and LEDs 27 Basic Operation There are four data display screens Table 2 e COs Waveform e CO Trend 30 minutes e CO Trend 8 hours Meter Mode CO Waveform The CO waveform screen displays a real time CO waveform and respiration rates The end tidal CO and bpm 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 6seconds for Adult Mode e 3 seconds for Neonatal Mode 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 base CO Trends e 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 D
35. 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 circuits TECHNICAL ASSISTANCE For technical information contact your local distributor The service manual includes information that is required by qualified personnel to service the monitor 69 SPECIFICATIONS Physical Environmental Safety Standards Performance Power Specifications Components and User Interface PHYSICAL Size 206 mm H x 88 mm W x 53 mm D 8 11 H x 3 46 W x 2 06 D Weight including battery pack 750 grams 1 66 Ib Noise Emission maximum 45 dB A ENVIRONMENTAL Temperature Operating 0 C to 45 C 32 F to 113 F Storage 35 C to 70 C 31 F to 158 F Relative Humidity 10 to 95 noncondensing 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 71 Specifications SAFETY STANDARDS The monitor was designed to comply with EN60601 1 1990 A1 1993 A2 1995 EN60601 1 1 1992 A1 1996 UL 2601 1 and CSA 22 2 No 601 1 M90 EN864 1997 ISO9918 1993 PERFORMANCE Sampling Rate CO Range Accuracy EtCO readings Respiration Rate Warm up Time Frequency Response System Response Time delay time Rise Time neonate adult 50 7 5 ml min 0 99 mmHg 0 13 2 kPa and 0 1
36. monitor by sliding the ON OFF switch to the ON position 2 Verify that the monitor is working properly Proper working condition is verified by completing the power on self test described in the following step When turned on the TH initialization screen appears M ICFOS l reali the monitor automatically performs a self test and the self test bar fills for up to 15 seconds The display and ERIS alarm functions are tested Figure 3 Initialization activating the LCD alarm bar Screen seven segment displays alarm silence indicator and buzzer In this mode all alarms are disabled Refer to Figure 3 u XXX During Self Test the EtCO and Respiration Rate LED s show dashes When the monitor is Ready and the FilterLine circuit is connected the dashes in the EtCO and Respiration Rate LED s are replaced by numeric values If the FilterLine circuitis not connected to the monitor dashes will appear on the LED s 21 Initial Setup MEASURING MODE 22 In Measuring Mode the monitor is measuring displaying and storing event data or printing data that has been stored in its memory While taking measurements the monitor displays ECO and respiration rate readings on the digital displays The waveform and other information according to the selected screen see the Basic Operation section of this manual are shown on the graphic display The monitor begins measuring EtCO after recognizing one breath af
37. n optional accessory The Printer and PC when connected to the patient through the Communication Adapter must be distanced from the patient environment by at least 1 5 m Safety Information Electro Magnetic Interference WARNING This device has been tested and found to comply with the requirements for medical devices according to the standard EN60601 1 1990 A1 1993 A2 1995 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 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 SYMBOLS The following symbols appear on the monitor and accessories J See Instructions for Use Gas Outlet GAS ft Defibrillator proof typeType BF equipment patient electrically isolated sa Audio Alarms Off Plug Icon a Battery Icon AA in Breaths per minute EtCO End tidal carbon dioxide value Safety Information The following symbols appear on the Communication Adapter di Serial communications port DC output l DC input Printer interface PC interface INTRODUCTION Moni
38. nd Vol at sea level Table 3 Factory Default Alarm Range Values Parameter Adult Neonate Maximu Minimum Default Default m EtCO high 50 6 7 50 67 100 13 0 50 5 EtCO low 15220 15120 991129 010 0 FiCO high 8ILI 8 l 1 99 12 9 2 0 1 See the Instrument Settings Menu section for a list of parameters that are set by the user and stored in the memory CO Scale Options 0 50 mmHg 0 7 kPa or Vol 0 99 mmHg 0 14 kPa or Vol Autoscale Changes from lower to higher scale after 12 consecutive breaths with ECO values larger than low level scale limit Changes from higher to lower scale after 12 consecutive breaths with EtCO values smaller than low level scale limit 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 32 ALARM LIMITS MENU Table 4 explains how to access the Alarm Limits menu and to change the parameters and values Table 4 Alarm Limits Basic Operation Objective Action Result To access the Alarm e Patient dad Limits menu from any EtcOz T EA x 15 3 long press measuring display Fit e T 8 COe Scale B Sa To change the patient VN Patient mode C 9 Petco T ER x 1 short press FicOs T 8 COe
39. number of seconds elapsed since the last valid breath has been detected Cautions Caution messages appear during Measuring Mode and indicate that a problem has occurred requiring the operator s attention The message appears on screen followed by the alarm bar will flash yellow and a special repetitive caution tone is heard Table 16 Message Table 16 Caution Messages Possible Causes Troubleshooting Action Check Unit Instrument fault Contact authorized service representative Battery j Message appears when battery charge level is very low Prepare to replace or recharge battery or connect monitor to AC power FilterLine FilterLine is disconnected or not securely connected to the monitor Connect FilterLine to input connector or tighten connection Blockage FilterLine is twisted or clogged The message appears after 30 seconds of unsuccessful purging Microstream airway adapter clogged Check the FilterLine and if necessary replace it Check the Microstream airway adapter and if necessary replace it 59 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 advis
40. o not revert to defaults when moving to and from Standby mode 39 COMMUNICATION INTERFACE Communication Adapter Communication Options to a Printer and PC Communication Interface to a Printer Communication Interface to a PC Troubleshooting Additional Information The Handheld Capnograph monitor can interfaced to a Seiko DPU 414 printer or to a personal computer PC to download real time and trend values for EtCO FiCO and Respiratory Rate The monitor interfaces to the PC or Printer with the Communication Adapter Kit available as an optional accessory 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 distributor 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 WARNING When using the printer PC with main line power it is recommended to use a medical grade power supply complying with the following standards EN60601 1 UL 2601 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 complying with standard EN60601 1 1 COMMUNICATION ADAPTER The monitor has a single input output port During normal operating conditions this port is used
41. only to other equipment with circuits that are electrically isolated 15 Initial Setup Battery and Power Usage If power is lost when the monitor is operating from AC power the monitor automatically switches to its internal battery pack for power A plug shaped icon 2 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 a 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 the monitor for the first time it is recommended to charge and discharge the battery 3 times to ensure full battery capacity Internal Recharge Function Caution Do not attempt to disassemble the battery 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 in the OFF position the battery pack charges automatically During charging if the instrument is on the battery shaped icon displays a filling pattern It takes appr
42. ory tone is heard Table 17 Table 17 Advisory Messages Message Possible Causes Check Unit Instrument fault Action Contact authorized service representative Battery Empty Battery pack is discharged Replace or recharge the battery or connect to AC power Battery Message appears when battery charge level is low Prepare to replace or recharge the battery or connect to AC power FilterLine tube twisted or clogged with water Purging Check the FilterLine and if necessary untwist it or replace it 60 Troubleshooting Silent Advisories Silent Advisories are instrument status messages indicating the operational state of the monitor or circuits Silent advisories are low priority signals and only a message appears with no exclamation marks nor any other visual or audible indicator Table 18 Table 18 Silent Advisory Messages Message FilterLine Possible Causes Action FilterLine is not connected Connect FilterLine to to the instrument Message input connector appears before measuring Autozero Monitor automatically No action required performs a zero point calibration CO CO module is preparing Wait for Ready Warm up itself for operation message before measuring for EtCO No action required BTPS On BTPS On BTPS setting No action required Ready is on Ready CO module is operational but breath is not det
43. oximately 4 5 hours to fully charge an empty battery pack Additional battery packs can be purchased from your local distributor The recommended temperature for battery charging is between 5 C to 45 C 16 Initial Setup 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 It is recommended to replace or recharge the battery pack when the advisory message Battery 8 appears on the graphic display screen refer to the Troubleshooting section Handling Do not immerse the battery pack in water it may malfunction Only recharge the battery pack in the monitor or use a charger provided by your local distributor to avoid possible heating burning or rupture of the battery pack Storage Short term storage one month or less The battery pack has an automatic discharge feature You 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 cold 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 Dispo
44. promised 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 appropriate for the patient being monitored WARNING Check the audible alarm silence duration before temporarily silencing the audible alarms Safety Information WARNING The monitor is not to be used as an apnea monitor An apnea message appears if a valid breath has not been detected for 15 seconds neonatal mode or 30 seconds adult mode This indicates the time elapsed since the last valid breath and is not a diagnosis ire Hazard WARNING When using the monitor with flammable gases or anesthetics such as high concentrations of oxygen or nitrous oxide connect the gas outlet to a scavenger system lectrical WARNING 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 a
45. sal Do not dispose of the battery pack in a fire it may explode Besure to follow local governing ordinances and recycling instructions regarding disposal or recycling of batteries 17 Initial Setup UNPACKING AND INSPECTION Components 1 Remove the monitor and the circuits from the box carefully 2 Check that the following items are included Table 1 Table 1 Packaged monitor Contents of Package Handheld Capnograph Monitor Microstream EtCO Circuit Kit AC Adapter AC Adapter Power Cable Operator s Manual Quick Guide Adhesive Label Qty 1 kit 3 Inspect each component If the package is damaged or any component is missing contact your local representative 18 Initial Setup Optional Accessories The following items are available from your local distributor for use with the monitor Carrying Case Clamp Rechargeable Battery Pack External Battery Charger Battery Pack Carrying Pouch Communication Adapter Kit for interface to PC or printer Calibration Gas Kit Service Manual Important To protect the unit the manufacturer recommends using either the carrying case or the clamp depending on the type of application 19 Initial Setup START UP AND SELF TEST WARNING Do not lift the monitor by the FilterLine as it could disconnect from the monitor causing it to drop on the patient WARNING To ensure patient safety do not place
46. stems is out of order 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 EtCO values read erratically Mechanically ventilated patient who breathes spontaneously A leak in the airway No action needed Check for connection and line leaks to patient and correct if necessary 63 Troubleshooting Table 19 Troubleshooting Guide Continued Problem EtCO values are consistently higher or lower than expected Cause Physiological cause Ventilator malfunction Improper calibration BTPS setting ON or OFF Note When BTPS is on the correction lowers the EtCO reading to compensate for Body Temperature Pressure and Saturation Action Check patient Check ventilator and patient Check calibration See CO Check Calibration section Check BTPS setting on the graphic display after Power on Contact your local service representative 64 MAINTENANCE Periodic Maintenance Service Cleaning CO 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
47. ter monitor power up or after exiting Standby The monitor recognizes two breath measurement ranges Valid breath values 7 5 mmHg for adult mode or 5 0 mmHg for neonatal mode Low readings breath values lt 7 5mmHg 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 an APNEA 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 an APNEA message and emit warning signals see the Troubleshooting section of this manual EtCO readings between 3 0 7 0 mmHg adult mode or 3 0 5 0 mmHg neonatal mode appear as numerical values on the EtCO LED s Readings 3 0mmHg show as 0 zero on the LED s The monitor begins measuring Respiration Rate after two valid breaths The waveform appears on the graphic display for all ECO values Initial Setup HANDHELD CAPNOGRAPH QUICK GUIDE 1 Connect only Microstream EtCO circuits to the monitor 2 Battery pack operation First switch the monitor ON check that the battery pack is charged at measuring mode check that the battery icon at 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
48. tes you can proceed to Start Cal Check process 67 Maintenance Table 21 CO Calibration Check Continued 20 minutes Note If the monitor has been continuously measuring EtCO for 20 minutes you can proceed to Start Cal Check process Objective Action Result Prepare for Cal Before connecting the EtCO2 BE min Check calibration gas wait Lj Connect Gas Cal Check Start Cal Check process Connect the FilterLine to the calibration gas Connect Gas Check the measured values shown in Vol in the EtCO digital display Press the gas valve for 15 seconds until the readings stabilize Cal Check EtCO2 E min 5 m LI Connect Gas Cal Check Stop cf EtCO2 Ek min Calibration is not required if the measured value is the same as the concentration of the calibration gas 45 of reading 68 Maintenance Table 21 CO Calibration Check Continued GEM Jam at To return to etu nm Measuring Mode if 40 mmHg Calibration is not required long press i If calibration is required contact your local service representative RETURNING THE MONITOR If it is necessary to return the monitor for repairs call the local distributor for shipping instructions To repack the monitor disconnect the circuits from the instrument and wrap each item separately Pack
49. ths 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 Approximately 4 5 hours internal recharging Period Charger Type Internal COMPONENTS AND USER INTERFACE Displays Graphic LCD 128 x 64 dots with LED backlight display dimension 75 mm x 53 mm Two numeric 3 digits each using 7 segment LED fields dimension 22 mm x 14 mm Alarm bar yellow red 73 Specifications Controls and Indicators Front Panel button Contrast Value change button Event Home button Next Menu button Connections ON OFF switch Alarm Silence Alarm Menu Front Panel CO Input connector Rear Panel Clamp connector Socket for AC Adapter or Communication Side Panel Adapter Gas outlet 74
50. to connect the monitor to the external medical grade AC adapter When printing functions or communication to the PC are required the port is connected to the Communication Adapter The Communication Adapter uses the port as an input port to connect the monitor to the AC power supply 41 Communication Interface and or as an output port to connect the monitor to a printer or PC For further information refer to the Communication Adapter Kit Directions for Use COMMUNICATION OPTIONS TO A PRINTER AND PC Table 9 lists and describes the options available to download information from the monitor to either a printer and or PC Table 9 Print Options Screen The measuring mode displayed on To printer the screen is printed in graphic form Real Time The real time trend data is printed To printer Graphic Trend in graphic form and PC Tabular Trend The stored trend data is printed in To printer History graphic and tabular form Tab Trend 5s The real time trend data is printed To printer in tabular form every 5 seconds and PC Tab Trend Im The real time trend data is printed To printer in tabular form every minute and PC Tab Trend 14 The stored trend data for the last 14 To Hr hours is printed in tabular form printer and PC When downloading to a PC the graphic will appear as garbled data t is not recommended to download 14 hour trend history to a printer due to the large volume of data
51. tor Features This manual provides directions for setup and operation of the handheld capnograph monitor The device is a handheld capnograph that continuously monitors end tidal carbon dioxide ECO and respiratory rate The monitor is for attended 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 mobile use when protected from excessive moisture such as direct rainfall The monitor is intended for use on adult pediatric and infant neonatal patients MONITOR FEATURES e Capnograph in a small handheld lightweight monitor e Measures and displays EtCO and respiration rate in one graphic and two digital displays e Displays CO waveforms and trends e Utilizes a wide range of Microstream ECO circuits and adapters for all applications Operates on main line power or a rechargeable Nickel Metal Hydride battery pack Employs audible and visual alarm warnings for monitored parameters and instrument malfunctions Provides user selectable language options English French German Spanish e Displays ECO values in mmHg kPa or Vol Provides output for printer or PC OVERVIEW Principles of Operation Displays Controls and Connectors PISIS The monitor incorporates Oridion s Microstream capnography technology PRI
52. uring the 14 hour tabular trend period the data of up to the last 100 patients are stored A new patient is defined each time the monitor is turned on off or enters Standby 28 Basic Operation Note In the case of the Autoscale Option the CO scale is that of the maximum range e The FiCO value is shown as light pixels 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 and as a vertical line on the graphic trend printout When you enter a trend display a temporary message Press ce To Erase appears for 3 seconds This allows you to erase all old trends This message will not appear during an alarm but the trend erase function will still work The real time ECO and respiration rate values are shown on the 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 at Low see Table 6 e When the monitor display is exposed to direct sunlight affecting the digital display reading Graphic Display Screen Contrast The LCD contrast
53. y warning messages Apnea ECO high ECO low FiCO high print after each graph after 5 hours If two or more alarms occur simultaneously only the alarm with the highest priority will appear on the printout refer to the Handheld Capnograph s Operator s Manual for alarm priorities Time grid is drawn every 10 minutes Time label prints every 30 minutes e FiCO values appear as white marks at the bottom of the CO graph Events are marked with a horizontal line beside the time Patient Data Event Mark Time label FiCO Values Time grid Alarm Listing Figure 7 Graphic Trend Printout 44 Communication Interface Trend History The Trend History option prints in tabular form the current trend history of EtCO FiCO and Respiratory Rate values It is printed out in 30 minute and 8 hour scales The CO units print according to the units selected in the Instrument Settings menu Trend information is stored for 8 hours with a 4 minute resolution and 30 minutes with a 15 second resolution The printout includes the following information in the order listed below refer to Figure 8 Trend History Printout Printout header e 30 minute graphic trend e 8 hour graphic trend e 30 minute tabular trend e 8 hour tabular trend The printout includes the following data Patient data includes both 30 minute and 8 hour intervals in both graphic and tabular form New Patient prints when the unit is
54. you can choose to permanently disable a specific audio alarm or all audio alarms Whenever an alarm is disabled indefinitely the alarm silence indicator KA 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 ALL All the alarms are turned off CO CO alarms including apnea message are turned off Note When any alarm is disabled a single caution burst can sound once every three minutes if opted through Institutional Settings refer to Institutional Settings in this chapter If an alarm condition occurs when any corresponding alarm is disabled a message is generated on the monitor display 34 Basic Operation ALARM SILENCE STANDBY MENU Table 5 Alarm Silence Standby Objective Action Result To access the Alarm KA Alarm Silence Silence Standby menu from any measuring CD long press display ge To change the silence Alarm Silence period short press To access any displayed parameters amet Alarm Silence short press To change the setting Alarm Silence of the selected parameter All Alarms short press To exit and return to measuring display at eT 40 mmHg z any point in the Alarm long press E Silence Standby menu Tf after 15 seconds no action is taken the display returns to measuring mode Alarm silence limits are from 1 2 minut
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