Poet®IQ 8500H Agent Gas Analyzer Operator`s
Contents
1. 60 N20 Bal Np 634 Cal Gas Aerosol 1 Halothane 5 CO2 60 N20 Bal No 635 Cal Gas Aerosol 1 Sevoflurane 5 CO2 60 N20 Bal N3 1367 Cal Gas Aerosol 4 Desflurane 5 CO2 60 N20 Bal No 1366 Poet IQ 8500H Operator s Manual Page A 1 Gas Testing Kits Publications Page A 2 Operator s Manuals Service Manuals Os Gas Calibration kt 1548 80 Op cylinder 5 CO cylinder regulator valve plastic storage case Simulator Kit 8500H 0 cece ccc eee ce eeseeeeeseeesseeessueeesaeeeeaeeeens 1549 Breath Rate Simulator serial test cable software tool sample line regulator valve 2 gas regulator tubes Anesthetic Agent Verification Kit 5 Agent sssss 630 One of each five aerosol agents ISO ENF HAL SEV DES as described above includes plastic regulators with tubing Poet IQ 8500H Operators Manual CD English 2215 CD Poet IQ 8500H Operator s Manual CD Multi Language 2216 CD Poet IQ 8500H Service Manual CD English 2217 CD Poet IQ 8500H Operator s Manual Criticare Systems Inc Appendix B Connecting with nCompass 8100H Series Patient Monitor The 8500H agent gas analyzer connects to the nCompass 8100H Series patient monitor using a special communication power cable No external power supply is needed for the 8500H gas analyzer when connected to the 8100H host monitor Power is supplied thro2. BENCH FAIL AGT IR FAIL AGT PNEUMATICS AGT BADCAL AGT MISSING CAL AGT WARMING AGT MANUAL AGT AUTOMATIC Criticare Systems Inc Priority Medium Medium Low Low Low Low Low Low Informational Informational Informational Section 5 Alarms and Messages Description The sampling line or water trap to the 8500H analyzer is completely blocked The 8500H analyzer will attempt to clear the block by drawing the occlusion into the water trap Replace sampling line as necessary The water trap on the 8500H analyzer is not inserted Trap is partially blocked wrong type of trap or defective Replace the trap Scavenging line on the 8500H analyzer is blocked or the scavenging system is defective Remove blockage or correct gas scavenging system The host monitor as detected a hardware failure in the 8500H analyzer Contact the CSI Service Department The host monitor as detected a hardware failure in the 8500H analyzer Contact the CSI Service Department The host monitor as detected a hardware failure in the 8500H analyzer Contact the CSI Service Department The 8500H analyzer was unable to calibrate the agent gas detector Contact the CSI Service Department The 8500H analyzer was unable to calibrate the agent gas detector Contact the CSI Service Department The 8500H analyzer has not attained full accuracy for agent concentrations The host monitor is set to manual id
3. Contact the CSI Service Department as soon as possible Time is critical The longer any liquid remains in the device the more damage it can do It is important to service the analyzer immediately after any liquid is spilled into it Criticare Systems Inc Poet IQ 8500H Operator s Manual Page 6 1 Section 6 Maintenance Testing and Calibration Refer to the Poet IQ 8500H Gas Analyzer Service Manual for information about calibration and testing Annual Safety Tests The analyzer should be electrically tested annually Have a qualified service technician perform annually the safety testing listed in the 8500H service manual Perform complete functional testing of the analyzer Test the analyzer for electrical safety The functional tests to be performed as part of the annual safety tests are found in the Poet IQ 8500H Series Gas Analyzer Service Manual Annual safety tests include checking the flow rate and CO absorber and verifying the agent gas calibration Service Checks If the analyzer shows any signs of physical damage return it to the CSI Service Department for repair Do not remove the cover Refer all servicing to a qualified technician Descriptions of these tests can be found in the Poet IQ 8500H Gas Analyzer Service Manual Some tests may require specialized equipment Maintenance Schedule Every Patient nspect the accessories and cables for damage and proper connection Change the gas samplin
4. I E _ P Poet IQ 8500H Operator s Manual age viii Criticare Systems Inc EC Declaration of Conformity Poet IQ 8500H To view the Declaration of Conformity visit the Criticare website at Agent Gas Analyzer www csiusa com A copy of the Declaration can also be faxed Contact Criticare s customer service department at 262 798 8282 to obtain a faxed copy of the Declaration Representative in the MDSS GmbH 30175 Hannover Germany Criticare Systems Inc Poet IQ 8500H Operator s Manual Page ix Section 1 Introduction Description Intended Use Integrated CO and Agent Gas Detector Capnometry Measurement of CO Criticare Systems Inc The 8500H agent gas analyzer measures real time concentrations of anesthetic agent gases The device measures gases using a sidestream method The primary module measures concentrations of CO Nat and halogenated anesthetic agents The device can also measure oxygen concentrations using a galvanic cell The 8500H analyzer is intended to be used with an approved host monitoring system with the appropriate software or software upgrades Follow supplier s instructions for compatibility and operating instructions The 8500H analyzer with a host monitor is designed to monitor physiological parameters of patients within clinical care settings The 8500H analyzer with host monitor is intended to monitor concentrations of halothane enflurane isoflurane sevoflurane and desflur
5. Inc Section 1 Introduction The 8500H analyzer has an internal barometer and thermistor that allow compensation for changes over a range of temperature and atmospheric pressures The analyzer complies with EN 864 and EN12598 standards for cyclical pressure The accuracy of a single agent measurement is defined by the formula m 0 04M 0 1 X m 0 04M 0 1 where m is equal to the measurement in percent and x is the tolerance range Example of 5 HAL measurement calculating the high limit of the tolerance range 5 HAL x 0 04peading 0 1 apsotute 0 3 5 HAL 0 3 Tolerance 5 3 Final tolerance range is 4 7 to 5 3 HAL The 8500H analyzer uses the sidestream method of measuring Oo The gas is sampled from the same gas intake system used for the integrated CO agent detector The shared water trap removes moisture and particulate matter from the gas samples The gas sample is measured using a reactive oxygen cell The oxygen sensor is a galvanic electrochemical cell that works by a process known as oxidation reduction Oxygen from the sampled gas comes in contact with a highly reactive metal reacts with the metal and produces a current As the oxygen reacts this reactive metal is gradually being used up Once the metal is used up the cell is depleted and can no longer sense oxygen The cell generates a voltage output proportional to the amount of oxygen in the sampled gas This oxygen cell
6. Q 8500H Series Gas Analyzer Service Manual 1 Criticare Systems Inc Install a new CAT 938F NC water trap on the 8500H analyzer and attach a CAT 625N sample line Allow the analyzer to read the ambient O level for at least 30 seconds The ambient O level should be within 3 of 21 Establish a breath waveform by breathing across the opening of the sample line approximately 10 times Then supply the CAT 1547 80 O canister directly to the sample line using a CAT 623 regulator valve and CAT 613B regulator tube Allow the gas to flow for at least 30 seconds The 80 reading should be within 4 when using CAT 1547 calibration gas NOTE The pressure in the Os canister must be sufficient that gas exhausts out of the CAT 613B regulator tube during testing Poet IQ 8500H Operator s Manual Page 6 3 Section 6 Maintenance Expendable Components Long Term Storage Disposal Page 6 4 The internal oxygen cell Os sensor and carbon dioxide absorber will degrade over time Replacement requires opening the analyzer s case and should be performed by a qualified service technician See the Poet IQ 8500H Gas Analyzer Service Manual for instructions No special preparation is necessary for long term storage of the analyzer At the end of its useful life the analyzer and its accessories may be disposed of according to your institution s policies and procedures for disposal of patient contact medical
7. the maximum CO concentration at the end of expiration The analyzer measures the CO concentration and the monitor displays the numerical value The EtCO value is updated continuously with each breath cycle The amount of CO in the gas mixture inhaled by the patient is the Fractional Inspired CO FICO Poet Q 8500H Operator s Manual Page 1 1 Section 1 Introduction Agent Gas Measurement Page 1 2 Conditions of Use The analyzer measures CO using the principles of infrared absorption spectrometry An unknown concentration of gas CO3 is calculated by comparing its absorption of infrared light to that of a known standard The absorption of light is directly related to the concentration of the gas As infrared light passes through the sample gas chamber the light transmitted is converted to a voltage signal The analyzer converts the voltage into CO concentration data that can be expressed numerically or as waveforms by the monitor The Beer s Law calculation is performed by the software of the external 8500H module Infrared analysis of the gas samples is done using Beer s Law The formula for Beer s Law is as follows Ihe amp A ed I Infrared value of measured sample lo Infrared value of light source e Exponential function amp A Extinction coefficient c Concentration of the gas sample d Distance measured through the sample The agent detector samples gas breathed by the patient through a side
8. Manual Criticare Systems Inc Section 5 Alarms and Messages Alarm Description Alarm and Message List Respiration Alarms and Messages LOW RESP HIGH RESP Capnometry CO Alarms and Messages LOW ETCO2 HIGH ETCO2 LOW INCO2 HIGH INCO2 Criticare Systems Inc The 8500H analyzer host monitoring system provides both audible and visible alarm indicators to alert the operator of status alarms and physiological parameter alarms All alarms conform to the requirements of the host monitor Included here is a list of messages and warnings that may be generated by the 8500H analyzer See the appropriate appendix for any host monitor specific messages Alarms and messages for respiration may be generated by more than one sampling technology module Priority Description Medium The respiration value has dropped below the value set at the host monitor Medium The respiration value has exceeded the value set at the host monitor Priority Description Medium The end tidal CO value has dropped below the value set at the host monitor Medium The end tidal CO value has exceeded the value set at the host monitor Medium The inspired CO value has dropped below the value set at the host monitor Medium The inspired CO value has exceeded the value set at the host monitor Poet Q 8500H Operator s Manual Page 5 1 Section 5 Alarms and Messages Agent Gas Alarms and Messages Page 5 2 AGT NO BREATH WRO
9. Nasal cannula endotracheal adapters and sample lines are single patient use only NOTE The water trap is intended to be used until filled or occluded Once this occurs discard the trap as it is not to be reused and replace it with a new one Do not attempt to drain and reuse the water trap Water trap capacity exceeds 8 hours under fully saturated conditions A REPLACE TRAP alarm is generated when the trap is full Page 4 4 Poet Q 8500H Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring Placement of Nasal If using the nasal cannula position it directly under the patient s nose Cannula with the prongs extending into the nostrils Slide the adjuster forward to close the loop around the head Figure 4 2 Nasal Cannula Intubated Patients The agent gas analyzer can be used with intubated patients Recommended sampling lines and water traps assemblies should be used Sampling lines and water traps should be checked regularly Ventilation Circuit Adapters Two adapters for patient ventilation circuits are available The adapters come with a Luer lock sampling port for use with the CAT No 625N sampling line CAT No 616 Straight Tee Adapter and CAT No 617 Mask Elbow Adapter If additional adapters are required Criticare recommends that they be no longer than two inches Extending the sampling line will cause a delay in response time Cat No 616 Cat No 617 Figure 4 3 Ventilation Circuit Adap
10. at Different Concentrations Agent Agent Volume Change of Agent CO 0 096 0 096 2 596 0 096 5 096 410 296 10 096 410 196 Halothane 0 596 0 096 1 096 0 096 4 096 410 296 Enflurane 0 596 0 096 1 096 0 096 5 096 410 196 Isoflurane 0 596 0 096 1 096 0 096 5 096 410 296 Sevoflurane 0 596 0 096 1 096 0 1 5 0 0 1 Desfluranet 5 0 0 0 10 0 0 1 15 0 0 2 N O 30 0 0 8 65 0 1 0 Oo 15 0 40 396 21 096 40 596 40 096 0 4 60 0 40 896 100 096 0 1 Gas mixtures balanced with Nitrogen t Presence of 15 Desflurane in a mixture with other halogenated gases will result in the display of 15 Desflurane readings or greater Page 4 14 Poet IQ 8500H Operator s Manual Criticare Systems Inc Measurement Accuracy for Gas Mixtures Criticare Systems Inc Section 4 Patient Monitoring The monitor will report small changes in agent concentrations when anesthetic agents and other gasses are used Expected agent changes are provided here for the purpose of comparison Measurement Accuracy for Mixed Gases Agent Agent Volume Change of Agent CO 5 0 0 0 N O 30 0 0 1 Oo 40 0 0 4 Halothane 2 0 0 0 CO 5 096 0 1 N O 30 0 0 8 Oo 40 0 0 4 Enflurane 2 0 0 1 CO 5 096 10 196 N20 30 0 1 0 O5 40 096 0 3 Isoflurane 2 0 0 1 CO 5 096 10 196 N20 30 0 1 2 Oo 40 0 0 4 Sevoflurane 2 0 0 1 CO 5 0 0 1 N O 30 0 1 7 Oo 40 0 0 6 Desfl
11. between and quantifying various halogenated anesthetic agents The halogenated agents which can be identified and simultaneously quantified at any given time are halothane enflurane isoflurane desflurane and sevoflurane Nitrous oxide and carbon dioxide are also identified and quantified and their effect in quantifying mixtures with the five halogenated agents is negligible The presence of ethyl alcohol metabolic ketones helium and acetone do not interfere with the agent detector and will not significantly affect accuracy If any anesthetic agent other than those specified for monitoring is present it won t be identified and may interfere with reported agent concentrations If a waveform for a halogenated agent is displayed it will be the primary agent that was manually set in the host monitor or the primary agent as determined through automatic detection The abbreviation for the agent will also appear above the expired value the second column in the gas numerical values box The abbreviation for the agent will also appear at the beginning of the agent waveform channel The primary agent is the halogenated agent having the highest concentration during mixed gas conditions The primary agent can be set to halothane isoflurane enflurane desflurane sevoflurane or automatic When the monitor is manually set for a specific primary agent the alarms will be keyed to the halogenated agent selected The alarm limit levels will be t
12. free of DBP and DEHP in any areas that would be intended for patient contact with blood mucous membranes or continuous skin tissue contact Poet IQ 8500H Operator s Manual Page 1 11 Section 2 Controls and Connections Poet IQ 8500H Gas Analyzer Front Panel Criticare Systems Inc This section provides an overview of the monitoring system The accessory connections and communication ports for connecting a host monitor to the 8500H analyzer are described For control panels switches and displays refer to the host monitor manual The Poet IQ 8500H agent gas analyzer is an external gas sampling module for use with an external host monitor Sampling for the analyzer is conducted through its own sampling port located on the front panel The gas intake manifold is designed to accept Criticare WaterChek water traps The 8500H analyzer receives all its power from a host monitor A green LED located on the left side of the front panel indicates that the analyzer module is receiving power from the host monitor Water Trap Manifold Green Power LED Figure 2 1 Poet IQ 8500H Front Panel Poet Q 8500H Operator s Manual Page 2 1 Section 2 Controls and Connections Rear Panel Ambient Air Intake Host Monitor Communication Exhaust Port Figure 2 2 Rear Panel AMBIENT AIR INTAKE An ambient air intake port located next to the exhaust port is used for making zero gas concentration calibrations Do no
13. has an internal thermistor and circuitry that adjusts the output voltage based on current temperature of the cell A predictive circuit electronically speeds up the cell response necessary for breath by breath measurements This voltage is then processed by the microprocessor and displayed to the user Poet IQ 8500H Operator s Manual Page 1 3 Section 1 Introduction Page 1 4 Conditions of Use Stability of Accuracy The relationship between gas concentration and pressure is calculated by the microprocessor The numerical value displayed by the host monitor O5 Calculated is generated using the following formula 20 9 Pc O Calculated O Measured x OjAmbient x P The measured O predictive value is multiplied by a fixed value derived from room pressure divided by room ambient oxygen levels The measurement is further adjusted by multiplying the ratio of the pressure determined at calibration Pc with the current pressure Po There is a negligible effect on oxygen measurements due to humidity The oxygen monitoring feature is appropriate for measuring respiratory O concentrations in all patient populations The oxygen monitor is suitable for use in breathing systems and with the use of inhalation anesthetic agents The oxygen cell contains temperature correction circuitry The oxygen sensor temperature is maintained at a nominal 40 degrees Celsius to maintain a consistent performance Poet IQ 8500H Operator s Ma
14. the rights of others Criticare Systems Inc does not assume any liability arising out of any infringements of patents or other rights of third parties PROPERTY OF CRITICARE SYSTEMS INC ALL RIGHTS RESERVED High IQ is a trademark WaterChek and Poet are registered trademarks of Criticare Systems Inc Page ii Poet IQ 8500H Operator s Manual Criticare Systems Inc Contents EENEG e dee Ee PE RE e Pe P de ERU P EE Rae ii Contents iii Warranty zs Service Return Pollo viii EG Declaration of Conformily nei e e eed ne ix Section 1 Introduction Description m 1 1 Intended USe geriet Keele eta ror tic cite b RE I n CU ed Po Odes 1 1 Integrated CO and Agent Gas Detector eee eee cece teee seinen eetaetaeeeneeeae 1 1 Capnometry Measurement of COs vee 1 1 Agent Gas Measurement 00 cecceccseceeseeeeeeeeceeeeeecaeseeeceseeeeaeeeeesaeeeeeeeeeeeseeeeeeeate 1 2 Conditions of USE 5 nter erre ete e eiie eere ener Weed 1 2 Stability of AGUER 1 3 Agent Accuracy of Measurement nennen 1 3 Oxygen O5 Measurement we 1 3 Ee gr 1 3 CONDITIONS OF EE 1 4 Stability of Accuracy 1 4 Specifications 1 5 Symbols 1 8 SCIT 1 9 ET s sies terpa aeai aaae SERRE 1 9 Cautons we 1 9 Leakage Current 1 10 Nuel E ele EE 1 10 Software Error Related Hazard Mediation eene 1 10 Potential Interference AA 1 10 Bioc
15. those specified for whichever agent is currently at the higher concentration When more than one halogenated agent is detected above its threshold limits the second highest halogenated agent is identified as a secondary agent The Mixed message will be activated in the numerical parameter box for agent gas Measurements for secondary agent expired and inspired values will appear The secondary agent is automatically identified by its three letter abbreviation DURING AUTOMATIC PRIMARY AGENT SELECTION If the primary agent concentration falls and or is exceeded by another agent the primary agent may become the secondary agent when automatic primary agent selection mode is used The three letter agent name and values for the secondary agent may switch with the primary agent when the concentration of one agent exceeds another MIXED AGENT CONDITIONS The message MIXED AGENT will appear as a medium level alarm whenever more than one halogenated agent is detected The alarm is active whether automatic or manual primary agent selection is used Their are no concentration limit alarms associated with the secondary agent that is displayed The presence of additional halogenated agents below the concentration of the secondary agent are not reported by the monitor To identify an agent the concentration of the agent individually or in mixture must be above the identification threshold limit A secondary agent is considered part of a mix if that agent i
16. 4 1 0 Enflurane 5 1 2 Isoflurane 5 1 3 Sevoflurane 5 1 0 Desfluranet 5 1 2 Helium 50 0 4 Ethanol 1 0 8 Isopropanol 196 1 5 Acetone 1 0 1 Methane 1 0 5 Metered does inhaler propellant 1 0 3 Xenon 80 Not intended for use with Xenon Gas mixtures balanced with Nitrogen t Presence of 15 Desflurane in a mixture with other halogenated gases will result in the display of 15 Desflurane readings or greater Criticare Systems Inc Poet IQ 8500H Operator s Manual Page 4 11 Section 4 Patient Monitoring CO Monitoring Capnometry Page 4 12 When a patient is connected the monitor begins displaying the end tidal and inspired CO values in the parameter box The capnogram CO waveform if selected as a displayed waveform will provide a graphic representation of the patient s respiration cycle A capnograph waveform is displayed using the agent detector data when the agent monitoring system is used The waveform is generated by the capnometer when the host monitor is used by itself and has the internal feature installed The numerical respiration displayed value can be manually set to the capnogram source if desired The host monitor may also generate a breath by breath bar chart in the waveform slots that can graphically indicate the relative strength of each breath The graphical and numerical display of the capnogram will appear the same whether a host monitor s internal capnome
17. Manual Criticare Systems Inc Water Trap Connections Section 4 Patient Monitoring The agent gas analyzer has a front mounted water trap The trap slides out and can quickly be replaced if it becomes occluded Use water trap Cat No 938F NC WaterChek 2 as indicated The water trap has a fitting located at the top that connects into the trap receptacle gas manifold of the analyzer The analyzer s gas sampling connection from the water trap will accept gas sampling lines using the male Luer style connections The attachment location of the sampling line is shown below with the water trap properly inserted This sampling line Cat No 625N is used for agent gas monitoring with the Poet IQ 8500H agent gas analyzer Use the gas sampling accessories only as directed Figure 4 1 8500H Sampling Line Connection Startup and Calibration Criticare Systems Inc Allow the 8500H analyzer and host monitoring system to warm up and auto calibrate before use It is necessary to have the water trap and sampling line attached so that the analyzer draws the correct air flow The 8500H analyzer will automatically begin an auto calibration sequence when powered up During calibration the monitor will display flat waveforms for gas concentrations When the calibration and warm up sequence is over normal operation will begin Poet IQ 8500H Operator s Manual Page 4 3 Section 4 Patient Monitoring Procedure for Gas The followin
18. NG AGENT MIXED AGENT LOW INS AGENT HIGH INS AGENT LOW EXP AGENT HIGH EXP AGENT LOW INS N20 HIGH INS N2O LOW EXP N2O HIGH EXP N2O Priority High High Medium Medium Medium Medium Medium Medium Medium Medium Medium Description No breath detected Check patient for apnea Check sampling device and adjust placement if necessary May indicate a leak in the breathing circuit The primary agent that the operator has selected does not match the highest concentration agent detected by the analyzer Check the primary agent setting and the agent delivery system immediately This alarm is not active when automatic primary agent detection is selected More than one halogenated agent is present The inspired agent value has dropped below the value set at the host monitor The inspired agent value has exceeded the value set at the host monitor The expired agent value has dropped below the value set at the host monitor The expired agent value has exceeded the value set in the ALARMS menu The inspired N O value has dropped below the value set at the host monitor The inspired N O value has exceeded the value set at the host monitor The expired N5O value has dropped below the value set at the host monitor The expired N5O value has exceeded the value set at the host monitor Poet IQ 8500H Operator s Manual Criticare Systems Inc AGT OCCLUSION AGT INSERT TRAP AGT NO EXHAUST AGT
19. Poet IQ 8500H Agent Gas Analyzer Operator s Manual C Eos Cat No 2215 Part No 39198B001 Date 11 10 Revision 2 Copyright COPYRIGHT CRITICARE SYSTEMS INC 2009 2010 CRITICARE SYSTEMS INC Criticare owns all rights to this unpublished work and intends to maintain this work as confidential Criticare may also seek to maintain this work as an unpublished copyright This publication is to be used solely for the purposes of reference operation maintenance or repair of Criticare equipment No part of this publication may be reproduced in any manner or disseminated for other purposes In the event of inadvertent or deliberate publication Criticare intends to enforce its rights to this work under copyright laws as a published work Those having access to this work may not copy use or disclose the information in this work unless expressly authorized by Criticare to do so All product specifications as well as information contained in this publication are subject to change without notice All information contained in this publication is believed to be correct Criticare Systems Inc shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this material This publication may refer to information and products protected by copyrights or patents and does not convey any license under the patent rights of Criticare Systems Inc nor
20. Systems Inc the following procedure should be followed Obiain return authorization Contact the CSI Service Department at 800 458 2697 to obtain a Customer Service Authorization CSA number Outside the US call 001 262 798 8282 The CSA number must appear on the outside of the shipping container Return shipments will not be accepted if the CSA number is not clearly visible Please provide the model number serial number and a brief description of the reason for return Freight policy The customer is responsible for freight charges when equipment is shipped to CSI for service this includes customs charges Loaner service In the U S If it is necessary to provide a loaner unit to any U S customer CSI will ship the unit within one 1 working day if available by secure transport means For units under warranty a loaner unit if required will be made available upon request For unit out of warranty in the event of a loaner unit being required after the product warranty has expired and no extended service contract is in place a charge will be applied to the customer s account Loaner units must be returned to CSI at the customer s expense within one 1 week after receipt of the repaired goods If the unit is not returned within that time the customer will be invoiced for the full purchase price of the equipment Outside the U S No loaners are available from CSI internationally Contact your local CSI representative
21. ame whether oxygen monitoring is performed by the internal oxygen sensor of the host monitor if available or by the external oxygen sensor of the 8500H analyzer When the 8500H analyzer is in operation agent gas numerical values may appear in the box normally used for the display of oxygen concentrations The oxygen numerical values may still appear in the same location inside the box INTERFERING GASES FOR O2 The monitor reports small changes in Oo when anesthetic agents and and other gasses are used with oxygen Expected O changes are provided here for the purpose of comparison For Gas Mixtures of O Agent Agent Volume Change of Os N O 60 0 1 Halothane 4 0 2 Enflurane 5 0 2 Isoflurane 5 0 2 Sevoflurane 5 0 2 Desfluranet 596 0 2 Helium 50 0 3 Ethanol 1 0 2 Isopropanol 196 40 596 Acetone 196 0 1 Methane 1 0 1 Metered dose inhaler propellant 1 0 2 Xenon 80 Not intended for use with Xenon Gas mixtures balanced with Nitrogen t Presence of 15 Desflurane in a mixture with other halogenated gases will result in the display of 15 Desflurane readings or greater Criticare Systems Inc Poet Q 8500H Operator s Manual Page 4 13 Section 4 Patient Monitoring Measurement Accuracy The monitor will report small changes in agent readings when different concentrations are introduced Expected agent changes are provided here for the purpose of comparison Measurement Accuracy
22. ane during anesthetic surgery The user is responsible for the interpretation of the monitored data that is made available It is intended that the user is a professional health care provider Physiological data system alarms and patient data analysis are available to the care provider from the host monitor The analyzer is designed to be used with only one patient at a time The primary hardware module of the 8500H analyzer is an integrated CO j agent detector bench The integrated detector measures carbon dioxide CO3 nitrous oxide N20 and five halogenated anesthetic agent gases using the same sample collection path and testing apparatus The analyzer uses proprietary High IQ V technology to identify and quantify agent gases There are no moving parts reducing size of the detector and enhancing reliability The 8500H analyzer uses the sidestream method of measuring COs and anesthetic agent gases Gas is drawn through a nasal cannula or endotracheal adapter The gas sample enters the monitor from a sampling tube into a water trap which removes water vapor and particulate matter from the gas sample The gas then enters the CO agent detector where it is analyzed The analyzer measures CO concentrations and sends data suitable for continuous waveform display The analyzer also detects end tidal and fractional Inspired CO levels sending the data to the monitor where it is displayed numerically End tidal CO EtCO is defined as
23. ange of Isoflurane N O 60 0 0 Halothane 4 0 1 Enflurane 5 0 6 Isoflurane 5 N A Sevoflurane 5 0 2 Desfluranet 596 0 2 Helium 50 0 0 Ethanol 1 0 1 Isopropanol 196 0 1 Acetone 1 0 1 Methane 1 0 0 Metered does inhaler propellant 1 0 1 Xenon 80 Not intended for use with Xenon For Gas Mixtures of 2 Sevoflurane Agent Agent Volume Change of Sevoflurane N O 60 0 0 Halothane 4 0 3 Enflurane 5 0 6 Isoflurane 5 0 2 Sevoflurane 5 N A Desfluranet 5 0 2 Helium 50 0 0 Ethanol 1 0 1 Isopropanol 196 10 196 Acetone 196 0 1 Methane 1 0 0 Metered does inhaler propellant 1 0 1 Xenon 80 Not intended for use with Xenon Gas mixtures balanced with Nitrogen t Presence of 15 Desflurane in a mixture with other halogenated gases will result in the display of 15 Desflurane readings or greater Page 4 10 Poet IQ 8500H Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring For Gas Mixtures of 2 Desflurane Agent Agent Volume Change of Desflurane N O 60 0 0 Halothane 4 0 5 Enflurane 5 0 4 Isoflurane 5 0 5 Sevoflurane 5 0 1 Desfluranet 5 N A Helium 50 0 1 Ethanol 1 0 0 Isopropanol 196 0 096 Acetone 196 0 096 Methane 196 0 1 Metered does inhaler propellant 1 0 2 Xenon 80 Not intended for use with Xenon For Gas Mixtures of 40 N O Agent Agent Volume Change of N O N O 60 N A Halothane
24. avertevsievertedsanevsnesscecevestaavencenuvnceviereeas A 1 Gas Testing Kits ae aA eaa aee aaa aa aoaaa nennen nennen A 2 SEI le ie TEE A 2 Operators Manuals nnne tenentes A 2 Seivice Manuals crc re E VO FH PREMIO Te RIMIS A 2 Appendix B Connecting with nCcompass 8100H Series Patient Monitor Poet IQ 8500H Operator s Manual Page v Warranty Workmanship amp Materials Exemptions Safety Reliability amp Performance In Case of Emergency Contact Criticare Systems Inc Criticare Systems Inc CSI warranties new equipment to be free from defects in workmanship and materials for a period of two 2 years from date of shipment under normal use and service The following exceptions apply to this statement and the warranty period as indicated Internal Batteries one 1 year O2 Cells and CO2 Absorbers six 6 months Y Style SpO2 Sensors six 6 months CSI s obligation under this warranty is limited to repairing or replacing at CSI s option any part which upon CSI s examination proves defective EXCEPT AS DESCRIBED IN THE PARAGRAPH ABOVE CSI MAKES NO WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE CSI s obligation or liability under this warranty does not include any transportation or other charges or liability for direct indirect or consequential damages or delay resulting from the improper use or application of the product
25. ble from both the monitor and the analyzer before cleaning either device Shock Hazard Never immerse the agent gas analyzer or the host monitor e Additional cleaning and maintenance warnings and cautions are listed in the host monitor s literature Do not use abrasive cleaners on the host monitor or on any sensors or probes Abrasive cleaners can damage the monitor sensors and probes The exterior surface of the analyzer may be wiped clean with alcohol and dried with a soft dry cloth It is best to use a cotton cloth to clean the analyzer Accidental Wetting NWARNING A Shock Hazard The host monitor with the 8500H analyzer is an AC powered system Saturated electronic devices present a danger to anyone who handles them The action to be taken following accidental wetting of the equipment is as follows 1 Turn the power off Disconnect the AC power cord from the host monitor or from the external power supply 2 If monitoring a patient transfer the patient to another monitor as quickly as possible 3 Use a clean dry towel or cloth to remove the liquid from the device housing 4 The analyzer or monitor should be inspected by a service technician as soon as possible 5 f the internal mechanism is saturated allow the liquid to drain out for 24 hours before shipping 6 If liquid has entered the analyzer it will need to be dried and cleaned internally Full testing is required before the device can be used
26. condensing 1000 ft to 10 000 ft 300 m to 3000 m Class II Equipment Ilb EU Class Equipment Type CF Defibrillator Proof Ordinary Complies with the ingress protection test specified in IEC 601 2 27 ECG Safety Standard All specifications are subject to change without notice Poet IQ 8500H Operator s Manual Page 1 7 Section 1 Introduction Symbols Symbol A A C Eon ert NA ele F Ci Witz Page 1 8 Poet IQ 8500H Operator s Manual Definition Refer to Operator s Manual for Information Shock Hazard European Community Mark of Approval Electrical Testing Laboratories ETL Mark Underwriters Laboratories Recognized Mark external power supply Dispose of unit and or accessories following proper facility procedures or local laws Technical Support Phone Number Type B Equipment Gas Sampling Connection Gas Scavenging Connection Signal connection to a host monitor Power Source Single use device only Do not reuse Criticare Systems Inc Safety Warnings A Criticare Systems Inc Cautions A WARNING N Section 1 Introduction Definitions for Warning and Caution symbols Designates a possible dangerous situation Non observance may lead to death or the most severe injuries Designates a possible dangerous situation NCAUTION A Non observance may lead to minor injuries or damage to the product NWARNING N Read this manual entir
27. eakage Current Voltage Fluctuations Software Error Related Hazard Mediation Potential Interference Page 1 10 The monitoring system complies with leakage current limits required by medical safety standards for patient connected devices Standards include Underwriter s Laboratories UL 2601 and the International Electrotechnical Commission IEC 601 1 2nd edition 1988 Part 1 A hazard caused by the summation of leakage currents is possible when several pieces of equipment are interconnected When operated in the line voltage range specified in this manual any fluctuation will have a negligible effect Very low line voltage will cause the monitoring system to revert to battery power The monitor is designed with circuitry that will turn the device off before spurious readings can be caused by a low battery condition Criticare Systems Inc has quality control practices and procedures in place to review potential hazards as they relate to software This device has been successfully tested to IEC 601 1 2 specified levels for emissions of and resistance to electromagnetic energy fields External disturbances which exceed these levels may cause operational issues with this device Other devices which are sensitive to a lower level of emissions than those allowed by IEC 601 1 2 may experience operational issues when used in proximity to this device MAGNETIC FIELDS Use of the device in an MRI environment may interfere with MRI image
28. ear indicating that the monitor is in either manual or automatic primary agent identification mode Respiration waveforms capnogram and numerical breath rate will be available in one minute from powering the analyzer The analyzer will reach full accuracy for agent concentrations in less than 20 minutes If the 8500H analyzer fails to auto calibrate upon being plugged in the message AGT BAD CAL or AGT CAL MISSING may appear If the 8500H analyzer continues to fail auto calibration contact the Criticare Technical Service Department The 8500H oxygen monitoring module also requires an auto calibration sequence and is performed at the same time as the agent detector calibration If the Os module fails to auto calibrate the message O2 SENSOR may appear Once auto calibration is complete the host monitor will display values for monitored gases Primary Agent Selection The primary agent for monitoring should be correctly entered depending on the host monitor The analyzer has two modes of agent gas monitoring Depending on the host monitor the user may select a specific halogenated agent to be designated as the primary agent The user may otherwise set the monitor to automatically detect and identify the current primary gas of a mixture NWARNING N e Always confirm the primary agent selection before use Incorrect primary agent setting may result in erroneous limit alarms Alarm characteristics of the monitor are altered when automatic p
29. ely before attempting clinical use of the monitoring system A possible explosion hazard exists Do not use the monitoring system in the presence of flammable anesthetics Cables cords and sampling lines may present a risk of entanglement or strangulation Verify safe and proper positioning of these items after patient application Unapproved modifications to the analyzer or host monitor may cause unexpected results and present a hazard to the patient Risk of electrical shock Do not remove cover Refer servicing to qualified personnel U S Federal law restricts this device to sale by or on the order of a physician NCAUTION N Use the monitoring system only with recommended accessories Use of unapproved accessories may cause inaccurate readings Equipment accuracy may be affected at extreme temperatures Do not store equipment at extreme temperature Temperatures exceeding specified storage temperatures could damage the system Do not press on the keys with surgical instruments or other tools Sharp or hard objects could damage the keys Use only your fingertips to press on the keys Changes or modifications not expressly approved by Criticare Systems Inc may void the user s authority to operate the equipment and may also void the warranty The AC power cord can be disconnected from the external power supply to serve as an AC disconnect Poet IQ 8500H Operator s Manual Page 1 9 Section 1 Introduction L
30. entification of a selected primary agent The WRONG AGENT warning may appear if the selected agent does not match the detected primary agent The host monitor is set to automatic identification of the current primary agent Poet Q 8500H Operator s Manual Page 5 3 Section 5 Alarms and Messages Oxygen Monitoring O3 Alarms and Messages LOW ETO2 HIGH ETO2 LOW INO2 HIGH INO2 O2 SENSOR Page 5 4 Priority Medium Medium Medium Medium Low Description The expired Os value has dropped below the value set at the host monitor The expired O value has exceeded the value set at the host monitor The inspired O value has dropped below the value set at the host monitor The inspired Os value has exceeded the value set at the host monitor The Os cell inside the 8500H analyzer is expended and requires replacement Contact Criticare Technical Service NCAUTION A Additional alarms and messages associated with other non gas monitoring modules may appear on the screen of the host monitor Additional host generated alarms may alternate with any of the alarms listed in this section At no time will any alarm message or alert cause another message to not be displayed Poet IQ 8500H Operator s Manual Criticare Systems Inc Section 6 Maintenance Cleaning and Disinfecting WARNING A Shock Hazard The cable from the host monitor to the 8500H analyzer can be the power source Unplug the ca
31. g description is provided for general monitoring of single Monitoring or multiple gas conditions with the 8500H analyzer Read the entire section for complete instructions for monitoring specific gases 1 2 Check the Flow Rate setting of the host monitor If halogenated anesthetic gases are going to be used verify the Primary Agent setting in the host monitor The primary agent may be designated by the user or set to automatic identification Slide the WaterChek 2 water trap CAT No 938F NC into the trap receptacle of the 8500H analyzer Confirm that a cover is placed over the unused host receptacle if present Attach a scavenging line CAT No 655 to the rear exhaust port of the agent gas analyzer if anesthetic agents are being used The exhaust port of the host monitor is not used when the agent gas analyzer is attached Attach a sample line CAT No 625N to the Luer connector located on the front of the WaterChek 2 water trap Make sure there are no kinks or other obstructions in the line extending from the water trap Attach a patient sampling device to the sampling line Use either a nasal cannula mask or ventilation tube adapter Replace sampling devices lines and water traps if they become blocked WARNING N Cables cords and sampling lines may present a risk of entanglement or strangulation Verify safe and proper positioning of these items after patient application NOTE
32. g device sampling line Every Week Change the water trap or as needed Every 3 Months Clean the exterior of the unit or clean as needed e Check the O cell for drift Calibrate if necessary Every Year Perform the annual safety tests Verify the agent gas calibration Change the Oo cell Check the gas flow rate Check the CO absorber and replace if necessary Page 6 2 Poet IQ 8500H Operator s Manual Criticare Systems Inc 3 Month O Drift Check Section 6 Maintenance Equipment Needed The following equipment is required WaterChek 2 Water Trap CAT 938F NC Sample Line CAT 625N Regulator Valve CAT 623 Regulator Tube CAT 613B Calibration Gas 80 O with No Balance CAT 1547 NCAUTION A Calibration kits contain compressed gas cylinders Read and obey all instructions listed on the gas cylinder labels Do not use if the calibration gas cylinder is beyond its expiration date O Drift Check The O function should be checked every three months to confirm accurate operation of the O cell The analyzer must be allowed to warm up prior to checking to ensure full accuracy Allow the analyzer to run for up to ninety 90 minutes from the time of first ambient air readings before proceeding with the Os Drift Check NOTE Analyzers coming from cold storage may require a longer warm up period If the analyzer does not pass the 3 month Op drift check the cell must be calibrated Refer to the Poet
33. he current primary alarm limits and should be manually updated if a new primary agent is selected The current agent alarm limits will not change while monitoring unless done manually The WRONG AGENT alarm will be active and the monitor will continually check for an incorrect agent If another halogenated agent exceeds the selected primary agent a high priority alarm will occur If the agent is being displayed in a waveform the alarm message will appear in large red text in the waveform slot If the WRONG AGENT alarm appears immediately check the anesthetic delivery system for incorrect anesthetic gases Poet Q 8500H Operator s Manual Page 4 7 Section 4 Patient Monitoring Automatic Primary Agent Detection Secondary Agent Detection Agent Identification Thresholds Page 4 8 When the user selects a specific halogenated agent as the primary that agent will always be the agent displayed in the waveforms A flat line will appear when the halogenated agent is not present The primary agent is identified by the monitoring system as the agent with the highest current concentration In mixed gas conditions the primary agent may change as the measured gas concentrations change The waveform and waveform heading will also change to the new agent When the monitor is set for automatic primary agent detection the alarms will be adjusted to the current primary agent as defined at the host monitor The alarm limits will be updated to
34. ible Carbon dioxide Negligible Nitrous oxide Negligible Helium Negligible Acetone Negligible Ether Contraindicated Cyclopropane Contraindicated Methoxyflurane Contraindicated Percent Inspired Os Expired Os Numerical values waveform Oxidation reduction galvanic cell 0 100 1 3 vol 0 90 x 4 vol 91 100 for breath rates up to 60 breaths minute 0 90 600 milliseconds 1 5 seconds Criticare Systems Inc Criticare Systems Inc Pneumatics Flow rate Occlusion Clearing Filters Sample Lines Pneumatic Sound Pressure Section 1 Introduction 100 150 200 ml min User Selectable Automatic WaterChek 2 Cat No 625N 8 foot 45 dBa maximum 1 meter Communications Connections Communication IBench Data Port Charger Port Async Serial RX TX CANBUS DB 9 connector 12 0VDC nominal 1 0 Amp nominal Mechanical Electrical 8500H Analyzer Weight Size Mechanical Shock Resistance Power Voltage 7 5 lbs 3 4 kgs 4 20 H x 13 75 W x 10 75 D 10 7 cm H x 34 9 cm W x 27 3 cm D Negligible affect up to 40G 6W peak 3W typical 12 VDC Typical Environmental 8500H Monitoring System Operating Temperature Storage Temperature Operating and Storage Humidity Altitude Medical Device Electrical Protection Degree of Protection Protection against ingress 59 to 95 F 15 to 35 C 23 to 122 F 5 to 50 C 15 to 90 non
35. n Percent Numerical Inspired N O Expired N20 N O waveform Page 1 5 Section 1 Introduction Halogenated Agents Method Units Resolution Range Accuracy Identification Threshold Mixed Gas Threshold Primary Agent Identification Mixed Agent Identification Rise Time Response Time Warm up Time Calibration Auto Zeroing Display Effect of Interfering Gases Oxygen Monitoring O Units Display Method Range Resolution Accuracy Rise Time Response Time Page 1 6 Poet Q 8500H Operator s Manual Sidestream non dispersive infrared Volume Percent 0 1 Volume Percent Halothane 0 to 10 0 vol 96 Isoflurane 0 to 10 0 vol 96 Enflurane 0 to 10 0 vol 96 Desflurane 0 to 20 0 vol 96 Sevoflurane 0 to 10 0 vol 96 x 0 196 abs 4 of reading for breath rates up to 60 breaths minute Halothane 0 2 vol 96 Isoflurane 0 3 vol 96 Enflurane 0 3 vol 96 Desflurane 0 3 vol 96 Sevoflurane 0 3 vol 96 0 2 vol 96 10 of total concentration User Selectable or Automatic Automatic secondary agent 450 msec for 10 90 at 150 ml min 2 5 seconds 1 minute to first waveforms lt 20 minutes to full accuracy Auto calibrating Manual Calibration Occurs 30 to 60 minutes Duration 3 0 to 7 0 seconds Primary agent inspired and expired numerical values Primary agent waveform Secondary mixed agent numerical values Ethyl alcohol Negligible Metabolic ketones Neglig
36. nal capnometer is activated the zero calibration will immediately begin for the capnometer and internal oxygen sensor if present A zero cal message should appear momentarily The internal capnometer is auto calibrated upon start up on 24 hour intervals and upon every 3 C of ambient temperature change Manual calibration can be performed during transport or during changing environmental conditions There is a temporary loss of COs and O monitoring data during zero calibration of the capnometer When the 8500H analyzer is connected zero calibration will begin immediately for the agent gas analyzer and the 8500H oxygen sensor Since CO levels are measured by the agent detector hardware there is no separate calibration for capnometry with the 8500H analyzer The 8500H analyzer continuously auto calibrates on intervals not greater than 40 minutes Auto calibrations will last approximately 5 seconds and may temporarily interrupt waveform display No manual calibration of the 8500H analyzer is necessary during normal operation Poet IQ 8500H Operator s Manual Criticare Systems Inc N O Compensation Criticare Systems Inc Section 3 Setup Procedure Since nitrous oxide has a similar infrared signature to that of COs and it also affects infrared signature characteristics of COs special care must be taken when measuring CO while nitrous oxide is being used There are two forms of N2O compensation with the 8500H analyzer N2O compen
37. nual Criticare Systems Inc Specifications For the 8500H Analyzer Capnometry CO when used with a host Method monitor Range Resolution Accuracy Flow Rate Flow Tolerance Rise Time Response Time Time from Cold Stat Calibration Units Display CO Respiration Source Range Resolution Accuracy Nitrous Oxide N20 Method Range Resolution Accuracy Identification Threshold Rise Time Response Time Calibration Units Display Criticare Systems Inc Poet Q 8500H Operator s Manual Section 1 Introduction Sidestream non dispersive infrared 0 99 mmHg 0 to 12 5 0 to 12 5 kPa 0 to 99 Torr 1 mmHg 0 1 0 1 kPa 1 Torr 0 2 abs or 4 of reading for breath rates up to 60 breaths minute 100 150 200 ml min user selectable 10 10 90 350 milliseconds 150 ml min 2 25 seconds 1 minute to first waveforms lt 20 minutes to full accuracy Auto calibrating Manual Calibration mmHg Volume Percent kPa Torr Inspired CO Expired CO End Tidal Numerical values capnograph and breath by breath EtCO bar graph Capnogram 1 to 100 breaths minute 1 breath minute 2 breaths minute or 2 of reading Sidestream non dispersive infrared 0 to 99 volume percent 196 x 1 596 abs 4 of reading for breath rates up to 60 breaths minute 596 for single and mixed agents 10 9096 400 milliseconds 2 5 seconds Auto calibrating Manual Calibratio
38. ometry 4 12 Oxygen O Monitoring 4 138 Measurement ACcuracy 24 14 Measurement Accuracy for Gas Mixtures sess 4 15 Drift of Measurement Accuracy sssssssssseeeeeeeenee nennen rennen enne 4 16 Section 5 Alarms and Messages Alarm Descriptloni uec rt nineteenth dE 5 1 Alarm and Message List 571 Respiration Alarms and Messages 541 Capnometry CO Alarms and Messages 5 1 Agent Gas Alarms and Messages 5 2 Oxygen Monitoring O5 Alarms and Messages e 5 4 Section 6 Maintenance Cleaning and Disintechng 6 1 Accidental Wetting Testing and Calibration Annual Safety Tests i Service CHECKS vise crcssscevteceniaccasislaacoviavveiventeuteusdvelaveatessievaces ET aE E EE Ra Maintenance Gchecdule nennen enne nnne 3 Month O Drift Check Equipment Needed Op Drift Check 6 3 Expendable Components 1 6 4 Long Term Storage oo cee neers ne cess setae cae cesee seca tn nnne trennen 6 4 Disposals 6 4 Poet IQ 8500H Operator s Manual Criticare Systems Inc Criticare Systems Inc Contents Appendix A Accessories Gas Monitoring Accessories ebessen ease Fosse ee ERU ne A 1 Sampling Devices 0 0 0 ce ceeceeceeeeeseeeeeeseeaeeeeeeaeeeeesaeseeeaeceeeeaeseeesaeeeeeaeeateeaeeneeeaes A 1 Gas Testing Accessories eene coes
39. ompatibility Latex Gonterit 45 ee ee eebe eer tint E AAEE DEHP Gontent 15 5 5 ener Ne Section 2 Controls and Connections Poet IQ 8500H Series Gas Analvzer nenne 2 1 FrontPanel 2 utet t tete teen t eve pedo acce Y d YE e DIL 2 1 Ral PANG P 2 2 Section 3 Setup Procedure Monitor Setup EE 3 1 Auto calibration and Warm Up gd Primary Agent Selection e 3 1 Flow Rate Setting s 3 2 Zero Calibration Peguet 3 2 N O CGompenseaton sse nnne tnnt 3 3 Poet IQ 8500H Operator s Manual Page iii Criticare Systems Inc Contents Page iv Section 4 Patient Monitoring Introduction to Clinical Use nnne 4 1 Before you Begin 4 1 Gas Monitoring Safety 42 Water Trap Connectons ener 4 3 Startup and Calibration e 2 t rni da c cb tta teeth i t tee vs 4 3 Procedure for Gas Monitoring 4 4 Placement of Nasal Cannula 45 Intubated Patents 4 5 Ventilation Circuit Adapters nennen 4 5 Sce ID B Anesthetic Gas Monitoring s Anesthetic Agent Identification and Quantification ssssusssss 4 7 Primary Le EU 4 7 User Selected Primary Agent 4 7 Automatic Primary Agent Detection 4 8 Secondary Agent Detection 4 8 Agent Identification Thresholds AAA 4 8 Interfering Gases For Anesthetic Agents 4 9 CO Monitoring Capn
40. or the substitution upon it of parts or accessories not approved by CSI or repair by anyone other than a CSI authorized representative This warranty shall not extend to any instrument which has been subjected to misuse negligence or accident any instrument from which CSI s original serial number tag or product identification markings have been altered or removed or any product of any other manufacturer Criticare Systems Inc is not responsible for the effects on safety reliability and performance of the 8500H Agent Gas Analyzer if assembly operations extensions readjustments modifications or repairs are carried out by persons other than those authorized by Criticare Systems Inc or the 8500H Agent Gas Analyzer is not used in accordance with the instructions for use or the electrical installation of the relevant room does not comply with NFPA 70 National Electric Code or NFPA 99 Standard for Health Care Facilities Outside the United States the relevant room must comply with all electrical installation regulations mandated by the local and regional bodies of government CRITICARE SYSTEMS INC Telephone 262 798 8282 N7 W22025 Johnson Drive Tech Support 800 458 2697 Waukesha WI 53186 Orders 800 458 4615 USA Fax 262 798 8290 Internet www csiusa com Poet Q 8500H Operator s Manual Page vii Service Return Policy Return Procedure In the event that it becomes necessary to return a unit to Criticare
41. quality Use of MRI may interfere with the device The gas module is not intended for use in an MRI environment RADIO FREQUENCY INTERFERENCE The device conforms with IEC 1000 4 3 for radio frequency interference and will operate with negligible adverse effects CONDUCTED TRANSIENTS The device conforms with IEC 1000 4 4 and IEC 1000 4 5 for conducted transients and will operate with negligible adverse effects X RAY The device will operate with negligible adverse effects in an x ray environment However the device should not be placed directly in the x ray beam which could damage the internal electronics of the analyzer OTHER INTERFERENCE There is a negligible adverse effect to the device from electrocautery and electrosurgery infrared energy and defibrillation Poet Q 8500H Operator s Manual Criticare Systems Inc Biocompatibility Latex Content DEHP Content Criticare Systems Inc Section 1 Introduction All patient contact or user contact materials in this device and it s accessories have passed ISO 10993 5 10 amp 11 biocompatibility tests or have been in use in clinical environments in large numbers over an extended period of time predating these standards All Criticare Systems Inc products including the agent gas analyzer the monitoring system and accessories are free from latex in any location that may result in patient contact All Criticare Systems Inc products currently shipping are
42. rimary agent detection is activated Never substitute a primary agent setting for a different halogenated agent or any agent not listed The agent detection is specific to the listed gases only Criticare Systems Inc Poet IQ 8500H Operator s Manual Page 3 1 Section 3 Setup Procedure Flow Rate Setting Zero Calibration Request Page 3 2 NWARNING N The alarm WRONG AGENT may appear when the primary agent that is manually selected by the physician does not match the primary agent detected Consult the instructions for your specific host monitor The halogenated agent waveform and waveform label may automatically change to a different halogenated agent when automatic primary agent detection is used If no primary agent is detected dashes will appear in the waveform label when automatic primary agent detection is used Consult the instructions for your specific host monitor The Flow Rate setting adjusts the amount of sample gas that is drawn in by the gas monitoring system The analyzer has been calibrated to be functional at 100 150 and 200 ml min Consult the instructions for your specific host monitor A zero calibration request may be made from the host monitor The user may initiate a manual zero calibration for the internal capnometer only The zero calibration setting will not appear when using the 8500H analyzer Set a zero cal request from the host monitor to start a zero calibration When the inter
43. ropane or ether The analyzer is not intended for monitoring gas mixtures containing methoxyflurane or halogenated hydrocarbons not specifically listed as a monitored gas Environmental pollution of nitrous oxide and halogenated agents may cause accuracy errors Always use anesthetic gas scavenging systems AGSS with the monitoring system Infectious agents may be transferred between patients through the return of the analyzer s exhaust to the patient s breathing circuit Infectious agents may be transferred between patients through contaminated masks and nasal cannulas Change the sample device and sampling line before use with each new patient Never attach intravenous tubes to gas sampling connections Gas sampling lines may be inadvertently connected to intravascular fluid systems allowing air into a blood vessel Never place the gas analyzer or monitor inside an oxygen tent or any gas containment apparatus Do not use anti static or electrically conductive breathing tubes in the presence of electrocautery or electrosurgery equipment NCAUTION N e Gas mixtures of oxygen or nitrous oxide with agents such as halothane methoxyflurane or enflurane can be flammable Do not operate the monitoring system if high ambient agent concentrations or anesthetic gas leaks are suspected Always use a scavenging line connected to the exhaust port and to the facility scavenging system Page 4 2 Poet IQ 8500H Operator s
44. s above its mix threshold limit Poet IQ 8500H Operator s Manual Criticare Systems Inc Interfering Gases For Anesthetic Agents Criticare Systems Inc Section 4 Patient Monitoring The monitor will report small changes in agent concentrations when anesthetic agents and other gasses are used Expected agent changes are provided here for the purpose of comparison For Gas Mixtures of 2 Halothane Agent Agent Volume Change of Halothane N O 60 0 1 Halothane 4 N A Enflurane 5 0 1 Isoflurane 5 0 1 Sevoflurane 5 0 1 Desfluranet 5 0 1 Helium 50 0 1 Ethanol 1 0 0 Isopropanol 196 10 196 Acetone 196 0 196 Methane 196 0 096 Metered does inhaler propellant 1 0 0 Xenon 80 Not intended for use with Xenon For Gas Mixtures of 2 Enflurane Agent Agent Volume Change of Enflurane N O 60 0 0 Halothane 4 0 3 Enflurane 5 N A Isoflurane 5 0 1 Sevoflurane 5 0 2 Desfluranet 596 410 196 Helium 5096 40 196 Ethanol 196 0 1 Isopropanol 196 0 1 Acetone 1 0 1 Methane 1 0 0 Metered does inhaler propellant 1 0 1 Xenon 80 Not intended for use with Xenon Gas mixtures balanced with Nitrogen t Presence of 15 Desflurane in a mixture with other halogenated gases will result in the display of 15 Desflurane readings or greater Poet IQ 8500H Operator s Manual Page 4 9 Section 4 Patient Monitoring For Gas Mixtures of 2 Isoflurane Agent Agent Volume Ch
45. sation for the internal capnometer and the gas analyzer function independently and differently A manual form of NoO compensation is provided with the settings for the internal capnometer Since the capnometer does not measure the amount of N5O present the compensation is generalized for NO levels within a 40 to 80 percent range This feature must be manually activated when N O is being used The 8500H agent gas analyzer uses a polychromatic infrared technology to measure N O and CO levels independently The measuring process used in the 8500H detector is inherently unaffected by CO and N5O mixtures If the N5O level exceeds its threshold for the detection limit the monitoring system when set can accurately compensate for a range of N O concentrations Poet Q 8500H Operator s Manual Page 3 3 Section 4 Patient Monitoring Introduction to This section provides instructions for patient connections and Clinical Use monitoring The caregiver is expected to be fully familiar with patient monitoring techniques and with the functions of the monitoring system before using it with a patient Before you Begin Protect yourself and your patient Read the precautions for each measured parameter that appears in this section These instructions describe the use of basic sampling devices and accessories that come with your monitoring system An extended list of approved accessories can be found in the appendix of this manual The monitor sho
46. stream circuit It measures the concentrations of CO N20 and halogenated anesthetic agents in the sampled gas The detector uses far infrared measurements to identify concentrations of halothane enflurane isoflurane sevoflurane desflurane anesthetic agents and their mixtures The analyzer uses the principles of infrared absorption spectrometry to measure anesthetic gases in the same manner as explained for CO measurement The integrated detector determines the concentrations of anesthetic gases and CO by measuring the optical absorption of the sampled patient gas at a number of specific wavelengths in the medium to long wave infrared region The 8500H monitoring system has been calibrated with dry NIST traceable calibration gases at room temperature and pressure 21C 740 mmHg Given the small effect of water vapor on agent gas and CO measurements and the system s built in temperature and pressure measurements and compensations this 8500H system method of gas analysis per EN 864 is best described as ATPS Ambient Temperature and Pressure Saturated 21C 750mmHg 100 Humidity Saturated The 8500H monitoring system is suitable for sustained pressure breathing circuit monitoring environments and has been tested per Clause 102 Sustained Pressure of EN 864 Poet IQ 8500H Operator s Manual Criticare Systems Inc Stability of Accuracy Agent Accuracy of Measurement Oxygen 0 Measurement Method Criticare Systems
47. t block or attach anything to the air intake port EXHAUST PORT NCAUTION A Always use a scavenging line connected to the exhaust port and to the facility scavenging system An exhaust port is located on the rear panel This port removes gases process by the 8500H analyzer HOST MONITOR PORT The host monitor port is designated for the transfer of data between the 8500H analyzer and the host monitor Power to the 8500H analyzer is supplied through the interface cable from the host monitor NCAUTION A The HOST MONITOR Port is reserved only for the transfer of data between the 8500H analyzer and the host monitor This is not an RS 232 port and should not be used for printing or download applications The female DB 9 data port allows the 8500H analyzer to communicate data to and from the host monitor Page 2 2 Poet Q 8500H Operator s Manual Criticare Systems Inc section 3 Setup Procedure Monitor Setup This section provides an overview of the setup procedures for using the 8500H analyzer The host monitor should be set up by the health care provider before using it on patients If the monitor is new preparations such as loading paper and batteries should be performed Auto calibration The agent gas analyzer may require a short warm up period and and Warm Up auto calibration sequence similar to an internal capnometer The message AGT WARMING appears The informational message AGT MANUAL or AGT AUTOMATIC may app
48. ter is used or the capnogram is drawn from the external gas 8500H analyzer module INTERFERING GASES FOR CO2 The monitor will report small changes in CO when anesthetic agents and other gasses are used Expected CO changes are provided here for the purpose of comparison For Gas Mixtures of 5 CO Agent Agent Volume Change of CO N O 60 0 2 Halothane 4 0 1 Enflurane 5 0 1 Isoflurane 5 0 1 Sevoflurane 5 0 2 Desfluranet 596 0 096 Helium 5096 0 096 Ethanol 196 40 196 Isopropanol 196 0 096 Acetone 196 0 1 Methane 1 0 0 Metered dose inhaler propellant 1 0 0 Xenon 80 Not intended for use with Xenon Gas mixtures balanced with Nitrogen t Presence of 15 Desflurane in a mixture with other halogenated gases will result in the display of 15 Desflurane readings or greater The 8500H agent gas analyzer automatically compensates for the presence N O The table above indicates interference after this compensation has occurred Poet IQ 8500H Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring Oxygen O2 Monitoring When a patient is connected the monitor begins displaying the expired and inspired O numerical values in the parameter box All procedures for patient setup water traps and occlusions apply to the O measurement because the sample is taken from the same source as the CO and the halogenated gases The parameters and procedures for oxygen monitoring are the s
49. tors Criticare Systems Inc Poet IQ 8500H Operator s Manual Page 4 5 Section 4 Patient Monitoring Occlusions The monitor displays a visual message OCCLUSION if the gas Page 4 6 sampling system is blocked using either the internal capnometer or the gas analyzer The message CO2 OCCLUSION always refers to the internal capnometer gas circuit of the host monitor The message AGT OCCLUSION always refers to the external 8500H analyzer gas circuit The 8500H analyzer will momentarily attempt to clear a blockage automatically drawing it into the collection basin of the water trap If the sampling line or water trap becomes completely blocked the sample line and or the water trap should be replaced There will be a brief interruption in gas monitoring during automatic occlusion clearing The monitor displays NO EXHAUST if the scavenging line is blocked on the gas analyzer Poet IQ 8500H Operator s Manual Criticare Systems Inc Anesthetic Gas Monitoring Anesthetic Agent Identification and Quantification Primary Agent User Selected Primary Agent Criticare Systems Inc Section 4 Patient Monitoring Allow the 8500H analyzer host monitoring system to warm up and auto calibrate before use It is necessary to have the water trap and sampling line attached so that the 8500H analyzer draws the correct air flow The analyzer is an agent specific monitor which means that it is capable of simultaneously distinguishing
50. ugh the interface cable See the nCompass 8100H Series operator s manual for information about control panels switches and screen displays Connecting to the An 8100H to 8500H interface cable is all that is required to connect 8100H Series Monitor the agent gas analyzer to the 8100H host monitor The cable is available in two lengths 1 meter 8100H to 8500H interface cable CAT 2041 e 3 meter 8100H to 8500H interface cable CAT 2042 Criticare Systems Inc Poet Q 8500H Operator s Manual Page B 1
51. uld always be checked by the caregiver before use for actual patient monitoring Perform the following procedure before using the monitor with a patient 1 Confirm that the selected monitor is fully compatible with the gas analyzer 2 Make sure that monitor has been fully charged before use Check that the monitoring system s AC power cord is plugged in for long term monitoring situations Check the communications cable for secure connection to the monitor and analyzer 3 Check the menus and default settings on the monitor to confirm that the monitor is set up correctly 4 Examine the accessories for wear damage or contamination Replace or disinfect the accessories as required WARNING N All accessories connected to the gas analyzer and the patient monitor must comply with applicable EN and IEC standards for such products e Substitution of recommended sensor and sampling accessories may cause inaccurate measurements and degrade patient safety or may damage the gas analyzer and host monitor Criticare Systems Inc Poet IQ 8500H Operator s Manual Page 4 1 Section 4 Patient Monitoring Gas Monitoring Safety The following instructions describe precautions and contraindications for gas monitoring Use all safety procedures and protocols for anesthetic safety as designated by your health care facility NWARNING A Do not use this monitoring system in conjunction with highly flammable anesthetics such as cyclop
52. uranet 8 0 0 3 Gas mixtures balanced with Nitrogen t Presence of 15 Desflurane in a mixture with other halogenated gases will result in the display of 15 Desflurane readings or greater Poet IQ 8500H Operator s Manual Page 4 15 Section 4 Patient Monitoring Drift of Measurement The monitor will report small changes in agent concentrations over Accuracy time Expected agent changes are provided here for the purpose of comparison Drift of Measurement Accuracy Agent Agent Volume Change of Agent Over Time 0 hours 3 hours 6 hours CO 0 096 0 096 0 096 0 096 2 596 0 1 0 1 0 1 5 0 0 0 0 1 0 1 10 0 0 0 0 1 0 1 Halothane 0 5 0 0 0 0 0 0 1 0 0 0 0 0 0 0 4 0 0 1 0 1 0 1 Enflurane 0 5 0 0 0 0 0 0 1 0 0 0 0 0 0 0 5 0 0 2 0 2 0 2 Isoflurane 0 5 0 0 0 0 0 0 1 0 0 0 0 0 0 0 5 0 0 2 0 2 0 2 Sevoflurane 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 1 5 0 0 2 0 2 0 2 Desfluranet 5 096 0 096 0 096 0 096 10 096 0 1 0 2 0 2 15 0 0 2 0 2 0 2 N O 30 0 0 2 0 8 0 3 65 0 0 8 0 8 0 4 Oo 15 0 0 2 0 2 0 0 21 0 0 5 0 4 0 0 40 0 0 6 0 8 1 0 60 0 0 1 0 4 0 4 100 0 0 4 0 2 1 0 Gas mixtures balanced with Nitrogen t Presence of 15 Desflurane in a mixture with other halogenated gases will result in the display of 15 Desflurane readings or greater Page 4 16 Poet IQ 8500H Operator s
53. waste Alternately the analyzer and its accessories may be returned to Criticare Systems Inc for safe disposal The shipping address is Criticare Systems Inc N7 W22025 Johnson Drive Waukesha WI 53186 Poet IQ 8500H Operator s Manual Criticare Systems Inc Appendix A Accessories Gas Monitoring Accessories Sampling Devices Gas Testing Accessories Criticare Systems Inc Sample Lines use with CAT 938F NC Box of 25 625N Nasal Cannulas Box of 10 624 Divided Nasal Cannulas Box of 10 628 Endotracheal Adaptor Straight Box of 10 s 616 Endotracheal Adaptor Elbow Box of 10 ennnen 617 WaterChek 2 Water Trap Box Of 201 938F NC Oxygen Sensor Cell 644 COs Absorbe enee ee 780 Scavenging Exhaust Tube ceeeeceeeeeeeeeeeeeeeeeeneeeeeeeeeeeeeeesaaeees 655 Scavenging Exhaust Tube International 655 I Cal Gas Cylinder 5 CO Balance No ou eee eee eee eens 621 Cal Gas Cylinder 10 CO Balance Nah 622 Cal Gas Cylinder 80 Op BalanceNal 1547 Regulator Valve ssssssse n nn nnne 623 Gas Regulator Tube 613B Breath Rate Simulator ssssssssseene 1466 8500A Serial Test Cable aieeeeeeeeeeeeeeeeennneneene P N 90837A001 Software O Calibration Tool P N 75667B001 Cal Gas Aerosol 1 Isoflurane 5 CO2 60 N2O Bal Np 631 Cal Gas Aerosol 1 Enflurane 5 CO2
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