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TidalGuard Sp

1. External power supply excluded 44 TidalGuard Sp Users Manual Rev B Additional Features Specifications Battery Life Approximately 4 5 hours of continuous use with fully charged DR30 NiMH rechargeable battery pack Display LED backlit 2 5 x 1 25 LCD adjustable contrast LED indicators for Low battery adapter type audio alert status indicates audio off 2 minute suspend active alert and external power Electromagnetic Emissions Conforms to Medical Device Directive 93 42 EEC IEC60601 1 2 2001 CISPR11 1991 IEC61000 3 2 2001 IEC61000 3 3 2003 Electromagnetic Immunity Conforms to Medical Device Directive 93 42 EEC IEC60601 1 2 2001 IEC61000 4 2 1995 IEC61000 4 3 2002 IEC61000 4 4 2004 IEC61000 4 5 1995 IEC61000 4 6 2003 IEC61000 4 8 1994 IEC61000 4 11 2004 Additional Features Hev B Audible SpO Trend Feature Pitch of Pulse Rate beep tracks the SpO value user selectable volume Alert Limits Automatic or menu selected high and low limits for ETCO Respiratory Rate SpO and Pulse Rate NO RESPIRATION alert selectable between 20 40 and 60 seconds Visible and audible alerts are immediate 2 Minute Suspend When 4 key is pressed audible alerts are suspended for two minutes Indicated by yellow 2 minute LED and flashing ft bell icon Audio Off Press and hold 4 key for 3 seconds to deactivate audible alerts Indicated by flashing yellow Audio Off LED and flashing
2. 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 596 Ur gt 95 dip in Uy for 0 5 cycle 40 Ut 60 dip in UT for 5 cycle 70 Ur 30 dip in Uy for 25 cycles 596 Ur gt 95 dip in Uy for 5 sec 596 Ur gt 95 dip in Uy for 0 5 cycle 40 Ut 60 dip in Uy for 5 cycle 70 Ut 30 dip in Uy for 25 cycles 596 Ur gt 95 dip in Uy for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the TidalGuard Sp requires continued operation during power interruptions it is recommended that the Tida Guard Sp be powered from an uninterruptible power supply or a battery TIDAL WAVE Sp User s Manual Rev B Electromagnetic Immunity Electromagnetic Compatibility Guidance and manufacturer s declaration Electromagnetic immunity Continued Power frequency 3 A m 3 A m Power frequency magnetic fields should be at 50 60 Hz levels characteristic of a typical location in a magnetic field typical commercial or hospital environment IEC 61000 4 8 NOTE Ur is the a c mains voltage prior to the application of the test level Guidance and manufacturer s de
3. 22 TidalGuard Sp User s Manual Rev B Adapter Zero Procedure Sensors and Patient Connections Rev B 3 With all sources of CO away from the adapter including the patient s and your own exhaled breath press the amp ZERO key to begin the procedure or 44 CANCEL to exit 2 al 3f mmHa AGLT Og 30 ZERO CANCEL NOTE e If breaths are detected while attempting to zero the adapter the AN icon will display and the zero menu will be exited automatically remove the CO source wait 15 seconds and repeat the procedure from step 1 e f the sensor is not at the proper temperature the i icon will display and the zero menu will be exited automatically wait 15 seconds and repeat the procedure from step 1 e The TidalGuard Sp will return to monitor mode automatically when the procedure is complete TidalGuard Sp User s Manual 23 Section 4 CAPNOSTAT CO2 Sensor and Airway Adapter Setup CAPNOSTAT CO Sensor and Airway Adapter Setup Patients requiring mechanical ventilation 1 Selecta new airway adapter Regular Adult Cat No 6063 for ET tube size greater than 4 0 mm see Fig 1 Exotic Neonatal Cat No 6312 for ET tube size 4 0 mm or less see Fig 2 Verify that the windows are clean and dry Place the airway adapter in the patient s ventilator circuit It should be positioned between the ET tube elbow and the circuit wye with its window in a vertical position NOTE In a regu
4. SpO2 AUTO LIMITS SET RESETTING TO All setup and alert settings have just been reset to factory default values FACTORY DEFAULTS ERASING STORED The trends stored in the monitor s memory have been erased TRENDS CHECK CLOCK Time and date may not be properly set The time and date can be adjusted in TIME AND DATE the CONFIGURATION menu by pressing the Backlight key See Configuration Settings on page 17 AUTO POWER OFF The monitor will shut off if there is no CO breath detection or key IN X XX depressions for ten minutes from when the unit powers on The timer X XX will then count down from two minutes to zero Pressing the adapter key or detection of a CO breath will cancel the shutdown UNKNOWN ERROR Remove the monitor from use and contact service personnel Capnography Messages Message Description CAPNO Sensor is under temperature Wait for the CAPNOSTAT CO WARMING sensor to reach operating temperature CHECK Excessive moisture or secretions detected in the adapter Change ADAPTER adapter Adapter type has been changed e g regular adult to exotic neona tal Zero the adapter No adapter detected Place an adapter on the CAPNOSTAT CO sensor RESP 0 A breath has not been detected for the indicated time XX seconds m ss This message appears when the time since the end of expiration of the last detected breath exceeds the NO RESP TIMER setting in the configuration menu See Configuration Settings on page 17
5. IEC 60601 1 The BaseStation is an optional accessory onto which hand held monitors can be placed providing a platform for communication support between the monitor and a host computer The BaseStation is meant for table top horizontal not pole mounted vertical applications and can be used anywhere the TidalGuard Sp monitor is used including but not limited to the sleep lab ICU anesthesia post anesthesia emergency department respiratory care home care and pre hospital emergency The BaseStation provides RS232 serial communications as supported by the monitor with or without the external power supply connected In addition the BaseStation is capable of providing power to charge a rechargeable battery inside the monitor when used with the external power supply The internal battery will slowly discharge over long periods of non use TidalGuard Sp Users Manual 15 Section 3 Configuration Menus Configuration Menus CONFIGURATION menus are provided on the TidalGuard Sp to allow customizing of various settings To access the CONFIGURATION menus press and hold the D key then simultaneously press the 2x key until the first CONFIGURATION menu is displayed Press the PAGE key to move through the menus The SELECT key moves the arrow pointer the parameter chosen will flash Press the e EXIT key at any time to return to monitoring mode selections will be saved 16 GAS COMPENSATION ROOM AIR Oz 3 BBX HzO gt 68
6. SPO2 PRB OFF PAT displayed 2 Tape the Y Sensor to your index finger Does the monitor show reasonable SpO and pulse rate values 3 A YES to BOTH 1 and 2 indicates that the sensor is working properly Apply the sensor to the patient as instructed above The quick check is also a functional test of the extension cable 26 TidalGuard Sp User s Manual Rev B Rev B Section 5 Monitoring Display of Data The TidalGuard Sp measures and displays EtCO respiration rate saturation and pulse rate Until valid data is received for any parameter that parameter will show a dash When valid data is received the value will display If the parameter is lost the value will return to dashes This will also occur when the monitor is first turned on and before any valid patient data is obtained When monitoring if valid data is received then lost for ETCO respiratory rate SpO or pulse rate an alert condition will occur If the 4 Alert key is pressed and valid data is still not available the numeric value of the parameter in question will display If the 4 key is not pressed within 30 seconds after the loss of data the display will automatically turn to dashes Monitoring Mode Three monitoring modes are available for the TidalGuard Sp CO SpO CO and SpO gt The factory default is CO7 SpO To choose a different mode press and hold the 6 Power key to access the menu The currently selec
7. then the S EXIT key to confirm and exit Configuration Settings The CONFIGURATION menus can be programmed by the user to customize the TidalGuard Sp Any changes made will be retained when the monitor is turned off NOTE To reset the monitor to its factory default settings with the monitor off press and hold the zi key and the X key then press the key to turn the monitor on Options are listed below with descriptions following Parameter Settings and Description Factory Default GAS COMPENSATION Room air O gt 6096 N20 gt 60 Use this setting to enter the gas composition in order to compensate the CO measurement for gas density Any setting other than the default will cause the mon itor to display O or O N20 on the screen beside the respiration value Room Air CO WAVEFORM SCALE Small Medium Large Select the desired size of the capnogram waveform Medium CO WAVEFORM SPEED Slow Fast Medium Select the desired speed of the capnogram waveform Medium NO RESP TIMER 20 sec 40 sec 60 sec Alert setting activates if the end tidal CO portion of the monitor cannot detect regular breaths for periods longer than 10 seconds 20 sec A If FiO is less than 60 and N5O is selected as the balance gas an incorrect INSP O settings may cause the reported CO value to be overestimated too high by up to 11 7 of its reading If FiO is greater tha
8. 5 by facsimile at 724 387 5236 or by e mail at service Orespironics com for technical inquiries or clinical Orespironics com for clinical inquiries After hours telephone support requests before 8 00 AM and after 5 00 PM Eastern Time will be responded to promptly by the Technical Support on call staff After hours facsimile and e mail requests will be answered the next business day It is suggested that any person calling in for technical support have the equipment available for product identification and preliminary troubleshooting Respironics reserves the right to repair or replace any product found to be defective during the warranty period Repair may be provided in the form of replacement exchange parts or accessories on site technical repair assistance or complete system exchanges Repairs provided due to product abuse or misuse will be considered non warranty and invoiced at the prevailing service rate Exchanged materials are expected to be returned to Respironics within 10 days for full credit Return materials should be cleaned as necessary and sent directly to Respironics referencing the RA number provided Transferring return materials to a local sales or dealer representatives does not absolve you of your return responsibility If the customer requires the return of their original product the exchange material will be considered loaner material and exchanged again after the customer equipment is repaired Please contact Techni
9. EXIT PAGE SELECT C z WAVEFORM SCALE SMALL sa MEDIUM LARGE EXIT PAGE SELECT os COz WAVEFORM SPEED SLOW sa MEDIUM we FAST EXIT e PAGE SELECT HO RESP TIMER 27H sec 48 sec 6H sec EXIT PAGE SELECT COz UNITS mmHo kFa x EXIT PAGE SELECT ALERT VOLUME DISABLED Lik HIGH ERIT PHGE SELECT RSZ32 INTERFACE HOWACOMM SEIKO 414 RESERUED 1 EXIT PHGE SELECT TidalGuard Sp User s Manual MPS Li gs Lg MS my S mE uid G Z HOL WAVEFORM FILL UNFILLED FILLED EIT FAGE SELECT ETCOz AVERAGING 1 BREATH FAGE SELECT SPOz AVERAGIHG z SEC a amp SEC M EXIT cy PAGE SELECT ALERT LIMITS DISABLED ay gt ENABLED ah pel EXIT e PHGE SELECT PULSE BEEP VOLUME DEF Coly HIGH EXIT PAGE SELECT RESP TREHD SCALE SMALL ay MEDIUM L ARGE EXIT FAGE SELECT os AUTO POWER OFF ENABLED DISABLED i PHGE SELECT Press SELECT to scroll down to INST in the EtCO Averaging menu Configuration Menus Rev B Displays selected setting Selects screen Press to set time date Preparation for Use ETCOJRR mmm S pO P R Changes settings of selected item Press to exit NOTE If an attempt is made to change CO units after data has been collected a message warning that trend memory will be erased is displayed To change units and erase trends press the 4 OK key to continue
10. INSP An inspired CO level of 3 mmHg or 0 4 or kPa was detected for XX 20 consecutive seconds ZRO HOLD The current through the CAPNOSTAT 9CO sensor source emitter has ADPT KEY changed or the system is detecting EtCO values less than 3 0 mmHg TidalGuard Sp Users Manual 31 Section 5 Messages Message Description CAPNO FAULTY The following errors may be present 1 The current through the source is too high or low 2 The checksum for the CAPNOSTAT calibration data is wrong 3 The revision of the calibration data in the CAPNOSTAT is not compatible with the software in the TidalGuard Sp Monitor Refer servicing to qualified personnel CAPNO The temperature of the case or detector heater is over 50 C HI TEMP Refer servicing to qualified personnel CAN NOT An error was detected which did not allow the system to zero the ZERO CO2 current adapter being used Refer servicing to qualified personnel CO OUT The detected waveform value is beyond the measurement range of the OF RANGE monitor 0 100 mmHg 0 13 2 or kPa A changing level of CO was detected during an adapter zero procedure Wait 30 seconds and retry The CAPNOSTAT CO sensor has not reached operating tempera ture while attempting to zero Wait for the sensor to reach operating temperature ADAPTER ZERO IN PROGRESS TIME REMAINING 0 XX An airway adapter zero is in progress XX indicates the number of seconds
11. LA bell icon Trend Memory 24 hour trend memory capacity battery backed On screen 30 minute trends for ETCO Respiration Rate and SpO Other parameters are stored internally and can be downloaded to a PC Digital Data Output Serial RS232 connect only to approved devices Internal Battery backed Real Time Clock TidalGuard Sp User s Manual 45 Section 8 Additional Features This page intentionally blank 46 TidalGuard Sp User s Manual Rev B Section 9 Electromagnetic Compatibility Medical equipment needs special precautions regarding electromagnetic compatibility EMC and needs to be installed and put into service according to the EMC information provided in this document The TidalGuard Sp monitor complies with IEC 60601 1 2 2001 providing reasonable protection against electromagnetic interference in a typical medical installation The equipment generates uses and can radiate electromagnetic interference EMD and if not installed and used in accordance with the instructions may cause interference with other devices in the vicinity If interference does occur correct it using one or more of the following measures Move the receiving device or increase separation between the equipment e Consult Respironics or members of the hospitals engineering department for more information Warnings e The use of portable and mobile radio frequency RF communications equipment can affect this and other pieces of medical
12. Use and Options Preparation for Use Rechargeable Batteries The DR30 NiMH rechargeable battery pack Cat No 400043 can be used to power the TidalGuard Sp for approximately 4 5 hours of continuous operation Optional DR30 Rechargeable battery NiMH 7 2 vdc NOTE Refer to the instruction sheet packaged with the rechargeable battery for complete operating instructions To charge a rechargeable battery while in the monitor External Power Supply Alternatively plug the external power supply directly into the DC power jack on the side of the monitor and connect a hospital grade line cord to an AC source The AC icon v will illuminate green and the battery will charge in approximately 5 5 hours If the monitor has been stored with the battery installed for thirty 30 days or more charge the battery for 24 hours prior to use DC input External power supply Cat No 9220 10 Connect line cord Cat No 600075 CAUTION e Use only approved devices when connecting to the power input jacks on the TidalGuard Sp or on the BaseStation Do not attempt to use the adapter for the external battery charger for this function NOTE e When powered by the external power supply the TidalGuard Sp will not overcharge a rechargeable battery e The external power supply has a universal power input The IEC 320 input receptacle for line cord connection allows compatibility with every country s voltage
13. connected or removed whether or not the monitor is turned on Y Sensor The reusable Y Sensor is a flexible sensor designed for use on any patient It is secured to the patient using a lingual clip see below m PEM The Y Sensor center strip is not a functional part of the sensor Its twofold purpose is to aid in the placement of the sensor into the Y Strip or other securing system and to keep the distance between the sensor heads to no more than 25mm The center strip may be removed carefully cut away if the distance between the sensor heads needs to be reduced to less than 25mm Sensor heads Center strip Strip may be removed Rev B TidalGuard Sp User s Manual 25 Section 4 SpO Sensors Y Sensor Applicators The flexible and versatile Y Sensor is applied to the patient using the Lingual Clip applicator 6131 00 Lingual Clip Using the Lingual Clip 1 Slide each Y Sensor head into a Lingual Clip receptacle with the blue button facing outward 2 Open the clip by squeezing its ends and applying it to the Blue n tongue Button J ea It may be necessary to rub the A tongue with your fingers in order to increase circulation prior to applying the sensor be i Squeeze to Apply Y Sensor Quick Check 1 With the Y Sensor connected to the monitor but not applied to the patient position the sensor heads so that they face each other the red light shines at the detector Is
14. external power supply from the AC power source before cleaning e The monitor BaseStation and external power supply can be cleaned and disinfected by wiping with solutions such as a 70 isopropyl alcohol 2 gluteraldehyde or 10 bleach solution Wipe down with a water dampened clean cloth to rinse Dry before use Do not immerse the monitor BaseStation or external power supply e Do not attempt to sterilize the monitor BaseStation or external power supply SpO Y Sensor Do not immerse connector on the Y Sensor The Y Sensor may be immersed up to but not including the connector in a 2 gluteraldehyde solution or 10 bleach solution Refer to manufacturer s instructions and standard hospital protocols to determine recommended times for disinfection and sterilization e Rinse thoroughly with water and dry before use do not rinse the connector Do not attempt to sterilize Y Sensor except as stated above e After cleaning or sterilizing the Y Sensor verify that the sensor is physically intact with no broken or frayed wires or damaged parts Make certain that the connectors are clean and dry with no signs of contamination or corrosion Do not use a broken or damaged sensor or one with wet contaminated or corroded connectors e Perform a Quick Check to verify the integrity of the sensor see Y Sensor Quick Check on page 26 Lingual Clip Do not immerse the lingual clip e Clean the lingual clip w
15. is dependent upon both the Power key and the power source The monitor can operate for up to 4 5 hours while powered from a fully charged internal battery The battery is charging when the monitor is powered through its DC input and the keypanel icon is green The battery will charge even if the monitor is off Power to the DC input is supplied by the external power supply Cat No 9220 10 with or without the optional BaseStation Cat No 6998 00 Rechargeable and disposable battery capacity is shown in the table titled Battery Life and Recharge Times on page 14 Times may be reduced in colder temperatures operation with the backlight off may slightly increase these times Battery Status and Alerts When the monitor is operating on battery power and the battery is sufficiently charged the battery icon LED Es on the keypanel will be green The battery level is reflected on the battery icon by different colors for example battery fully charged green battery low flashing yellow The Feil LED on the keypanel flashes red when the monitor is powered by its internal battery and approximately 5 minutes remain The monitor will sound an audible alert then when the battery is depleted turn itself off This alert can only be silenced by connecting the external supply or turning the monitor off The NiMH battery pack should be replaced or the TidalGuard Sp BaseStation Cat No 6998 00 or external power supply Cat No 9220 10 sh
16. of a defibrillator The patient sensors must not be located between defibrillator pads when a defibrillator is used on a patient e To reduce the hazard of burns in the high frequency surgical neutral electrode connection the patient sensors should not be located between the surgical site and the electro surgical unit return electrode e The use of accessories sensors and cables other than those specified by Respironics may increase emissions or decrease immunity of the equipment e The use of portable and mobile radio frequency RF communications equipment can affect this and other pieces of medical equipment CAUTIONS Indicates a condition that may lead to equipment damage or malfunction e Caution Federal U S A law restricts this device to sale distribution or use by or on the order of a licensed medical practitioner e Use only an approved external power supply with this device Use of any other power supply may damage the TidalGuard Sp and void the warranty Do not operate TidalGuard Sp or its accessories when it is wet due to spills or condensation Do not operate TidalGuard Sp if it appears to have been dropped or damaged Keep TidalGuard Sp and its accessories clean e Inspect the integrity of the TidalGuard Sp and its accessories prior to use e Never sterilize or immerse the monitor sensor or accessories in liquids e Do not sterilize or immerse sensors except as directed in this m
17. remaining WARNING CHANGING CO2 UNITS ERASES STORED TRENDS Changing CO units mmHg 96 kPa in the Configuration menu will cause this message to appear Oxygen Saturation Messages Message Description SPO2 LOW The pulse strength as detected by the sensor is too small for proper monitor STRENGTH operation This message will disappear when the problem is corrected INSUFF Sensor is placed on a site too thick opaque for adequate light transmission Move LIGHT sensor to a different site PULSE Pulse must be within 30 250 beats per minute inclusive RANG ERR SHIELD Ambient light source sunlight warming lights etc are interfering with sensor SPO2 PRB operation Shield sensor from these light sources SPO2 PRB Remove sensor from use and contact qualified service personnel FAULTY SPO2 BAD Monitor not receiving valid signals from the sensor May be caused by excessive SIGNAL motion cardiac arrhythmia or other situations leading to poor signal CONNECT Sensor not connected to unit SPO2 PRB TidalGuard Sp User s Manual Hev B Alerts Monitoring Message Description SPO2 PRB Sensor not on patient OFF PAT MONITOR Remove the monitor from use and contact qualified service personnel FAULTY Alerts Alerts are generated for ETCO respiration rate SpO and pulse rate These alerts occur when the high or low limits for a particular parameter are exceeded Th
18. servicing the monitor WEEE ROHS Recycling Directives Waste electrical and electronic equipment and restriction of the use of certain hazardous substances in electrical and electronic equipment WEEE RoHS recycling directives If you are subject to the WEEE RoHS directives refer to www respironics com for the Xx Compliant with the WEEE RoHS recycling directives passport for recycling this product The internal battery will slowly discharge over long periods of non use 42 TidalGuard Sp User s Manual Rev B Section 8 Specifications General Specifications for the TidalGuard Sp Monitor are listed for informational purposes only and are subject to change without notice Capnograph Principle of Operation Non Dispersive Infrared NDIR absorption dual wavelength ratiometric single beam optics e Sensor Type Mainstream no gas sample drawn from breathing circuit e Initialization Time Capnogram in 15 seconds full specifications in 60 seconds e Response Time 60 ms e Gas Compensation Room Air O gt 60 N50 gt 60 Operator selectable in configuration screen Barometric Pressure Compensation Automatic range 400 800 mmHg CAPNOSTAT CO Sensor and Airway Adapter Weight Less than 18 g without cable Sensor Size 1 3 x 1 67 x 85 inches 3 30 x 4 24 x 2 16 cm 6 foot cable 1 83 m Construction Durable high performance plastic ultra flexible cable Shock Resistant CAPNOSTAT CO senso
19. Breath bar CO Waveform Screen Capnogram Respiration rate CO units Status messages are displayed here Selected gas compensation displayed here N2O O or Pulse rate blank if set to room air displayed here balance Oxygen perfusion EtCO value SpO3 displayed here Capnogram scale upper Capnogram CO waveform can number flashes if CO is Indicates CO be filled or unfilled and sweep off scale waveform screen speed is selectable NOTE The capnogram sweep speed is automatically adjusted when switching modes It will increase one step when switched from regular adult to exotic neonatal and decrease one step when switched from exotic neonatal to regular adult 28 TidalGuard Sp User s Manual Rev B Screen Displays Monitoring SpO Waveform Screen Plethysmogram The pitch of the user selectable Pulse Rate beep tracks the SpO value Decreasing SpO values are signaled by lower pitched beeps increasing values are signaled by higher pitched beeps The plethysmogram waveform is proportional to the signal strength Respiration rate CO units Status messages are displayed here EtCO value Pulse rate displayed here Selected gas compensation displayed here N20 O or Oxygen perfusion blank if set to room air SpO displayed balance here Indicates plethysmogram Plethysmogram screen waveform Trend Screens SpO trend screen Thirty 30 minutes of data are displayed moving from rig
20. Guard Sp Users Manual 39 Section 6 Power and RS232 Serial Port Communications The RS232 Serial Port 9 pin D connector allows connection to a host computer RS232 Serial Port for optional Serial Cable Power input jack Downloading Data to a PC Connect the Serial Cable PN 600075 sold separately to the RS232 Serial Port connector on the BaseStation Connect the external power supply to the power input jack on the BaseStation then connect a line cord from the power supply to an AC source It is recommended that the monitor be powered by the BaseStation using the external power supply when downloading data from the monitor or updating software This will prevent power loss from a depleted battery Plug the other end of the serial cable into the host computer NOTE The COM port on the computer will be either a 9 pin or a 25 pin D connector Use an adapter if the COM port on the host computer does not match the connector on the end of the Serial Cable Set the monitor inside the BaseStation verify the In Use LED illuminates Refer to the 6993 23 BaseStation User s Manual for more information 40 TidalGuard Sp Users Manual Rev B Section 7 Maintenance Cleaning and Sterilization Follow the cleaning and sterilization instructions listed below to clean and or sterilize the monitor and its accessories Monitor BaseStation and External Power Supply Turn the monitor off and unplug the BaseStation and the
21. TidalGuard Sp Capnograph Pulse Oximeter SHARN VETERINARY INC HANDHELD CAPNOGRAPH OXIMETER Model TidalGuard August 18 2006 Catalog No 1027688 B Sharn Veterinary 12706 Casey Road Tampa FL 33618 Copyright 2005 2006 Respironics Inc and its affiliates All rights reserved Rev B Revision History 10 Aug 05 Release Rev A CO_N2391 18 Aug 06 Rev B CO_N3229 Declaration of Conformity with European Union Directive The Authorized Representative for this equipment is Respironics Deutschland Gewerbestrasse 17 82211 Herrsching Germany Tel 49 8152 93060 0086 Guarantee Equipment manufactured or distributed by Respironics Inc is fully guaranteed covering materials and workmanship for a period of one year from the date of shipment except for certain disposable products and products with stated guarantees other than one year Respironics reserves the right to perform guarantee service s at its factory at an authorized repair station or at the customer s installation Respironics obligations under this guarantee are limited to repairs or at Respironics option replacement of any defective parts of our equipment except fuses batteries and calibration gasses without charge if said defects occur during normal service Claims for damages during shipment must be filed promptly with the transportation company All correspondence concerning the equipment must specify both the model name
22. and frequency requirements Rev B TidalGuard Sp Users Manual 11 Section 3 Battery Use and Options Optional BaseStation Power for the BaseStation is supplied by an external power supply PN 9220 10 or the internal battery When the power supply is properly connected to the BaseStation and a monitor is placed within the station the green In Use LED will illuminate The y icon on the monitor will also illuminate indicating that external power is connected Connect the external power supply jack to the monitor and connect a hospital grade line cord from the external power supply to an AC source Green In Use LED illuminates indicatin a monitor is in place and the power supply External power supply is active Cat No 9220 10 DC input Monitor in BaseStation Gonnaet line cord BaseStation Cat No 6998 00 IEC 320 receptacle Cat No 600075 The 9220 10 Power Supply is approved by the following regulatory agencies 54 Canadian Standards Assoc VDE Germany O DEMKO Denmark SEMKO Sweden ED FINKO Finland CAUTION e Although other connectors may physically fit do not attempt to connect any device other than power supplies that have been approved for use with this device Doing so may damage the TidalGuard Sp and will void the warranty Never sterilize or immerse the monitor sensor or accessories in liquids 12 TidalGuard Sp Users Manual Rev B Battery U
23. and number and the serial number as it appears on the equipment Improper use mishandling tampering with or operation of the equipment without following specific operating instructions will void this guarantee and release Respironics from any further guarantee obligations Customer Service amp Product Support USA and Canada Phone 1 800 345 6443 Customer Service Fax 1 800 886 0245 Product Support Fax 1 724 387 5236 International Phone 724 387 4000 Fax 724 387 5012 service respironics com clinical respironics com www respironics com Caution Federal U S A law restricts this device to sale distribution or use by or on the order of a licensed medical practitioner TidalGuard Sp Users Manual iii Copyright O 2006 Respironics Inc and its affiliates This document contains information which is proprietary and the property of Respironics and may not be reproduced stored in a retrieval system translated transcribed or transmitted in any form or by any means without prior explicit written permission from Respironics Service Policy The Respironics Hospital Services Group provides depot service for monitors and 24 hour a day access to technical support through its Technical Support Department in Murrysville PA Outside the U S primary technical support is handled through our qualified international sales and service distributors Contact the Technical Support Department by telephone toll free at 800 345 6443 ext
24. anual e Do not apply excessive tension to sensor cable e Do not store the monitor or sensors at temperatures less than 14 F 10 C or above 131 F 55 C e Do not operate the monitor or sensors at temperatures below 50 F 10 C or above 104 F 40 C e Ifan adapter leaks or becomes occluded replace and discard the occluded adapter e tis recommended that the CAPNOSTAT CO sensor be removed from the circuit whenever an aerosolized medication is delivered This is due to the increased viscosity of the medications which may contaminate the sensor windows causing the sensor to fail prematurely e Where electromagnetic devices i e electrocautery are used patient monitoring may be interrupted due to electromagnetic interference Electromagnetic fields up to 3V m will not adversely affect system performance e Refer servicing to qualified personnel e Use only approved sensors and accessories with the TidalGuard Sp monitor Observe precautions for electrostatic discharge ESD and electromagnetic interference EMI to and from other equipment Where electromagnetic devices i e electrocautery are used patient monitoring may be interrupted due to electromagnetic interference Electromagnetic fields up to 3 V m will not adversely affect system performance 8 ridalGuard Sp Users Manual Rev B Rev B rs 1 Safety Sudden erratic changes in the CO and pressure waveforms that do not correlate to the physiological con
25. atient and operator safety you must follow the following warnings and cautions WARNINGS Indicates a potentially harmful condition that can lead to personal injury Explosion Hazard DO NOT use TidalGuard Sp in the presence of flammable anesthetics Use of this instrument in such an environment may present an explosion hazard e Electrical Shock Hazard Always turn TidalGuard Sp off and remove any external devices before cleaning it Refer servicing to qualified service personnel Failure of Operation If the monitor fails to respond as described do not use it until the situation has been corrected by qualified personnel Do not operate TidalGuard Sp if it appears to have been dropped or damaged Do not operate TidalGuard Sp or its accessories when it is wet due to spills or condensation Never sterilize or immerse the monitor sensor or accessories in liquids e The monitor does not alert for NO RESPIRATION if the airway adapter is removed from the CAPNOSTAT CO sensor e Verify the No Resp Timer setting prior to use Do not position any sensor cable in a way that may cause entanglement or strangulation e The TidalGuard Sp is not intended to be used as a primary diagnostic apnea monitor and or recording device e Patient Safety Care should be exercised to assure continued peripheral perfusion distal to the SpO sensor site after application e Inspect the SpO sensor site often for adeq
26. cal Support for information on these additional programs and services Technical amp Clinical Training Test Equipment and Test Kits Service Contract Parts Insurance Plans On Site Service Support Trademarks and Patents CAPNOSTAT is a registered trademark and TidalGuard M Y Sensor SuperBright and OxySnap are trademarks of Respironics Inc Velcro is a registered trademark of Velcro USA Inc Cidex is a trademark of Arbook Inc Nafion is a registered trademark of Dow Corning Corp The TidalGuard Sp monitor and its sensors and accessories are covered by the following US patents 4 859 858 4 859 859 4 914 720 5 146 092 5 153 436 5 190 038 5 206 511 5 251 121 5 369 277 5 398 680 5 448 991 5 616 923 5 693 944 5 793 044 5 820 550 5 891 026 5 999 834 Other patents pending iV TidalGuard Sp User s Manual Rev B Rev B Contents General DesScriptiON ocasion 1 Indication for Se io debo 1 Keypanel Controls and Indicators sssssse eene 1 Connections and Labeling nnne hene eher hotte EAEE 4 Prncipleof operatloh ccoo x ER e e re HR EIFE D ESSE Rae de 5 Safety ea acercan cin HERR ERE re REC e Eee tere ERE dues 7 Preparation for Use riada ERR ARES 9 AC Battery Operation 9 Battery Status and AlenS dia 9 Battery Use and Options 4 3 t egt ia end n Ag LEER M IEEE ERR UR nace 10 Configuration Menus s n patr mE Pere Pa p M RR 16 Sensors and Patient Connections oocooncn
27. claration Electromagnetic immunity The TidalGuard Sp is intended for use in the electromagnetic environment specified below The customer or user of the TidalGuard Sp should assure that it is used in such an environment Immunity IEC 60601 complanes Electromagnetic environment guidance Test test level level Portable and mobile RF communications equipment should be used no closer to any part of the TidalGuard Sp 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 IEC 61000 4 6 150 kHz to 80 MHz 150 kHz to 80 MHz 3 5 d WP Fi 3 9 d G 80 MHz to 800 MHz Radiated RF 3 V m 3 V m Ei IEC 61000 4 3 80 MHz to 2 5 GHz 80 MHz to 2 5 GHz 7 qe le 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 meters m Field strength 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 vicinity of equipment marked with the following symbol Ko A NOTE 1 At 80 MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorpt
28. creen Icon Displayed beside any Trend screen i Temperature Icon Sensor not up to temperature icon Displayed when performing an adapter zero and the sensor is not at operating temperature p Waveform Icon CO detected icon Displayed when selecting an adapter zero and the monitor detects breaths v Heart Icon Pulse detected icon Displayed when SpO sensor is attached to patient and the monitor detects a pulse TidalGuard Sp User s Manual 3 Section 1 Connections and Labeling a Lung Icon Breaths detected icon Displayed when CAPNOSTAT CO sensor is attached to patient and breaths are detected Connections and Labeling Endview DB 9 SpO sensor connection CO sensor connection Sideview DC input Rearview Use PN 9220 10 only Id gt RS232 connection and external power input from BaseStation Battery compartment 4 TidalGuard Sp Users Manual Rev B Principle of operation General Description Symbols Patient isolation Identifies connection as type BF Attention Consult manual for detailed information DC input Connect external power supply to this port Use only an approved external power supply Catalogue number 9220 10 o gt PA Recyclable item This symbol is found on the internal battery and should not concern the common user Refer to qualified service personnel when battery replacement is required Compliant with the WEEE ROHS recycling directives Separate c
29. dition of the patient may be signs that the monitor is experiencing electromagnetic interference TheTidalGuard Sp monitor should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the equipment should be observed to verify normal operation in the configuration in which it will be used The TidalGuard Sp monitor complies with IEC 60601 1 2 2001 providing reasonable protection against electromagnetic interference in a typical medical installation The equipment generates uses and can radiate electromagnetic interference EMD and if not installed and used in accordance with the instructions may cause interference with other devices in the vicinity If interference does occur correct it using one or more of the following measures Move the receiving device or increase separation between the equipment e Consult Respironics or members of the hospital s engineering department for more information The TidalGuard Sp monitor is not intended for use in a hyperbaric chamber or an MRI Magnetic Resonance Imaging environment Indicates points of particular interest or emphasis for more efficient or convenient operation The TidalGuard Sp monitor is intended for operation with airway adapters Operating the TidalGuard Sp below 50 F 10 C will result in longer warm up time and reduce battery life Components of this product and its associated accessories which have patient con
30. equipment e The use of accessories sensors and cables other than those specified by Respironics may increase emissions or decrease immunity of the equipment e The TidalGuard Sp should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the equipment should be observed to verify normal operation in the configuration in which it will be used Cautions e Observe precautions for electrostatic discharge ESD and electromagnetic interference EMI to and from other equipment e Where electromagnetic devices i e electrocautery are used patient monitoring may be interrupted due to electromagnetic interference Electromagnetic fields up to 3 V m will not adversely affect system performance e Sudden erratic changes in equipment performance that do not correlate to the physiological condition of the patient may be signs that the monitor is experiencing electromagnetic interference Rev B TIDAL WAVE Sp User s Manual 47 Section 9 48 Electromagnetic Emissions Electromagnetic Emissions Guidance and manufacturer s declaration Electromagnetic emissions The TidalGuard Sp is intended for use in the electromagnetic environment specified below The customer or user of the TidalGuard Sp should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance RF emissions Group 1 The TidalGuard Sp uses RF energy onl
31. ere is also an alert when there is a loss of pulse rate or when there is a loss of respiration for a consecutive twenty seconds other limit times may be selected for the NO RESP TIMER see Configuration Menus on page 16 Alert messages are displayed in the message center or in the particular area of the display when they occur For example a RESP 0 message will be displayed in the respiration section of the screen When any of the parameters are violated with alert limits ENABLED two up 7T or two down JV arrows will replace the parameter indicating whether the violation was above or below the alert limit Acs Ir Data Screen RESP PR Y 96 Indicates respiration rate lower limit violation Setting Alert Limits The alert limits for the monitor can be manually or automatically adjusted To access AUTO ALERTS or SET ALERTS the alert limits must be ENABLED from the Configuration menu See Configuration Menus on page 16 NOTE To configure the monitor with the default limit values power up while pressing and holding the Backlight and 4 Alert keys This will cause all parameters to return to their default values Rev B TidalGuard Sp Users Manual 33 Section 5 Setting Alert Limits Manually Setting Alert Limits Press the Alert key to access the ALERT menu Press the SET ALERTS softkey to display the SET ALERT LIMITS menu When selected this screen will appear for 3 seconds then automatically re
32. ght second resolution The chart below describes the storage interval for each parameter Stored parameter values can be downloaded transferred to a PC and viewed using the optional NovaCARD software See RS232 Options on page 39 for more information To erase stored trends hold both Xx and keys during the power up cycle until ERASING STORED TRENDS appears on the display Trending Storage Interval ETCO Maximum value Resp Rate Average Inspired CO Maximum value SpO Average Pulse Rate Average Messages Status Messages Status messages indicate conditions that should be corrected or monitored they may or may not be tied to an alert condition These conditions can be a result of a hardware or sensor fault condition Status messages are displayed on the screen in the same manner as alert messages Following is a list of status and alert messages that may appear on the monitor 30 TidalGuard Sp User s Manual Rev B Messages Rev B System Messages Monitoring Message Description PRESSURE FAULTY The barometric pressure sensor is returning a value which is out of range lt 400 mmHg or gt 800 mmHg The monitor will default to 760 mmHg for calculation purposes Refer servicing to qualified personnel EtCO2 AUTO LIMITS This message is displayed when the monitor has successfully determined and SET set the auto alert limits for SpO and ETCO
33. grapbi i O ineo In Rn iMi 43 SpOs Section ates eon ern d etae n er n d FR ceti bend ede 44 Pulse Rate SOCtony ene ett RR ore ORE BS e ID 44 Mohitor SpeciflCatlors e itte p bg ied tabe iia 44 Additional Features a a e aT Te A a a aa ae cnn nene m nnns nennen snnt nennen 45 Electromagnetic Compatibility oooonoonniccnnnnn nico 47 WarnilQS tic ha A 47 CAOS erp mE 47 Electromagnetic EMISSIONS orriren E E E TEE aE ETEEN 48 Electromagnetic Immunity 2 orraa ES E E AEA EREE E TRE 48 Vi TidalGuard Sp Users Manual Rev B Section 1 General Description Indication for use The TidalGuard Sp handheld portable Capnograph Oximeter are intended to be used for monitoring end tidal CO respiration rate functional oxygen saturation and pulse rate in monitoring environments such as ventilatory support emergency and anesthesia TidalGuard Sp is designed to monitor veterinary patients Tida Guard Sp is not intended for any other purpose NOTE Components of this product and its associated accessories which have patient contact are free of latex Keypanel Controls and Indicators Page key Display screen Power key Alert key Backlight key Adapter key Battery charge indicator o AC indicator and LED Alert LED Controls O Power Key Switches power on off Press the POWER key to place the unit into operate mode ON or to turn the unit OFF Refer to AC Battery Operation on page 9 With m
34. ht to left on the screen Each data point represents 16 8 seconds New data is added on the right side of the screen Refer to the CONFIGURATION menus for scale adjustment NOTE Changing the CO UNITS in the Configuration menu will result in a loss of all stored data When changing CO UNITS in the Configuration menu the message WARNING CHANGING CO2 UNITS ERASES STORED TRENDS will display Press the 4 OK key to acknowledge the warning this does not erase the data and return to the CO2 UNITS menu Select the correct unit or press to EXIT EtCO and Respiration Rate Trend Screen Previous data discarded as new data Current data trend is stored graph starts here 29 rr Trend icon indicates f mmHa AGLT g Indicates EtCO or that trend screen is Respiration Rate trend displayed Thirty 30 minutes of data are displayed moving from right to left on the screen Each data point represents 16 8 seconds Rev B TidalGuard Sp Users Manual 29 Section 5 Messages SpO Trend Screen Previous data Status messages are displayed here discarded as new data is stored Current data trend Trend icon indicates graph starts here that trend screen is displayed S Trend Memory In addition to on screen trends the TidalGuard Sp has internal battery backed trend memory that stores EtCO respiration rate SpO and pulse rate calculated parameters for 24 hours at an ei
35. ifying monitor accuracy with calibration gas should be performed only by qualified service personnel TidalGuard Sp User s Manual 19 Section 3 Configuration Menus This page intentionally blank 20 TidalGuard Sp Users Manual Rev B Section 4 Sensors and Patient Connections Adapter Types Available Regular Adult Airway Adapter Catalog No 6063 Val E For intubated patients with endotracheal tube diameters greater than 4 mm Adds approximately 5 cc of deadspace Exotic Neonatal Airway Adapter Catalog No 6312 For intubated patients with endotracheal tube diameters no more than 4 mm Adds approximately 5 cc of deadspace Setting Adapter Type The TidalGuard Sp uses two types of adapters Regular Adult and Exotic Neonatal Press the S Adapter key to access the adapter menu then the SELECT key to move the arrow pointer to the correct type The selected adapter type is displayed in the message area in the center of the display screen 3f mmHa BHDLT 9 SET AD ULT ADAPTER HEOHATAL TWPE EXIT SELECT 9 If the adapter type placed on the CAPNOSTATO CO sensor does not match the currently selected adapter type a CHECK ADAPTER message will appear If the adapter type is correct see the Adapter Zero Procedure on page 22 Rev B TidalGuard Sp Users Manual 21 Section 4 Adapter Zero Procedure Adapter Zero Procedure An adapter zero allows the monitor to accommodate the o
36. ion and reflection from structures objects and people a Field strengths from transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be consid ered If the measured field strength in the location in which the Tida Guard Sp is used exceeds the applicable RF com pliance level above the equipment should be observed to verify normal operation If abnormal operation is observed additional measures may be necessary such as reorienting or relocating the TidalGuard Sp b Over the frequency range of 150 kHz to 80MHz field strengths should be less than 3 V m Rev B TIDAL WAVE Sp User s Manual 49 Section 9 Electromagnetic Immunity Recommended separation distances between portable and mobile RF communications equipment and the TidalGuard Sp The TidalGuard Sp is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Tida Guard Sp can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the TidalGuard Sp as recommended below according to the maximum output power of the communications e
37. ith a cloth dampened with 70 isopropyl alcohol After cleaning wipe the lingual clip down thoroughly with a clean water dampened cloth to rinse Rev B TidalGuard Sp Users Manual 41 Section 7 Battery Maintenance CAPNOSTAT CO Sensor e Clean the sensor surface with a damp cloth e Make certain that the sensor windows are clean and dry Do not immerse the CAPNOSTAT CO sensor Do not attempt to sterilize the CAPNOSTAT CO sensor Battery Maintenance If the monitor has not been used or powered by the external power supply for an extended time 3 months or more allow the battery to charge before use or replace the battery with a fully charged battery and continue monitoring The monitor may not power up on battery power if the battery is not sufficiently charged Refer to Battery Life and Recharge Times on page 14 for charging times and instructions Maintenance Schedules When the monitor powers up a self test is performed which checks the internal electronics of the monitor If this self test fails remove the monitor from use and contact qualified service personnel The monitor should undergo routine inspection and safety checks on a quarterly basis or according to hospital protocol The TidalGuard Sp Service Manual Catalog No 9110 90 9146 90 contains procedures and safety test instructions component parts lists circuit diagrams theory of operation and other information to assist qualified service personnel in
38. lar adult or exotic neonatal ventilator s circuit the elbow may not be present Fig 2 2 Be sure the airway adapter is positioned vertically and located so that patient secretions and condensated water will flow AWAY from the adapter s windows not through or into it 3 Snap the CAPNOSTAT CO sensor onto the airway adapter 4 Capnogram CO waveform or EtCO trend EtCO values and respiratory rate should be displayed on the monitor Fig 1 Regular adult airway adapter Cat No 6063 CAPNOSTAT Wye CO sensor Patient connector Regular Adult Fig 2 Exotic neonatal airway adapter Cat No 6312 CAPNOSTAT CO sensor s y Patient co GS Exotic Neonatal 24 TidalGuard Sp User s Manual Rev B SpO Sensors Sensors and Patient Connections SpO Sensors CAUTION Connect only approved SpO sensor extension cables and or SuperBright SpO sensors to the TidalGuard Sp Do not use other SpO sensors or accessories with TidalGuard Sp Before connecting to the patient or to the monitor ensure that sensor extension cables and or sensors are physically intact with no broken frayed or damaged components Plug the connector into the end panel SpO sensor input The sensor connector is keyed to fit into the input in only one direction TidalGuard Sp SuperBright series DB 9 connector The connector clicks into place when properly seated Sensors may be
39. le a pulsating vascular bed such as the patient s tongue The remaining light energy not absorbed by the tissue sample reaches a photodiode light receptor in the sensor Oxygen saturated blood absorbs different amounts of light at each wavelength as compared to desaturated blood Therefore the amount of light absorbed by the blood in each pulse can be used to calculate oxygen saturation The TidalGuard Sp is calibrated to display functional saturation This differs from the fractional saturation value displayed by most co oximeters Functional saturation is defined as HbO 100 COHb METHb Functional Saturation HbO Fractional Oxyhemoglobin COHb Carboxyhemoglobin METHb Methemoglobin This can be considered to represent the amount of oxyhemoglobin as a percentage of the hemoglobin that can be oxygenated Dysfunctional hemoglobins COHb and METHb are not included in the measurement of functional saturation Pulse Rate is calculated by measuring the time interval between peaks of the infrared light waveform The inverse of this measurement is displayed as pulse rate The oxygen saturation and pulse rate values are updated once each second Presence of a pulse is indicated visibly by a plethysmogram graphic display and audibly by a beep when configured The TidalGuard Sp must be used in conjunction with SuperBright Sensors 6 ridalGuard Sp Users Manual Rev B Section 2 Safety For maximum p
40. n 60 and N3 is selected as the balance gas an incorrect INSP O setting may cause the reported CO value to be underestimated too low by up to 6 4 of its reading TidalGuard Sp Users Manual 17 Section 3 Configuration Menus CO UNITS mmHg kPa mmHg Select the desired units for both the capnogram and ETCO values Note that changing the CO units in the Configuration menu will result in a loss of all stored data The message WARNING CHANGING CO2 UNITS ERASES STORED TRENDS will display Press CANCEL By or press the OK key to acknowledge the warning and return to the CO2 UNITS menu Press the Adapter key to EXIT ALERT VOLUME Disabled Low High High Select the desired volume of audible alerts Note that care should be taken to set the volume level above ambient noise levels RS232 INTERFACE NOVACOMM used when connected to an external NOVACOMM PC with optional software RESERVED 1 and RESERVED 2 WAVEFORM FILL Unfilled Filled Unfilled Select the desired appearance of the capnogram waveform ETCO AVERAGING 1 Breath 10 sec 20 sec INST 10 sec Select the interval from which the displayed value of end tidal CO ETCO is calculated SpO gt AVERAGING 2 sec 8 sec 8 sec Select the interval from which the displayed value of oxygen saturation SpO is calculated ALERT LIMITS Disabled Enabled Disabled Enable or disable the Alert Limits function Select the desired high and low ale
41. nd the alert silence LED will flash red TidalGuard Sp Users Manual 35 Section 5 Capnogram Sample Waveforms and Interpretations Press the 44 Alert key to suspend an audible alert for 2 minutes Press again to cancel Press and hold the 4 Alert key to disable audible alerts Press and hold again to cancel The monitor will always power up with the audible alerts settings retained in memory The audible alert volume can be adjusted or disabled from the CONFIGURATION menu Press the Xx Backlight and S Adapter keys simultaneously then the By Page key until the ALERT VOLUME menu appears NOTE Make sure that the audible alert volume is not set too low to be heard over ambient noise levels Capnogram Sample Waveforms and Interpretations Normal The normal capnogram is a waveform that represents the varying CO level throughout the breath cycle Rebreathing Elevation of the baseline indicates rebreathing may also show a corresponding increase in EtCO Obstruction Obstructed expiratory gas flow is noted as a change in the slope of the ascending limb of the capnogram the expiratory plateau may be absent ae aa a Endotracheal tube in the esophagus en 36 TidalGuard Sp Users Manual Rev B Reference Handbooks Monitoring Inadequate seal around endotracheal tube The downward slope of the plateau blends in with the descending limb Accidental extubation AMET A Reference Ha
42. ndbooks For a discussion on waveform interpretations refer to the Reference Handbooks on capnography respiratory mechanics and pulse oximetry Contact Customer Service or your local sales representative for more information Rev B TidalGuard Sp Users Manual 37 Section 5 Reference Handbooks This page intentionally blank 38 TidalGuard Sp User s Manual Rev B Section 6 RS232 Options Power and RS232 Serial Port Communications A serial communications mode is available for the TidalGuard Sp The NovaCOMM Interface is designed to output data in formats easily read by a computer The monitor must be placed in the BaseStation PN 6998 00 to use the serial communication mode Located on the BaseStation is a six pin modular contact which provides an RS232 interface as well as a power output for unit operation and battery charging when connected to hand held monitors This connector meets the patient safety requirements of IEC 60601 1 When the monitor is placed within the BaseStation contact is made between the 6 pin connector in the BaseStation and the Features connector on the bottom of the monitor This connection is transferred to the RS232 Serial Port connector on the BaseStation Features connector BaseStation 6 pin connector WARNING Patient safety may be compromised if an external device e g printer or computer is connected to the RS232 serial port on the BaseStation Rev B Tidal
43. nds e Audible SpO Trend Feature Pitch of user selectable pulse rate beep tracks the SpO values i e decreasing SpO values are signaled by lower pitched beeps e Settling Time Display settles to within 1 of final reading less than 15 seconds after the sensor is properly applied e Alerts The Tida Guard Sp will have user selectable alert limits for SpO Pulse Rate Section e Range 30 250 beats per minute bpm e Accuracy 1 standard deviation 1 of full scale e Display Resolution 1 bpm e Averaging Time menu selectable times of 2 and 8 seconds default is 8 seconds e Settling Time Display settles to within 1 of final reading less than 15 seconds after the sensor is properly applied e Alerts The Tida Guard Sp will have user selectable alert limits for Pulse Rate Monitor Specifications e Classification IEC60601 1 Class I internally powered type BF enclosure protection rating of IPXI Operating Environment 50 to 104 F 10 to 40 C 0 90 relative humidity non condensing e Transport Storage short term 14 to 122 F 10 to 50 C with NiMH battery long term 14 to 95 F 10 to 35 C with NiMH battery storage 14 to 131 F 10 to 55 C without NiMH battery e Size 7 9 x 3 25 x 1 5 e Weight 24 ounces Power 100 250 VAC 38A 50 60 Hz Battery Rechargeable DR30 NiMH battery pack Cat No 400043 or equivalent AA lithium batteries Energizer L91 or equivalent
44. old to adjust contrast for up down viewing angles and for adjustment due to extreme temperature variations Indicators Es Battery Alert Indicator Illuminates when the unit is on battery power Green battery is fully charged slow flashing yellow battery power is low approximately 20 minutes of operation remains Fast flashing red battery is exhausted approximately 5 minutes of operation remains The battery alert indicator is off when external power is connected Refer to AC Battery Operation on page 9 for information on connecting AC power and charging the battery Y AC Power Indicator Illuminated green when the monitor is connected to an AC power source e g the external power supply PN 9220 10 or the BaseStation PN 6998 00 while powered by the external power supply 2 TidalGuard Sp Users Manual Rev B Keypanel Controls and Indicators General Description Rev B Icons The icons listed below may appear on the display screen when the TidalGuard Sp is in use LA Alert Silence Icon Audible alerts silenced fac 2 Minute Suspend Icon Audible alert suspended for two minutes ur Alert Limits Disabled Icon Alert limits disabled Select ENABLED or DISABLED in the CONFIGURATION menu D Airway Adapter Icon Indicates adapter key ety Time Date Icon Set time date Press XX from the CONFIGURATION menu to set time and date WS v Backlight Icon Indicates backlight key luli Trend S
45. ollection Appropriate steps must be taken to ensure that spent batteries are col lected separately when disposed of pa Es Principle of operation CO TidalGuard Sp uses the CAPNOSTAT CO sensor to measure CO by using the infrared absorbtion technique which has endured and evolved in the clinical setting for over two decades and remains the most popular and versatile technique today The principle is based on the fact that CO molecules absorb infrared IR light energy of specific wavelengths with the amount of energy absorbed being directly related to the CO concentration When an IR beam is passed through a gas sample containing CO the electronic signal from the photodetector which measures the remaining light energy can be obtained This signal is then compared to the energy of the IR source and calibrated to accurately reflect CO concentration in the sample To calibrate the photodetector s response to a known concentration of CO is stored at the factory in the monitor s memory A reference channel accounts for optical changes in the sensor allowing the system to remain in calibration without user intervention Rev B TidalGuard Sp User s Manual 5 Section 1 Principle of operation SpO The TidalGuard Sp determines oxygen saturation using sensors that contain red and infrared 660 and 940 nanometer light sources called light emitting diodes LEDs The light energy from each LED is beamed through a tissue samp
46. onconononcconcnnncnonnnnnnnnnnnnnnnnnnnnnnnnncnnnnnnnnanenennnnns 21 Adapter Types Avallable 1 2 41 teet le Go eate bett hd eise feat as 21 Settirig Adapter Type idol A naaa 21 Adapter Zero Procedute 2 ite edt tee eie rue eain 22 CAPNOSTAT CO Sensor and Airway Adapter Setup ssssss 24 Nue viiraa enaa ataia ahi aaia ap dell lan 25 Monitoring E 27 Display ot Data A Re n A E 27 Monitoring MOGO 1 2 Le top PE t n Ee mte E dg Pad d ri ab e es 27 Screen DISplays s 2iteitenitobten i prc ER t e on eR LU ED Ioa et Ce ER Lp dn 28 Messages oc odia am tinte hod oae tiani iate 30 AGIS ccce cT d LM cA m RA Meis 33 Settirig Alert Lirilts coccion ra gatio e Peel eA p ues 33 FAIS AU sow LP CHI 35 Capnogram Sample Waveforms and Interpretations ooocociniiccccconoccccccnnccinnnicnnannnnnns 36 Reference Handbooks A 37 RS232 Options cicle das 39 Power and RS232 Serial Port Communications oooccccccccnccnncnnoncononcnnnnnnnnnnnnnnnnnnnnnnns 39 Maintenance AAA iare ene ERROR RR XERARNERRRERRSRMADSRERU RE RRRAKRR NR SERENA SRERERRRYRR ANA 41 Cleaning and Sterilization oooooocconnncccnnnnnocccccnnncannnccn nana nnn rca nano T eene 41 Battery Maintenance mc lao 42 Maintenance Schedules sssssssssssssssseseeeeee en ener nennen nnns 42 WEEE ROHS Recycling Directives oooooooccccnnnncccccnnnonccccnnnaonnccnnnnnnnncc rai cnc cnn EE 42 TidalGuard Sp User s Manual W DPECIMICAIONS Ai Ascari 43 erue 43 Capno
47. onitor ON press and hold the POWER key to enter the MONITORING MODE selection menu Refer to Monitoring Mode on page 27 for more information Rev B TidalGuard Sp Users Manual 1 Section 1 Keypanel Controls and Indicators PAGE B Page Key Press to set display screen to Data Display EtCO waveform plethysmogram EtCO trend Respiration trend or SpO trend Alert Key Press to suspend audible alerts for 2 minutes and display the SET ALERTS menu If the SET ALERTS menu is not needed it will automatically disappear after 3 seconds For 2 minute suspend the Jal icon will illuminate for the duration Press again to cancel Press and hold for 3 seconds to disable audible alerts and the LA icon will flash Press and hold again to cancel The Alert Key LED will display the following e Steady yellow audio suspended for 2 min no alert in progress e Flashing yellow audio silenced no alert in progress e Flashing red and yellow alert in progress audio is off or 2 minute suspend Audible alerts may be permanently disabled from the Configuration menu Refer to Configuration Menus on page 16 for more information Adapter Key Press to set adapter type regular adult or exotic neonatal Press and hold for 4 seconds to zero an adapter See Adapter Zero Procedure on page 22 for more information Press to cancel Auto Power Off function Y Q Backlight Key Press to turn backlight on off or press and h
48. ould be connected to recharge the battery rechargeable batteries only and power the monitor See Battery Life and Recharge Times on page 14 NOTE When the battery is low red blinking battery LED Es on keypanel the monitor has shut down CO and SpO functions Connect to AC power as soon as possible TidalGuard Sp Users Manual 9 Section 3 Battery Use and Options NOTE The battery life indicator may not reflect the true battery status upon power up for approximately 30 seconds The battery life indicator is inactive when the monitor is powered by the BaseStation or the external power supply Battery Use and Options Removing and Installing the Battery Grasp the finger grips on each end of the battery cover Squeeze together and pull so that the cover opens to reveal the internal battery the cover is hinged on the bottom of the case Remove the battery from the monitor Finger grip Power jack Use with PN 9220 10 only Hinged side Interface connector Battery cover WARNING Do NOT connect to any device that has not been approved for use The battery is keyed so that it can be installed in only one way see illustration inside battery compartment The contacts should go in first and be located toward the top left of the monitor when inserting Make certain the battery cover is properly closed before operating the monitor 10 TidalGuard Sp User s Manual Rev B Battery
49. ptical characteristics of each different type of adapter Before zeroing verify the selected adapter type is correct and the adapter setting is correct NOTE This procedure is to be performed with a new unused adapter only Perform this procedure only if the CHECK ADAPTER message persists or if deemed necessary by qualified personnel Do not perform this procedure while the CAPNO WARMING message is displayed Do not perform this procedure while the adapter is connected to a breathing circuit or mouthpiece The Regular adult and Exotic neonatal adapters must be zeroed independently ensure that the proper adapter type is selected If an adapter leaks or becomes occluded replace and discard the occluded adapter 1 Attach the selected adapter type to the CAPNOSTAT CO sensor Select the adapter type Regular adult or Exotic neonatal to be zeroed by pressing the Adapter key to access the adapter menu Press the SELECT key to move the arrow pointer to the correct type of adapter and confirm the selection with the EXIT key 2 Press and hold the S Adapter key for five seconds to enter the zero menu WARNING Zeroing with the incorrect adapter type will cause incorrect readings Zeroing the wrong adapter type on the wrong adapter setting will cause incorrect readings e Do not zero the CAPNOSTAT CO sensor without an adapter attached Incorrect readings or no readings will result
50. quipment 50 Separation distance according to the frequency of transmitter meters Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Watts 3 5 di G d z P as z v V E E 1 1 1 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated by using the equation applicable to the frequency of the transmitter where P is the maximum power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people TIDAL WAVE Sp User s Manual Rev B
51. r Press YES The monitor will automatically set alert limits based on recent patient data mM 45 ri 3r mmHa AGLT gf Alert Screen AUTO SET ALERTS ALERTS The screen will display ETCO2 AUTO LIMITS SET and SPO2 AUTO LIMITS SET messages Press By CONTINUE to return to the previous screen If auto alert limits cannot be determined for one or both limits the message ETCO2 AUTO LIMITS NOT SET and or SPO2 AUTO LIMITS NOT SET will appear If one or both of the screen messages say LIMITS NOT SET exit this screen resume monitoring and retry in 30 seconds when the monitor has collected sufficient data ETCOZ AUTO LIMITS SET SrF 2 AUTO LIMITS SET COHTIHUE NOTE Auto Alert Limits are not stored by the monitor If Auto Alert Limits are selected and the unit is powered down default limits will appear on power up regardless of stored values Alert Audio A NO RESPIRATION alert will sound after 20 40 or 60 seconds depending upon the configuration setting if no breaths are detected When this occurs a RESP 0 timer appears indicating the number of seconds since the last detected breath Three breaths must first be detected to initialize this alarm An audible alert is generated any time an alert condition is detected provided that neither the 2 minute suspend nor the audible alert muting are enabled If the ALERT VOLUME is set to DISABLED an audible alert is not generated a
52. r withstands a 6 foot drop to a tile floor e Regular Adult Airway Adapter Less than 5 cc deadspace meets ANSI Z 79 e Exotic Neonatal Airway Adapter Less than Y cc deadspace meets ANSI Z 79 EtCO Section Mainstream e Range 0 150 mmHg CO partial pressure Accuracy 0 40 mmHg 2 mmHg 41 70 mmHg 5 of reading 70 150 mmHg 8 of reading e Warm up Time Operational in 15 seconds 1 minute to full specifications Step Response Time 60 ms regular adult less than 50 ms exotic neonatal e Averaging Time 1 breath 10 seconds default 20 seconds instantaneous e Display Resolution 0 25 0 50 and 0 150 mmHg in 31 pixels e Alerts User selectable alert limits for EtCO Allows for halogenated anesthetic agents which may be present at normal clinical levels The presence of desfluane in the exhaled breath beyond normal levels 5 6 may positively bias carbon dioxide values by up to an additional 2 3 mmHg Maintained up to 70 breaths per minute Rev B TidalGuard Sp Users Manual 43 Section 8 SpO2 Section Respiratory Rate Mainstream e Range 0 150 breaths min e Accuracy 1 breaths min e Alerts The TidalGuard Sp has user selectable alert limits for Respiratory Rate e Averaging Time 8 seconds SpO Section e Range 0 100 e Accuracy 70 100 2 SpO 1 standard deviation 0 69 unspecified e Display Resolution 1 e Averaging Time menu selectable times of 2 and 8 seconds default is 8 seco
53. rd Sp from AA lithium batteries insert seven disposable batteries Energizer L91 or equivalent into the optional Battery Case Cat No 6862 00 following the polarity markings on the Battery Case Standard AA lithium batteries 7 ea disposable WARNING e Batteries can explode leak or catch on fire if heated or exposed to fire or high temperatures Do not mix battery types e g disposable and rechargeable AA batteries Battery Life and Recharge Times Configuring the monitor to turn off unused functions will result in longer battery life The following table lists battery operation times see Monitoring Mode on page 27 Power source Approximate Monitoring Times Configuration Rechargeable NiMH battery AA lithium batteries CO SpO 4 5 hours 4 0 hours CO only 4 5 hours 4 0 hours SpO only 7 0 hours 6 5 hours Recharge Time 4 5 hours n a External charger w adapter Recharge Time 5 5 hours in monitor n a External power supply or External power supply BaseStation NOTE Excessive alerting reduces battery life when operating on battery power 14 TridalGuard Sp Users Manual Rev B Battery Use and Options Preparation for Use Rev B Automatic Power Off Feature The automatic power off feature is included to conserve battery power in the event of an unintentional power up of the monitor This option will shut the monitor off if there is no CO b
54. reath or pulse detection after 5 minutes from when the unit powers on or after 20 minutes of no monitoring no breath or pulse detected and no alert conditions After the 5 or 20 minutes has elapsed an AUTO POWER OFF IN X XX message will appear on the screen and the timer X XX will count down from one minute to zero Pressing the adapter key or detection of a CO breath or pulse will cancel the shutdown otherwise the unit will shut off Long Term Storage If the monitor has not been used or powered by the external power supply for an extended time 3 months or more allow the battery to charge before use or replace the battery with a fully charged battery and continue monitoring The monitor may not power up on battery power if the battery is not sufficiently charged Refer to Battery Life and Recharge Times on page 14 NOTE New batteries or batteries stored for extended periods of time may need to be fully charged and discharged up to five 5 times before performing at full capacity With a new battery or a battery that has not been used for 30 days charge the battery for 24 hours prior to use Serial Communications Power Interface Connector Located on the enclosure rear is a six pin modular contact which provides an RS232 interface as well as a power input for unit operation and battery charging when connected to approved accessories This connector meets the patient safety requirements of the following agency
55. rt limits by exiting the CON FIGURATION menu and pressing the Alert key PULSE BEEP VOLUME Off Low High OFF Select the desired volume of pulse beep Note that care should be taken to set the volume level above ambient noise levels RESP TREND SCALE Small Medium Large Medium Select the desired size of the respiration trend waveform AUTO POWER OFF Enabled Disabled Enabled Selects automatic shut off of unit if no signal is detected to conserve battery power 18 TidalGuard Sp Users Manual Rev B Configuration Menus Rev B Preparation for Use The following parameters are accessed by pressing X from one of the previous Configuration menus Press XX to move through the menus SET TIME AND DATE Press the 24 hour format Day number short month name year e g 14 DEC 1998 From within the CONFIGURATION Menu press XX key to access this screen Select to program or change the time and date The format is TIME HH MM DDmmmY YY Y where HH hours from 00 23 MM minutes from 00 59 DD days of the month from 01 31 mmm month Y Y Y Y year using all four digits LANGUAGE All languages available in the current software release are listed in this menu SOFTWARE REVISIONS MAIN PROGRAM Date time and version of software currently loaded in to this unit CAPNOSTAT SERIAL VERIFY ACCURACY Serial number of CAPNOSTAT CO sensor attached to this monitor Ver
56. se and Options Preparation for Use Charging NiMH Rechargeable Battery with External Charger In a non patient area connect the adapter to an AC source then plug the adapter jack into the charger Remove the battery from the TidalGuard Sp and insert it into the external charger The battery will be fully charged in approximately 4 5 hours The external charger is for use with the DR30 NiMH rechargeable battery pack Cat No 400043 only Refer to the instructions supplied with the charger for additional information DR30 NiMH Rechargeable Battery Cat No 400043 Connect adapter Battery is keyed to fit into slot in only one direction WARNING e The external battery charger should NOT be used to recharge the battery near or in close proximity to patients and or other medical equipment in operation It is intended for use in service areas only i e nurses station biomed lab etc NOTE e With a new battery or a battery that has not been used for 30 days or more charge the battery for 24 hours prior to use e When powered by the external power supply or the BaseStation the TidalGuard Sp will not overcharge a rechargeable battery The monitor may not operate on battery power if the battery is not sufficiently charged e Dispose of batteries in accordance with local laws Rev B TidalGuard Sp Users Manual 13 Section 3 Battery Use and Options AA Lithium Batteries To power TidalGua
57. tact are free of latex Certain rebreathing circuits or the presence of artifacts such as cardiogenic oscillations may cause TidalGuard Sp to react to non respiratory CO fluctuations as if they were breaths This condition affects the RESP numerical displays and may also affect the ETCO display when using single breath averaging the capnogram display continues to provide an accurate picture of the CO waveform After the life cycle of our equipment and all accessories has been met disposal of the equipment should be accomplished following the national requirements Contact the local customer service representative for questions concerning disposal Accessories equipment connected to the analog and digital interfaces must be certified to the respective IEC standards IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 60601 1 1 TidalGuard Sp Users Manual 9 Section 2 This page intentionally blank 10 TidaiGuard Sp Users Manual Rev B Rev B Section 3 Preparation for Use The TidalGuard Sp can be powered four ways from seven AA disposable lithium batteries a rechargeable DR30 NiMH battery the 9220 10 external power supply or a 6998 00 BaseStation combined with the external power supply AC Battery Operation Press the POWER key to place the unit into operate mode ON or to turn the unit OFF The status of the unit
58. ted mode will flash Press the 4 SELECT key to move the arrow pointer to the correct mode and the EXIT key to exit the menu When the monitor is in CO mode SpO screens are not be available in SpO mode CO screens are not available All screens are available in CO gt SpO mode MONHITORIHG MODE Lz 5P z co 2 Sr z EXIT SELECT NOTE Significant power savings can be realized by shutting down monitor functions that are not currently being used Refer to Battery Life and Recharge Times on page 14 Parameters are measured and displayed on the various screens in the following sections TidalGuard Sp User s Manual 27 Section 5 Screen Displays Screen Displays The last screen used will automatically appear on power up with the exception of the Trend screens Data Screen The Data screen displays End Tidal CO respiration rate oxygen saturation and pulse rate in larger easy to read text without waveforms A pulse bar that is proportional to the signal strength appears in the lower right corner indicating the patient s pulse a breath bar in the lower left corner indicates the patient s inhaled and exhaled breaths Selected gas compensation displayed here N5O O or CO units Status messages are displayed here blank if set to room air balance Oxygen perfusion SpO gt displayed here EtCO value 3 gr mmHa HDLT A Pulse rate RESP displayed here Respiration rate p eJ Pulse bar
59. turn to the previous display mM 23 ri 3f mmHa AGLT gf Alert Screen AUTO SET ALERTS ALERTS Using the menu control keys adjust the settings as desired press the SELECT key to move to the desired parameter for adjusting the selected parameter will flash Use the xXx Backlight key to decrease V a parameter value and the e Adapter key to increase the selected value Maximum and minimum high and low limits are preset for each parameter and cannot be exceeded Also the range between high and low alert limits is restricted to a minimum of five units For example default ETCO settings are high 55 mmHg low 25 mmHg If the user decreases the high setting to 30 mmHg within 5 units of the low setting and continues to lower the setting both high and low ETCO settings will decrease maintaining the five unit range Selected parameter Default values are shown will flash NOTE When the monitor is turned off manual alert limit settings will be retained even if AC power and the battery are disconnected Alert Limits Ranges ETCO 150 max 10 min Resp Rate 150 max 5 min SpOs 100 max 50 min Pulse Rate 249 max 30 min 34 TidalGuard Sp User s Manual Rev B Alert Audio Rev B Monitoring Auto Alert Limits To set alert limits EL press the B Alert key and AUTO ALERTS will appear over the Page key Press the B Page key and ENABLE AUTO ALERTS will appea
60. uate circulation at least once every four hours When applying sensors take note of patient s physiological condition For example burn patients may exhibit more sensitivity to heat and pressure and therefore additional consideration such as more frequent site checks may be appropriate e Data Validity As with all pulse oximeters inaccurate SpO and Pulse Rate values may be caused by Incorrect application or use of sensor Significant levels of dysfunctional hemoglobin carboxyhemoglobin or methemoglobin A Significant levels of indocyanine green methylene blue or other intravascular dyes Exposure to excessive illumination such as surgical lamps especially those with a xenon light source or direct sunlight Excessive patient movement Venous pulsations Electrosurgical interference e The external battery charger should NOT be used to recharge the battery near or in close proximity to patients and or other medical equipment in operation It is intended for use in service areas only i e nurses station biomed lab etc Rev B TidalGuard Sp User s Manual 7 Section 2 e Connection of an external device e g printer or computer to the RS232 serial port on the BaseStation may compromise patient safety e Useofthe TidalGuard Sp monitor is restricted to one patient at a time Do not connect the sensors to multiple patients simultaneously e The TidalGuard Sp monitor provides no protection against the effects
61. y for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby equipment RF emissions Class A Class A CISPR 11 The TidalGuard Sp is suitable for use in all establishments other than domestic and those directly connected to the public low Harmonic emissions Class A voltage power supply network that supplies buildings used for IEC 61000 3 2 domestic purposes Voltage fluctuations flicker Complies emissions IEC 61000 3 3 Electromagnetic Immunity Guidance and manufacturer s declaration Electromagnetic immunity The TidalGuard Sp is intended for use in the electromagnetic environment specified below The customer or user of the TidalGuard Sp should assure that it is used in such an environment Immunity Test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic Discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air 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 transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5

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