Gas Module 3 Operators Manual
Contents
1. GM Agent Mismatch HAL Appears when the system detects Halothane as the primary agent and the manually selected agent is not Halothane Match the Agent administered with the Agent selected or select Agent Auto ID GM Agent Mismatch ISO Appears when the system detects Isoflurane as the primary agent and the manually selected agent is not Isoflurane Match the Agent administered with the Agent selected or select Agent Auto ID GM Agent Mismatch ENF Appears when the system detects Enflurane as the primary agent and the manually selected agent is not Enflurane Match the Agent administered with the Agent selected or select Agent Auto ID GM Agent Mismatch SEV Appears when the system detects Sevoflurane as the primary agent and the manually selected agent is not Sevoflurane Match the Agent administered with the Agent selected or select Agent Auto ID GM Agent Mismatch DES Appears when the system detects Desflurane as the primary agent and the manually selected agent is not Desflurane Match the Agent administered with the Agent selected or select Agent Auto ID GM Unknown Agent Appears when the system detects a gas that does not match the spectroscopic signatures of the five known anesthetic agents Use recognized agent GM Cannot Zero RETRYING Appears when the bedside monitor requests Zeroing either on the automatic cycle or2. 2 Verify that the water trap container is less than half full 3 Occlude the sampling line and verify that the occlusion alarm functions properly 4 Breathe into the sampling line and verify that a CO waveform is correctly displayed on the monitor 5 Sample room air for 30 seconds and verify that the monitor oxygen output is 20 95 sensor inaccuracy Gas Module 3 Operating Instructions 0070 10 0696 02 2 3 Gas Monitoring with Gas Module 3 Operations 2 1 2 2 1 2 1 y TM Gas Monitor Calibration Passport 29 Spectrum9 Spectrum OR Accuracy verification of the Gas Module 3 is recommended at one 1 year intervals or whenever gas readings appear to be in error The date of the last successful mixture calibration appears at the bottom of the gas Calibration Menu During the calibration session gas readings and all other gas functions are not available Span calibration is a set of prompted commands that enables the operator to align the gas display s to specific gas concentration s within the Mindray DS Calibration Gas canister Span calibration can be initiated by the operator any time the gas module s readings are suspected to be inaccurate Always verify accuracy using a full canister of Mindray DS approved precision calibration gas after calibration is performed Never use calibration gas that has expired has a different concentration or a canister that is indicating low pressure The pressure indicator
3. AppendiX eccococccconoccccnnonccnnnocccnnoncncnnonoccnnoneccnncocconococcnnenccconococcnnonoccnncccconaconccnanocicanacccnnnaacoso Y 1 Environmental and Safety Characteristics c ccccesceseeseceeceeceeeeeeescescesesseeeeseeeceeceseneceseeseseeeeessesseeeeneenrentetens 5 1 Agency Complices dd ads 5 2 Electromagnetic Capability 3 le 5 7 9 9 Phone Numbers and How To Get Assistance conocia na nnnocnnnonononononnnonnnnnnonnnnnnnnnnnnnnnnnncncnnnnnininess 5 Mindray DS s Responsibility 22 5 2220 23 teres abad a ea e Ee E A cio aE 5 Gas Module 3 Operating Instructions 0070 10 0696 02 i This page intentionally left blank Gas Module 3 Operating Instructions 0070 10 0696 02 ii Foreword Introduction Foreword The Gas Module 3 Operating Instructions manual is intended to provide information for proper operation General knowledge of monitoring of airway gases and an understanding of the features and functions of the Mindray DS Gas Module 3 are prerequisites for ts proper use NOTE Do not operate this device before reading these instructions Information for servicing this instrument is contained in the Gas Module Service Manual Addendum part number 0070 00 0522 For additional information or assistance please contact an authorized Mindray DS representative in your area CAUTION U S Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by state
4. Start Calibration f Select to start calibration FIGURE 2 7 Calibration Menu 2 Select Gas Selection from the Calibration Menu and choose the calibration gas type Choices are Mixture 5 CO 55 Oz 33 N20 and 2 Des 3 Select Start to begin calibration At the start of the calibration the message Zeroing will be initially displayed for each of the gas labels as the Gas Module zeros the gas channels After successful zeroing the Gas Module will request the calibration gas as indicated in the next step NOTE If the Gas Module cannot zero a zeroing error will be displayed and the previous calibration data will be restored Repeat the calibration procedure from step 1 If problems persist contact Mindray DS Technical Support 0070 10 0696 02 Gas Module 3 Operating Instructions Operations Gas Monitoring with Gas Module 3 4 The message Feed calibration gas will be displayed At this point attach the calibration gas canister to the regulator and turn it on Increasing gas values will appear in the window as the Gas Module samples the calibration gas Calibration Menu Calibration Menu Previous Menu Previous Menu Zeroing 0 0 Zeroing 0 0 Zeroing Zeroing 0 0 Feed calibration gas Date of last suc Calibration 01 0 y Date of last succ ful Calibration Select to return to previous menu Select to return to previous menu FIGURE 2 8 Gas Calibration Menu FIGURE 2 9 Gas C
5. WARNING WARNING WARNING WARNING WARNING Connection of the Gas Module 3 exhaust port to the hospital s waste gas scavenging system is strongly recommended to prevent exposure of hospital personnel to the patient s respiratory sample Vacuum negative pressure should not exceed 1 mmHg at the Gas Module Pump Exhaust fitting Excessive scavenge vacuum may result in damage to the Gas Module s internal pump The use of gas sampling accessories in Gas Module 3 other than specified by Mindray DS may cause significant measurement errors and patient risk Use of accessories transducers and cables other than those specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Gas Module 3 With the exception of stacking under a bedside monitor with the appropriate mounting brackets the Gas Module 3 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the Gas Module 3 should be observed to verify normal operation in the configuration in which it will be used If the water trap breaks or becomes damaged during operation there is a risk that bacteria and or mucus may contaminate the Gas Module Do not use Adult Pediatric type water traps and or sampling lines with neonates to avoid high sampling flow The Gas Module must not be used with flammable anesthetic agents The Gas Module water trap sampling line and airwa
6. Mindray DS maintains a network of service representatives and factory trained distributors Prior to requesting service perform a complete operational check of the instrument to verify proper control settings If operational problems continue to exist contact the Mindray DS Service Department at 800 288 2121 or 201 995 8116 for assistance in determining the nearest field service location Please include the instrument model number the serial number and a description of the problem with all requests for service Any questions regarding the warranty should be directed to the nearest Mindray DS location A list of international offices along with their phone numbers is provided at the end of this manual NOTE Upon request Mindray DS will provide circuit diagrams component part lists descriptions calibration instructions or other information which will assist the user s appropriately qualified technical personnel to repair those parts of the Mindray DS equipment which are designated by Mindray DS as repairable Mindray DS s Responsibility Mindray DS is responsible for the effects on safety reliability and performance of the equipment only if a assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by Mindray DS and b the electrical installation of the relevant room complies with the appropriate requirements and c the equipment is used in accordance with t
7. box of 10 0683 00 0424 10 Nasal Cannula CO2 02 7 2 1 m box of 10 0683 00 0452 10 Adapter Straight Tee ET box of 12 0683 00 0242 22 Adapter Mask Elbow ET box of 12 0683 00 0242 12 DRYLINE Neonate Sample Line Patient 2 5 ml box of 25 0683 00 0524 25 DRYLINE Adult Pediatric Sample Line Patient 2 5 m box of 25 0683 00 0525 25 DRYLINE Neonate Water Trap Assembly box of 10 0202 00 0181 10 DRYLINE Adult Pediatric Water Trap Assembly box of 10 0202 00 0182 10 Gas Scavenging Adapter Assembly Quick Connect 0997 00 0923 Gas Scavenging Adapter Assembly Luer 0997 00 0984 Bedside Monitor Gas Module Mounting Kit 0040 00 0287 03 Wall Mount For U S use only Gas Module 3 Operating Instructions 0070 10 0696 02 0436 00 0061 01 Accessories This page intentionally left blank 0070 10 0696 02 Gas Module 3 Operating Instructions 5 0 Appendix 5 1 Transport and Storage Temperature Transport and Storage Humidity Operating Temperature Operating Humidity Operating Altitude Shipping Shock Vibration Drop Environmental and Safety Characteristics 40 C to 70 C 5 to 100 condensing 10 C to 40 C 10 to 95 RH non condensing in Airway 0 100 RH condensing Sea Level to 8 000 feet ISTA shipping procedure 1A IEC 60068 2 27 peak acceleration 150 m s 15 3 g duration 11 ms pul
8. law to use or order the use of this device NOTE Figures in this manual are provided for reference purposes only Screens will likely differ based on the monitoring device configuration licenses available parameters selected and patient configuration of the bedside monitor Patents This device is covered under one or more of the following U S Patents 6 589 028 6 896 713 and foreign equivalents Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would alone or in combination with this device fall within the scope of one or more of the patents relating to this device Warnings Cautions and Notes Please read and adhere to all Warnings Cautions and Notes listed here and in the appropriate areas throughout this manual A WARNING is provided to alert the user to potential serious outcomes death injury or serious adverse events to the patient or the user A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury but about which the user should be aware Cautions are also provided to alert the user to adverse effects on this device of use or misuse and the care necessary to avoid such effects A NOTE is provided when additional general inf
9. meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the rel vicinity of equipment marked with the following symbol NOTE At 80 MHz and 800 MHz the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Held 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 the oretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an elec tromagnetic site survey should be considered If the measured field strength in the location in which the Gas Module 3 is used exceeds the applicable RF compliance level above the Gas Module 3 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Gas Module 3 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Gas Module 3 Operating Instructions 0070 10 0696 02 5 5 Electromagnetic Capability Appendix TABLE 5 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUN
10. PADA P d lt P gt Mm MA Attention Consult Accompanying Documents Refer to Manual Dangerous Voltage Equipotentiality Alternating Current AC Data Input Output Crossed out wheelie bin indicates separate treatment from general waste at end of life For single patient use only do not reuse For Neonatal use Not for Neonatal use SYMBOL G SW DESCRIPTION Type BF Equipment Gas Port Input Gas Port Output Direct Current DC Interference may occur in the vicinity of equipment marked with this symbol Manufacturer s reference catalogue number Manufacturer s batch number Serial number Software Version Conformit Europ enne CE Marking of Conformity to European Medical Device Directive CEyyyy represents the Notified Body number Gas Module 3 Operating Instructions 0070 10 0696 02 vi This page intentionally left blank Gas Module 3 Operating Instructions 0070 10 0696 02 vii 1o General Product Description 1 1 Front Panel FIGURE 1 1 Gas Module 3 Front Panel 1 Input Port This port is used to connect the sampling tubing to the Gas Module 3 2 Water Trap Assembly includes Water Trap Reservoir Adult Pediatric P N 0202 00 0182 10 Neonate P N 0202 00 0181 10 The Water Trap Assembly is used to capture moisture drawn in with the patient sample The Water Trap Reservoir m
11. Support 0070 10 0696 02 Gas Module 3 Operating Instructions z0 User Maintenance 3 1 Care and Cleaning of Gas Module WARNING Do not clean the Gas Module while it is on and or plugged in 1 The Gas Module enclosure may be cleaned with a mild soap and water solution or ammoniated window cleaner Apply cleaning solution to the cloth not directly onto the Gas Module DO NOT apply large amounts of liquid DO NOT use abrasive cleaning agents or organic solvents CAUTION The internal sampling system of the Gas Module does not need to be cleaned or sterilized There is no reverse flow back to the patient If the internal sampling system is suspected to be clogged or dirty the module should be serviced by an authorized service person only 2 The DRYLINE Water Trap Assembly consists of a filter housing and reservoir that must be checked and emptied whenever changing patients or if it is more than half full WARNING The contents of the water trap should be handled as a potential infection hazard NOTE Replace the complete DRYLINE Water Trap Assembly every month or more often if indicated on the monitor e To remove the DRYLINE Water Trap Assembly from its receptacle press the lugs on its sides and pull out An Air Leak message will be displayed The monitor will suspend sampling e Detach the reservoir from the filter housing by twisting and separating these two parts e Empty the reservoir and rinse with water o
12. Ur gt 95 lt 5 Ur gt 95 dip in Uy for dip in Uy for 5 sec 5 sec Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz magnetic field IEC 61000 4 8 should be at levels characteristic of a typical location in a typical commercial or hospital environment Uy is the A C mains voltage prior to application of the test level 0070 10 0696 02 Gas Module 3 Operating Instructions Appendix Electromagnetic Capability TABLE 5 3 GUIDANCE AND MINDRAY DS USA INC DECLARATION ELECTROMAGNETIC IMMUNITY The Gas Module 3 is intended for use in the electromagnetic environment specified below The customer or the user of the Gas Module 3 should assure that it is used in such an environment IMMUNITY IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC TEST LEVEL LEVEL ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the Gas Module 3 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 2x JP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 2x JP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3x JP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in
13. an environment IMMUNITY TEST Electrostatic discharge ESD IEC 61000 4 2 IEC 60601 TEST LEVEL 6 kV contact 8 kV air COMPLIANCE LEVEL 6 kV contact 8 kV air ELECTROMAGNETIC ENVIRONMENT GUIDANCE Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of transient burst supply lines supply lines a typical commercial or hospital IEC 61000 4 4 1 kV for input 1 kV forinput environment output lines output lines Surge IEC 1 kV differential 1 kV differential Mains power quality should be that of 61000 4 5 mode mode a typical commercial or hospital 2 kV common 2 kV common environment mode mode Voltage dips lt 5 Ur gt 95 lt 5 Ur gt 95 Mains power quality should be that of short dip in Uy for dip in Uy for a typical commercial or hospital interruptionsand 0 5 cycle 0 5 cycle environment If the user of the Gas voltage Module 3 requires continued variations on 40 Ur 60 40 Uy 60 operation during power mains power supply dip in Uy for dip in Uy for interruptions it is recommended that input lines IEC 5 cycles 5 cycles the Gas Module 3 be powered from 61000 4 11 an uninterruptible power supply or a 70 Ur 30 70 Ur 30 battery dip in Uy for dip in Uy for 25 cycles 25 cycles lt 5
14. service person only CAUTION To avoid permanent damage do not expose metal components pins sockets snaps to disinfectants soaps or chemicals CAUTION Gas Module 3 must be moisture protected whenever transported This can be done with a protective plastic bag in which water absorbing materials e g silica gel have been included CAUTION Contamination with CO N2O or Anesthetic Agent in the air surrounding the Gas Module 3 may cause significant measurement errors Notes NOTE Potential hazards due to errors in software or hardware have been minimized by actions taken in accordance with IEC 60601 1 4 Indication For Use The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and or assisted respiration The intended environment of use is the anesthesia department including the Operating Room OR and post anesthesia care units PACU etc Unpacking Remove the instrument from the shipping carton and examine it for signs of shipping damage Save all packing materials invoice and bill of lading These may be required to process a claim with the carrier Check all materials against the packing list Contact the Mindray DS Service Department at 800 288 2121 or 201 995 8237 for prompt assistance in resolving shipping problems 0070 10 0696 02 Gas Module 3 Operating Instructions Symbols and Descriptions Introduction Symbols and Descriptions SYMBOL DESCRIPTION
15. ICATIONS EQUIPMENT AND THE GAS MODULE 3 The Gas Module 3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Gas Module 3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Gas Module 3 as recommended below according to the maximum output power of the communications equipment RATED MAXIMUM OUTPUT POWER P OF TRANSMITTER IN WATTS SEPARATION DISTANCE 49 IN METERS m WwW ACCORDING TO FREQUENCY OF TRANSMITTER 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz d 1 2x JP d 1 2x JP d 2 3x JP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 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 recommended separation distance d in meters m can be determined 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 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 5 6 0070 10 0696 02 Gas Module 3 Operating Instructions Appendix Warr
16. Operating Instructions Gas Module 3 NORTH AMERICA DRYLINE is a trademark of Artema Medical AB Passport 2 is a US registered trademark of Mindray DS USA Inc Spectrum is a U S registered trademark of Mindray DS USA Inc Spectrum OR is a US trademark of Mindray DS USA Inc Copyright Mindray DS USA Inc 2008 All rights reserved Contents of this publication may not be reproduced in any form without permission of Mindray DS USA Inc 0070 10 0696 02 Gas Module 3 Operating Instructions Table of Contents A ART ii NEE ii Warnings Cautions andiNotes Au dit bites lirica Leia TA e A Stes divs Masten shes A ii INN a A AA va es nated aoa a E TE e iS iii CAU A Seid A A bss v KEE v Indication For Us Sii A A A AA N AA v Unpacking E v Symbols and Descriptions mannaia a E A aa ERA EE EAS E AAEE REE A AAA e vi General Product Description sssessecesseeoosssossosecseecosseososeeossseossecesssossoseossesesssesosseossssesssseo 1 Front deI EREE A AEE E E de AAA ee A E E E NAA E 1 1 O RS NS 1 2 Operations 0cee00 Gas Monitoring with Gas Module Sramana aa aaa a iris 2 EE A eegne deed EE Ula okt Wane NA Male 2 Gas Monitor Calibration Passport 2 Spectrum Spectrum OR 2 EE NN o CG bk KRW re EE Gas Module Troubleshooting geren ta tana a eta bas le do cla N A a E I Core opd Cleaning of Gas Module cccononocionnanoninision ainda cita ioiai E E E E 3 1 A Wen
17. The numeric data for all agents will appear as and the agent waveform will be a flatline Ensure proper gas mixture is attached tightly and regulator is on Repeat calibration procedure If problem persists contact Mindray DS Technical Support GM Failed Appears when the Gas Module detects an unrecoverable error in its own operation Contact Mindray DS Technical Support GM Disconnected Appears when the bedside monitor cannot detect signals being sent by the Gas Module Ensure Gas Module is turned on and interface cable is properly connected If problem persists contact Mindray DS Technical Support Sampling Error Appears when a sampling error occurs on one or more Gas Module channels during calibration Repeat calibration procedure If problem persists contact Mindray DS Technical Support Not Ready For Calibration Appears when the Gas Module is unable to initialize calibration Repeat calibration procedure If problem persists contact Mindray DS Technical Support Calibration Error Sampling Error Appears when a sampling error occurs in all four Gas Module channels during calibration Repeat calibration procedure If problem persists contact Mindray DS Technical Support Calibration Error Zeroing Error Appears when the Gas Module cannot perform a Zeroing during calibration Repeat calibration procedure If problem persists contact Mindray DS Technical
18. alibration Menu 5 When calibration is complete the Feed calibration gas message will be removed from the display and the message Complete will be displayed next to each value that was successfully measured If at least one gas was successfully measured the Accept menu choice will become available If the values are acceptable select Accept To cancel calibration and re install the previous calibration values select Abort Calibration Menu Previous Menu Gas Selection Mixture Abort Accept Complete Complete Complete Select to Accept the Calibration FIGURE 2 10 Gas Calibration Menu NOTE When the Accept menu choice is selected the message Disconnect calibration gas will be displayed To avoid premature emptying of the gas canister always remove the regulator at the end of the procedure Gas Module 3 Operating Instructions 0070 10 0696 02 2 7 Gas Monitoring with Gas Module 3 Operations NOTE If any input data is corrupt or if there are other errors a Calibration Error message will appear after the Accept button is selected The Gas Module 3 will not accept span calibration with errors in any channel 2 1 2 3 MESSAGE PROBLEM GM Warming Up Gas Module Troubleshooting REASON Appears when the system has been turned on and the sensors have not reached their stable operating temperature SOLUTION Wait for the message to go away It takes up to five m
19. anty Statements 5 4 Warranty Statements Mindray DS USA Inc warrants that components within the monitor unit will be free from defects in workmanship and materials for the number of years shown on the Mindray DS invoice Under this extended warranty Mindray DS USA Inc will repair or replace any defective component at no charge for labor and or materials This extended warranty does not cover consumable items such as but not limited to batteries displays external cables and sensors Recommended preventative maintenance as prescribed in the Service Manual is the responsibility of the user and is not covered by this warranty Except as otherwise provided herein the terms conditions and limitations of Mindray DS s standard warranty will remain in effect USA Canada Mexico and Puerto Rico Mindray DS USA Inc warrants that its products will be free from defects in workmanship and materials for a period of one 1 year from the date of purchase except that disposable or one time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use whichever is sooner This warranty does not cover consumable items such as but not limited to batteries external cables sensors cuffs hoses or mounts Mindray DS USA Inc will not be liable for any incidental special or consequential loss damage or expense directly or indirectly ari
20. as any authority to bind Mindray DS USA Inc to any affirmation representation or warranty concerning its products and any affirmation representation or warranty made by any agent employee or representative shall not be enforceable by buyer This warranty is expressly in lieu of any other express or implied warranties including any implied warranty or merchantability or fitness and of any other obligation on the part of the seller Damage to any product or parts through misuse neglect accident or by affixing any non standard accessory attachments or by any customer modification voids this warranty Mindray DS USA Inc makes no warranty whatever in regard to trade accessories such being subject to the warranty of their respective manufacturers A condition of this warranty is that this equipment or any accessories which are claimed to be defective be returned when authorized by Mindray DS freight prepaid to Mindray DS USA Inc Mahwah New Jersey 07430 Mindray DS USA Inc shall not have any responsibility in the event of loss or damage in transit Calibration may be performed without the need to disassemble the instrument It is the responsibility of the purchaser to perform calibration as necessary in accordance with the instructions provided in this manual 5 8 0070 10 0696 02 Gas Module 3 Operating Instructions Appendix 5 5 5 6 Phone Numbers and How To Get Assistance Phone Numbers and How To Get Assistance
21. by a user request and the Gas Module is unable to initialize the cycle Allow system to retry without intervention If problem persist contact Mindray DS Technical Support GM CO Uncalibrated Appears after an unsuccessful calibration attempt of the CO sensor The numeric data for CO will appear as and the CO waveform will be a flatline Ensure proper gas mixture is attached tightly and regulator is on Repeat calibration procedure If problem persists contact Mindray DS Technical Support Gas Module 3 Operating Instructions 0070 10 0696 02 2 Gas Monitoring with Gas Module 3 MESSAGE PROBLEM GM O Uncalibrated REASON Appears after an unsuccessful calibration attempt of the O sensor The numeric data for O will appear as and the Oz waveform will be a flatline Operations SOLUTION Ensure proper gas mixture is attached tightly and regulator is on Repeat calibration procedure If problem persists contact Mindray DS Technical Support GM N2O Uncalibrated Appears after an unsuccessful calibration attempt of the N20 sensor The numeric data for N20 will appear as and the NO waveform will be a flatline Ensure proper gas mixture is attached tightly and regulator is on Repeat calibration procedure If problem persists contact Mindray DS Technical Support GM Agents Uncalibrated Appears after an unsuccessful calibration attempt of the agent sensor
22. ervice according to the EMC information provided below Portable and mobile RF communications equipment can affect the Gas Module 3 See tables 5 1 through 5 4 that follow GUIDANCE AND MINDRAY DS USA INC DECLARATION ELECTROMAGNETIC EMISSIONS The Gas Module 3 is intended for use in the electromagnetic environment specified below The customer or the user of the Gas Module 3 should assure it is used in such an environment EMISSIONS TEST RF emissions CISPR 11 COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE Group 1 The Gas Module 3 uses RF energy only for their internal function Therefore their RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The Gas Module 3 is suitable for use in all CISPR 11 establishments other than domestic establishments and Harmonic Class A those directly connected to the public low voltage power emissions IEC supply network that supplies buildings used for domestic 61000 3 2 purposes Voltage Complies fluctuations Flicker emissions IEC 61000 3 3 Gas Module 3 Operating Instructions 0070 10 0696 02 5 3 Electromagnetic Capability TABLE 5 2 Appendix GUIDANCE AND MINDRAY DS USA INC DECLARATION ELECTROMAGNETIC IMMUNITY The Gas Module 3 is intended for use in the electromagnetic environment specified below The customer or the user of the Gas Module 3 should assure that it is used in such
23. filter for blockage clear sampling line if possible Replace sampling line and or filter if necessary Check exhaust line for blockage and clear if possible If problem persists contact Mindray DS Technical Support This is normal operation Wait for message to clear GM CO Zero Error Appears when the system has been unable to successfully zero the CO sensor Manually start zeroing the system again If problem persists contact Mindray DS Technical Support 0070 10 0696 02 Gas Module 3 Operating Instructions Operations MESSAGE PROBLEM GM O Zero Error REASON Appears when the system has been unable to successfully zero the O sensor Gas Monitoring with Gas Module 3 SOLUTION Manually start zeroing the system again If problem persists contact Mindray DS Technical Support GM N20 Zero Error Appears when the system has been unable to successfully zero the N20 sensor Manually start zeroing the system again If problem persists contact Mindray DS Technical Support GM Agent Zero Error Appears when the system has been unable to successfully zero the anesthetic agent sensor Manually start zeroing the system again If problem persists contact Mindray DS Technical Support GM Pump Off Appears when the system has turned off the pump due to a pneumatic error Restart the pump from the Gas Menu If problem persists contact Mindray DS Technical Support
24. he instructions for use Gas Module 3 Operating Instructions 0070 10 0696 02 5 9 0070 10 0696 02 Rev C September 6 2010 Mindray DS USA Inc e 800 MacArthur Boulevard e Mahwah NJ 07430 e USA e Dom Customer Service 1 800 288 2121 e Intl Customer Service 1 201 995 8000 e Dom Fax 1 800 926 4275 e Intl Fax 1 201 995 8680 e www mindray com Mindray Medical Netherlands B V e PO Box 26 e 3870 CA Hoevelaken e The Netherlands e Tel 31 33 25 44 911 e Fax 31 33 25 37 621 Mindray UK Limited e 3 Percy Road e St John s Park e Huntingdon e Cambridgeshire PE29 6SZ e United Kingdom e Tel 01480 416840 e Fax 01480 436588 Mindray Medical France SARL e Europarc Cr teil 123 Chemin des Bassins e 94035 Cr teil Cedex e France e Tel 0 1 45 13 91 50 e Fax 0 1 45 13 91 51 Mindray Medical German GmbH e Zwischen den Bdchen 4 e 64625 Bensheim e Germany Tel 49 6251 17524 0 e Fax 49 6251 17524 20 Mindray Medical International Ltd e 2813 Office Tower Convention Plaza e No 1 Harbour Road e Wanchai e Hong Kong e Tel 852 2793 5596 e Fax 852 2344 8824 0002 08 8918
25. in the event of loss or damage in transit Gas Module 3 Operating Instructions 0070 10 0696 02 5 7 Warranty Statements Appendix Calibration may be performed without the need to disassemble the instrument It is the responsibility of the purchaser to perform calibration as necessary in accordance with the instructions provided in this manual International excluding North America Mindray DS USA Inc warrants that its products will be free from defects in workmanship and materials for a period of two 2 years from the date of purchase except that disposable or one time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use whichever is sooner This warranty does not cover consumable items such as but not limited to batteries external cables sensors cuffs hoses or mounts Mindray DS USA Inc shall not be liable for any incidental special or consequential loss damage or expense directly or indirectly arising from the use of its products liability under this warranty and the buyer s exclusive remedy under this warranty is limited to servicing or replacing at Mindray DS s option at the factory or at an authorized Mindray DS Distributor any product which shall under normal use and service appear to the Company to have been defective in material or workmanship No agent employee or representative of Mindray DS USA Inc h
26. inutes for the device to warm up GM Exhaust Blocked Appears when the system detects a blockage at the exhaust gas outlet as indicated by an increase in internal pressure Remove waste gas scavenging assembly check if message disappears Check exhaust line for blockage and clear if possible If message persists contact Mindray DS Technical Support GM Mixed Agents Appears when more than one anesthetic agent is detected by the system Message will disappear when a single agent is detected again GM Air Leak Appears when the system detects a pneumatic leak Also may appear when the Gas Module has been turned on without a sample line attached Gas Module has been on for a long period of time without the bedside monitor being on Turn Gas Module and bedside monitor Off Install check sample lines filters water trap and electrical connections Turn off Gas Module Turn on Gas Module and bedside monitor GM Replace Trap Indicates residue build up on the water trap membrane that is decreasing air flow Replace water trap reservoir GM Occlusion GM Zero In Progress Appears when the system detects an obstruction in the sampling line or the water trap bottle is full Appears when the system is zeroing all of its channels This appears whether initiated by the user or is automatic Empty and rinse water trap Change water trap if necessary Check sampling line and
27. line connected to a breathing circuit intubated Gas Menu Normal Sereen Select Agent Auto Calibrate gt Grid Off O Scale 100 0 Color EH Agent scale 20 S Agent Color Zero Gases Select to return to normal screen FIGURE 2 1 Gas Menu NOTE The bedside monitor will interface to the Gas Module 3 via the Serial Port Connector on the Comm Port that is mounted in the rear of the bedside monitor Gas Module 3 Operating Instructions 0070 10 0696 02 2 1 Gas Monitoring with Gas Module 3 Operations WARNING When using the Gas Module 3 the maximum sampling rate at the nasal cannula is 200 ml min with an Adult Pediatric water trap and 120 ml min with a Neonatal water trap This device should not be used on patients whose breathing could be impaired by this vacuum flow rate NOTE The Gas Module 3 is equipped with automatic barometric pressure compensation NOTE The Gas Module 3 uses a fixed correction of 11 hPa to compensate for the influence of water vapor in the gas sample when converting the gas readings to ATPD An increase in the ambient H20 partial pressure to 30 hPa i e 28 C 80 RH or 33 C and 60 RH will cause a general error for all gases of only 2 REL Monitoring Anesthetic Gases 0 N20 and or CO NOTE To prevent moisture from entering the pneumatic system ensure that the Gas Module 3 is always installed and operated in the horizontal orientation shown in a
28. ll graphical depictions Turn on the Gas Module 3 and the bedside monitor and configure the bedside monitor serial port to be used with the Gas Module Hold the DISCHARGE key in while powering unit on Set alarms as desired 7 Foot Nasal Cannula P N 0683 00 0424 10 Adapter Straight Tee ET 7 Adult Pediatric P N 0683 00 0525 25 P N 0683 00 0242 22 7 _ Neonate P N 0683 00 0524 25 Adapter Mask Elbow ET P N 0683 00 0242 12 7 Foot Nasal Cannula CO2 02 P N 0683 00 0452 10 2 5 Meter Sample Line Patient Gas Scavenging Adapter Assy P N 0997 00 0923 or P N 0997 00 0984 FIGURE 2 2 Gas Module 3 Airway Adapter NOTE DRYLINE Sample Lines are for use with Gas Module 3 only 2 For non intubated patients apply the nasal cannula to the patient For intubated patients connect the sample line to the breathing circuit Refer to instruction provided in the sample line packets Connect the other end of the nasal cannula or sample line to the Gas Module at the input port Ensure all tubing connections are tight 0070 10 0696 02 Gas Module 3 Operating Instructions Operations Gas Monitoring with Gas Module 3 WARNING Connection of the Gas Module 3 exhaust port to the hospital s waste gas scavenging system is strongly recommended to prevent exposure of hospital personnel to
29. nly e Tightly re attach the reservoir to the filter housing e Re install the DRYLINE Water Trap Assembly into the Gas Module ensuring that it snaps into place Check that the Air Leak message disappears and monitoring resumes Gas Module 3 Operating Instructions 0070 10 0696 02 Care and Cleaning of Gas Module User Maintenance NOTE Only the reservoir of the DRYLINE Water Trap Assembly may be cleaned and or disinfected NOTE If an Occlusion message appears it may be necessary to replace the DRYLINE Water Trap Assembly Adult Pediatric P N 0202 00 0182 10 Neonate P N 0202 00 0181 10 3 2 0070 10 0696 02 Gas Module 3 Operating Instructions zo Accessories DESCRIPTION PART NUMBERS Calibration Gas 0075 00 0028 Calibration Gas Regulator 0119 00 0166 Mounting Bracket Gas Module to Bedside Monitors 0040 00 0299 02 includes 4 screws Part Number 02 12 17 0606 Mounting Plate Gas Module to Wall Mount 0386 00 0344 includes 4 screws Part Number 021 1 03 5008 Mounting Plate Gas Module to Bedside Monitors 0436 00 0160 requires 4 screws Part Number 021 1 04 4010 YPower Cord 120V 0012 00 1081 01 YPower Cord 220V 0012 00 1081 02 YPower Cord 240V 0012 00 1081 03 Cable Gas Module to Bedside Monitor Serial Port short 0 3 m 0012 00 1276 01 Cable Gas Module to Bedside Monitor Serial Port long 1 8 m 0012 00 1276 02 Nasal Cannula CO2 7 2 1 m
30. oad the MPSO Do not connect other equipment to the same MPSO with the Gas Module 3 as it may increase system leakage current Reliably attach Potential Equalization connector to the safety ground when interconnecting the Gas Module 3 with other medical or non medical electrical equipment to minimize the risk of excessive leakage current and or shock hazard Do not reuse disposable devices Compressed gasses are considered Dangerous Goods Hazardous Materials per 1 A T A And D O T regulations It is a violation of federal and international law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified packed marked classified labeled and documented according to D O T and I A T A regulations Please refer to the applicable 1 A T A Dangerous Goods Regulations and or the Code of Federal Regulations 49 Transportation Parts 171 180 for further information Do not use a damaged or broken unit or accessory When using the Gas Module 3 the maximum sampling rate at the nasal cannula is 200 ml min with an Adult Pediatric water trap and 120 ml min with a Neonatal water trap This device should not be used on patients whose breathing could be impaired by this vacuum flow rate iii 0070 10 0696 02 Gas Module 3 Operating Instructions Warnings Introduction WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING
31. on the Mindray DS gas regulator must operate in the green zone during the entire calibration session NOTE The Gas Module 3 must be fully warmed up before performing a gas calibration For maximum accuracy a warm up time of 10 minutes is recommended Passport 2 Spectrum 1 Select Calibrate from the Gas Menu The Calibration Menu opens 2 Select Gas Selection from the Calibration Menu and choose the calibration gas type Choices are Mixture 5 CO 55 Oz 33 N20 and 2 Des 3 Select Start to begin calibration 4 At the start of the calibration the Gas Module will zero the gas channels After successful zeroing the Gas Module will request the calibration gas Calibration Menu Previous Menu Gas Selection Mixture Start Date of Last S Select to start calibration FIGURE 2 3 Calibration Menu 0070 10 0696 02 Gas Module 3 Operating Instructions Operations Gas Monitoring with Gas Module 3 NOTE If the Gas Module cannot zero a zeroing error will be displayed and the previous calibration data will be restored Repeat the calibration procedure from step 1 If problems persist contact Mindray DS Technical Support 5 The message Feed Calibration Gas will appear At this point attach the calibration gas canister fo the regulator and turn it on Increasing gas values will appear in the window as the Gas Module samples the calibration gas Calibration Menu Calibration Menu Previous Menu P
32. ormation is applicable Gas Module 3 Operating Instructions 0070 10 0696 02 ii Introduction Warnings Warnings WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Internal Electrical Shock Hazard This unit does not contain any user serviceable parts Do not remove instrument covers Refer servicing to qualified personnel Trace Gas Hazard When using the Gas Module 3 a health hazard exists when trace amounts of vaporized anesthetic agents are chronically inspired by operating room personnel See Appendix A in NFPA 56A on Inhalation Anesthetics During any procedure where such agents are employed the Gas Module 3 exhaust output should be connected to a medical gas scavenging system Do not use this device during MRI Magnetic Resonance Imaging scanning Induced current could potentially cause burns Accuracy of measurements on this unit and the MRI unit may also be affected For continued protection against a fire hazard replace all fuses with the specified type and rating Observe extreme caution when a defibrillator is used on a patient Do not touch any part of patient table or monitor when a defibrillator is in use Do not put MPSO Multiple Portable Socket Outlets i e Multiple outlet extension cords used with the Gas Module 3 on the floor Connect only a bedside monitor to the same MPSO as the Gas Module 3 Do not overl
33. revious Menu co Zeroing 0 Yo Zeroing N O 3 0 Zeroing Zeroing des 0 0 Feed Calibration Gas Date of last sucoessful Calibration O 02 Date of last successful Calibration 01 Select to return to previous menu Select to return to previous menu FIGURE 2 4 Gas Calibration Menu FIGURE 2 5 Gas Calibration Menu 6 When sampling is complete the Feed Calibration Gas message will disappear and Adjusting will appear next to each value An Accept menu item will also appear If the values are acceptable select Accept To cancel calibration and re install the previous calibration values select Abort Men Calibration Menu Previous Menu Gas Selection Mixture Adjusting Adjusting Adjusting Adjusting Date of last suc ful Calibration 01 Select to Accept the Calibration FIGURE 2 6 Gas Calibration Menu Gas Module 3 Operating Instructions 0070 10 0696 02 2 5 Gas Monitoring with Gas Module 3 Operations 2 1 2 2 NOTE To avoid premature emptying of the gas canister always remove the regulator at the end of the procedure NOTE If any input data is corrupt or if there are other errors a Calibration Error message will appear after the Accept button is selected The Gas Module 3 will not accept span calibration with errors in any channel Spectrum OR 1 Select Calibrate from the Gas Menu The Calibration Menu opens Calibration Menu Previous Menu Gas Selection Mixture
34. se shape half sine number of shocks 3 shocks per direction per axis 18 total IEC 60068 2 64 IEC 60068 2 32 1 After storage in a condensing atmosphere the unit shall before use be kept for more than 24 hr in an environment equivalent to the operating atmosphere Gas Module 3 Operating Instructions 0070 10 0696 02 Agency Compliance 5 2 Appendix Transport and Storage Temperature 40 C to 70 C Spillage and Ingress of Fluids Non protected Equipment IPXO as specified in IEC 60529 1 After storage in a condensing atmosphere the unit shall before use be kept for more than 24 hr in an environment equivalent to the operating atmosphere CAUTION Gas Module 3 must be moisture protected whenever transported This can be done with a protective plastic bag in which water absorbing materials e g silica gel have been included Agency Compliance The Gas Module 3 was designed to comply with the following industry standards e EN 60601 1 IEC 60601 1 e UL 60601 1 e CSA Standard C22 2 No 601 1M90 e EN 60601 1 4 IEC 60601 1 4 e ISO 21647 The Gas Module 3 has been certified by CSA 0070 10 0696 02 Gas Module 3 Operating Instructions Appendix Electromagnetic Capability 5 3 Electromagnetic Capability The Gas Module 3 meet the requirements of IEC 60601 1 2 EN 60601 1 2 NOTE NOTE TABLE 5 1 The Gas Module 3 needs special precautions regarding EMC and needs to be installed and put into s
35. sing from the use of its products liability under this warranty and the buyer s exclusive remedy under this warranty is limited to servicing or replacing at Mindray DS s option at the factory or at an authorized Mindray DS Distributor any product which shall under normal use and service appear to the Company to have been defective in material or workmanship No agent employee or representative of Mindray DS USA Inc has any authority to bind Mindray DS USA Inc to any affirmation representation or warranty concerning its products and any affirmation representation or warranty made by any agent employee or representative shall not be enforceable by buyer This warranty is expressly in lieu of any other express or implied warranties including any implied warranty or merchantability or fitness and of any other obligation on the part of the seller Damage to any product or parts through misuse neglect accident or by affixing any non standard accessory attachments or by any customer modification voids this warranty Mindray DS USA Inc makes no warranty whatever in regard to trade accessories such being subject to the warranty of their respective manufacturers A condition of this warranty is that this equipment or any accessories which are claimed to be defective be returned when authorized by Mindray DS freight prepaid to Mindray DS USA Inc Mahwah New Jersey 07430 Mindray DS USA Inc shall not have any responsibility
36. the patient s respiratory sample Vacuum negative pressure should not exceed 1 mmHg at the Gas Module Pump Exhaust fitting Excessive scavenge vacuum may result in damage to the Gas Module s internal pump CAUTION Contamination with CO N20 or Anesthetic Agent in the air surrounding the Gas Module 3 may cause significant measurement errors 4 Check for a clean water trap 5 Select CO or AUTO as the Resp Source in the Resp Menu 6 Observe the capnogram on the monitor s display On bedside monitor powerup Oz Agent and N20 numbers will display CO2 numbers will be displayed when a valid breath is detected NOTE The Gas Module 3 must be warmed up a minimum of 45 seconds for ISO accurate CO O2 N20 and agent readings 7 If not already set use the Display Setup Menu to select the gas waveforms to be displayed 8 If desired the gas waveform speed can be changed via the Monitor Setup Menu and the scale can be changed in the Gas Menu 2 1 1 Pre use Test Prior to each use perform the following test with the Gas Module 3 to verify that the gas analyzer and sample system are functioning properly 1 Verify that the appropriate water trap is properly installed and that the appropriate sampling line is connected e DRYLINE Adult Pediatric water trap used with DRYLINE Adult Pediatric sampling line colorless Luer lock nut e DRYLINE Neonatal water trap used with DRYLINE Neonatal sampling line blue Luer lock nut
37. ust be emptied and rinsed with water only whenever more than half full or whenever changing patients Refer to section 3 1 for more details 3 Power Indicator Lamp This lamp illuminates when the Power Switch is in the ON position 4 Power Switch A switch used to power the unit ON and OFF Gas Module 3 Operating Instructions 0070 10 0696 02 Rear Panel 1 2 General Product Description Rear Panel Gas Module 3 FIGURE 1 2 Gas Module 3 Rear Panel 5 AC Power Input This input is used to attach the special Y Shaped Power Cord 6 Exhaust Port This panel mount coupling is used for attaching a gas scavenging system P N 0997 00 0923 or P N 0997 00 0984 to the Gas Module 3 7 External Interface Port A communication interface port used to connect the Gas Module 3 to a Mindray DS bedside monitor Passport 29 Spectrum and Spectrum OR 8 Equipotential lug Provides Equipotential grounding of hospital equipment 0070 10 0696 02 Gas Module 3 Operating Instructions 20 Operations The menus shown in the following sections are from Mindray DS Passport 20 Spectrum and Spectrum OR bedside monitors 2 1 Gas Monitoring with Gas Module 3 The Gas Module option in Mindray DS bedside monitors allows for the measurement of anesthetic gases O2 N20 and CO levels Measurement can be acquired via a nasal cannula non intubated for oxygen and CO only or through a sampling
38. y adapter should be disposed of in accordance with local regulations for contaminated and biologically hazardous items Do not clean the Gas Module while it is on and or plugged in Connect only DRYLINE gas sampling lines to the water trap Note that there may be other compatible tubes present that must not be used e g IV lines Do not use DRYLINE Neonatal sampling lines blue Luer lock nuts with DRYLINE Adult Pediatric water traps as this could result in incorrect measurement data Do not use DRYLINE Adult Pediatric sampling lines TM colorless Luer lock nuts with DRYLINE Neonatal water traps as this could result in incorrect measurement data The contents of the water trap should be handled as a potential infection hazard Do not use other cleaning methods for the DRYLINE water traps Do not clean or wash the filter housing of the water trap Never allow alcohol to enter the filter housing Never force air through the water trap Gas Module 3 Operating Instructions 0070 10 0696 02 iv Introduction Cautions Cautions CAUTION Use recommended Mindray DS supplied power cords If a substitute is necessary use only hospital grade power cords CAUTION The internal sampling system of the Gas Module does not need to be cleaned or sterilized There is no reverse flow back to the patient If the internal sampling system is suspected to be clogged or dirty the module should be serviced by an authorized
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