Home

N-85™ - MedWrench

1. 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 Changing Instrument Settings Table 9 on page 53 and Table 10 on page 54 describe how to change the instrument settings Note If after 15 seconds no action is taken the display returns to Measuring mode Portable Bedside Capnograph Pulse Oximeter Instrument Settings Menus Table 9 Changing Instrument Settings Menu 1 Objective Result To access the Instrument Settings menu 1 From any measuring display the 1 long press accesses the Alarm Limits menu The 2 long press accesses the Instrument Settings menu 1 long press x2 Parameter To change a parameter setting VN c short press CO2 Units mmHa FicO2 Off Power Mgmt Normal Print Screen Parameter Both To access the next displayed parameter gt short press CO2 Scale 6 99 CO2 Units FiCO2 OH Power Mamt Normal Print Screen Parameter Both To change the parameter s setting NY AN C short press C02 Scale 6 99 CO2 Units FicO2 D I Power Mgmt Normal Print Screen Parameter Both To exit and return to the Measuring mode at any point in the Instrument Settings menu Kal long press To exit and return to the Alarm gt COs Scale 8 14 Limits menu
2. Performance Capnograph Performance Parameter Value Sampling Rate CO Range Accuracy EtCO readings Respiration Rate Warm up Time Frequency Response System Response Time Rise Time Neonate Adult Ambient Pressure Alarms 50 ml min 0 99 mmHg 0 13 2 kPa and 0 13 0 Vol at sea level From power up until steady state is reached the CO reading accuracy is 0 38 mmHg 4 mmHg 39 99 mmHg 12 of reading The CO reading reaches its steady state accuracy 20 minutes after power up 0 38mmHg 2 mmHg 39 99 mmHg 5 of reading 0 08 for every 1 mmHg above 40mmHg 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 includes delay time and rise time 190 msec with low dead space endotracheal tube adapter 240 msec with FilterLine airway adapter Compensated internally automatic EtCO high EtCO low RR high RR low FiCO high No Breath Portable Bedside Capnograph Pulse Oximeter 83 Specifications Display Update Interval 2 seconds Pulse Oximeter Parameter Value SpO 0 100 SpO Saturation Range Saturation SpO 1 SD Accuracy OxiMax oxygen tra
3. 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 6 on page 49 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 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 audible alarms are turned off e CO2 CO audible alarms including No Breath message are turned off SpO2 SpO alarms and pulse tone are turned off PAT Patient Both CO including No Breath message and SpO gt alarms are turned off Pulse Pulse tone is turned off and the alarm silence is not lit Refer to Institutional Settings on page 55 Note 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 Institutio
4. Sample line 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 FilterLine Recognition Safeguard When the FilterLine is attached to the monitor the FilterLine Recognition Safeguard FRS identifies the FilterLine and activates the pump thus enabling measuring Airway Adapter The airway adapter design provides multiple channels for the sampled air from the airway minimizing the possibility of water Portable Bedside Capnograph Pulse Oximeter 17 Overview 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 Pulse Oximetry Operating Principles Pulse oximetry is based on two principles 1 oxyhemoglobin and deoxyhemoglobin which differ in their absorption of red and infrared light spectrophotometry and 2 changes in the volume of arterial blood in tissue during the pulse cycle plethysmography and hence light absorption by that blood A pulse oximeter determines SpO by passing red and infrared light into an arteriolar bed and measures changes in light absorption during the pulsatile cycle Red and infrared lowpower light
5. commercial and or hospital 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 Portable Bedside Capnograph Pulse Oximeter Electrical 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 IEC 60601 1 2 Compliance Electromagnetic Test Test Level Environment Guidance Conducted 3 Vrms 3 Vrms Portable and mobile RF RF IEC 150 kHz to 80 communications equipment 61000 4 6 MHz should be used no closer to any part of the monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 VP Portable Bedside Capnograph Pulse Oximeter 91 Specifications Immunity IEC 60601 1 2 Compliance Electromagnetic Test Test Level Environment Guidance Radiated 3 V m 3 V m d 1 2NP 80 MHz to 800 MHz dee 3 80 MHz to 2 5 d 2 3 NP 800 MHz to 2 5 Ka GHz GHz where P is the maximum outpu
6. 40 kg single patient use MAX I 3 to 20 kg MAX P 10 to 50 kg MAX A gt 30 kg MAX AL gt 30 kg MAX R gt 50 kg MAX FAST 40kg OxiMAx OxiCliq oxygen transducer P 10 to 50 kg single use only N lt 3 or gt 40 kg I 3 to 20 kg A gt 30 kg OXIMAX Dura Y multisite oxygen D YS gt 1 kg transducer Nonsterile reusable For use with Dura Y sensor Ear clip Reusable nonsterile D YSE 30 kg Pedi Check pediatric spot check clip Reusable nonsterile D YSPD 3 to4kg OxiMax Oxiband oxygen OXI A N lt 3 kg or gt 40 kg transducer OXI P I 3 to 40 kg Reusable with disposable nonsterile adhesive OxiMAX Durasensor oxygen DS 100A gt 40 kg transducer Nonsterile reusable 36 Portable Bedside Capnograph Pulse Oximeter Nellcor SpO2 Sensors Performance Considerations WARNING Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and patient conditions WARNING Tissue damage can be caused by incorrect application or inappropriate duration of use of an SpO sensor Inspect the sensor site as directed in the sensor Directions for Use WARNING Use only Nellcor approved sensors and pulse oximetry cables Other sensors or oximetry cables may cause improper monitor performance Inaccurate measurements can be caused by incorrect application of the sensor placement of the sensor on an extremity with a blood pressure cuff a
7. Gas Cal Check EtCO2 SpO296 digital display stabilize Connect Gas Cal Check i Calibration is not required if the measured value is the same as the concentration of the calibration gas 0 3 Vol of readings Portable Bedside Capnograph Pulse Oximeter 75 Maintenance Objective TT Result TTT To return to Ex Measuring mode if 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 the local representative for shipping instructions To repack the monitor disconnect the accessories from the instrument and wrap each item separately Pack them 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 sensors Microstream EtCO consumables or power cords If the monitor malfunctions carefully package the monitor with the consumable used at the time of malfunction and return it with the monitor for inspection Technical Assistance For technical information contact your local representative The Service Manual includes information that 1s required by qualified personnel to service the monitor 76 Portable Bedside Capnograph Pulse Oximeter Specifications Physical Environmental Safety Standards Compliance Manufactu
8. Introduction Provides interface to hospital nurse call systems 14 Portable Bedside Capnograph Pulse Oximeter Overview Principles of Operation FilterLine Pulse Oximetry Displays Controls and Connectors The monitor combines Oridion s Microstream capnography technology with Nellcor pulse oximetry technology Principles of Operation Capnography 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 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 EtCO gt consumables deliver a sample of the inhaled and exhaled gases from the ventilator consumable or directly from the patient via an oral nasal cannula 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 sampling flow rate reduces liquid and secretion accumulation decreasing the risk of obstruction in the sample pathway in humid ICU environments Once inside the Microstream CO sensor the gas sample goes through a micro
9. Surge IEC 61000 4 5 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode Guidance Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3095 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 Portable Bedside Capnograph Pulse Oximeter 89 Specifications Immunity Test IEC 60601 1 2 Test Level Compliance Level Electromagnetic Environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 Note 90 lt 5 UT 79594 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur 95 dip in Ur for 5 sec 3 A m lt 5 Ur 79595 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur 95 dip in Ur for 5 sec 3 A m Guidance Mains power quality should be that of a typical
10. and Power The wavelength range of the light emitted are near 660 nm and 890 nm with the energy not exceeding 15 mW 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 Therefore its RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment RF emissions Class B The monitor is suitable for use in all establishments including domestic establishments and those directly CISPR 11 connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emission IEC 61000 3 3 88 Portable Bedside Capnograph Pulse Oximeter Electromagnetic Immunity Electrical 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 IEC 60601 1 2 Compliance Immunity Test Test Level Electromagnetic Environment Electrostatic discharge ESD IEC 61000 4 2 Electric fast transient burst IEC 61000 4 4
11. communication 1 7 ft 0 5 m fluctuations flicker emission IEC cable contained in 048127 communication 100053 adapter kit Electrostatic discharge ESD 15 pin D type output 10 ft 3 m IEC 61000 4 2 connector cable Electric fast contained in 063755 transient burst D A Converter kit IEC 61000 4 4 RS232 monitor cable 1 7 ft 0 5 m Surge IE 61000 contained in 063755 4 5 D A Converter kit Conducted RF luxu ca E vl IEC 61000 4 6 060606 12 VAC 2 3 ft 0 7 m not adapter cable extended Radiated RF IEC 61000 4 3 94 Portable Bedside Capnograph Pulse Oximeter Electrical Sensors Cable Sensor Patient Type Maximum Complies Length with DEC 4 Extension 4 ft 1 2m RF emissions cable CISPR 11 Class DEC 8 Extension 8 ft 2 4 m B Group 1 cable Harmonic OxiMax Sensors emissions IEC 61000 3 2 MAX A Adult 1 5 ft 0 5 m Voltage MAX AL Adult longer 3 ft 0 9m fluctuations flic cable ker emission MAX P Pediatric 1 5 ft 0 5 m IEC 61000 3 3 MAX I Infant 1 5 ft 0 5 m Electrostatic discharge MAX N Neonatal Adult 1 5 ft 0 5 m ESD IEC MAX R Adult Nasal 1 5 ft 0 5 m 61000 4 2 MAX FAST Adult 2 5ft 0 8m Electric fast Forehead transient burst OxiMax SoftCareTM IEC 61000 4 4 SC PR Pre term infant 3 ft 0 9m Surge IE lt L5 kg 61000 4 5 SC NEO Neonatal 3 ft 09m Conduc
12. lTETTON Initial Setup eere eee Accessories cc enuunnuanuuuuRRRRRRRRRRRRRRRRE Basic Operation Communication Interface Troubleshooting 2 uses Maintenance er rrrr unum Specifications iso ERE Portable Bedside Capnograph Pulse Oximeter Table of Contents Safety Information css 7 Clg CN 7 I c MEC 7 MRI Scanning iieri ride dit ea 8 AlafMS et eee e etant beteren TE FEET 8 Fire Hazard aen ener nnee venen enen en en senenenn 9 Electa enisinia a aiai aii 9 Electro magnetic Interference 10 SVIMDOIS e X 10 Introduction ennen renerne rn enean aua REENEN 13 Monitor Features eee ennen nna ennensenn nuu 13 OVerVIOW EE 15 Principles of Operation oeessssesess 15 lee re TC le E 15 Microstream EtCO Consumables 16 IE E gEeEEEN 17 Pulse Oximetry eorr o ponto rtt arua pen ringe 18 Displays Controls and Connectors 21 Initial Setup elie i nes 23 Power Requirements nn nnananne nnen enenenenennenenennenen 23 Battery and Power Usage nnen 24 Battery Pack tec dette e render eade 24 Unpacking and Inspection suus 26 Components sss 26 Optional Accessori S nanne eenen e
13. to access the information screen in the Service mode The battery pack should be replaced once every two years Portable Bedside Capnograph Pulse Oximeter 71 Maintenance Table 17 Accessing the Service Mode Objective Action Result To access the During Self Test Service mode press and hold simultaneously A D I d n Of mm p and Self Test Service Mode 12345 Operating Hours 5 783 COS WX XX SpOs WX XXX Note Contact your local representative 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 The Troubleshooting section on page 61 discusses potential difficulties their possible causes and suggestions for resolving them Contact your local representative for service instructions and performance tests and checks CAUTION The monitor must be returned for repair if the Check Unit message appears 72 Portable Bedside Capnograph Pulse Oximeter Cleaning 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 CAUTION Microstream EtCO consumables are designed for single patient use and
14. use carefully read the sensor Directions for Use including all warnings cautions and instructions Do not use a damaged sensor Do not use a sensor with exposed optical components Use only Nellcor sensors for Sp measurements Other sensors may cause improper monitor performance Note Biocompatibility testing has been performed on the materials used in Nellcor pulse oximetry sensors per ISO 10993 1 and found to be compliant Nellcor pulse oximetry sensors contain light emitting diodes LEDs that emit red 660 nm and infrared 900 nm light with a total optical output power of less than 15 mW 34 Portable Bedside Capnograph Pulse Oximeter Nellcor SpO2 Sensors This information of sensor wavelength range can be especially useful to clinicians e g those performing photodynamic therapy Sensor LED light output falls within Class 1 Level per IEC 60825 1 2001 Safety of Laser Products no special safety precautions are needed Selecting Nellcor SpO Sensors When selecting a sensor consider the patient s weight and activity the adequacy of perfusion the available sensor sites and the anticipated duration of monitoring The sensor models are summarized in Table 2 For further information please contact your local representative Portable Bedside Capnograph Pulse Oximeter 35 Accessories Table 2 Nellcor SpO Sensors Oxygen Sensor Model Patient Weight OxiMax oxygen transducer MAX N lt 3 kg or gt
15. verify the proper functionality of Nellcor pulse oximeter sensors cables and monitors See the individual testing device s Operator s Manual for the procedures specific to the model of tester being used While such devices may be useful for verifying that the pulse oximeter sensor cabling and monitor are functional they are incapable of providing the required data needed to properly evaluate the system s SpO gt reading accuracy Fully evaluating SpO reading accuracy requires at a minimum accommodating the wavelength characteristics of the sensor and reproducing the complex optical interaction of the sensor and patient s tissue capabilities beyond the scope of known bench top testers SpO2 accuracy can only be evaluated in vivo by comparing pulse oximeter readings with values traceable to SaO measurements obtained from simultaneously sampled arterial blood made using a laboratory CO oximeter Many functional testers and patient simulators have been designed to interface with the pulse oximeter s expected calibration curves and may be suitable for use with Nellcor monitors and or sensors Not all however are adapted for use with the Nellcor OxiMax digital calibration system While this will not affect use of the simulator for verifying system functionality displayed SpO gt values may differ from the setting of the test device For a properly functioning monitor this difference will be reproducible over time and from monitor to mo
16. 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 w 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 battery pack Itis 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 CAUTION Important The following information relates to the safe handling storage and disposal of the monitor battery pack Portable Bedside Capnograph Pulse Oximeter Power Requirements Battery T
17. 4 PC Digital to Analog Converter Nurse Call Interface Kit MSM Interface Kit provides remote paging and central station networking to Oxinet III and MSM Bernoulli systems 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 Note The Digital to Analog converter does not communicate O saturation WARNING WARNING 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 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 When using the printer PC with mains line power it is recommended to use a medical grade power supply complying with the following standards EN60601 1 UL 60601 1 CSA C22 2 No 601 1 M90 Ifthe power supply is not medical grade the printer must be placed at least 1 5 meters from the patient environment to comply with standard EN60601 1 1 Portable Bedside Capnograph Pulse Oximeter 59 Troubleshooting Alarms and Messages Troubleshooting Guide This section lists the alarms and messages and the corresponding actions the operator sho
18. 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 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 Portable Bedside Capnograph Pulse Oximeter 81 Specifications item Compliant With emissions Electrostatic discharge immunity Radiated radio frequency electromagnetic field immunity Electrical fast transient burst immunity Surge immunity Conducted EMI susceptibility Power frequency magnetic fields Laser Safety Operation with line voltage variations 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 IEC 61000 4 6 at 3 V m IEC 61000 4 8 at 3A m The sensor LED light output falls within Class I level according to 60825 1 2001 No special safety precautions are required IEC 61000 4 11 Manufacturer s Declaration WARNING The use of accessories transducers sensors and cables other than those specified may result in increased emission and or decreased immunity of the equipment and or system 82 Portable Bedside Capnograph Pulse Oximeter
19. Ca Units Volz i long press AS EP Power Mamt Normal Print Screen Parameter Both Portable Bedside Capnograph Pulse Oximeter 53 Basic Operation Table 10 Changing Instrument Settings Menu 2 Objective Action Result To access the Instrument p Check Cal OTT Settings menu 2 From Language English long press x3 FactoryDef OH any measuring display the 1 long press accesses the Alarm Limits menu The 2rd long press accesses the Instrument Settings menu 1 The 3 long press accesses the Instrument Settings menu 2 To change the check cal NA Check Cal option Cc Language English Factory Def OH short press To access the language gt Check Cal option Language short press Factory Def To switch languages VN Check Cal Cc Language rancals Factory Def OH short press desired language appears 54 Portable Bedside Capnograph Pulse Oximeter Instrument Settings Menus Institutional Settings The factory default parameter settings in Table 11 below can be changed by your local service representative Table 11 Institutional Settings Factory Default Setting Alarm Default Settings See Table 4 Factory Default Alarm Range Values on page 46 3 Min Alert OFF to remind user that alarms are set to off BTPS body temperature ON pressure saturation assumed 37 C 47mmHg Pulse Tone OFF Pump Off 15 minutes Sp
20. O alarm limits can only be permanently changed in the Institutional Settings menu between 80 100 Calculations are made according to PCO FCO x Pb 47 Where FCO is the Fractional concentration of CO in dry gas FCO CO2 100 Pb the ambient pressure PCO the partial pressure of CO at BTPS Portable Bedside Capnograph Pulse Oximeter 55 Basic Operation MRI Scanning WARNING Do not use Nellcor oximetry sensors during magnetic resonance imaging MRI scanning Conducted current could cause burns The sensors may affect the MRI image and the MRI unit may affect the accuracy of oximetry measurements 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 attaching the FilterLine 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 10 cm 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 magn
21. Q NELLCOR OXIMAX N 35 Operator s Manual Portable Bedside Capnograph Pulse Oximeter Operator s Manual Portable Bedside Capnograph Pulse Oximeter Notice Purchase of this instrument confers no express or implied license under any Oridion Medical patent or Nellcor Puritan Bennett 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 6 491 643 6 656 127 6 168 958 5 300 859 and 4 755 675 and their foreign equivalents LO KO HATH ORF 1980816 t HI C OO FED SOILED TIR ENTEN ET Microstream and FilterLine are registered trademarks and Smart CapnoLine CapnoLine Smart BiteBloc and NIV Line are trademarks of Oridion Medical 1987 Ltd Nellcor Puritan Bennett Incorporated is an affiliate of Tyco Healthcare The following are trademarks of Nellcor Puritan Bennett Incorporated Oxiband Durasensor OxiCliq Dura Y and OXIMAX Pulse Oximetry is covered by one or more of the following US patents and foreign equivalents 4 802 486 4 869 254 4 928 692 4 934 372 5 078 136 5 485 847 5 743 263 5 865 736 6 035 223 6 298 252 6 463 310 6 591 123 6 675 031 6 708 049 6 801 797 Re 35 122 010191 B 07 06 Contents Safety Information EE Ken Introduction EEN KE KEE ERR e VC
22. Safety Information Warnings Symbols To use the portable capnograph pulse oximeter monitor correctly and safely carefully read this operator s manual and the Directions for Use for the SpO sensors and 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 uncertain about the accuracy of any measurement check the patient s vital signs by alternate means 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 SpO sensor and FilterLine to reduce the possibility of patient entanglement or strangulation Do not lift the monitor by the SpO gt sensor cable or FilterLine as they 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 The use of accessories transducers sensors and cables other than those specified may result in increased emission and or decreased immunity of the equipment and or system Portable Bedside Capnograph Pulse Oximeter 7 Safety Information WARNING CO readings respiratory rate pulse
23. UTION 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 ECO consumables and retired Nellcor pulse oximetry sensors according to standard operating procedures or local regulations for the disposal of contaminated medical waste Portable Bedside Capnograph Pulse Oximeter 33 Accessories WARNING The FilterLine may ignite in the presence of O 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 e ntubated 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 EtCO Consumables Directions for Use for proper connection Nellcor SpO Sensors WARNING WARNING WARNING Before
24. a scavenger system The monitor is not suitable for use in the presence of flammable anesthetic mixture with air oxygen or nitrous oxide 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 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 To ensure patient electrical isolation connect only to other equipment with circuits that are electrically isolated 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 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 to the patient through the Communication Adapter must be distanced from the patient environment by at least 1 5 m Portable Bedside Capnograph Pulse Oximeter 9 Safety Information 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 re
25. able with O delivery NIV Line for use under oxygen CPAP Bi PAP or NPPV mask Smart BiteBloc for use during upper endoscopy procedures Note Smart products provide oral and nasal sampling H products are for long term use 16 Portable Bedside Capnograph Pulse Oximeter FilterLine Special Procedure FilterLines FilterLine XL Provides extended length so that the monitor can be used safely during MRI see page 56 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 proved challenging to capnography in ICU emergency and intra transport applications These elements are 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 extremely 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
26. anus 77 Physical eese eese eaae nnn tnn nn anna ann 77 hl 77 Welg iui sure eno raritas 77 Noise Emiseion 77 ENVITONMCN 5 440 rer 77 Temperature 77 Pressure and Altitude for operating and storage 78 Portable Bedside Capnograph Pulse Oximeter Transport and Storage sss 78 OxiMax Sensor Power Dissipation 79 Safety Standards eene 79 Compliance e 80 ISO 9919 2005 Compliance 000000000nnoananaeaneeaa 80 Manufacturer s Declaration enne 82 Performance nnnuunnenseenseenseerserenseenseenseersoersnersnervsoens 83 lee e TE ET 83 Display Update Internal 84 Pulse Oximeter nnn nnen nennen ennen nennen eenn 84 Power Specifications eese 87 External Power Source nnn ennen eneen 87 Internal Power Source aaneen neee eenen 87 Electrical 88 Instrument 88 OxIMAX Sensors 88 Electromagnetic EMISSIONS seeee ee 88 Electromagnetic Immunity sess 89 Electromagnetic Immunity ssssse 91 Recommended Separation Distances 93 Electric and Communication Cables 94 Te 95 Components and User Interface 97 DI eene 97 Controls and Indicators nnn eenen 97 eee e aderen beeke aande edad 97 Portable Bedside Capnogra
27. 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 the 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 Itis 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 Note No calibration of the pulse oximetry portion of the monitor is required Portable Bedside Capnograph Pulse Oximeter 73 Maintenance 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 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 Scott Medical part number 0304653ORFBD consisting of e Calibration Gas containing 5 CO 21 O2 Tubing Adapter 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 Calib
28. asonable 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 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 Symbols 10 The following symbols appear on the monitor and monitor LCD liquid crystal display Symbol See Directions for Use De Gas Outlet d Defibrillator proof Type BF equipment LI patient electrically isolated Audible Alarms Off Portable Bedside Capnograph Pulse Oximeter EtCO2 SpO AN RS 232 Pump Off On Symbols Plug Icon Battery Icon End tidal carbon dioxide value Oxygen saturation value DC Input Refer to manual for connector interface and other information Pump Off Portable Bedside Capnograph Pulse Oximeter 11 Introduction Monitor Features This manual provides directions for setup and operation of the mo
29. atient movement presents a problem try one or more of the following remedies Verify that the sensor is properly and securely applied Move the sensor to a less active site Use an adhesive sensor that tolerates some patient motion Useanew sensor with fresh adhesive backing If poor perfusion affects performance consider using the MAX R sensor it obtains measurements from the nasal septal anterior ethmoid artery an artery supplied by the internal carotid This sensor may obtain measurements when peripheral perfusion is relatively poor Portable Bedside Capnograph Pulse Oximeter 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 FiCO user selected SpO and pulse rate 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 EtCO warning is according to the value in the 7 Segment display The SpO and ECO values are shown in the digital displays Waveform or trends respiratory rate and pulse rate values are shown in the graphic dis
30. beat and shows the relative non normalized pulse amplitude As the detected pulse becomes stronger more bars light up with each pulse This indicator is only available in the CO Waveform screen SpO Trends The trends graphs represent data of the last 30 minutes or 8 hours 15 second or 4 minute resolution respectively SpO gt values appear on the digital display The respiration and pulse rate values are shown on the graphic display Graphic Display Screen Contrast The LCD contrast intensity can be adjusted during Measuring mode To adjust the contrast press on the contrast button C5 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 Portable Bedside Capnograph Pulse Oximeter 43 Basic Operation Displayed Data Options Table 3 Display Screens TO View Press Result CO waveform Appears automatically CO Trend 30 min 13 short press CO Trend 8 hr and short press Meter Mode 31d short press Plethysmograph t 4 th short press SpO gt Trend 30 min t 5th short press t SpO gt Trend 8 hr 6th short press CO waveform t 7th short press Note To return to CO waveform from any
31. bility of patient entanglement or strangulation When using the monitor with anesthetics such as high concentrations of oxygen or nitrous oxide 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 and Nellcor SpO gt sensors to ensure that the monitor functions properly Do not connect anything other than an SpO sensor to the sensor port for example do not attempt to connect a PC to the monitor at the sensor port Portable Bedside Capnograph Pulse Oximeter 27 Initial Setup 28 Preparation Prior to start up l Slide open the FilterLine input connector shutter and connect the appropriate FilterLine Connect the appropriate Nellcor SpO sensor firmly into the sensor port Connect the FilterLine and Nellcor Sp sensor to the patient as described in the Directions for Use If needed use a Nellcor SpO sensor extension cable model DEC 4 or DEC 8 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
32. e Base New Time Base Base Change Condition 6 seconds gt 35 bpm for 10 seconds 3 seconds 3 seconds lt 25 bpm for 10 seconds 6 seconds Any Initialization No Breath or 6 seconds blockage 40 Portable Bedside Capnograph Pulse Oximeter Data Display Screens 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 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 8 hours 5 second resolution is relevant for the print PC option only During the 8 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 Autoscale 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 e When the monitor is turned on a trend data border will mark the end of the previous tre
33. e pump is currently off FilterLine tube twisted or clogged FilterLine is not connected to the instrument Monitor automatically performs a zero point calibration SpO gt is ready for measurement CO module is preparing itself for operation Monitor requires calibration Sensor is not connected to the instrument User mistakenly activated Demo mode Activate the E by one long press Check the FilterLine and if necessary untwist or replace it Connect FilterLine to input connector No action required Wait for Ready message before measuring for EtCO No action required Calibrate Unit Check sensor and sensor extension cable connection and or sensor placement on patient Reset the monitor by sliding the on off switch to the off position and then to the on position Portable Bedside Capnograph Pulse Oximeter 65 Troubleshooting Possible Causes BTPS On Ready FiCO XX CO Off SpO Off 6 sec 3 sec Press Fi erase BTPS setting is on SpO and CO modules are operational but neither pulse nor breath are detected Note If BTPS is set to OFF only Ready appears The FCO value xx mmHg or x x Vol or kPa Activated by user CO function is temporarily disabled only SpO gt is being measured SpO function is temporarily disabled only CO is being measured Patient setting for Adult mode or respiration rate is low Pat
34. ecommended Separation Distances Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the monitor IEC60601 1 2 Rated Separation distance according to frequency maximum of transmitter output power 159 kHz to 80 80 MHz to 800 800 MHz to 2 5 of transmitter m MHz MHz GHz d 1 2NP d 12NP d 2 3NP 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 metres 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 Pulse Oximeter 93 Specifications Electric and Communication Cables Cables and Maximum Complies OxiMAX Sensors Length with 791001 Power cord 10 ft 3 m e RF emissions North America CISPR 11 Class B Group 1 RJ11 communication 10 ft 3 m Harmonic cable contained in emissions IEC 048127 communication 61000 3 2 adapter kit Voltage RJ45
35. efore any patient input has been detected by the monitor or during operation The message appears on the screen followed by The alarm bar will display a yellow light and a special one time advisory tone is heard Table 14 Advisory Messages below Table 14 Advisory Messages Message Possible Causes Check Unit Instrument fault Check CO CO module fault Contact authorized service representative Check SpO SpO module fault Battery Empty Battery pack is Replace or recharge discharged the battery or connect to AC power Pump Off xxx The pump is currently Restart pump off timer off by one long press Battery Message appears when Prepare to replace or battery charge level is low approximately 40 minutes left recharge the battery or connect to AC power xxx is the remaining time in seconds until the pump turns back on 64 Portable Bedside Capnograph Pulse Oximeter Silent Advisories Alarms and Messages Silent Advisories are instrument status messages indicating the operational state of the monitor or accessories Silent advisories are low priority signals and only a message appears with no exclamation marks and no other visual or audible indicator See Table 15 Silent Advisory Messages Table 15 Silent Advisory Messages Possible Causes Pump Off Clearing FilterLine FilterLine Autozero CO Warm up Calibration Required SpO Sensor Demo Th
36. emitting diodes LEDs in the oximetry sensor serve as light sources a photodiode serves as the photodetector Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial hemoglobin the monitor uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The monitor bases its SpO measurements on the difference between maximum and minimum absorption measurements at systole and diastole The focus of light absorption by pulsatile arterial blood eliminates the effects of nonpulsatile absorbers such as tissue bone and venous blood 18 Portable Bedside Capnograph Pulse Oximeter Pulse Oximetry Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies an oximeter must know the mean wavelength of the sensor s red LED to accurately measure SpO gt During monitoring the instrument s software selects coefficients that are appropriate for the wavelength of that individual sensor s red LED These coefficients are then used to determine Sp Additionally to compensate for differences in tissue thickness the light intensity of the senso
37. esting 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 Batteryv appears on the graphic display screen refer to Troubleshooting on page 61 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 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 Pulse Oximeter 25 Initial Setup Unpacking and Inspection 26 Components l 2 Remove the monitor and the accessories fro
38. et 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 56 Portable Bedside Capnograph Pulse Oximeter Standby 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 6 on page 49 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 A arm 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 1s suspended to facilitate drug delivery suctioning and equipment changes while avoidin
39. ettings Menus Instrument Settings Menu Parameters 50 Table 7 below and Table 8 on page 51 explain the user defined parameters that can be set from the Instrument Settings menus Table 7 Instrument Settings Parameters Menu 1 CO units Power Mgmt Print Parameter CO scale FiCO mmHg kPa Vol Full Display backlight on and 7 segments LEDs at high intensity Normal Display backlight on and 7 LEDs segments at normal intensity Low Backlight and 7 LEDs segments off Note During AC power power management appears as Full Screen the current display is printed Graphic Trend real time trend is printed in 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 8H with a resolution of 5 seconds Stored trend is communicated in tabular form CO Only SpO is disabled SpO Only CO is disabled Both CO and SpO function 0 50 mmHg 0 7 kPa or Vol 0 99 mmHg 0 14 kPa or Vol Autoscale On display FiCO Off do not display FiCO Default Off Portable Bedside Capnograph Pulse Oximeter Instrument Settings Menus 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
40. f __ Possible Causes Instrument fault CO module fault SpO module operational SpO module fault CO module operational Message appears when battery charge level is very low approximately 15 minutes left FilterLine is disconnected or not securely connected to monitor Sensor or sensor extension cable may not be connected to monitor Sensor off patient or improperly placed Sensor not connected to extension cable Sensor or sensor extension cable may be damaged Contact authorized service representative Contact authorized service representative Contact authorized service representative Prepare to replace or recharge battery or connect monitor to AC power Connect FilterLine to CO input connector or tighten connection Connect sensor to monitor socket Place sensor properly on patient Connect sensor to extension cable Replace the sensor or sensor extension cable Portable Bedside Capnograph Pulse Oximeter 63 Troubleshooting Possible Causes Blockage FilterLine is twisted or clogged The message appears after 30 seconds of unsuccessful clearing of the FilterLine FilterLine airway connection is clogged Disconnect and reconnect the FilterLine Disconnect and replace with a new FilterLine Check the airway adapter and if necessary replace the FilterLine Advisory Messages Advisories are informative messages appearing at start up b
41. g 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 p mode by long pressing T once Press dg Resume Monitoring Figure 7 Pump Off Portable Bedside Capnograph Pulse Oximeter 57 Basic Operation Note During Pump Off mode the CO parameter is dashed and the SpO function operates normally Note 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 Ka except during the last two minutes 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 be disabled One long press n Figure 8 Pump Off resets Pump Off mode to the Additional Time default time Another long press Ka will exit the Pump Off mode Pump Off On Label The Pump Off adhesive label is included in the monitor packaging Adhere the label to the monitor as shown in Figure 1 Monitor Front View on page 21 Pump Off On Figure 9 Pump Off On Label 58 Portable Bedside Capnograph Pulse Oximeter Communication Interface The monitor can integrate data to the following devices Communication Adapter Kit Printer Seiko DPU 41
42. h xxx ELCO fur EtCO V RR RR n SpO Tu SpO Y Pulse 4 Pulse FiCO xx No valid breath has been detected for xxx seconds The EtCO exceeded the EtCO high alarm limit The EtCO fell below the EtCO low alarm limit The RR exceeded the RR high alarm limit The RR fell below the RR low alarm limit The SpO exceeded the SpO high alarm limit The SpO fell below the SpO gt low alarm limit The pulse rate exceeded the pulse rate high alarm limit The pulse rate fell below the pulse rate low alarm limit The FiCO exceeded the FiCO high alarm limit First check the patient then ventilation equipment if used and then the alarm settings refer to Alarm Limits Menu on page 47 xxx the number of seconds elapsed since the last valid breath has been detected The FCO value is displayed if selected in the Instrument Settings menu 1 See Table 7 page 50 62 Portable Bedside Capnograph Pulse Oximeter Cautions Alarms and Messages Caution messages appear during Measuring mode and 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 Table 13 Check Unit Check CO Check SpO Battery Vr t FilterLine SpO Sensor Table 13 Caution Messages _Message_ f
43. ickel 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 7 on page 50 for a description of the power management options WARNING Use only the medical grade AC adapter provided by the manufacturer 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 Pulse Oximeter 23 Initial Setup 24 Battery and Power Usage If power is lost when the monitor is operating from AC power it automatically switches to its internal battery pack A plugshaped icon D 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
44. ide Capnograph Pulse Oximeter 85 Specifications Parameter Value Accuracy Specifications Accuracy specifications are based on controlled hypoxia studies with healthy non smoking adult volunteers over the specified saturation SpO range Pulse oximeter SpO readings were compared to SaO values of drawn blood samples measured by hemoximetry All accuracies are expressed as X digits This variation equals one standard deviation 1SD which encompasses 68 of the population Neonatal Accuracy When sensors are used on neonatal subjects as recommended the specified accuracy range is increased by 1 digit to account for the theoretical effect on Oximeter measurements of fetal hemoglobin in neonatal blood Pulse Rate Range Perfusion Range Pulse Rate Accuracy 20 250 beats per minute bpm 0 03 to 20 3 bpm Note Pulse rate accuracy is expressed as t 3 bpm across the display range This variation equals 1 standard deviation 1SD which encompasses 68 of the population Alarms SpO high SpO low Pulse high Pulse low 86 Portable Bedside Capnograph Pulse Oximeter Power Specifications Parameter Value Reading accuracy in the presence of low perfusion detected IR pulse modulation amplitude lt 1 5 was validated using signals supplied by a patient simulator SpO and pulse rate values were varied across the monitoring range over a range of weak signal conditions and compared to known
45. ient setting for Neonate mode or respiration rate is high Trend screen displayed CO Trend 8 hrs SpO Trend 8hrs CO Trend 30 min SpO Trend 30 min No action required No action required For CO measurements go to Parameter option at Setup menu For SpO measurements go to Parameter option at Setup menu No action required No action required No action required To erase trends press and hold Kal until message disappears 66 Portable Bedside Capnograph Pulse Oximeter Troubleshooting Guide Troubleshooting Guide Table 16 Troubleshooting Guide below lists potential problems you may experience while using the monitor and suggestions for resolving them If you are unable to correct the problem contact qualified service personnel or your local representative Table 16 Troubleshooting Guide Monitor does not turn on Monitor switches on but then switches off automatically EtCO values read erratically Power cable improperly attached or disconnected or cable has faulty electrical connection Battery pack may be discharged The battery 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 Mechanically ventilated patient who breathes spontaneously A leak in the airway Check power cable connection a
46. ltaneously measure CO and SpO There is an option to individually measure either CO or SpO as follows e CO Accessed during Self Test Table 1 page 30 or from the nstrument Setup menu see Basic Operation on page 39 e SpO Accessed during Self Test Table 1 page 30 or from the nstrument Setup menu see Basic Operation on page 39 Note Every time the monitor is turned on it automatically reverts to its default setting measuring both CO and SpO Portable Bedside Capnograph Pulse Oximeter 29 Initial Setup Table 1 Single Parameter Setup Options Display Startup measuring both CO No action required and SpO factory set option EtCO Lo E a Startup measuring only CO gt long press during Self Test Startup measuring only SpO F long press during Self Test 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 SpO gt readings on the digital displays Waveform respiration rate pulse rate and other information according to the selected screen see the Basic Operation section of this manual are shown on the graphic display A beep sounds once for each pulse beat The tone of the pulse beat varies in proportion to the saturation level If the saturation level is high the pitch is higher if the saturatio
47. m Limits Menu Alarm Limits Menu Table 5 explains how to access the Alarm Limits menu and to change the parameters and values CAUTION No Resp will appear as No Breath on the monitor display Table 5 Alarm Limits Objective Action Result EtCO2 F 58 f a FicCOa c 8 MoRespo3a To access the Alarm Limits menu from any measuring display long press RR RIO X 3 Sp02 Top 85 Pulse T 140 55 To change the patient VN Patient short press EtCO2 F 66 6 FiCO2 Ff 8 MoRespo2 0 RR T1150 12 Sp s T 95 x s Pulse T2800 op To access any displayed parameter short press To change the selected N A parameter s value CL short press RR RIS 12 Sp0e T 95 i 80 Pulse F200 i 100 FiCO2 F 8 NoResp 20 RR T1150 12 Sp0e F 95 x s Pulse T 288 To exit and return to Measuring mode at any point in the Alarm Limits menu long press If after 15 seconds no action is taken the display returns to Measuring mode The Neonatal mode is used when a patient s breath rate is gt 50 breaths per minute The default lower SpO alarm limit in the Neonatal mode is 80 however institutions may reset this limit to a greater value by following the information in the service manual under Default Alarm Limits xxx Long press the value advances quickly Portable Bedside Capnograph Pulse Oximeter 47 Basic Operation 48
48. m the box carefully Check that the items listed in the table 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 Protective Boot Carrying Case Clamp Rechargeable Battery Pack Microstream Capnograph Battery Charger Battery Pack Carrying Pouch 12 Volt Cable Communication Adapter Kit Calibration Gas Kit Service Manual Digital to Analog D A Converter Seiko DPU 414 Printer Nurse Call Interface Kit MSM Microstream Monitor Interface Kit Note For information on operating the monitor with any accessory refer to the specific accessory s Directions for Use Portable Bedside Capnograph Pulse Oximeter CAUTION Start Up and Self Test 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 CAUTION Do not lift the monitor by the SpO gt sensor cable or the FilterLine as they 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 patient cabling SpO sensor and FilterLine to reduce the possi
49. measuring display screen long press the Kal button 44 Portable Bedside Capnograph Pulse Oximeter Alarm Functions Alarm Functions WARNING Do not turn off the audible alarm or decrease the audible alarm volume if patient safety could be compromised Pressing the alarm silence button turns the audible 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 61 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 5 on page 47 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 SpO gt high and low levels Pulse rate high and low levels 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 Portable Bedside Capnograph Pul
50. n ennennen 26 Start Up and Self Test eessen 27 Prepatatlon an eec aaia 28 Initialization csse 28 2 Portable Bedside Capnograph Pulse Oximeter Single Parameter Setup Options 29 Measuring Modle eese eren nerne rener 30 Battery Pack and AC Operation 31 Quick Guide irit retenue eniti and 32 Pun 33 Microstream EtCO Consumables e 33 Basic Principles seeseeeeenenenneeeererrtnnsersrrrnn rennene 34 Nellcor SpO Sensors nnnnnnnarananannnenenenenenenenenenenen 34 Selecting Nellcor SpO Sensors 35 Performance Considerations 37 Basic Operation tineis inesse eo rk arre REELLE En 39 Data Display Screens esee 39 CO Waveform anneer aii 40 CO Time Bastanu nne A iede 40 e CM 41 Meter Mode seeren 42 Plethysmograph Waveform Display 42 SpO Data Update Period nn 42 Pulse Bar Amplitude Indicator 43 SPOs Trends eee es 43 Graphic Display Screen Contrast 43 Displayed Data Options ener rn nee 44 Alarm FUunctiOons noie era rele 45 AI IM 45 Factory Default Alarm Range Values 46 Alarm Limits Menu RSR 47 Alarm Silence nn
51. n level is low the pitch is lower 30 Portable Bedside Capnograph Pulse Oximeter Measuring Mode The monitor begins measuring 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 the Troubleshooting section of this manual EtCO gt readings between 3 0 7 0 mmHg adult mode or 3 0 5 0 mmHg neonatal mode appear as numerical values on the EtCO LEDs Readings 3 0 mmHg show as O zero on the LEDs The waveform appears on the graphic display for all ECO values Battery Pack and AC Operation 1 Connect only Microstream EtCO consumables and Nellcor Sp sensors to the monitor 2 Battery pack operation First switch the monitor on and check that the battery pack is charged at the Measuring mode check that the battery icon on the right side of the graphic display is full AC operation Connect the AC adap
52. n neen ennenene nennen en ennennen 48 Alarm Silence Standby Menu 49 Instrument Settings Menus eren 50 Instrument Settings Menu Parameters 50 CO Scale Autoscal neee ennen 51 User defined Parameters Stored as Defaults 52 Portable Bedside Capnograph Pulse Oximeter Changing Instrument Settings 52 Institutional Settings nnn ennen ennen 55 MRI Scanning 2257553 SALE ES REE DANSE SEE EA 56 Standby 57 Pump Off Meoede EET deni ro 57 Pump Off On Label naan cases siiis eene nnne 58 Communication Interface eeeeeesees 59 Troubleshooting ssir ainsana nasaan 61 Alarms and Messages eese eret 61 Alarm and Message Priorities 61 lUe 61 OE 63 Advisory Messages nennen eee 64 Silent Advisories eseeaseeeenens teener nens reerrnnrnn nnee 65 Troubleshooting Guide sss 67 Maintenance siosioina pana esa n a epar eu gna ae need 71 Periodic Maintenance seen 71 I Ea 72 73 Cali Da E 73 CO Calibration Check ennen nerne renen nunne nn ne 74 Returning the Monitor seen 76 Technical Assistance ren rr nano piane 76 Specifications a enes naar onte raria
53. nal Settings on page 55 If an alarm condition occurs when any corresponding alarm is disabled a message is generated on the monitor display Note 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 Portable Bedside Capnograph Pulse Oximeter Alarm Silence Standby Menu Alarm Silence Standby Menu Table 6 Alarm Silence Standby Objective a ReSUlt To access the Alarm Silence Standby menu from any measuring Ee display long press To change the silence NSA AN a SS short press To access any displayed p parameters short press To change the setting of v AN the selected parameter C short press To exit and return to measuring display at any point in the Alarm Silence Standby long press menu Alarm Silence All Alarms Ca Alarms Sp02 Alarms Pulse Tone Standby Alarm Silence All Alarms COz Alarms SpOz Alarms Pulse Tone Alarm Silence All Alarms COz Alarms Sp02 Alarms Pulse Tone Alarm Silence COs Alarms Sp02 Alarms Pulse Tone Standby 40 mmHg If after 15 seconds no action is taken the display returns to measuring mode Alarm silence limits are from 1 2 minutes Portable Bedside Capnograph Pulse Oximeter 49 Basic Operation Instrument S
54. nd 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 vertical line on the graphic trend printout When you enter a trend display a temporary message e Press yToEn35 appears for 3 seconds You now have the option to erase the old trends of all parameters as follows Press GE the message begins to flash and hold it until the message disappears This message will not appear during an alarm The EtCO and SpO values are simultaneously shown on the real time digital display The respiration and pulse rate values are shown on the graphic display Portable Bedside Capnograph Pulse Oximeter 41 Basic Operation Meter Mode The Meter mode screen includes the four numerical parameters for CO SpO respiration rate and pulse rate This mode is recommended in the following cases When the power management is Low see Table 7 page 50 e When the monitor display is exposed to direct sunlight affecting the digital display reading Plethysmograph Waveform Display The graph shows the changes in the blood s volume at the point of measurement The pulse rate and respiration rate are also displayed at the top of the graphic display screen The SpO values show on the digital display The display provides the non normalized real time sensor signal see the following section on Sp Data Update Period The relative pul
55. nd 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 No action needed Check for connection and line leaks to patient and correct if necessary Portable Bedside Capnograph Pulse Oximeter Troubleshooting EtCO values are consistently higher or lower than expected EtCO values are consistently higher or lower than expected Loss of pulse or SpO signal Zero display for oxygen saturation and pulse rate 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 BodyTemperature Pressure and Saturation Sensor is improperly applied to patient Patient s perfusion may be too poor Sensor or sensor extension cable may be damaged Excessive patient motion or electrosurgical interference Check patient Check ventilator and patient Check calibration See CO Calibration Check on page 74 Check BTPS setting on the graphic display after Power on Contact your local service representative Check sensor application Check the condition of the patient Replace
56. nitor The monitor is a portable bedside capnograph pulse oximeter that continuously monitors end tidal carbon dioxide EtCO respiratory rate RR fractional inspired carbon dioxide FiCO oxygen saturation SpO and pulse rate The unit is indicated 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 Combines a capnograph and pulse oximeter in a small portable lightweight monitor Measures and displays EtCO FiCO respiration rate SpO gt and pulse rate in one graphic and two digital displays Displays CO and SpO waveforms and trends Utilizes a wide range of Microstream EtCO consumables and Nellcor SpO sensors for all applications Operates on mains 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 Italian Dutch Swedish Norwegian and Portuguese Displays EtCO and FCO values in mmHg kPa or Vol Provides output for printer PC and Digital to Analog Converter Portable Bedside Capnograph Pulse Oximeter 13
57. nitor within the performance specifications of the test device 20 Portable Bedside Capnograph Pulse Oximeter Displays Controls and Connectors Displays Controls and Connectors Figure 1 Monitor Front View The numbered labels in Figure 1 are described below 1 2 ON nr A W SpO Connector Off On Switch Alarm Bar Digital Display of SpO Graphic Display Contrast Value Change Button Alarm Silence Alarm Silence Menu Button Next Menu Button 9 10 11 12 13 14 15 16 17 Portable Bedside Capnograph Pulse Oximeter Battery Pack FilterLine Input Connector Gas Outlet Digital Display of EtCO Photo Resistor Alarm Silence Indicator Port for AC Adapter or communication adapters Event Home Button Pump Off On Adhesive Label 21 Overview Figure 2 Monitor Rear View The numbered labels in iind 2 are described below FilterLine Input Battery Pack Release Connector Button 2 Clamp Connector 6 Battery Pack 3 Space for Quick Guide T SpO Connector Latch Adhesive Label 4 Serial Number Label 22 Portable Bedside Capnograph Pulse Oximeter Power Requirements Initial Setup Power Requirements Unpacking and Inspection Start Up and Self Test Single Parameter Setup Options Measuring Mode Quick Guide Power Requirements The monitor operates on batteries or on AC power It is equipped with a rechargeable N
58. nsducer single patient use MAX A 70 100 2 digits MAXAL 0 69 Unspecified MAX N 70 100 2 digits Adult 0 69 Unspecified MAX N 70 100 3 digits Neonate 0 69 Unspecified MAX P 70 100 2 digits 0 69 Unspecified MAX I 70 100 2 digits 0 69 Unspecified MAX R 70 100 3 5 digits 0 69 Unspecified MAX FAST 70 100 2 digits 0 69 Unspecified OXICLIQ oxygen transducer single patient use OxiCliq A 70 100 2 5 digits 0 69 Unspecified OxiCliq P 70 100 2 5 digits 0 69 Unspecified 84 Portable Bedside Capnograph Pulse Oximeter Performance Parameter Value OxiClig N Adult OxiClig N Neonate OxiClig I Reusable Sensor Models D YS Infant to Adult D YS Neonate D YS amp D YSE D YS amp D YSPD DS 100A OXLA N Adult OXI A N Neonate OXI P I 70 100 0 69 70 100 0 69 70 100 0 69 70 100 0 69 70 100 0 69 70 100 0 69 70 100 0 69 70 100 0 69 70 100 0 69 70 100 0 69 70 100 0 69 2 5 digits Unspecified 3 5 digits Unspecified 2 5 digits Unspecified 3 digits Unspecified 4 digits Unspecified 3 5 digits Unspecified 3 5 digits Unspecified 3 digits Unspecified 3 digits Unspecified 4 digits nspecified 3 digits c nspecified Portable Beds
59. ntion symbol consult accompanying documentation External case made with non conductive plastic No holes in case top Safety Standards IEC 60601 1 same as EN60601 1 CSA 601 1 UL 60601 1 ISO 21647 ISO 9919 Exception of Clause 50 102 and EN IEC 60601 1 2 Class I or II on AC power Internally powered on battery power Type BF Applied part Continuous 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 80 Portable Bedside Capnograph Pulse Oximeter Compliance item Compliant With 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 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 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 1 IEC 60601 1 sub clause
60. oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions WARNING The monitor is a prescription device and is to be operated by qualified healthcare personnel only MRI Scanning WARNING Do not use Nellcor oximetry sensors during magnetic resonance imaging MRI scanning Conducted current could cause burns The sensors may affect the MRI image and the MRI unit may affect the accuracy of oximetry measurements 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 using the FilterLine XL Refer to MRI Scanning page 56 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 appropriate for the patient being monitored WARNING Check the audible alarm silence duration before temporarily silencing the audible alarms 8 Portable Bedside Capnograph Pulse Oximeter Fire Hazard WARNING WARNING WARNING Electrical WARNING WARNING WARNING WARNING Warnings When using the monitor with anesthetics such as high concentrations of oxygen or nitrous oxide connect the gas outlets to
61. ph Pulse Oximeter List of Figures Figure 1 Monitor Front View 21 Figure 2 Monitor Rear View nennen eneen 22 Figure 3 Initialization Screen smsen 28 Figure 4 Self Test Screen cesser 29 Figure 5 Quick Guide nnn nonnen nennen ennen 32 Figure 6 Monitor Display Screen and LEDs 40 Figure 7 Pump Off rara cese nnne sene 57 Figure 8 Pump Off Additional Time nn 58 Figure 9 Pump Off On Label 58 List of Tables Table 1 Single Parameter Setup Options 30 Table 2 Nellcor SpO Sensors nnn naren eneen 36 Table 3 Display Screens nn nanne nennen ennenneneen 44 Table 4 Factory Default Alarm Range Values 46 Table 5 Alarm Lmmte esns 47 Table 6 Alarm Silence Standby nennen 49 Table 7 Instrument Settings Parameters Menu 1 50 Table 8 Instrument Settings Parameters Menu 2 51 Table 9 Changing Instrument Settings Menu 1 53 Table 10 Changing Instrument Settings Menu 2 54 Table 11 Institutional Settings annen 55 Table 12 Warning Messages 62 Table 13 Caution Messages 63 Table 14 Advisory Messages nennen 64 Table 15 Silent Advisory Messages 65 Table 16 Troubleshooting Guide sssssne neneeese ereenn 67 Table 17 Accessing the Service Mode 72 Table 18 CO Calibration Check 75 6 Portable Bedside Capnograph Pulse Oximeter
62. play Figure 6 Monitor Display Screen and LEDs If a parameter is turned off the related screens are skipped and that parameter s value of the display indicates OFF 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 D I and a short duration tone sounds The event is stored in the monitor s memory and will appear on the data printout marked by an asterisk CS on the tabular trend printout and as a horizontal line on the graphic trend printout Portable Bedside Capnograph Pulse Oximeter 39 Basic Operation Figure 6 Monitor Display Screen and LEDs There are seven graphic display screens refer to Table 3 on page 44 e CO Waveform Plethysmograph e CO Trend 30 SpO Trend 30 minutes minutes e CO Trend 8 Sp Trend 8 hours hours Meter Mode CO Waveform The CO waveform screen displays real time CO waveform pulse bar numeric pulse and respiration rates The end tidal CO and SpO 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 6 seconds for Adult Mode 3 seconds for Neonatal Mode The instrument automatically changes the time base of the CO waveform according to the actual respiration rate as follows Current Time Tim
63. r Interface Displays Graphic LCD display 128 x 64 dots with LED backlight dimension 75 mm x 53 mm Two numeric fields 3 digits each using 7 segment LED dimension 22 mm x 14 mm Alarm bar yellow red Controls and Indicators Parameter Value Front Panel On off switch Alarm Silence Alarm Silence Menu button Contrast Value change button Event Home button Next Menu button Connections Parameter Value Front Panel CO Input connector Top Panel SpO Input socket Rear Panel Clamp connector Side Panel Power supply communication adapter port gas outlet Portable Bedside Capnograph Pulse Oximeter 97 Package Components Portable Bedside Capnograph Pulse Oximeter Package Components Capnography Pulse Oximetry monitor ECO Sample Kit Sp Sensor Assortment Pack or Reusable Sensor Sensor Extension Cable Power Cord Power Supply Operation Manual English only Operation Manual CD operation manual in 17 languages Other documentation Quick Guide Sticker Pump Off Label amp NELLCOR Tyco Healthcare Group LP Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton CA 94588 USA Authorized Representative Tyco Heathcare UK LTD 154 Fareham Road Gosport PO13 OAS U K 2006 Nellcor Puritan Bennett Inc All rights reserved C 0123 tyco 10007023B 0806 Healthcare
64. r s LEDs is adjusted automatically Functional versus Fractional Saturation This monitor measures functional saturation oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen It does not detect significant amounts of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin In contrast laboratory hemoximeters report fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin including measured dysfunctional hemoglobins To compare functional saturation measurements to those from an instrument that measures fractional saturation fractional measurements must be converted as follows fractionalsaturation functionalsaturation x100 100 carboxyhenvglobin methemogldin Measured versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen PO the calculated value may differ from the SpO measurement of a pulse oximeter This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO and saturation pH temperature the partial pressure of carbon dioxide PCO 2 3 DPG and fetal hemoglobin Portable Bedside Capnograph Pulse Oximeter 19 Overview Use of Functional Testers and Patient Simulators Some models of commercially available bench top functional testers and patient simulators can be used to
65. ration Check mode disables this correction CAUTION 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 Note If this process is performed while a battery powers the device make sure that the battery is fully charged Note Prior to calibration verify that the Calibration Line supplied with the Calibration Kit is firmly attached 74 Portable Bedside Capnograph Pulse Oximeter CO2 Calibration Check Start the process from the Setup menu as described in Table 18 Table 18 CO Calibration Check Objective Action NCL Access Instrument Settings menu Change option to start Start Check Cal An Autozero process begins Start Cal Check process Check the measured values shown in Vol in the EtCO gt long press x3 long press x2 for software versions prior to 2 7 gt NAAN Cc short press short press Connect the calibration gas via the connecting means Press the gas valve for 15 seconds until the readings Check Cal Language English Factory Def OH Check Cal Star t Language English Factory Def OH Autozero Please Wait EN EtCO2 SpO2 96 Connect
66. readings If the CO scale is not appropriate the waveform will be either incomplete or small CO Scale Autoscale When Autoscale is selected the CO scale changes as follows From lower to higher scale after 12 consecutive breaths with EtCO values greater than low level scale limit From higher to lower scale after 12 consecutive breaths with EtCO values less 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 Stored as Defaults on page 52 Table 8 Instrument Settings Parameters Menu 2 Languages English French German Spanish Italian Dutch Swedish Norwegian and Portuguese Check Cal Off Start See the CO Calibration Check section Table 18 CO Calibration Check Page 75 Factory Off Start Delt This option will reset the device to the factory default settings Portable Bedside Capnograph Pulse Oximeter 51 Basic Operation 52 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 e CO Scale e CO Units CO Mode Patient Print Language Power Management
67. rer s Declaration Performance Pulse Oximeter 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 850 grams 1 87 Ib including battery pack Noise Emission maximum 45 dB A Environmental Temperature Operating 0 C to 45 C 32 F to 113 F Relative Humidity 10 to 95 non condensing Storage 35 C to 70 C 31 F to 158 F Portable Bedside Capnograph Pulse Oximeter 77 Specifications Pressure and Altitude for operating and storage Parameter Value 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 Relative Humidity 10 to 95 non condensing 78 Portable Bedside Capnograph Pulse Oximeter OxiMAx Sensor Power Dissipation Safety Standards MET jai SIDatiOn OxiMAx MAX N OxiMAx MAX I OxiMAx MAX P OxiMAx MAX A OxiMax MAX AL OxiMAx MAX R OxiMax Oxiband OXI A N OxiMAX Oxiband OXI P I OxiMAX Durasensor DS 100A OxiMax OxiCliq P OXIMAX OxiCliq N OXIMAX OxiClig I OXIMAX OxiCliq A OXIMAX Dura Y D YS O
68. rterial catheter or intravascular line ambient light prolonged and or excessive patient movement interavascular dyes or externally applied coloring such as nail polish or pigmented cream failure to cover the sensor site with opaque material in high or ambient light conditions Loss of pulse signal can occur for the following reasons the sensor is applied too tightly ablood pressure cuff is inflated on the same extremity as the one with the sensor attached there is arterial occlusion proximal to the sensor poor peripheral profusion Select an appropriate sensor apply it as directed and observe all warnings and cautions presented in the directions for use accompanying the sensor Clean and remove any substances such as nail polish from the application site Periodically check to ensure that the sensor remains properly positioned on the patient Portable Bedside Capnograph Pulse Oximeter 37 Accessories 38 High ambient light sources such as surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight can interfere with the performance of an SpO gt sensor To prevent interference from ambient light ensure that the sensor is properly applied and cover the sensor site with opaque material CAUTION Failure to cover the sensor site with opaque material in high ambient light conditions may result in inaccurate measurements If p
69. sample 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 Micro Beam IR source illuminates the micro sample cell and the reference cell This proprietary IR light source generates only the Portable Bedside Capnograph Pulse Oximeter 15 Overview specific wavelengths characteristic of the CO absorption spectrum Therefore no compensations are required when different concentrations of N20 Os anesthetic agents and water vapor are present in the inhaled and exhaled breath The IR that passes through the micro sample cell and the IR that passes through the reference cell 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 FilterLine Set for non humid environments FilterLine H set for humid environments Nasal Cannulas for Non intubated patients Smart CapnoLine Plus for use in procedural sedation Also available with O gt delivery Smart CapnoLine H Plus for use in post op pain management Also available with O delivery e CapnoLine H for patients receiving hi flow oxygen by mask on long term CPAP or Bi PAP or post op pain management Also avail
70. satile strength and quality of the incoming signal can be observed SpO Data Update Period The advanced signal processing in the algorithms automatically extends the amount of data required for measuring SpO and pulse rate depending on the measuring conditions During normal measurement conditions the averaging time is six to seven seconds approximately three seconds in Fast Mode The monitor automatically adjusts the signal processing during degraded conditions such as those caused by low perfusion interference e g external interference like ambient light electromagnetic interference and patient motion or a combination of these which results in an increase in the dynamic averaging beyond the minimum as set by monitor If the result of the dynamic averaging time exceeds 20 seconds for SpO the PULSE SEARCH indicator is illuminated solid and the SpO and pulse rate will continue to be updated every second As these conditions extend the amount of data required continues to increase If the dynamic averaging time for SpO reaches 40 seconds and or 50 42 Portable Bedside Capnograph Pulse Oximeter Data Display Screens seconds for Pulse Rate a low priority alarm state results the pulse search indicator begins flashing the SpO and pulse rate displays flash zeros indicating a loss of pulse condition and the audible alarm state 1s activated Pulse Bar Amplitude Indicator The Pulse Bar Amplitude Indicator indicates pulse
71. se Oximeter 45 Basic Operation Factory Default Alarm Range Values Table 4 lists the default values of the various alarm ranges These can be changed from the Alarm Limits menu CAUTION CAUTION Note Make sure that the monitor default alarm settings are appropriate for the specific patient being monitored The monitor will revert to its default alarm limit settings 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 nstitutional Settings on page 55 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 Table 4 Factory Default Alarm Range Values Parameter EtCO high EtCO low FiCO high RR high RR low No Breath delay SpO high SpO low Pulse rate high Pulse rate low Adult Default 60 8 0 0 8 1 1 150 3 30 100 85 140 55 Neonate Maximum Default 60 8 0 0 8 1 1 150 12 20 95 80 200 100 100 13 0 99 12 9 99 12 9 150 149 60 100 99 250 245 Minimum 0 10 21 20 5 0 No Breath appears in the Alarm Limits menu as No Resp See the Instrument Settings Menus on page 50 for a list of parameters that are set by the user and stored in the memory 46 Portable Bedside Capnograph Pulse Oximeter Alar
72. sensor or sensor extension cable If possible keep patient still Check whether the sensor is secure and properly placed Replace if necessary move the sensor to a new site or usea sensor that tolerates more motion 68 Portable Bedside Capnograph Pulse Oximeter Troubleshooting Guide Inaccurate SpO Excessive illumination measurements Sensor placement on an extremity that has a blood pressure cuff arterial catheter or intravascular line or nail polish Patient s condition Excessive patient movement Check sensor placement or cover sensor with a dark or opaque material Check sensor placement Check patient If possible keep patient still and use a sensor that tolerates more motion Portable Bedside Capnograph Pulse Oximeter 69 Maintenance Periodic Maintenance Service Cleaning Calibration CO Calibration Check Returning the Monitor Technical Assistance Periodic Maintenance Periodic maintenance is recommended according to operating hours Pump and Flow System should be replaced every 7 000 operating hours 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 17 on page 72 describes how
73. t power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol a Note 1 At 80 MHz and 800 MHz 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 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the monitor is used exceeds the applicable RF compliance level above the monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the monitor gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 92 Portable Bedside Capnograph Pulse Oximeter Electrical R
74. ted RF 1 5 5 kg TEC 61000 4 6 SC A Adult gt 40 kg 3 ft 0 9m Radiated RF IEC 61000 4 3 OxiMax Oxiband Sensors OXI A N Adult Neonatal 1 5 ft 0 5 m lt 3 kg or gt 40 kg OXI P I Pediatric Infant 3 ft 0 9m Sensor 3 40 kg OXIMAX Durasensor Sensors DS 100A Adult Finger 3 ft 0 9m Clip Sensor gt 40 kg Portable Bedside Capnograph Pulse Oximeter 95 Specifications Cable Sensor Patient Type Maximum Length Complies With OxiMax OxiCliq Sensors OC 3 OxiCliq Sensor Cable 3 ft 0 9m Pediatric 10 50 kg 3 ft 0 9m Neonatal Adult lt 3 kg or gt 40 kg 3 ft 0 9m Infant 3 20 kg 3 ft 0 9m A Adult gt 30 kg 3 ft 0 9m OXIMAX Dura Y Sensors D YS gt 1 kg 4 ft 1 2m D YSE Ear Clip for Dura Y Sensor 730 kg 4 ft 1 2m D YSPD 96 PediCheck Pediatric Spot Check Clip for Dura Y Sensor 3 40 kg Portable Bedside Capnograph Pulse Oximeter 4 ft 1 2m RF emissions CISPR 11 Class B Group 1 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flick er 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 Components and User Interface Components and Use
75. ter 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 5 Quick Guide on page 32 for all button functions 3 Adjust the parameters in the Alarm Limits menu Instrument Setup menu and A arm Silence menu to the values appropriate to the patient s condition Portable Bedside Capnograph Pulse Oximeter 31 Initial Setup Quick Guide The Quick Guide adhesive label is included in the monitor packaging Apply the label to the monitor as shown in Figure 2 Monitor Rear View on page 22 Quick Guide Power On Short Press Long Press Changes Displays Accesses Selects Parameters Menus CO2Waveform Pump Off Other Modes Home Erase Trend Changes Values Contrast Quick Scroll ce Menu Data Transfer ON OFF Accesses Silen Figure 5 Quick Guide 32 Portable Bedside Capnograph Pulse Oximeter Accessories Microstream EtCO Consumables Nellcor SpO Sensors Microstream EtCO Consumables FilterLine Set FilterLine H Set Smart CapnoLine and Smart CapnoLine Plus available with O delivery Smart CapnoLine H Plus available with O delivery CapnoLine H available with O delivery NIV Line Smart BiteBloc For a description of Microstream EtCO consumables see page 16 CAUTION Before use carefully read the Microstream EtCO consumables Directions for Use CA
76. true saturation and pulse rate of the input signals Reading accuracy in the presence of motion was validated in part in studies conducted on healthy adult volunteers under controlled laboratory conditions over the saturation range 70965 10096 Pulse oximeter Sp was compared to SaO measured to blood CO oximetry and PR was compared to EKG heart rate Sensors were fitted on the digits and optically shielded from one another with subjects instructed to move their fingers with tapping rubbing and non repetitive movements in response to a random noise at 1 4 Hz and with an amplitude of 1 to 2 cm 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 Parameter Value Operating Time fully Between 4 and 7 hours depending on power 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 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 Charger Type Internal Portable Bedside Capnograph Pulse Oximeter 87 Specifications Electrical Instrument Rated 100 250VAC 50 60HZ 0 5A OxiMax Sensors Wavelength
77. uld take The Troubleshooting section discusses potential problems and suggestions for resolving them If the problem persists and the message remains contact a qualified service person or your local representative Alarms and Messages The monitor displays the following four types of alarms and messages in order of priority Warnings e Cautions Advisories e Silent Advisories Alarm and Message Priorities The messages in the following tables Tables 12 15 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 a system alarm since the patient may not be monitored during certain alarm 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 Portable Bedside Capnograph Pulse Oximeter 61 Troubleshooting 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 12 Table 12 Warning Messages Message Possible Causes No Breat
78. 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 When turned on the monitor automatically performs a Self Test The display and alarm functions are tested Microstrear activating the LCD alarm bar seven segment displays alarm silence indicator and buzzer In this mode all Figure 3 Initialization alarms are disabled The Screen initialization screen displays for 5 seconds refer to Figure 3 Capnograph Pulse Oximeter Portable Bedside Capnograph Pulse Oximeter Single Parameter Setup Options 6 As the monitor continues to test its internal subsystems the Self Test screen appears refer to Figure 4 During this test there is an option to choose a single parameter operation This option is also available from the Setup Figure 4 Self Test menu see the Basic Screen Operation section of this manual During Self Test the EtCO and SpO LEDs show dashes When the monitor is ready and the FilterLine is connected the dashes in the FCO LEDs are replaced by numeric values If one or both the FilterLine consumable or SpO probe are not connected to the monitor dashes will appear on their respective LEDs Single Parameter Setup Options The monitor is preset at the factory to simu
79. xiMax MAX FAST 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW 52 5 mW Nellcor pulse oximetry sensors contain light emitting diodes LEDs that emit red 660 nm and infrared 900 nm light with a total optical output power of less than 15 mW This information of sensor wavelength range can be especially useful to clinicians e g those performing photodynamic therapy Sensor LED light output falls within Class 1 Level per IEC 60825 1 2001 Safety of Laser Products no special safety precautions are needed Safety Standards The monitor complies with EN60601 1 UL 60601 1 and CSA C22 2 No 601 1 M90 ISO 21647 and ISO 9919 Portable Bedside Capnograph Pulse Oximeter 79 Specifications Compliance ISO 9919 2005 Compliance When used with Nellcor OxiMax sensors and the appropriate Nellcor pulse oximetry cable the Portable Bedside Handheld Capnograph and Pulse Oximeter is compliant with ISO 9919 2005 with the following exceptions Clause 50 101 See SpO Data Update Period information in this document Clause 201 5 4 1 See Alarm Functions information in this document item Compliant With Equipment classification Type of protection Degree of protection Mode of operation Resistant to liquid ingress Degree of safety in presence of a flammable anesthetic Applied sensor label to indicate Type BF applied part Atte

N-85™ - MedWrench

Contents

Download Pdf Manuals

Related Search

Related Contents

N-85&trade; - MedWrench

Contents

Download Pdf Manuals

Related Search

Related Contents

N-85™ - MedWrench