Home

Operating Instructions

1. Lead mm Delta ST I 44 9 vi 1 2 2 7 ve 2 5 III 1 8 v3 1 5 1 8 2 8 _ 0 5 yS 4 1 aVF 2 2 2 8 FIGURE 2 69 Average ST Complex Format Cardiac Output Printing Cardiac Output waveforms and data is initiated from the Cardiac Output Menu by selecting Print Runs Only valid Cardiac Output runs will be printed The printout data will include patient demographic data date of printout and patient parameter data prior to printing the waveform data Following the digital information up to five 5 Cardiac Output runs with time Cardiac Output data and Cardiac Index data will be printed followed by the Average Cardiac Output Cardiac Index and catheter specific data NOTE Cardiac Output report printing from the recorder is only available if the CO Source is the EPM 114 0070 10 0648 02 Spectrum Operating Instructions Operations Printing Optional PAWP To print PAWP Pulmonary Artery Wedge Pressure waveforms access the PAWP Menu and select Print Wedge This printout is continuous and will only be aborted by pressing the PRINT WEDGE key again or by running out of recorder paper The printout data will include patient demographic data time date of printout and waveform speed just prior to printing the waveform data Following the digital information 2 wav
2. 5 1 Safety designations per 60601 1 Standard eene 5 1 Patient Parameter Specilicalions tete tit ere yis 5 3 oce 5 3 ECG Respiration Performance Requirements essere eerte 5 7 NIBP Performance and Functional Characteristics sss eee eene 5 7 IBP Performance Characteristics eem m o a t te I b het be cde bt ties 5 10 Temperature Parameter Performance Characteristics 5 12 SpO Performance Requirements natn cete voa WO OE Gr E Re eet tuse 5 13 Masimo SET SpO Performance Requirements ce ceceeseeseeseeseeseeeeeeeeneceseeseesenseeseeseeseeeeieeneentensetes 5 13 Nellcor Performance Requirements sse eene ern 5 15 Performance Characteristics esses eene nennen 5 15 MediCO Microstream Only in monitors with serial numbers below 05000 5 15 MiniMediCO Microstream Only in monitors with serial number MSO5000 and higher 5 17 Spectrum Operating Instructions 0070 10 0648 02 iii Table of Contents Cardiac ERE IR E ERO I USENET DURER GS 5 19 Special Eda 5 20 ST Segment Analysis Performance Requirements eere 5 20 EE
3. 2 3 5 1 Remote View The Remote View feature allows the simultaneous display of data from two patients on a single monitor The monitor at the user s current location is defined as the host monitor While maintaining visibility of the primary patient at the host monitor the Remote View Menu enables the user to view the numeric data and two selectable waveforms of another patient who is being monitored at a remote location The monitor at the remote location is defined as the remote monitor Visual and audio alarms occurring at the remote monitor are also received through the Remote View Menu at the host monitor Print Setup Parameters NOT FOR CLIN SE 1mV A Lb ll LB st Ados Aa Mo TE MISSIS DS Normal Screen Setup gt S 116 2 f 1 23 8 NI Select to return to normal screen FIGURE 2 9 Remote View Menu on Main Display Hardwired Spectrum monitors can function as host monitors with the ability to view other hardwired Spectrum monitors and 2 4 GHz wireless Spectrum monitors NOTE 2 4 GHz wireless Spectrum monitors cannot function as host monitors All Remote View controls are contained within the Remote View Menu Opening other menus from the monitor s keypad or by pressing the NORMAL SCREEN key will close the Remote View Menu 0070 10 0648 02 Spectrum Operating Instructions Operations Main Menus Remote View Menu Display The Remote View Menu displays data as follows The
4. Electrocautery or electrosurgical unit interference Rapid changes in cardiac output Using an incorrect computation constant WARNING Ensure that the conductive parts of ECG electrodes do not contact other conductive parts including earth ground WARNING Pacemaker patients rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias Do not rely entirely upon rate meter alarms Keep pacemaker patients under close surveillance See the Appendix section of this manual for disclosure of the pacemaker pulse rejection capability of this instrument WARNING Due to physiologic differences in the patient population the Spectrum may occasionally not alarm or may sound a false alarm for some arrhythmia patterns The arrhythmia analysis feature is intended to detect ventricular rhythms only High risk patients should be kept under close surveillance WARNING The View 12 ECG Analysis Module is not intended for use during electrosurgery If the electrosurgical ground connection is not satisfactory there exists a possibility of patient burns at the ECG electrode sites WARNING Computerized ECG Analysis should be reviewed by qualified medical personnel It should not be used exclusively for treatment or non treatment of patients Spectrum Operating Instructions 0070 10 0648 02 vii Introduction Warnings WARNING WARNING WARNING WARNING WARNING WARNING
5. D choices are for drugs that are not listed in the table 1 to 1100 lbs or 1 to 500 kg Select to choose medication Select to enter or change patient weight When any one of the menu items marked with an asterisk is changed the others are automatically updated Spectrum Operating Instructions 0070 10 0648 02 Calculations Drug Calculator Menu Structure Continued MENU TITLE ON SCREEN Drug Units MENU CHOICES mcg mg g units mU DEFAULT mcg for Drug A B C or D For drugs listed in the table in the Adult Medication Choices subsection see the DEFAULT UNITS column Operations ACTIONS COMMENTS This menu item is only selectable if Drug A B C or D is chosen Otherwise the default unit for the specified drug is used If Drug Units are changed for Drug A B C or D Drug Amount Solution Volume Dose min Dose hr Dose kg min and Dose kg hr will be reset to blank fields and Infusion Rate and Concentration will be invalidated Select to enter or change drug units Drug Amount Based on current Drug Units setting Select to enter amount of drug in IV bag Solution Volume 10 to 1000 ml Select to enter volume of solution in IV bag Dose min 0 01 to 10000 00 If the chosen drug is Vasopressin the Default is 0 200 For all other drugs the Default is 1 00 Select to enter dosage of drug to be infused per minute
6. DESCRIPTION Type B Equipment Type BF Equipment Defibrillator Proof Type BF Equipment Defibrillator Proof Type CF Equipment Alarm Off Icon Alarm Mute Icon Earth Ground Protective Earth Ground Battery Charging Full Battery Low Battery No Battery Present Analog ECG and IBP output for NIBP Connection IABP communication to an Intra Aortic Balloon Pump losers produci DEFIB Analog ECG out and Sync Pulse for connection to a Defibrillator Crossed out wheelie bin Interference may occur in the indicates separate treatment e pee ay vicinity of equipment marked with from general waste at end E of life this symbol For single patient use only do not reuse OM OrUHP COO e Manufacturer s reference catalogue number xvi 0070 10 0648 02 Spectrum Operating Instructions Symbols and Descriptions Introduction e For Neonatal use Manufacturer s batch number amp Not for Neonatal use SN Serial number Conformit Europ enne CE Marking of Conformity to C European Medical Device SW Software Version Directive CExyxx represents the Notified Body number Spectrum Operating Instructions 0070 10 0648 02 xvii Introduction Symbols and Descriptions This page intentionally left blank xviii 0070 10 0648 02 Spectrum Operating Instructions 1o General Product Description mindray LEAD SIZE VIEW Spectrum NIBP ALARMS PRINT DISP
7. including the patient s and your own exhaled breath and ventilator exhaust valves during the warm up period 0070 10 0648 02 Spectrum Operating Instructions Operations Operations Parameter Menus and Monitoring 2 4 6 3 Microstream CO Menu Accuracy verification of the Microstream CO is recommended at one 1 year intervals or whenever the readings appear to be in error The date of the last successful calibration appears on Calibration Menu Normal Screen Calbrate Scale 40 mmHg Grid Off Color I Change to Resporco 2 Select to return to normal screen FIGURE 2 41 CO Menu NOTE For maximum accuracy during calibration a 20 minute warm up time is recommended 1 Connect the tubing that comes with the calibration gas to the gas canister and to the FilterLine Use calibration gas part number 0075 00 0033 01 and a Microstream FilterLine Attach the gas tubing assembly to the CO input port on the Spectrum 2 Select the CO Parameter Tile by rotating Navigator Knob and pressing the Navigator Knob after the CO3 Menu is highlighted The same menu can be accessed by using the Parameters Tile and selecting CO 3 Select the Calibrate and press the button on the gas canister to begin releasing the gas mixture NOTE Auto zero occurs at the start of the CO monitoring session and periodically throughout the monitoring session Auto zero will last approximately 15 seconds
8. 55 sc ect ete ete ote al aces canta Dade Pete Foe 5 41 OPSCHUNT c cL 5 41 as Module SE and Gas Module iet aede ER OD 5 45 Warranty Statements RE eee Ree ee e enr tn etes Pe perpe qu cm ee EDD au teria ge Redes 5 49 Phone Numbers afid Hew To Get Assistdnce ect dei tee edat oet 5 51 Mindray s Responisibility 2 teer itt tne tene rto Ree eben doe 5 51 IO TTI IS AR s RAT ER Glossary of Terms iv 0070 10 0648 02 Spectrum Operating Instructions Foreword Introduction Foreword The Spectrum Operating Instructions are intended to provide information for proper operation General knowledge of monitoring and an understanding of the features and functions of the Mindray Spectrum Monitor are prerequisites for its proper use NOTE Do not operate this monitor before reading these instructions Information for servicing this instrument is contained in the Spectrum Monitor Service Manual part number 0070 00 0556 02 For additional information or assistance please contact an authorized Mindray 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 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
9. menu items Print Units Dose min Dose hr Dose kg min This menu item is Dose kg min Dose kg when the chosen automatically populated hr drug is weight with the appropriate based default when 1 a Drug Name is chosen 2 the Dose min whenthe patient Weight is chosen drug is non specified for a weight weight based based drug and 3 Dose min Dose hr Dose kg min or Dose kg hr is specified If the dose is entered as Dose min then the menu Choices will be Dose min or Dose hr If the dose is entered as Dose kg min then the menu choices will be Dose kg min or Dose kg hr If the dose is entered as Dose hr then Dose hr will be the only menu choice for the Print Units If the dose is entered as Dose kg hr then Dose kg hr will be the only menu choice for the Print Units If the chosen drug is Milrinone then Dose kg min will be the only menu choice for the Print Units Print Table Select to print Drug Calculation data When any one of the menu items marked with an asterisk is changed the others are automatically updated Spectrum Operating Instructions 0070 10 0648 02 2 93 Calculations Operations The following table details adult medication choices Adult Medication Choices IS THE PATIENT S WEIGHT USED IN DEFAULT DEFAULT GENERIC THE DEFAULT SOLUTION DRUG NAME BRAND NAME CALCULATION UNITS VO
10. Systolic Pressure Measurement Accuracy Range Adult Mode Pediatric Mode Neonatal Mode Diastolic Pressure Measurement Accuracy Range Adult Mode Pediatric Mode Neonatal Mode Static Pressure Measurement Range Static Accuracy Pulse Rate Range Adult Mode Pediatric Mode Neonatal Mode Resolution Accuracy 0070 10 0648 02 Appendix Mean error is less than 5 mmHg Standard Deviation is less than 8 mmHg 55 to 235 mmHg 55 to 160 mmHg 45 to 120 mmHg Mean error is less than 5 mmHg Standard deviation is less than x 8 mmHg 30 to 200 mmHg 30 to 150 mmHg 20 to 100 mmHg 0 300 mmHg 3 mmHg or 2 whichever is greater in the range of 20 to 275 mmHg 35 245 bpm 35 245 bpm 70 245 bpm 1 bpm The greater of x 3 bpm or 3 Spectrum Operating Instructions Appendix Patient Parameter Specifications Maximum Cuff Pressure The software controlled maximum cuff pressure Adult Mode 300 mmHg Pediatric Mode 195 mmHg Neonatal Mode 150 mmHg The hardware controlled maximum cuff pressure Adult Mode 330 mmHg Pediatric Mode 220 mmHg Neonatal Mode 165 mmHg Cuff Inflation The inflation source is capable of supplying sufficient air to bring a volume of 500 cc s to a pressure of 300 mmHg in no more than 35 seconds Reference ANSI AAMI SP10A 1996 EN60601 2 30 1995 does not have a requirement for this IF the cuff is not inflated to the desired pressure within 60 s
11. Trend Interval Off 1 2 5 5 10 Off Select to change time of trend data collection 15 20 30 min 1 hr 2 hr NIBP Trend On Off On Select to save numeric data to trend on NIBP measurements Alarm Trend On Off Off Select to save numeric data to trend on Alarms Nurse Call Off 1 second Off Select to choose the Nurse Call activation time Continuous Arrhythmia Menu This selection will open the Arrhythmia Menv NIBP Start Mode Interval Mode Timer Interval Mode Select the Interval mode to Mode synchronize NIBP start with the integral clock Select Timer Mode to synchronize NIBP start with the interval selected in relation to the real time clock Apnea Latch On Off On Select to turn apnea alarm latching on or off Arrhythmia Menu Optional MENU ITEM SELECTIONS FACTORY DEFAULT COMMENTS Previous Menu Select to return to previous menu Arrhythmia All On All Off Non lethals Factory default is All On Use Off Navigator Control knob to turn arrhythmia analysis on or off Irregular HR On Off Factory default is On Use Navigator Control knob to turn Irregular HR on or off Only available with 3 lead or 5 lead Spectrum Operating Instructions 0070 10 0648 02 2 11 Operations Arrhythmia Menu Optional Continued MENU ITEM SELECTIONS FACTORY DEFAULT COMMENTS V Tach 3 to 15 beats Factory default is 3 beats Use Navigator Control knob to select how many v
12. WARNING WARNING WARNING WARNING WARNING ST segment measurements may be affected by one or more of the following ECG rhythm morphologies wide complex QRS such as bundle branch blocks ventricular pacemaker rhythm left ventricular hypertrophy or Wolff Parkinson White Syndrome Consult with qualified medical personnel prior to treatment or non treatment When monitoring with a Spectrum the maximum sampling rate at the nasal cannula is 58 ml min This device should not be used on patients whose breathing could be impaired by this vacuum flow rate When monitoring CO connection from the exhaust port of the Spectrum to the hospital s waste gas scavenging system is recommended to prevent exposure of hospital personnel to the patient s respiratory sample When using the Gas Module the maximum sampling rate at the nasal cannula is 200 ml min 120 ml min for Gas Module 3 with a neonatal water trap This device should not be used on patients whose breathing could be impaired by this vacuum flow rate Connection of the Gas Module 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 Modules internal pump Do not clean the monitor while it is on and or plugged
13. 0070 10 0648 02 Spectrum Operating Instructions Appendix Warranty Statements 5 16 Warranty Statements Mindray DS USA 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 invoice Under this extended warranty Mindray DS USA 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 USA s standard warranty will remain in effect USA Canada Mexico and Puerto Rico Mindray DS USA 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 will not be liable for any incidental special or consequential loss
14. 1 10 1 20 External Parameter Modules Optional The module contains a YSI 400 700 temperature port and may also contain one or both of the following Two Invasive Blood pressure ports Cardiac Output port To connect the External Parameter Module to the Spectrum 1 Line up the connectors on the front of the Module security posts module hooks and EMT port 2 Slide the module forward towards the monitor front until an audible click is heard as the module hooks are engaged To remove the External Parameter Module from the Spectrum 1 Press the two release buttons on the top of the module 2 Slide the module straight back until all connectors are clear 3 Lift the module straight up for complete disengagement WARNING Do not clean the monitor while it is on and or plugged in 0070 10 0648 02 Spectrum Operating Instructions General Product Description External Parameter Modules Optional 1 10 1 External Parameter Module Top View x HEB Ue nen UE FIGURE 1 16 Diagram of Top View 1 Soft Grip Module Handle This integrated grip handle is used for carrying the Spectrum with the External Parameter Module attached 2 Release Buttons There are two release buttons at the top Press these two release buttons simultaneously during the removal of the
15. CO Source As noted in the introduction to the Cardiac Output section CO can also be measured through an Edwards Vigilance Monitor If both the EPM and the Vigilance are connected and the Installation Menu is properly configured CO Source enables the user to choose either device as the source for CO A detailed description of this configuration is provided in the CO from both Vigilance and EPM section 2 4 11 1 3 Measuring Cardiac Output with the EPM WARNING Inaccurate Cardiac Output measurements may be caused by e Incorrect placement or position of the catheter e Excessive variation in pulmonary artery blood temperature Clot formation on the thermistor Anatomical abnormalities for example cardiac shunts e Excessive patient movement Repeated intermittent flushes of cold fluid through the fluid lumens of the catheter Use of a manual pump such as the Abbott Blood Set with Pump and CAIR clamp Electrocautery or electrosurgical unit interference e Rapid changes in cardiac output e Using an incorrect computation constant Auto Start On Auto Mode 1 Connectthe proper Cardiac Output cable and PA catheter Open the CO Setup Menu and set Auto Start to On From the PA catheter package insert verify the correct computation constant for the catheter type injectate volume and injectate temperature Set the Computation Constant as necessary if it is different than the monitor s factory default of 0 500 Return to
16. Cable or sensor not plugged in Go to the Display Setup Menu choose to display Pleth in the waveform area Check cable and sensor Low amplitude SpO signal SpO sensor on same limb as cuff Patient has poor perfusion Check sensor placement move as necessary Switch limb Notify physician Spectrum Operating Instructions 0070 10 0648 02 Parameter Menus and Monitoring Operations 2 4 5 2 60 Temperature Menu The temperature measurement function of the Spectrum is designed to take a continuous temperature reading from YSI 400 or YSI 700 or compatible probes To display the Temperature Menu turn the Navigator Knob to the Parameters Menu Press the Navigator Knob and rotate down to highlight Temperature Press the Navigator Knob again and the Temperature Menu will appear Temperature Menu Mormal Screen Display Delta Yes Color co Change to Temp Select to return to normal screen FIGURE 2 39 Temperature Menu To display temperature in a parameter tile go to Display Setup Menu and select a tile in which to display temperature Measuring Temperature The Spectrum Monitor has three 3 potential temperature measurement sources the TI connector on the monitor the T2 connector on a Mindray External Parameter Module and a PA catheter T Blood from an EPM or an Edwards Vigilance Monitor Data for up to two 2 of these sources may be simultaneously displayed 1 an
17. Cleaning and Re use of a Nellcor Sensor Sensors may be reattached to the same patient if the emitter and detector windows are clear and the adhesive still adheres to the skin The adhesive can be partially rejuvenated by wiping with an alcohol wipe and allowing the sensor to thoroughly air dry prior to replacement on the patient Do not immerse any Oxisensor OxiMax Durasensor Oxiband or Duraform oxygen transducers the Nellcor RS 10 or Max Fast oxygen transducers or any Nellcor adhesive in water or cleaning solution Clean Durasensor Oxiband and Duraform oxygen transducers and the Nellcor RS 10 or Max Fast oxygen transducers by wiping with a disinfectant such as a solution containing 70 alcohol Do not sterilize by irradiation steam or ethylene oxide Use a new Oxiband adhesive wrap or FORM A adhesive bandage for each patient Do not re sterilize Oxisensor or OxiMax oxygen transducers 0070 10 0648 02 Spectrum Operating Instructions User Maintenance Sterilization and Cleaning of Reusable Bladderless Cuffs 3 5 Sterilization and Cleaning of Reusable Bladderless Cuffs Clean cuffs with warm water and a mild detergent Do not use a detergent containing hand conditioners softeners or fragrances NIBP cuffs can be sterilized with gamma sterilization without effecting the repeated performance of the cuff Steam sterilization is not recommended Use of a washing liquid containing bleach is not reco
18. IB 5 13 22 mhg 002 Insp Et mhg NIBP 137 88 103 mhg 00 Et Insp Interval Off Me0 Et 4 Insp 1 min Agent Et 7 Insp SINUS RHYTHM POSSIBLE LEFT ATRIAL ENLARGEMENT 1M P WAVE IN ViV2 Vent rate 69 BPM RSR GR IN V1 V2 CONSISTENT WITH RIGHT VENTRICULAR PR int 140 ms CONDUCTION DELAY GRS dur 88 ms BORDERLINE ECG GT GTc 396 7 416 ms P QRS T axes 71 71 71 FIGURE 2 68 12 lead ECG Format Spectrum Operating Instructions 0070 10 0648 02 2 113 Printing Optional Operations Average ST Complex To print the Average ST Complex use the Navigator Knob to select Average ST Complex from the Print Setup Menu This function is only available when the View 12 ECG Analysis Module is enabled and ST Analysis is occurring The internal recorder will print the patient s demographic data date time of printout waveform speed and source of the printout in the space prior to the waveform printing The recorder will print the average ST complex waveform for each of the 12 ECG vectors followed by the digital information associated with each waveform qe Name ARTHUR IAN ID 4 233 433 8608 Bed 4 303 Date 2 5 82 Time 10 16 38 Gender Male Date of Birth 1 20 1982 Speed 25 mm s ECG Filter ST Source Average ST Complex 1 cm m
19. NOTE Inflate the cuff only after proper application to the patient s limb Cuff damage can result if the cuff is left unwrapped and then inflated 7 The cuff begins to inflate to the selected cuff pressure After reaching the selected value the cuff begins to slowly deflate and the Spectrum collects oscillometric pulsations 8 If the initial cuff inflation is found to be inadequate the unit retries with a higher inflation pressure 50 mmHg in adult or pediatric mode 40 mmHg in neonate mode 9 The patient should remain still to avoid the introduction of unnecessary motion artifact After the cuff pressure drops below the diastolic pressure the results of the measurement are displayed Spectrum Operating Instructions 0070 10 0648 02 2 49 Parameter Menus and Monitoring Operations 2 4 3 2 2 50 If NIBP is the only parameter being measured with the Spectrum a heart rate can be derived from NIBP The HR Source Menu selection must be in the Auto Mode i e not selected for ECG IBP or with no heart rate alarm limits set If another heart rate source is available the NIBP heart rate will be replaced by the heart rate from the available source If NIBP is a selected trend source then NIBP data will be recorded in the trend with the time stamp of the reading If NIBP is not a selected trend source then NIBP data will be recorded in the trend with the next entry into the trend caused by another trigger i e ALARM
20. cable 2 44 m 8 0012 00 1099 01 PC12 SpO cable 3 66 m 12 0012 00 1099 02 4 2 0070 10 0648 02 Spectrum Operating Instructions Disposable Neonatal NIBP Cuffs Quick Connect DESCRIPTION Neonatal Size 1 limb circumference 3 6 cm Box of 10 PART NUMBERS 0683 13 0001 01 Neonatal Size 2 limb circumference 5 8 cm Box of 10 0683 13 0002 01 Neonatal Size 3 limb circumference 7 10 cm Box of 10 0683 13 0003 01 Neonatal Size 4 limb circumference 9 13 cm Box of 10 0683 13 0004 01 Neonatal Size 5 limb circumference 12 17 cm Box of 10 0683 13 0005 01 Disposable neonatal cuffs require NIBP hose part number 0683 04 0003 1 5 m Spectrum Operating Instructions Optional Accessories DESCRIPTION PART NUMBER Adt Adult single patient adhesive sensors for patients more than 30 0600 00 0043 01 kgs pkg of 20 LNOP Pdt Pediatric slender digit single patient sensors for patients more 0600 00 0044 01 than 10 kgs and less than 50 kgs pkg of 20 LNOP II In L Infant L single patient adhesive sensors for patients more 0600 00 0100 than 3 kgs and less than 10 kgs pkg of 20 Tape Infant L Series Package of 100 0600 00 0108 LNOP Neo Neonatal Y single patient adhesive sensors for patients more 0600 00 0045 01 than 1 kg and less than 10 k
21. After cleaning the ECG cables and leadwires should be wiped with water using a clean damp cloth then dried with a clean dry cloth CAUTION To avoid permanent damage do not expose metal components pins sockets snaps to disinfectants soaps or chemicals NOTE ECG cables and leadwires must never be immersed soaked in any fluids and they should not be cleaned with harsh chemicals such as acetone or non diluted bleach NOTE Do not autoclave radiation or steam sterilize ECG cables or leadwires NOTE Extended exposure to Ethylene Oxide gas may shorten life of the ECG cables and leadwires leading to poor signal quality 3 11 Care and Cleaning of View 12 ECG Analysis Module Clean cables and leadwires using a cloth wipe and warm water Use a dry clean cloth to dry leadwires and cables before placing them on a patient Do not use alcohol to clean the View 12 ECG Analysis Module Alcohol or other harsh chemicals will cause the cables and leadwires to become brittle or harden causing damage NOTE The View 12 ECG Analysis Module must never be immersed or soaked in any fluids Spectrum Operating Instructions 0070 10 0648 02 3 7 Care and Cleaning of View 12 ECG Analysis Module User Maintenance This page intentionally left blank 3 8 0070 10 0648 02 Spectrum Operating Instructions 40 Accessories 4 1 Optional Accessories 4 1 1 NIBP Accessories Hoses Adapters DESCRIPTION PART NUMBERS NIBP Hose 60 1
22. Dose hr 0 01 to 10000 00 If the chosen drug is Vasopressin the Default is 12 00 For all other drugs the Default is 60 00 Select to enter dosage of drug to be infused per hour Dose kg min If the chosen drug is Milrinone 0 005 to 2 000 For all other drugs 0 01 to 10000 00 If the chosen drug is Milrinone the Default is 0 375 For all other drugs the Default is 1 00 Select to enter dosage of drug to be infused per minute based upon patient weight Please verify patient weight Dose kg hr If the chosen drug is Milrinone 0 300 to 120 000 For all other drugs 0 01 to 10000 00 If the chosen drug is Milrinone the Default is 22 500 For all other drugs the Default is 60 00 Select to enter dosage of drug to be infused per hour based upon patient weight Please verify patient weight Infusion Rate This menu item is automatically calculated as previously described in this section using the values entered for other menu items When any one of the menu items marked with an asterisk is changed the others are automatically updated 0070 10 0648 02 Spectrum Operating Instructions Operations Calculations Drug Calculator Menu Structure Continued MENU TITLE ACTIONS ON SCREEN MENU CHOICES DEFAULT COMMENTS Concentration This menu item is automatically calculated as previously described in this section using the values entered for other
23. NOW 2 zll E pers 92 3 3 I 3 gt oo 2 gt 1 o T AT l min 96 Waveform 2 100 6 0 2 20 0 ES 1 28 80 1 Area 1 00 4 F 1 0 0 ME Module Interval 15 min 1 96 Gy NIBP Idle Message Area B Parameter Menus Parameter Areas Battery Indicator Panorama Icon FIGURE 1 3 Display 1 Waveform Area The waveform area is used to display windows which contain parameter waveforms Up to 8 waveforms may be displayed The top window is always set to display the ECG waveform and cannot be changed By default SpO Pleth waveform will appear as the second waveform if connected Respiration or will appear as the third waveform If pressure transducers are plugged into IBP1 and IBP2 the screen will reformat to display additional waveforms and the IBP waveforms will appear as the fourth and fifth waveform The setup can be changed to display any of the available parameters and waveforms 2 Main Menus The Main Menus enable the user to enter patient specific data customize the monitor setup printing or transfer patient data Use the Navigator Knob to access these functions Spectrum Operating Instructions 0070 10 0648 02 1 9 Display General Product Description 3 Parameter Menus The Parameter Menus enable the user to review and customize various parameter display and
24. OPERATING co TIME CONCENTRATION ACCURACY O 20 min 0 38 mmHg 4 mmHg 39 99 mmHg 12 20 min and up 0 38 mmHg 2 mmHg 0070 10 0648 02 Patient Parameter Specifications Appendix OPERATING TIME CONCENTRATION ACCURACY 39 99 mmHg 5 to 39 40 mmHg 0 08 for every 1 mmHg above 40 mmHg AL 760 mmHg Accuracy applies for respiration rates of up to 80 RPM For breath rates above 80 RPM accuracy complies with EN 864 ISO 9918 4 mmHg or 12 of reading whichever is greater for EtCO values exceeding 19 mmHg To achieve the specified accuracy for respiration rates above 60 respirations minute an endotra cheal tube adapter with low dead space must be used in neonatal mode The accuracy specification is maintained to within 4 for the following gas mixtures all values are in Vol ANESTHETIC N20 H20 AGENTS Oto 13 O to 97 5 O to 100 Oto 100 Dry to According to saturated EN864 Above 80 1 mmHg has to be added to the upper tolerance of the accuracy specs Sampling Rate Nominally 50 ml minute 7 5 ml min Respiration Rate Range 0 150 RPM Respiration Rate Accuracy Respiration Rate Oto 4ORPM 411070 RPM 7110 100 RPM 100 to 150 RPM Accuracy RPM 2 RPM 376 5 Auto Zero The Auto Zero process is performed only during measurement mode The MediCO2 PlusMediCO Plus 2001A updates the ambient pressure that is measured during the Auto Zero process The
25. Select to return to normal screen FIGURE 2 8 Functions Menu The Functions Menu provides the following choices Normal Screen Remote View Drug Calculator Hemo Calcs Menu Disable 12 Lead ECG Copy patient data to card and Copy patient data from card The Normal Screen selection returns the view to the normal screen The Remote View selection opens the Remote View Menu shown in FIGURE 2 10 This menu enables the user to view the numeric and waveform data of another patient who is being monitored at a remote location A more detailed description of this function is provided in the next subsection The Drug Calculator selection opens the IV Drug Calculation Menu This menu calculates both the infusion rate and the concentration rate of IV medications The Hemo Calcs Menu selection opens the Hemodynamic Calculations Menu This menu calculates the patient s hemodynamic status The Disable 12 Lead ECG selection toggles between Enable and Disable with regard to the View 12 ECG Analysis Module This selection activates or deactivates access to the 12 lead software This menu selection is only available when the View 12 ECG Analysis Module is installed There are two options for data transfer Copy patient data to card and Copy patient data from card options allow for the transfer of patient specific data from monitor to monitor Spectrum Operating Instructions 0070 10 0648 02 2 15 Main Menus Operations
26. away It takes typically 30 seconds for the sensor to warm up CO Auto zero In Progress The CO sensor is performing an auto zero Wait for the auto zero to complete 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring MESSAGE PROBLEM CO Auto zero Requested REASON An Auto zero was automatically requested by the System SOLUTION Wait for the auto zero to complete CO Failure CO system failure Contact Mindray Technical Support CO Occlusion Sampling pump line is blocked while the CO sidestream pump is on Check sampling line and filter for blockage clear sampling line if possible Replace sampling line if necessary Disconnect and reconnect the FilterLine from the Spectrum in order to clear this message CO Purge The system has detected a blocked Filterline and has attempted to unblock it by temporarily increasing the flow rate Check FilterLine and replace if necessary CO Check Flow Rate The system has detected a high or low flow rate Check FilterLine and replace if necessary Lead Message Increased impedance caused by one of the following Chest hair under electrodes Dried electrode gel Electrode off Lead off Cracked lead wires Poor skin prep Prep chest Change electrodes Replace electrode Replace lead Replace lead wires Clean and
27. it won t work properly On infants you should be able to easily move the cuff over the limb NOTE NIBP cannot be taken under all conditions Even manual methods employing a sphygmomanometer and stethoscope will not work on unstable or active patients NIBP Troubleshooting MESSAGE PROBLEM REASON SOLUTION NIBP Idle Displayed while system is idle Press START to take a single Note This is not displayed measurement Select an while in the interval mode interval and start timed measurements NIBP Deflate Displayed when a measurement Press START to take an that is in process is stopped by immediate measurement and pressing the STOP key resume timed measurements NIBP Interval Displayed during the interval Press STOP to suspend timed between two timed measurements measurements Change timer to OFF to stop timer NIBP Failure The system has detected an Power cycle unit If message unrecoverable failure of the NIBP system reappears contact Mindray Customer Support NIBP Measuring Displayed during a measurement Cuff pressure is also displayed Press STOP to suspend a measurement and deflate the cuff NIBP Retry Pump Higher measurement has been attempted but no reading was possible This results from inadequate cuff inflation Retry will be attempted Check that appropriate patient size is set Preset initial inflation pressure Spectrum Operating Instructions 0070 10 064
28. 0 0136 x ART mean x CO LCWI kg m m Left Cardiac LCW BSA Work Index RCW kg m Right Cardiac Work 0 0136 x PA mean x CO RCWI kg m m Right Cardiac Work Index RCW BSA LVSW gm m Left Ventricular Stroke SV x ART mean PAWP x 0 0136 Work LVSWI gm m m Left Ventricular Stroke Work Index LVSW BSA RVSW gm m Right Ventricular Stroke Work SV x PA mean x 0 0136 RVSWI gm m m Right Ventricular Stroke Work Index RVSW BSA Dubois equation Spectrum Operating Instructions 0070 10 0648 02 Alarms Operations 2 6 2 6 1 Alarms The Spectrum monitor provides a broad range of alarm settings For detailed information see Alarm Limits Settings for alarm delay times are also available Alarm Limits Menu PVC IBP1 Normal Screen Exit HR imin Sys Dia Sys Set Limits Le Cor Lor Corr AutoSet Alarm Setup amp L IL JE Off Off Off Off Off 2 2 heyt Dia Mean Sys Dia Mean Sys Off Off Off Off Off Off gt Off Off Off Off Off Off Select to return to normal screen FIGURE 2 57 Alarm Limits Menu Adjusting Alarms Setting Parameter Alarm Limits 1 access the Alarms Limits Menu press the ALARMS LIMITS key The main Alarm Limits Menu displays 2 Use the Nav
29. 1 3 Keys and Front Panel The front panel keys are used to access many main functions quickly and easily The figure below shows the keys and a brief explanation follows O6 coo ef eoe PRINT oiseLav LEAD start ZERO sme TRENDS N N y ALL IBP x NORMAL Jos y SCREEN MUTE CONT SIZE _ INTERVAL a DISCHARGE C FREEZE mo ffo f PRINT MARK f VIEW STOP y PAWP MUTE TREND EVENT 6650 e amp FIGURE 1 2 Keypad 1 LEAD Press this key to select the next ECG lead to display in Waveform 1 Each time you press this key the next available ECG lead displays 2 SIZE Press this key to select the next available size of ECG for Waveform 1 Each time you press this key the next available ECG size displays When the largest ECG size is displayed the next key press displays the smallest size 3 VIEW Press the VIEW key to see multiple leads of ECG when using the View 12 ECG Analysis Module or the 5 lead ECG cable Press this key to toggle between multi lead view and normal display 4 START Press this key to begin an NIBP measurement or to begin or re start automatic interval measurements 5 INTERVAL Press this key to modify the NIBP interval measurement time The choices are Off Continuous 1 min 2 min 2 5 min 3 min 5 min 10 min 15 min 20 min
30. 2 4 9 2 MESSAGE PROBLEM Damped Invasive Waveform IBP Troubleshooting REASON Air bubbles in tubing Kinked catheter Catheter against wall of blood vessel Blood in tubing Catheter partially occluded with clot SOLUTION Eliminate air from tubing Change position of catheter check patient Check for leaks at connector flush catheter Pump pressure bag up to 300 mmHg Consult physician IBP not Displayed No IBP Waveform Improper Setup Cable not plugged in Transducer not connected Stopcock turned improperly Transducer not zeroed Check display setup in monitor setup Check cable Check transducer connection Check transducer Check and zero the transducer Abnormally High or Low readings Transducer too HIGH or to LOW Check patient adjust transducer rezero Unable to Zero Stopcock not open to atmosphere Cable Transducer not plugged in Check transducer Check cable Spectrum Operating Instructions 0070 10 0648 02 Parameter Menus and Monitoring Operations 2 4 10 2 4 10 1 Pulmonary Artery Wedge Pressure PAWP Pulmonary Artery Wedge Pressure PAWP is a pressure measurement derived from a PA catheter when the PA distal balloon is inflated and the catheter advances and occludes a distal pulmonary artery PAWP pressure is a reflection of the pressure in the left ventricle at end diastole PAWP measurement is available if the Hemod
31. 5 m Female Rectus to Female Rectus 0683 04 0003 NIBP Hose 138 3 5 m Female Rectus to Female Rectus 0683 04 0004 NIBP Hose Neonate 60 1 5 m Female Luer to Female Rectus 0683 04 0005 for use with disposable neonate cuffs Color Coded Reusable Cuffs with Quick Connect fittings DESCRIPTION PART NUMBER Variety Kit I 6 cuffs 1 Small Child 1 Child 1 Small Adult 1 Adult 0020 00 0082 31 1 Large Adult 1 Adult Thigh Variety Kit Il 6 cuffs 1 Small Adult 2 Adult 2 Large Adult 0020 00 0082 33 1 Adult Thigh Variety Kit Ill 6 cuffs 1 Small Child 2 Child 3 Small Adult 0020 00 0082 32 Adult Thigh Brown 45 56 5 cm circumference 0998 00 0003 56 Large Adult Long Burgundy 35 5 46 cm arm circumference 0998 00 0003 58 Large Adult Burgundy 35 5 46 cm arm circumference 0998 00 0003 55 Adult Long Navy Blue 27 5 36 5 cm arm circumference 0998 00 0003 57 Adult Navy Blue 27 5 36 5 cm arm circumference 0998 00 0003 54 Small Adult Light Blue 20 5 28 5 cm arm circumference 0998 00 0003 53 Child Green 13 8 21 5 cm arm circumference 0998 00 0003 52 Small Child Orange 9 14 8 cm arm circumference 0998 00 0003 5 1 Spectrum Operating Instructions 0070 10 0648 02 Optional Accessories Accessories Disposable Cuffs with Quick Connect fittings DESCRIPTION PART NUMBER Adult Thigh White Brown 5 box 45 56 5 cm circumference 0683
32. 8 000 feet ISTA shipping procedure 2A IEC 60068 2 27 peak acceleration 150 m s 15 3 g duration 11 ms pulse shape half sine number of shocks 3 shocks per direction per axis 18 total IEC 60068 2 64 IEC 60068 2 32 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 0070 10 0648 02 Agency Compliance 5 14 5 14 1 5 14 2 5 40 Appendix Agency Compliance Spectrum The Spectrum was designed to comply with the following industry standards EN 60601 1 e UL 60601 1 e CSA Standard C22 2 No 601 1M90 e EN 60601 1 1 IEC 60601 1 1 e EN 60601 1 4 IEC 60601 1 4 EN 60601 2 27 IEC 60601 2 27 EN 60601 2 30 IEC 60601 2 30 EN 60601 2 34 IEC 60601 2 34 EN 60601 2 25 IEC 60601 2 25 EN 60601 2 26 IEC 60601 2 26 EN 60601 2 49 IEC 60601 2 49 The View 12 ECG Analysis Module complies with AAMI EC 11 for Diagnostic Electrocardiographic Devices The Spectrum has been certified by CSA The Spectrum has been tested for functionality following ESU Electrosurgery Unit Interference energy exposure as described in the draft Amendment A1 to I
33. Analysis Module must be installed and enabled Insert the View 12 ECG Analysis Module press the VIEW key to begin the VIEW ALL ECG mode then press the STRIP key The printout will contain patient demographic data date time of printout waveform speed ECG Filter and all patient parameter data prior to the waveform printing The waveform printing will show a 2 V second sample of each of the 12 ECG vector waveforms The printout waveforms represent the 2 Yo seconds prior to pressing the STRIP key The waveforms will then be followed by ECG measurement data and the 12 lead interpretation Please see the Physician s Reference Guide to Computerized ECG Analysis for more information on interpretive printouts 2 112 0070 10 0648 02 Spectrum Operating Instructions Operations Printing Optional 12 lead interpretation data statements will print only if the following conditions are met 1 The Patient Size must be set to Adult 2 The patient s Gender and Date of Birth must be entered 3 The patient must be at least 18 years old Name ARTHUR Date 2 5 82 ECG Filter ST ID 233 433 8608 Time 10 16 02 ST Mode Delta Bed 323 8 Speed 25 mm s 57 05 4 0 mm Gerder lale Source ALL ECG 57 14 42 8 Date of Birth 1 20 1982 Resp ECG ID 16 RPM Sr 1h 32 7 mm 78 BPM Sp02 137 71 94 mhg Temp 85 8 F
34. Arrhythmia detection ST Segment Analysis Cardiac Output Hemodynamic Calculations and Pulmonary Artery Wedge Pressure measurements for which the target populations are adult and pediatric only and Interpretation of Resting 12 Lead ECG and IV Drug Calculations for which the target population is adult only The Spectrum Monitor has the capability of interfacing with Mindray s Intra Aortic Balloon Pumps Central Stations and Gas Module products 0070 10 0648 02 Spectrum Operating Instructions Unpacking Introduction 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 Service Department at 800 288 2121 or 201 995 8237 for prompt assistance in resolving shipping problems Spectrum Operating Instructions 0070 10 0648 02 xv Introduction Symbols and Descriptions SYMBOL DESCRIPTION Attention Consult Accompanying Documents Refer to Manual Dangerous Voltage Equipotentiality Alternating Current AC Direct Current DC On only for a part of the equipment OFF only for a part of the equipment Data Input Data Output Data Input Output Gas Port Input Gas Port Output SYMBOL r Symbols and Descriptions
35. Auto Zero is triggered 1 During the first hour after entering measurement mode periodically for durations of typically 15 seconds at a rate which limits the total time consumed by Auto Zeros to less then 276 of the time in which active measurements are taken Following the first hour after entering measurement mode periodically from or durations of typically 15 seconds at a rate of at most once per hour 2 Ifa change of 8 degree C from the last Auto Zero is detected 3 Ifa pressure change of 20 mmHg relative to the last Auto Zero less than the purge threshold for period of 30 seconds is detected Pump Calibration No routine calibration is required 5 16 0070 10 0648 02 Spectrum Operating Instructions Appendix Patient Parameter Specifications Rise Fall Time lt 190 ms to display 10 to 90 step change with a 5 CO balance air test gas at 10 liters per minute flow through an airway adapter 190 ms to display 90 to 1076 step change with a 5 CO balance air test gas at a 10 liters per minute flow through an airway adapter 5 2 7 2 MiniMediCO Microstream Only in monitors with serial number MS05000 and higher Range 0 99 mmHg Accuracy specification of the measured partial pressure is according to the following table This testing is done according to ISO 21647 clauses 51 101 1 and 51 101 2 PARTIAL PRESSURE ACCURACY 0 38 mmHg 2 mmHg 39 99 mmHg 5 of reading 0 08 for e
36. Description 13 STRIP Press this key to initiate a printout to the selected device Ifthe print destination is the internal recorder then pressing this key will produce a 16 second strip of up to two 2 waveforms Pressing this key during a print job will abort the strip printout e If the print destination is a remote Central Station then pressing this key will initiate a printout at the Central Station Ifthe View 12 ECG Analysis Module is installed and the View All ECG screen is active pressing this key will initiate a 12 lead interpretative report that will be printed at either the internal recorder or a laser printer 14 CONT ECG Press this key to initiate a continuous ECG 1 and 2 waveform printout from the internal printer Press this key again to abort printing 15 PRINT TREND Press this key to initiate printing of the desired trend By default the monitor s stored trend information will be printed by the internal printer Pressing this key during a print job will abort printing If the print destination is a remote Central Station then pressing this key will initiate a trend report at the Central Station 16 STANDBY Press this key to place the Spectrum into a STANDBY mode While in STANDBY mode monitoring is discontinued and the alarms are in permanent suspension interval NIBP measurements are placed in idle mode pump is shut off and the display shuts down When in the STANDBY mode the
37. External With External Parameter Parameter Module Module mounted 11 9 wide 11 9 wide 10 5 high 10 7 high 7 4 deep including knob 7 5 deep including knob Maximum Weight 11 95 lbs without optional accessories 15 52 lbs with 2 Sealed Lead Acid batteries without optional accessories 13 52 lbs with 2 Lithium lon batteries without optional accessories PCMCIA Card Slot PCMCIA Card Slot Functions PCMT PCM2 Extended Trend Patient Data Transfer 12 lead ECG Monitor Configuration Transfer Software Download 12 lead ECG A tool is needed to eject the card from PCM1 Blank PCMCIA cards will fill the unused slots Cooling Fan Control The cooling fan is ON when the unit is powered from an external source AC The cooling fan is OFF when the unit is powered from the internal batteries 0070 10 0648 02 Spectrum Operating Instructions Appendix Monitor Physical Characteristics Normal Operating Noise The Sound Pressure Level SPL produced by the unit during normal operating conditions is 60 dBA at 1 meter when measured in accordance with ISO 3744 Maximum SPL is measured with no alarms sounding but all internal mechanical devices i e pumps fans running Spectrum Operating Instructions 0070 10 0648 02 5 35 Comm Port Physical Characteristics Appendix 5 11 Comm Port Physical Characteristics Maximum Weight 0 5 165 The CS1 MB1 RD1 Comm Port supports the following connections Ethernet Communication la
38. Gas Module Il and SE must be fully warmed up before performing a gas calibration For maximum accuracy a warm up time of 30 minutes is recommended 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 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 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 Spectrum Operating Instructions 0070 10 0648 02 2 69 Parameter Menus and Monitoring Calibration Menu Previous Menu Gas Selection Mixture Start ful Calibration Select to start calibration FIGURE 2 45 Calibration Menu Operations 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 Customer Support 5 The message Feed Calibration Gas will appear 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 a Calibration
39. Guide Multi Language Version 0070 00 0524 50 Mounting Kits and Accessories DESCRIPTIONS PART NUMBERS Rolling Stand with mounting bracket TRANSLBRKT Rolling Stand with quick release plate TRANSQRMTG Wall Mount Kit 0040 00 0287 02 VHM Wall Mount 0040 00 0287 04 Bedrail Mount Kit 0040 00 0293 Quick Release Mounting Plate Kit 0040 00 0299 01 Stationary Mounting Bracket Kit 0040 00 0299 02 Gas Module Mounting Kit 0040 00 0287 03 12 Lead ECG Mounting Kit 0040 00 0352 Spectrum Operating Instructions 0070 10 0648 02 Optional Accessories Accessories 4 1 13 Upgrade Kits DESCRIPTION PART NUMBERS CO Upgrade Kit with Masimo SpO2 0040 00 0353 01 CO Upgrade Kit with Nellcor Oxismart SpO 0040 00 0353 02 CO Upgrade Kit with Nellcor OxiMax SpOo Nell 3 0040 00 0353 03 MiniMedi Upgrade For use in units with serial number prefix MS 0040 00 0353 04 only with Masimo SpO includes installation at Mindray Repair Center MiniMedi Upgrade For use in units with serial number prefix MS 0040 00 0353 05 XXXX A6 and below only with Nellcor OxiSmart SpO includes installation at Mindray Repair Center CO MiniMedi Upgrade For use in units with serial number prefix MS 0040 00 0353 06 XXXX B and above only with Nellcor OxiMax SpO includes installation at Mindray Repair Center IBP Upgrade Kit Add IBP1 and IBP2
40. Instructions 0070 10 0648 02 1 11 Left Side Panel General Product Description 1 6 Left Side Panel ld FIGURE 1 5 Left Side Panel 1 CO Exhaust Connector Optional This connector is used to attach an exhaust line which can be used to connect to a gas scavenging system 2 TI Connector This connector mates with either the YSI series 400 or series 700 temperature probes The monitor automatically detects which probe is connected 3 IBP 1 Connector Optional This connector is used for Channel 1 Pressure Transducer connection 1 12 0070 10 0648 02 Spectrum Operating Instructions General Product Description Left Side Panel 4 IBP 2 Connector Optional This connector is used for the Channel 2 Pressure Transducer connection 5 5 Connector This connector is used to attach the SpO sensor to the monitor either Masimo SETS Nellcor Oxismart or Nellcor OxiMax technology 6 Battery Compartment This compartment houses the two optional user replaceable rechargeable batteries sealed lead acid or lithium ion These batteries provide power to the unit when it is not connected to an AC receptacle The batteries can be independently removed and
41. Instructions 0070 10 0648 02 2 119 Monitor Display Troubleshooting Operations 2 12 2 120 Monitor Display Troubleshooting MESSAGE PROBLEM No trace for a desired parameter REASON Improper attachment of transducer or cable to monitor Faulty transducer or cable SOLUTION Check transducer cable connection Try a new transducer or cable Trace Not Moving FREEZE key may have been pressed Press the FREEZE key to unfreeze the trace Display Appears to be Off Disabled Alarm Tone Mains power switch may not be on Unit may not be plugged into an AC outlet If used as a portable battery pack may be drained 124 card removed without disabling 12 lead MUTE key pressed Beep volume low Check mains power switch on side panel Check power cord Is it plugged in If battery pack is drained plug into an AC outlet to recharge the battery A period of 5 hours is required for a full charge of lithium ion batteries A period of 16 hours is required for a full charge of sealed lead acid batteries Always disable 12 lead card prior to removal Power unit back on Contact Mindray Customer Support Check for alarm mute symbol and message Increase beep volume Cooling Fan Failure Patient Information did not appear on display Incorrect Date or Time The unit running on AC power and the cooling fan is not operational No data entered Done wa
42. Menu Previous Menu Zeroing Zeroing Zeroing Zeroing Date of last successful Calibration 01 Select to return to previous menu FIGURE 2 46 Gos Calibration Menu 0070 10 0648 02 a Calibration Menu Previous Menu Calibration Gas Date of last successful Calibration 01 Select to return to previous menu FIGURE 2 47 Gas Calibration Menu Spectrum Operating Instructions Operations Parameter Menus and Monitoring 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 Previous Menu Gas Selection Abort Accept Date of last success Calibration Menu Mixture Adjusting Adjusting Adjusting Adjusting Calibration 0 Select to Accept the Calibration FIGURE 2 48 Gos Calibration Menu NOTE To avoid premature emptying of the gas canister always remove the regulator at the end of the procedure NOTE For Gas Module Il and SE if any channel cannot be calibrated due to a sampling error the Sampling Error message will appear Selecting the Accept button will NOTE Spectrum Operating Instructions calibrate only those channels that do not have a sampling error If any channel fails calibration the gas value
43. Module 3 are intended for use in the electromagnetic environment specified below The customer or the user of the Gas Module SE or Gas Module 3 should assure that they are used in such an environment EMISSIONS TEST RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE Group 1 Class A Class A Complies The Gas Module SE and Gas Module 3 use 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 The Gas Module SE and Gas Module 3 are suitable for use in all establishments other than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Spectrum Operating Instructions 0070 10 0648 02 45 Electromagnetic Capability TABLE 5 6 Appendix GUIDANCE AND MINDRAY DS USA DECLARATION ELECTROMAGNETIC IMMUNITY The Gas Module SE and Gas Module 3 are intended for use in the electromagnetic environment specified below The customer or the user of the Gas Module SE or Gas Module 3 should assure that they are used in such an environment IMMUNITY TEST Electrostatic discharge ESD IEC 61000 4 2 IEC 60601 TEST LEVEL 6 kV contact 8 kV air COM
44. NIBP Measurements 1 Select a blood pressure cuff that is appropriate for the size of the patient Measure limb for the best results NOTE A cuff that is too narrow for the limb will result in erroneously high readings The correct size of the pressure cuff for a given patient has among other considerations a direct bearing on the accuracy of the obtained NIBP measurements Base selection of the cuff size on the limb circumference of the patient The design dimensions of the cuffs and their intended uses are based on recommendations of the American Heart Association NOTE Cuffs become brittle as they age and sometimes develop permanent folds that can leave temporary marks on the limb Any cuffs that exhibit this effect should be replaced NOTE Ensure that the pressure tubes are not compressed or restricted NOTE The pressure on the limb may not fall to zero between measurements if the cuff is wrapped too tightly Therefore ensure that the cuff is properly applied 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring NOTE The skin is sometimes fragile i e on pediatrics geriatrics etc In these cases a longer interval between measurements should be considered to decrease the number of cuff inflations over a period of time In extreme cases a thin layer of soft roll or cotton padding may be applied to the limb in order to cushion the skin when the cuff is inflated This measu
45. Range Accuracy Excitation Bandwidth Baseline Impedance Range High Impedance Indication Linear Signal Range Noise User Selectable Scales Cardiovascular Artifact Rejection 5 2 3 Patient Parameter Specifications ECG Respiration Performance Requirements Lead Il or Lead II When 12 lead ECG is enabled the Spectrum is capable of acquiring respiration while using a 3 lead or 5 lead ECG cable 4 to 199 breaths per minute 2 or x 2 breaths per minute whichever is greater from 4 to 150 4 from 151 to 199 lt 550 uA RMS max 0 1 Hz to 3 Hz 3 dB for adults 0 2 Hz to 3 Hz 3 dB for pediatric and neonatal patients 200 Q to 2000 Q at patient with 1 k resistor in the ECG cable Greater than 2 2 kQ at patient 8 O p p minimum Less than 0 05 Q at 500 Q patient impedance using a standard ECG cable Function of respiration scale Waveform needs to be greater than 0 1 Q in order for breathes to be accurately detected Detected by algorithm NIBP Performance and Functional Characteristics The NIBP function is capable of providing systolic diastolic and mean blood pressure measurements in Neonate Pediatric and Adult modes non invasively using a blood pressure cuff The NIBP function is in accordance with the requirements of EN 60601 2 30 EN 1060 1 EN 1060 3 and SP 10 Spectrum Operating Instructions 0070 10 0648 02 Patient Parameter Specifications
46. SetUp Serial Port 2 WMTS Enabled Re boot in demo mode Restore factory defaults System Information Options Installation Menu English USA M D Y 12 hour 15 min 15 min No Ibs Ft inches mmHg Vigilance None No No Select to save current settings as defaults FIGURE 2 1 Installation Menu 1 Power up the Spectrum while holding down the DISCHARGE key To enter Installation Mode proceed as follows The Installation Mode is accessed by pressing and holding the DISCHARGE key during power on See the table that follows for descriptions of the Installation Menu choices 2 Set each item as necessary To save all of the chosen settings choose Save current before leaving this menu To return to normal operating mode power the unit Off and On again Spectrum Operating Instructions 0070 10 0648 02 Installation Mode Operations The following table describes the Installation Menu structure MENU TITLE ON SCREEN MENU CHOICES DEFAULT ACTIONS COMMENTS Save current Select to save current settings as defaults Select Language Set up at factory Select to change language Select Country Set up at factory Select to change country Date Format M D Y D M Y Per country Select to change date Y M D format Time Format 12 24 hour Per country Select to change time format NIBP Timeout 15 30 45 60 mins 15 min Select to change N
47. abrade skin before applying electrodes CVA Message Can be caused by shallow breathing or an apnea event Patient HR and respiratory rate identical Check the patient Adjust scales or leads if necessary Check the patient Spectrum Operating Instructions 0070 10 0648 02 Parameter Menus and Monitoring Operations 2 4 7 2 66 Gas Monitoring with Gas Module The Gas Module option allows for the measurement of anesthetic gases N9O and levels Measurement can be acquired via a nasal cannula non intubated for oxygen and CO only or through a sampling line connected to a breathing circuit intubated Gas Menu Normal Screen Select Agent Calibrate Grid Ott 0 Scale 100 0 Color Agent scale 20 Agent Color Zero Gases Select to return to normal screen FIGURE 2 42 Gas Menu NOTE The Spectrum will interface to the Gas Module via the Serial Port Connector on the Comm Port mounted onto the Spectrum WARNING When using the Gas Module the maximum sampling rate at the nasal cannula is 200 ml min 120 ml min for Gas Module 3 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 i
48. amp Arrhythmia Software Option Enable Kit 10 Licenses 0040 00 0300 63 4 12 0070 10 0648 02 Spectrum Operating Instructions Accessories Optional Accessories 4 1 14 Central Station Accessories DESCRIPTION PART NUMBERS Kit Telemetry 2 4 GHz 0040 00 0327 XX Kit Instrument Radio Panorama 608 MHz 0040 00 0361 01 4 1 15 External Parameter Module Accessories DESCRIPTION PART NUMBERS External Parameter Module with Temperature 0998 00 0501 04X External Parameter Module with Temperature and Cardiac Output 0998 00 0501 03X External Parameter Module with Temperature and IBP 0998 00 0501 02X External Parameter Module with Temperature Cardiac Output and IBP 0998 00 0501 01X Cable Cardiac Output Y two Temperature connections 0012 00 1447 01 Cable Cardiac Output Edwards LifeSciences in line injectate adapter 0012 00 1520 Cable Cardiac Output Edwards LifeSciences Bath probe adapter 0012 00 1519 Cable Cardiac Output Becton Dickinson in line injectate adapter 0012 00 1532 Cable Cardiac Output Abbott Labs in line injectate adapter 0012 00 1533 NOTE Please replace X with one of the following letters to designate language required A English P Spanish T Italian D Dutch F French G German N Danish Spectrum Operating Instructions 0070 10 0648 02 4 13 Optional Accessories Accessories This page intentionally left blank 4 14 0070 10 0648 02 Spectrum Operating Instructions so Ap
49. blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz At an amplitude of 1 to 2 cm and non repetitive motion between 1 to 5 Hz At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 to 100 SpO against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population The Masimo SET MS 3 pulse oximeter with LNOP Neo and Neo Pt sensors has been validated for neonatal motion accuracy in human blood studies on neonates while moving the neonate s foot at 2 to 4 Hz at an amplitude of 1 to 2 cm against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 6876 of the population The Masimo SET MS 3 pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo s simulator with signal strengths of greater then 0 02 and a transmission of greater than 5 for saturation s ranging from 70 to 100 This variation equals plus or minus one standard deviation Plus or minus on standard deviation encompasses 6876 of the population The LNOP ear sensors have an SPO accuracy of 70 to 100 3 576 for adults during motion conditions however since the monitor cannot display 2 digits the ac
50. displays The Graph Trend data window contains up to 4 parameter displays Use the vertical Scroll feature to view other parameters NOTE When scrolling vertically the topmost parameter remains displayed and does not scroll Time stamps are included at the top of the window with the most recent data appearing at the right end Use the horizontal Seroll feature to move the cursor though time Scroll bars along the right and bottom sides of the Graph Trend display indicate the position of viewed data in relation to the rest of the database The Event feature may be used to scroll quickly between events caused by Alarm entries and MARK EVENT keypresses The Rescale Waves feature automatically rescales the viewed parameters graphs so all data is displayed The Zoom feature may be used to adjust the amount of time shown in the trend window The top line of the Graph Trend display contains markers which indicate if the entry was triggered by an alarm violation or by pressing the MARK EVENT key These markers are red for priority 1 alarms yellow for priority 2 alarms and green if initiated by pressing the MARK EVENT key Spectrum Operating Instructions 0070 10 0648 02 2 105 Trends 2 106 Operations As the cursor is scrolled horizontally the digital data corresponding to the points in the graph is shown at the right side of the window Trend data in violation of an alarm is highlighted according to the priority of the alar
51. each other No ECG Waveform Gain set too low Lead wires and patient cable not fully or properly inserted Cable or lead wires damaged Readjust as required Set via the SIZE key Check for proper insertion Check with lead continuity tester Base Line Wander Patient moving excessively Patient s respiration Electrodes dry or loose Static build up around patient ECG Filter set to ST or Extended mode Secure lead wires and cable to patient Reposition electrodes Re prep skin and apply fresh moist electrodes Check with local biomedical personnel Set ECG Filter to Monitor mode Artifact Message The 12 lead ECG is detecting muscle artifact or electrical interference from auxiliary devices Check leads follow skin preparation procedure Check for electrical interferences replace wires as necessary Spectrum Operating Instructions 0070 10 0648 02 2 47 Parameter Menus and Monitoring 2 4 3 2 4 3 1 2 48 Non Invasive Blood Pressure Measurements NIBP Operations In the Spectrum Non Invasive Blood Pressure monitoring utilizes the oscillometric method of measurement The NIBP measurement includes Systolic Sys Diastolic Dia and Mean Blood Pressure NIBP Menu Normal Screen Set Start Pressure 180 Interval Off Color Select to return to normal screen FIGURE 2 36 NIBP Menu Manual
52. medium for moistness If the gel medium is not moist do not use the electrode patch Dry electrode patches are not conductive NOTE If using the snap type electrode wires attach the electrode patch to the lead wire before placing patch on the patient 2 Attach the electrode patch to the skin at the prepared site Smooth the electrode patch down in a circular motion to ensure proper skin contact If using soft gel electrodes never push down directly over the contact gel medium as this may displace the gel and cause monitoring artifact If using hard gel electrodes it is recommended that during application the center of the electrode should be slightly pressed onto the skin to ensure direct contact Consult the electrode patch manvfacturer s instructions for specific use 3 Secure the lead wires to the patient according to hospital practice For additional information see section 2 4 2 3 Lead Placement WARNING Ensure that the ECG lead wires are neatly secured in a manner that will prevent them from encircling the patient s neck creating a strangulation hazard Spectrum Operating Instructions 0070 10 0648 02 2 25 Parameter Menus and Monitoring Operations NOTE It is recommended that electrode patches be changed at least every 24 36 hours to maintain proper contact with the skin Some patients may require electrodes to be changed more often Electrode patches are disposable and should be applied only once Try to avoid re
53. message STANDBY TO BEGIN MONITORING PRESS STANDBY is displayed Press the STANDBY key again to exit the STANDBY mode and return to the normal screen NOTE Trend data is not cleared in the STANDBY mode When the STANDBY mode is released NIBP INTERVAL is in IDLE MODE and requires reactivation via the START key The CO pump automatically reactivates if the Microstream sensor is in place 0070 10 0648 02 Spectrum Operating Instructions General Product Description Keys and Front Panel 17 DISCHARGE Press this key to initiate the process of discharging the patient from the monitor A menu titled Patient Discharge will be displayed Depending on the monitor s configuration the Normal Screen menu choice will be provided along with one or more of the following selections Discharge From Monitor Discharge From Central and Discharge From Both If any discharge option is selected a confirmation box will be displayed Discharging a patient from the monitor deletes all patient trend and demographic data and places the monitor in STANDBY mode An onscreen message will display as follows e For Main Module Software Versions H xx and earlier the message STANDBY TO BEGIN MONITORING PRESS STANDBY is displayed e For Main Module Software Versions J xx and later the message PATIENT DISCHARGED MONITOR IN STANDBY MODE TO BEGIN MONITORING PRESS STANDBY is displayed Upon exiting STANDBY mode the monitor configuration reverts to currently
54. monitors have not been correctly set Clearing Trend Data To manually clear all trend data including Graph and OxyCRG trends choose Clear Trends from the menu A confirmation prompt will appear Once cleared the data cannot be restored All trend data is automatically cleared when the patient is discharged from the monitor All trend data is also cleared if the monitor s displayed time or date is changed Removing the List Trend Display The List Trend display does not automatically time out and must be manually removed to return to the normal waveform display To remove the List Trend display choose Normal Screen from the menu or press the NORMAL SCREEN key 0070 10 0648 02 Spectrum Operating Instructions Operations Trends 2 7 2 Graph Trends The Graph Trend display allows the user to view a graphic summary of stored patient vital signs and anesthetic gas data To access this display from the normal monitoring screen press the TRENDS key twice To access this display from the List Trends display press the TRENDS key once This display may also be accessed from other trend displays via menu selection Graph Trend Normal Screen Scroll Scroll Event Zoom Rescale Waves Clear Trends List Trend OxyCRG Setup t Event 5 li FIGURE 2 60 Graph Trends The left side of the Graph Trend display contains menu items for scrolling setup and access to other
55. must be set to Wired when using a hardwire Spectrum Enable Network must be set to Wireless for communication between the Spectrum and the Panorama via the 2 4 GHz wireless Symbol radio card WMTS Enabled must be set to Yes to allow for communication between the Spectrum and the Panorama via the Panorama Instrument Radio 608 Refer to the Panorama Operating Instructions Manual for a list of supported parameters The Spectrum is capable of transmitting a discharge command to a Panorama Central Station It is also capable of bi directional transmission of patient demographics and patient alarm settings with a Panorama Central Station When the Panorama Central is selected for operation the Patient Discharge menu selections will vary as follows For Main Module Software Versions H xx and earlier Discharge From Central and Discharge From Both will be displayed For Main Module Software Versions J xx and later Discharge From Both will be displayed When Discharge From Central or Discharge From Both are selected from the Patient Discharge menu the Panorama will discharge the patient If Trend is cleared or the patient is discharged at the Spectrum the Spectrum time and date will be synchronized with the Panorama Central Station time and date NOTE If the Edwards Vigilance Monitor is the source for CO CCO CCI SvO T Blood and AT measurements this data
56. 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 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 location A list of international offices along with their phone numbers is provided at the end of this manual NOTE Upon request Mindray 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 equipment which are designated by Mindray as repairable 12 1 Mindray s Responsibility Mindray 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 and b the electrical installation of the relevant room complies with the appropriate requirements and the equipment is used in accordance with the instructions for use Spectru
57. of ECG press the VIEW key Press the VIEW key once to view the first 6 ECG leads press again to view another 6 leads Pressing a third time will return to normal viewing View ECG Setup Menu Previous Menu Page 1 View ECG Size 1 emjimv Restore defaults Select to return to previous menu FIGURE 2 35 View ECG Setup Menu Select desired leads to view in the View ECG Setup Menu within the Monitor Setup Menu To change size of displayed waveforms go to the ECG Sizes Menu within the ECG Menu To remove the View 12 ECG Analysis Module turn monitor off or go to the Functions Menu and select Disable 12 lead ECG then use the Navigator Knob to select Yes or remove when power is off CAUTION Removal of the View 12 ECG Analysis Module without first disabling the 12 lead ECG card may cause a temporary disruption in patient monitoring Spectrum Operating Instructions 0070 10 0648 02 2 45 Parameter Menus and Monitoring Operations 2 4 2 9 1 12 lead Interpretation With a View 12 ECG Analysis Module installed and enabled the Spectrum is capable of providing 12 lead interpretive printouts to either the internal thermal printer or an attached laser printer To print this analysis press the VIEW key to view multiple ECG leads then press the STRIP key If all conditions for analysis have been met the recorder will include the results on the printout The analysis will consist of an interpretive
58. of list trend data and demographics data to and from the Spectrum using a PCMCIA card inserted into PCM2 is provided while in monitoring mode Only trended data for those parameters that are common between the monitors will be transferred The Transfer PCMCIA card has the ability to be write protected 0070 10 0648 02 Spectrum Operating Instructions Appendix 5 9 Printing Printing Integrated Thermal Printer The integrated printer is a maximum 2 trace thermal strip chart printer with integral paper spool The printer uses plain white thermal paper 5 cm wide The printer supports 5 paper speeds 3 125 6 25 12 5 25 50 mm sec each within 5 The printer sensitivity is 5 on a single trace and 50 if scale for dual trace 5 External Laser Printer The Spectrum has the ability to print 12 lead data to an external Hewlett Packard 4100N laser printer via a wired Ethernet connection The laser printer will print on 8 5 x 11 pre grided paper Spectrum Operating Instructions 0070 10 0648 02 5 33 Monitor Physical Characteristics Appendix 5 10 5 34 Monitor Physical Characteristics Mounting The monitor has the capability to be carried as a portable unit placed on a tabletop or mounted to a wall mount rolling stand bed rail or Gas Module or SE The monitor is capable of having a PatientNet instrument transmitter and an External Parameter Module mounted to it Maximum Size Without
59. on the monitoring device configuration licenses available parameters selected and patient configuration of the Spectrum Monitor Patents This device is covered under one or more of the following U S Patents 4 621 643 4 653 498 4 700 708 4 770 179 4 869 254 4 911 167 4 928 692 4 934 372 5 078 136 5 368 224 5 482 036 5 490 505 5 632 272 5 685 299 5 758 644 5 769 785 6 002 952 6 036 642 6 067 462 6 157 850 6 206 830 6 247 674 6 377 845 4 802 486 4 960 126 5 485 847 5 743 263 5 865 736 6 035 223 6 298 252 6 463 310 6 591 123 6 675 031 6 708 049 6 801 797 6 589 028 6 896 713 Re 35 122 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 Precautions and Notes Please read and adhere to all warnings precautions 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 s
60. process for ST measurements or Arrhythmia analysis The ST Menu selection opens the ST Menu The ECG Sizes Menu selection opens the ECG Sizes Menu The ECG Setup selection opens the ECG Setup Menu that is detailed in the following table The Resp Menu selection opens the Resp Menu ECG Setup Menu MENU ITEM SELECTIONS FACTORY DEFAULT COMMENTS Previous Menu Returns to the previous menu Filter Monitor Extended Select to change the filter mode for ECG Extended or ST ST must be used for ST analysis The filter setting affects both the display output and the printer output Monitor 0 5 40 Hz Extended 3 or 5 lead 0 05 100 Hz Extended 12 lead 0 05 150 Hz ST 0 05 40 Hz HR Source Auto ECG lt IBP1 Dependent on current settings the IBP Label Label lt IBP2 selections may remain as numbered or may be Label gt lt IBP3 substituted with one of the following Art PA CVP Label lt IBP4 ICP RA UA LV LA IABP Label SpO Pacer Reject On Off When set to On pacers are eliminated from the display Pacer On Off When set to On all detected pacemaker spikes are Enhancement displayed Notch Filter Off 50 Hz 60 Hz This menu item is used to filter out AC line noise from the ECG waveform The Off selection is not saved with the Save Current function and will be reset when the monitor is power cycled ESU Filter Auto Disable This menu item is used to filter o
61. reading Electrode sites should be clean and dry and should provide a smooth flat surface Incidental electrical activity and inaccurate readings may arise from incorrect skin preparation The following procedure is recommended for secure electrode patch application 1 Shave the chest hair from the electrode sites in a circular area with a diameter of 2 4 inches 2 Use a dry gauze pad to remove excess skin oils skin cells and residue from the electrode sites Never rub the skin until it is raw or bleeding NOTE Prepare the electrode site with alcohol only if the skin is extremely greasy If alcohol is used as a drying agent always allow the skin to dry before placing the electrode patch on the skin 2 4 2 2 Electrode Patch Location NOTE Store electrode patches at room temperature and open just prior to use NOTE Avoid more than one type of electrode on a patient because of variations in electrical resistance NOTE Avoid placing electrode patches directly over bone prominences or over any high activity movement areas such as shoulders or arms because muscle motion produces electrical activity If an electrode patch is placed over a large muscle such as the pectorals the monitor may detect this additional muscle activity and could lead to false arrhythmia calls 1 To prevent evaporation of the contact gel medium peel the backing off of the electrode patch only when it is ready for use Visually inspect the contact gel
62. replaced while the unit is Operating 7 NIBP Rectus Connector This connector is used to attach the NIBP hose to the unit 8 ECG Connector This connector is used to attach a 3 or 5 lead ECG cable 9 Input Connector Optional This connector is used to attach a Microstream FilterLine to the unit Spectrum Operating Instructions 0070 10 0648 02 1 13 Right Side Panel General Product Description 1 7 Right Side Panel FIGURE 1 6 Right Side Panel 1 PCMI and PCM2 Card Slots These sockets are used for extended trend memory software download to the CPU patient data transfer monitor set up transfers View 12 ECG Analysis Module and Panorama Instrument Radio 2 4 2 Power Switch momentary switch that turns power ON or OFF but does not prevent charging of the batteries Press the top of the switch once to turn the unit ON Press the top of the switch again to turn the unit OFF 3 DEFIB Connector Used to connect a defibrillator sync cable 1 14 0070 10 0648 02 Spectrum Operating Instructions General Product Description Right Side Panel 4 IABP Connector Used for triggering an Intra Aortic Balloon Pump from the Spectrum when using a 3 lead or 5 lead ECG cable 5 Recorder Optional A two trace thermal strip chart recorder with integral paper spool Spectrum Operating Instructions 0070 10 0648 02 1 15 Gas Module Optional 1 8 1 8 1 Ge
63. saved settings Selecting Normal Screen from the menu aborts the discharge 18 MARK EVENT Press this key to cause a time stamp event marker to be noted in the trend memory If connected to a Panorama Central Station a time stamp event marker will also be noted in the Central Station s trend memory 19 TRENDS Press this key to display the List Trend screen Press this key a second time to display the Graph Trend screen Press this key a third time to return to the normal display If Neonate or Pediatric is selected as the patient size a third press will display the OxyCRG Trend screen When OxyCRG trend is available a fourth press will return the monitor to normal display 20 FREEZE Press this key to freeze the waveform display When waves are frozen the message Waves Frozen is displayed Digital data will continue to be updated 21 NORMAL SCREEN Press this key at any time to return the screen to the normal monitoring mode All menus are closed 22 Navigator Knob Rotate this knob to highlight the various menus on the display Press the center of the knob to display the highlighted menu Once a menu is displayed rotate the knob to highlight the menu items listed Press the center of the knob to select a highlighted item 23 Warning LED LED used to indicate that an alarm has been tripped The WARNING or Priority 1 LED is red Spectrum Operating Instructions 0070 10 0648 02 1 7 Keys and Front Panel General
64. selected for monitoring should have an amplitude of 0 5 to 1 mV or more Learning The process of learning is used to establish a normal beat template for a patient The learn period is dependent on the heart rate and the dominant pattern Learning should not be initiated during a primarily ventricular rhythm because an ectopic beat may be established as normal A learn should be initiated when beats are not being properly detected or when they are being erroneously classified However if a signal is not strong enough or lead data is extremely noisy better signal quality must be established before a learn can be effective Beat Detection and Typing The following table describes the leads that are used to measure beot detection and beat typing DESCRIPTION 3 WIRE LEAD SET 5 WIRE LEAD SET VIEW 12 CARD Leads used for Determined by viewed lead V V1 and V5 Beat Detection Leads used for Determined by viewed lead V and V1 V5 and Il Beat Typing Leads used for Determined by viewed lead V V1 and V5 V Fib Detection The search for the next beat begins after a refractory period to avoid detecting T waves as valid QRS complexes For all patient sizes the minimum QRS amplitude that can be detected is between 0 15 and 0 45 mV depending on the width of the QRS complexes Spectrum Operating Instructions 0070 10 0648 02 2 35 Parameter Menus and Monitoring Operations 2 4 2 5 2 4 2 5 Beat typ
65. selected from the ST ECG or Arrhythmia Menus A Relearn is recommended after one or more of the following ECG electrodes have been repositioned Eight hours have passed since the last Relearn After significant changes to the patient QRS complex The observed ST measurement mode has been changed Delta or Absolute 12 lead only A clinician has observed clinically questionable arrhythmia calls A Relearn must be initiated if Learning occurred during a Leads Off condition 2 44 0070 10 0648 02 Spectrum Operating Instructions Operations Operations Parameter Menus and Monitoring 2 4 2 9 12 lead ECG Optional This feature is added to the Spectrum by inserting the View 12 ECG Analysis Module into one of the two 2 PCM slots on the right side of the monitor WARNING The View 12 ECG Analysis Module is not intended for use during electrosurgery If the electrosurgical ground connection is not satisfactory there exists a possibility of patient burns at the ECG electrode sites 1 Prep patient s skin prior to placement of electrodes See proper electrode placement and skin prep instructions 2 Insert View 12 ECG Analysis Module with cable attached into a PCM slot on the right side of the Spectrum The monitor will automatically initialize 3 If 12 lead function is disabled access the Functions Menu and select Enable 12 lead ECG using the Navigator Knob 4 To view multiple leads
66. start zeroing the system again If problem persists contact Mindray Customer Support 2 72 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring MESSAGE PROBLEM GM Zero Error REASON Appears when the system has been unable to successfully zero the sensor SOLUTION Manually start zeroing the system again If problem persists contact Mindray Customer Support GM N5O Zero Error Appears when the system has been unable to successfully zero the N2O sensor Manually start zeroing the system again If problem persists contact Mindray Customer 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 Customer 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 Customer Support 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 admi
67. statement a condition statement and a rhythm statement as specified in the Physician s Guide to Computerized ECG Analysis The conditions for printing the ECG analysis are 1 The Spectrum patient size must be set to Adult 2 The patient s Gender and Date of Birth must be entered via the Patient Menu 3 The patient must be at least 18 years old The monitor calculates the patient age from the date of birth entered WARNING Computerized ECG Analysis should be reviewed by qualified medical personnel It should not be used exclusively for treatment or non treatment of patients WARNING ST segment measurements may be affected by one or more of the following ECG rhythm morphologies wide complex QRS such as bundle branch blocks ventricular pacemaker rhythm left ventricular hypertrophy or Wolff Parkinson White Syndrome Consult with qualified medical personnel prior to treatment or non treatment 2 4 2 10 Troubleshooting MESSAGE PROBLEM REASON SOLUTION Noisy ECG traces Loose or dry electrodes Apply fresh moist electrodes Defective electrode wires Replace wires as necessary Patient cable or leads are Eliminate 60Hz interference routed too close to other electrical devices Excessive Electro surgical Wrong ECG cable used Use ESIS ECG cable with Interference internal filter block NOTE Respiration monitoring via the ECG electrodes will not be available when using the cable Muscle Noise Inadequate sk
68. sunlight In the event that you are unable to get a reading or the reading you get is inaccurate consider the following f your patient is poorly perfused try applying the sensor to another site such as a different finger or toe Check that the sensor is properly aligned In electrosurgery make sure sensor is not too close to ESU devices or cables Check to make sure the site area is clean non greasy Clean site and sensor if needed MESSAGE PROBLEM SpO No Sensor SpO s Sensor Off Masimo SET Only SpO Interference REASON Sensor is not plugged in to the Spectrum Sensor may not be connected to the patient Noise detected on the pulse signal prevents pulse discrimination SOLUTION Plug the sensor into the monitor Check patient connection Decrease patient motion check sensor SpO Pulse Search SpO No Pulse Nellcor Only Hardware settings are being adjusted in order to discriminate a pulse waveform No detectable pulse is measured Change to site where pulse is stronger if patient is vasoconstricted Change or readjust sensor if loose Check to patient connection and patient status SpOz Failure The system has detected an unrecoverable failure of the 5 system Power cycle unit If message reappears contact Mindray Customer Support SpOo Low Perfusion Masimo SET Only Patient perfusion is low Check to patient connection and p
69. the Cardiac Output Menu 2 When a stable baseline blood temperature is obtained the Inject when Ready message will be displayed Proceed with a bolus injection CAUTION Sudden changes in blood temperature such as those caused by bolus drug administration may cause a CO or CI value to be computed To avoid falsely triggered curves inject as soon as possible after the Inject when Ready message is displayed 3 Oncea bolus is injected the CO curve appears the Measuring message is displayed and the resultant CO measurement is displayed NOTE If a measurement is compromised as indicated by an Irregular Curve or Injectate Temp Error alert message the curve will be displayed in Red and an X mark will be displayed in the box Spectrum Operating Instructions 0070 10 0648 02 2 83 Parameter Menus and Monitoring Operations Note the injectate temperature and verify that the correct computation constant was set Subsequent cardiac output runs can be performed as desired when the Inject when Ready message reappears When sufficient CO runs are completed use Edit CO Runs to choose the runs to be computed in the CO Average Runs that have green waveform data and a check mark in the box will be included in the average Runs that have red waveform data and an X mark X in the box will be excluded from the average Select the Accept Average key to accept and store the CO Average To display Cardiac Index the patient weight
70. the Spectrum Clear Trends is chosen from the List Trend or Graph Trend menus the patient is discharged Transferring Monitor Default Settings When installing several Spectrum monitors with identical display and alarm settings it is not necessary to set each unit separately A Transfer Card may be used to copy the settings from monitor to monitor 1 Insert the Transfer Card into the PCM2 slot on the right side of the source monitor 2 Enter the Installation Menu Press and hold the DISCHARGE key during power up Select Copy Monitor defaults to card from the menu A status message will report completion of the transfer 3 Remove the card and insert it into the PCM2 slot of the receiving monitor 4 Enter Installation Mode on the receiving monitor Press and hold the DISCHARGE key during power up and select Copy monitor defaults from card A status message will report completion of the transfer 5 Select Save Current and power cycle the receiving monitor to enter normal monitoring mode 0070 10 0648 02 Spectrum Operating Instructions Operations Installation Mode 2 2 2 2 1 Installation Mode Installation Menu Save current Select Language Select Country Date Format Time Format NIBP Timeout CO amp PAWP Timeout Enable EPM Temperature units Weight Units Height Units CO Units Copy monitor defaults to card Copy monitor defaults from card SetUp Serial Port 1
71. to either On or Off In Auto Start Mode when Auto Start is set to On the monitor automatically displays the prompt Inject when Ready upon achieving a baseline blood temperature When injection is completed the Spectrum computes the CO and is ready to start another bolus injection In Manual Mode when Auto Start is set to Off the monitor will display the message Ready when a baseline blood temperature is achieved Manual mode of operation is similar to Auto Start except that you must press Start CO Run or the C O key on the Monitor or Module prior to each injection NOTE Refer to the catheter package insert provided with each PA catheter for the appropriate computation constant specific instructions on catheter placement and use warnings cautions and specifications WARNING Do not use a damaged or broken unit or accessory Computation Constant Computation Constant is used to change the monitor s factory default of 0 500 with the appropriate computation constant from the PA catheter package insert CO Time CO Time is used to adjust the time period for the current CO Run window shown in the top of the Cardiac Output Menu Choices are 30 sec and 60 sec CO Scale CO Scale is used to adjust the temperature scale for the current CO Run window shown in the top of the Cardiac Output Menu Choices are 0 5 C 1 C 2 C and 4 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring
72. via the Alarm Limits Setup menu The following alarm calls can be made when Arrhythmia Analysis is set to All On default setting Asystole Ventricular Tachycardia Ventricular Fibrillation Ventricular Rhythm Run PVC Min Couplet Bigeminy and Trigeminy For 3 lead or 5 lead ECG the following additional calls can be made Irregular HR and Bradycardia 2 40 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring For 12 lead ECG the following additional call will be made Pause The following alarm calls will be made when Arrhythmia analysis is set to Non lethals Off Asystole Ventricular Tachycardia and Ventricular Fibrillation When Arrhythmia analysis is set to All Off no arrhythmia alarm calls will be made The Spectrum initiates the Learning process for Arrhythmia measurements after one of the following Unit Power Up Return to normal monitoring from Standby mode Enabling Arrhythmia analysis The lead has been changed in ECG 1 waveform 3 lead only Patient Size is changed Whenever the Relearn function is selected from the ST ECG or Arrhythmia Menus It is recommended that a Relearn be initiated after one or more of the following The ECG electrodes have been repositioned e Sufficient time has passed since the last Relearn Any significant changes to the patient QRS complex Any significant changes to the patient ECG r
73. waveforms that are displayed are user selectable through the Remote View Setup Menu as described in the table on page 2 19 Corresponding numeric tiles are displayed to the right of the waveforms The numeric data for a maximum of fifteen 15 parameters that are not related to the waveforms is displayed in the Numeric Data Area located directly below the waveforms The following is a hierarchical listing of the parameters as they will display if they are not assigned to numeric tiles e HR and PVC min e SpO and PR IBP2 IBP3 IBP4 e CPP e PAWP e NIBP e Resp e CO e 5 e STI 572 e 513 O e N20 e Agent e T1 2 TBlood AT e CO e CI NOTE Respiration alarm text messages are also displayed in the Numeric Data Area as follows f Apnea is detected the message APNEA is displayed e If CVA is detected the message CVA is displayed e f high impedance is detected from the ECG electrodes the message CHK LEAD is displayed The colors of the waveforms and all numeric data correspond to the settings of the host monitor not the remote monitor When numeric data for a particular parameter is unavailable dashes are displayed f a high or low alarm limit has not been set an Alarm Off icon is displayed Remote View alarms follow the alarm settings at the remote monitor displaying in a priority appropriate reverse video color If the remote monitor
74. ways by choosing CO from the Parameters Menu by pressing the C O key on the front panel keypad by pressing the C O key on the EPM keypad 8 Open CO Setup Menu by choosing CO Setup Menu from the Cardiac Output Menu EPM CO Refer to the CO Setup Menu section Vigilance CO a Choose CO Source from the CO Setup Menu select Vigilance and then close the CO Setup Menu b Open the Vigilance CO Menu by choosing CO from the Parameters Menu or by pressing the C O key on the front panel keypad NOTE The key on the EPM keypad does not function when the Spectrum is configured to monitor Vigilance cardiac output measurements c Referto the Vigilance CO Menu section 2 4 11 2 2 Spectrum Operating Instructions 0070 10 0648 02 2 89 Calculations 2 5 2 5 1 2 90 Operations Calculations The Spectrum supports two types of calculation packages Drug IV Medications and Hemodynamics Calculations are accessible through the Functions Menu Drug Calculations The Spectrum has the ability to calculate and display IV drug infusion rate and concentration based upon patient weight and or drug dosage Drug calculations may also be accessed through the Patient Menu Drug calculations are only available if the Patient Size is set to Adult Drug Calculation Formulas For Drug Concentration the Spectrum uses the following formula Drug Amount Concentration Solution Volume For weight based Drug Infusion Rat
75. will not be available at the Panorama Central Station NOTE a Spectrum 608 radio is communicating with a Panorama Central Station Gas Module data and alarms V2 V6 waveform data and ST templates are not displayed at the Central Station 0070 10 0648 02 Spectrum Operating Instructions Operations Connection to Panorama Gateway 2 11 Connection to Panorama Gateway The Spectrum can communicate with an EMR system through a Panorama Gateway via a hardwired network connection to a Comm Port with a CS1 port or via wireless connection through a Panorama Central Monitoring System The Enable Network option in the Spectrum System Information menu must be set to Wired when using a hardwire Spectrum Enable Network must be set to Wireless to allow for wireless communication through a Panorama Central Station via the 2 4 GHz wireless Symbol radio card WMTS Enabled must be set to Yes to allow for wireless communication through a Panorama Central Station via the Panorama Instrument Radio 608 For the Spectrum to be recognized by the EMR system certain demographics content referred to as the Patient Key must be entered from its Patient Menu Each facility has its own unique Patient Key that must be entered before making a connection to the EMR The Patient Key consists of the required ID and optionally one or more of the following Patient Menu demographics fields First name Last name e Bed
76. year choices for Date of Birth To enter the patient s Date of Birth turn the Navigator Knob and scroll until you reach the desired dates When finished with the Date of Birth press the Navigator Knob to return to the Patient Menu 0070 10 0648 02 2 9 Main Menus 2 3 2 Monitor Setup Menu Operations Monitor Setup Menu Normal Screen Save current Display Setup View ECG Setup Rescale Waves Alarm Volume mm T Beep Volume mm 7 ECG Speed 25 mmis IBP Speed 25 mmjs Resp Gas Speed 12 5 mm s Advanced Setup Ls Select to return to normal screen FIGURE 2 4 Monitor Setup Menu Monitor Setup Menu MENU ITEM Normal Screen SELECTIONS Advanced Setup Menu Previous Menu Set Date 16 2004 Set Time 19 43 Trend Interval Off NIBP Trend On Alarm Trend Off Nurse Call Off Arrhythmia Menu NIBP Start Mode Interval Mode Apnea Latch n Select to return to previous menu ae FIGURE 2 5 Advanced Setup Menu FACTORY DEFAULT COMMENTS Select to return to normal screen Save Current A confirmation prompt appears Select Yes to save the current settings as the monitor defaults Display Setup Open an additional menu that enables changing the positions of the parameters and waveforms View ECG Setup Open an additional menu that enables changing the ECG leads that are displayed when the VIEW key is pre
77. 0 Hz 0 05 to 150 Hz 0 05 to 40 Hz 3 5 lead ECG 0 55 to 35 Hz 0 05 to 90 Hz 0 05 to 35 Hz analog output HP compatible cable Electrical Surgical Unit ESU Use Protection 3 and 5 lead ECG meets IEC 60601 2 25 clause 36 202 7 for functionality following ESU energy exposure The system is capable of withstanding ESU stress with no permanent damage and regain normal function within 10 seconds after removal of the disturbance The 12 lead ECG function does not provide ESU protection or suppression Withstand 3 and 5 lead ECG can withstand ESU stress from a High Frequency Surgical Unit operating at 300 Watts in cut mode and 100 Watts on coagulate mode The 12 lead ECG function does not provide ESU protection or suppression Noise Suppression 3 and 5 lead ECG peak noise is less than 2 mV from ECG baseline when used with AAMI compatible cables Noise level is unspecified when the monitor is used with HP compatible cables The 12 lead ECG function does not provide ESU protection or suppression Noise Detection An ESU noise declaration will be asserted if signals detected as pacers are detected at a rate greater than 50 Hz No noise declaration will be asserted if pacerJike signals are detected at rate less than 10 Hz The 12 lead ECG function does not provide ESU protection or suppression 5 4 0070 10 0648 02 Spectrum Operating Instructions Appendix ECG Filters ESU Interference Filtering 50 60 Hz Notch Filt
78. 0 Respiration Menu 2 4 6 1 Thoracic Impedance The Spectrum Monitor presents a small electrical signal across the RA and LA or R amp L ECG limb leads This signal changes as the patient s chest wall rises and falls during the breath cycle The advantage of the thoracic impedance method is that respiration is obtained non invasively It is important to use cables with internal resistors for thoracic impedance ESIS choke block cables have electrical filters that may be used in electro cautery environments where ECG interference can be substantial These filters remove the electro cautery noise but also block the signal used by the Spectrum Monitor to measure respiration Spectrum Operating Instructions 0070 10 0648 02 2 61 Parameter Menus and Monitoring 2 4 6 2 The filling and emptying of the heart chambers can interfere with the thoracic impedance signal so called cardiovascular artifact CVA such that the respiratory signal matches the heart rate The Spectrum warns the operator when the respiration value equals the heart rate by displaying CVA If the patient s airway is obstructed and the patient attempts to breath then the chest wall can move and create a respiratory signal even though no gas flow is occurring in the patient CAUTION Some pacemakers may contain a respiratory sensor that may produce artifact on an ECG waveform Microstream CO Monitoring Optional Microstream modules provide
79. 0040 00 0268 02 ST Software Option Enable Kit 1 License 0040 00 0300 01 ST Software Option Enable Kit 5 Licenses 0040 00 0300 02 ST Software Option Enable Kit 10 Licenses 0040 00 0300 03 Arrhythmia Software Option Enable Kit 1 License 0040 00 0300 1 1 Arrhythmia Software Option Enable Kit 5 Licenses 0040 00 0300 12 Arrhythmia Software Option Enable Kit 10 Licenses 0040 00 0300 13 ST amp Arrhythmia Software Option Enable Kit 1 License 0040 00 0300 21 ST amp Arrhythmia Software Option Enable Kit 5 Licenses 0040 00 0300 22 ST amp Arrhythmia Software Option Enable Kit 10 Licenses 0040 00 0300 23 Vigilance Software Option Enable Kit 1 License 0040 00 0300 31 Vigilance Software Option Enable Kit 5 Licenses 0040 00 0300 32 Vigilance Software Option Enable Kit 10 Licenses 0040 00 0300 33 Vigilance amp ST Software Option Enable Kit 1 License 0040 00 0300 41 Vigilance amp ST Software Option Enable Kit 5 Licenses 0040 00 0300 42 Vigilance amp ST Software Option Enable Kit 10 Licenses 0040 00 0300 43 Vigilance amp Arrhythmia Software Option Enable Kit 1 License 0040 00 0300 51 Vigilance amp Arrhythmia Software Option Enable Kit 5 Licenses 0040 00 0300 52 Vigilance amp Arrhythmia Software Option Enable Kit 10 Licenses 0040 00 0300 53 Vigilance ST amp Arrhythmia Software Option Enable Kit 1 License 0040 00 0300 61 Vigilance ST amp Arrhythmia Software Option Enable Kit 5 Licenses 0040 00 0300 62 Vigilance ST
80. 0683 00 0525 25 P N 0683 00 0242 22 Neonate P N 0683 00 0524 25 Gas Scavenging Adapter Assy Adapter Mask Elbow ET Oo P N 0997 00 0923 P N 0683 00 0242 12 or P N 0997 00 0984 FIGURE 2 44 Gas Module 3 Airway Adapter 21 81 94 21 12 34 ee ee ma e T Gas Module t Spectrum Operating Instructions 0070 10 0648 02 2 67 Parameter Menus and Monitoring Operations 2 4 8 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 Do not connect anything to the reference port on the rear of the Gas Module ll or SE This port is used to monitor the room air only Ensure all tubing connections are tight WARNING Connection of the Gas Module 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 Modules internal pump CAUTION Contamination with N5O or Anesthetic Agent in the air surrounding the Gas Module 3
81. 07 0036 01 Large Adult Long White Burgundy 10 box 35 5 46 cm 0683 07 0038 01 arm circumference Large Adult White Burgundy 10 box 35 5 46 cm arm circumference 0683 07 0035 01 Adult Long White Navy Blue 10 box 27 5 36 5 cm 0683 07 0037 01 arm circumference Adult White Navy Blue 10 box 27 5 36 5 cm arm circumference 0683 07 0034 01 Small Adult White Light Blue 10 box 20 5 28 5 cm 0683 07 0033 01 arm circumference Child White Green 10 box 13 8 21 5 cm arm circumference 0683 07 0032 01 Small Child White Orange 10 box 9 14 8 cm arm circumference 0683 07 0031 01 4 1 2 Oximetry Sensors and Accessories 41 2 1 Pulse Oximetry Masimo SET LNOP spO DESCRIPTION PART NUMBER LNOP DCI Adult Pediatric starter kit one reusable adult sensor 2 adult 0020 00 0130 and 1 pediatric single patient adhesive sensors and one 12 cable LNOP DCLAdult reusable finger sensor with added flaps for ambient 0600 00 0047 light shielding and 3 cable LNOP DC 12 Adult direct connect reusable finger sensor with attached 0600 00 0120 12 cable LNOP DCIP Pediatric slender digit reusable finger sensor 0600 00 0063 LNOP TCI Tip Clip Ear Sensor 0600 00 0110 Ear Clip 0600 00 0086 Ear Hanger pkg of 5 0600 00 0087 LNOP Yi Multisite reusable sensor 0600 00 0078 Multisite wrap box of 100 0600 00 0081 Multisite wrap foam pkg of 12 0600 00 0083 LNOP DCSC Adult spot check reusable sensor 0600 00 0077 8 5
82. 12 lead ECG function is in accordance with the applicable requirements of EN 60601 2 25 ECG Performance Requirements The ECG meets the Section 3 2 Performance Requirements of ANSI AAMI EC1 1 1991 The ECG meets the Section 3 2 Performance Requirements of ANSI AAMI 13 1992 Lead Definition ECG Type Acquired Leads Displayable Leads 3 lead ECG Il one vector at a time 5 lead ECG 1 Il and V n 1 Il Ill aVR aVL aVF V n 12ead ECG Il Ill V2 V3 VA V5 V6 Il Ill aVR aVL aVF V2 V3 VA V5 V6 Lead Fault Lead resistances lt 51 in parallel with 0 047 pF capacitance will not cause a lead fault condition Differential offsets lt 300 mV will not cause a lead fault condition 3 5 lead ECG Cable Detection Automatically detected using Mindray auto detecting cables 12 ead ECG Analysis Enabling 12 lead ECG analysis is automatically enabled when the 12 lead card is installed in the PCM1 or PCM2 slot prior to power up or while the Spectrum is in operating mode The Spectrum has the ability to enable and disable the 12 lead ECG function Once disabled the Spectrum will default back to the 3 or 5 lead ECG Spectrum Operating Instructions 0070 10 0648 02 5 3 Patient Parameter Specifications Appendix Frequency Response Bandwidth 3db ECG Type Monitor Mode Extended Mode ST Mode 3 5 lead ECG 0 5 to 40 Hz 0 05 to 100 Hz 0 05 to 40 Hz 124 ECG 0 5 to 4
83. 120 min To choose which waveform will print to the internal printer select Waveform 1 or 2 and then select any of the waveforms ECG 1 6 IBP 1 4 Pleth Resp CO2 O2 and Agent NOTE If a 3 lead cable is installed the ECG 2 through ECG 6 references will not be displayed The following printer options may be available Local Remote and Laser A default printer or combination of printers can be set Local printing will initiate a printout delivered via the internal printer Remote printing will send a printout to the printer associated with the Central Station Laser printing sends 12 lead data to the laser printer Spectrum Operating Instructions 0070 10 0648 02 2 13 Operations 2 3 4 Parameters Menu Parameters Menu Normal Screen ECG ST NIBP IBP1 IBP2 IBP3 IBP4 SpO Resp Temperature co NO Y Y Y YO CGU Sy ow v Select to return to normal screen FIGURE 2 7 Parameters Menu The Parameters Menu selections vary according to the optional features installed on the the monitor The possible selections are ECG ST NIBP IBP1 IBP2 IBP3 IBP4 5 CO Resp Gases Temperature and CO 2 14 0070 10 0648 02 Spectrum Operating Instructions Operations Main Menus 2 3 5 Functions Menu Normal Screen Remote View Drug Calculator e Hemo Cales Menu Disable 12 Lead ECG Copy patient data to card Copy patient data from card
84. 2 Key Fedlure c cot in eR e n een Oen ce a Bk 1 3 Keysand ere tre e ed VD Re eade ties tope ipe elei Di RO Ne enit 1 4 E DURER bd dett eh ui RN 1 9 Reat ViCW 350 2 M M 1 11 Lett Side Panel sese res tetto ue one trice Leet telat ics ter Me cdc Meow 1 12 RightiSide Panel etie 1 14 Gas Module Optional st 25 ble tse ae Ha c tese nt 1 16 Front Panel 16 Rear Panel 17 enu LEITET 1 18 Exiernal Parameter Modules Optianal 3 d RE rbd b delitti ius 1 20 External Parameter Module Top View oci feet pese epe be eR He ERE Ve e de d bees 1 21 External Parameter Module Front View e eei a det OR eed ea abes 1 22 Left Side View with External Parameter Module ssssssse eem EErEE EEEE EErEE Enersen 1 23 Rear View with External Parameter Module Operations 2 Getting Started Installation Mode Installation t te be eeu bet Pes osos Det Live boot System Information Menu Main Menus Patient Menu Monitor Setup Menu Print Setup Menu Parameters Menu infernum Remote View Parameter Menus and Monitoring ECG Monitoring ECG Menu Skin Preparation Electrode Patch Location Lead Placementsshtt arte oh
85. 30 min 1 hr 2 hr or 4 hr The Off selection means that NIBP measurements can only be initiated manually The Continuous selection means that measurements will be continuous one right after the other The continuous measurement interval will only last for 5 minutes and then automatically change to a 5 minute interval The 1 minute interval will last for 10 minutes and then automatically change to a 5 minute interval 1 4 0070 10 0648 02 Spectrum Operating Instructions General Product Description Keys and Front Panel 6 STOP Press this key to stop any NIBP measurement If the interval mode is activated pressing this key disables the interval mode measurements An NIBP Idle message displays until the interval mode is restarted If a Press STOP to clear message is displayed pressing this key will clear a Cuff Overpressure condition 7 ZERO ALL IBP Press this key to set the current pressure for all invasive pressure channels to zero This key does not affect any channels monitoring pressure During the zeroing process the message Zeroing is displayed The message Zero Complete displays when the zeroing process is successful If the zero process is not successful the message Unable to Zero is displayed 8 C O Press this key to open the Cardiac Output Menu or the Vigilance CO Menu If the Cardiac Output Menu is already open and the Ready message is displayed pressing the C O key activates the CO run sequence Pressing the C O key w
86. 4 Select Start from the Calibration Menu Once the Start option has been selected no CO waveform data will be displayed 5 The message Calibrating continue to apply 5 CO will appear in the Calibration Menu NOTE If no gas is being delivered or the mixture does not contain 5 the message Calibration error Caused by no gas or wrong gas concentration will appear Obtain a new gas canister and return step 1 Spectrum Operating Instructions 0070 10 0648 02 2 63 Parameter Menus and Monitoring Operations 6 When the proper gas mixture is applied the message Calibrating continue to apply 5 CO will appear in the Calibration Menu window When the calibration is complete the message will change to Calculating calibration gas can be removed Release the button and remove the connector from the canister 7 After a moment the message will change to Calibration Completed Successfully The date and time of the successful calibration will appear in the Calibration Menu 8 Rotate the Navigator Knob to Previous Menu and press to select 9 Rotate the Navigator Knob to Normal Screen and press to return to the monitor s normal display screen 10 When the Spectrum has detected valid breaths numbers will display for the CO Inspired and Respiratory Rate 11 The CO respiration waveform and data will automatically replace the ECG Respiration waveform and data on the display If respiration wave or data is not
87. 48 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring 2 4 3 3 Auscultatory verification be made at the same time the Spectrum is taking a measurement Apply a bell stethoscope over the brachial artery Do not allow the stethoscope to touch either the patient s clothing or the pressure cuff Newborn NIBP Technique Newborn patients present unique obstacles to NIBP measurement Their vital signs can change from moment to moment and their tiny physiological signals are very prone to noise interference The following suggestions will help you to obtain the best possible NIBP measurement 1 Try to measure infants when they are calm A kicking crying baby may disturb or jiggle the cuff causing noise within the system and resulting in unstable blood pressure readings If necessary hold the cuffed limb steady without impeding circulation Do not hold onto the cuff and do not pat the cuffed limb to comfort the child 2 Try the calf Irritable newborns will react to the cuff pressure but may tolerate the calf better than the arm Place the cuff just above the ankle 3 Use the correct size cuff Mindray offers Newborn and Infant size cuffs When applying verify the cuff s Index line falls between the Range lines 4 Try disposable cuffs Disposable cuffs are more pliant than reusable ones They generally fit smaller infants better 5 Place the cuff lightly If the cuff is too snug
88. 5 21 EGG Int rpretefi fr ede cde ced 22 Calculations 25 22 Hemodynamic Calculations 22 Information Display and Control 25 Input Output Communications RU HS HERRERA OR REOR SUR 5 27 Communications Protocols ss I i e er e e d He Ee a ERR ate E Deo e UE Ee MR ERN 5 28 I aT Mp HC 5 30 Battery POWer a Danae ge era bee ta e PO QE DRE IA RK dp URS E Eden RERO 5 30 Sealed Lead Acid P NO146 00 0043 scara e aaia raa eaa Aa An e eene nere eene 5 30 Lithium lon Battery P N 0146 00 0069 sssssssss eee e rennen eren erre 5 31 5 32 Printinge oered D 5 33 Monitor Physical Characteristics 22 tr E ERRARE SER SAFER R AE OEE EAA 5 34 Comm Port Physical Characteristics eet rte ient dede ero e da ed eain donee 5 36 External Parameter Module Physical Characteristics eesssssseeee eme emere 5 37 Environmental and Safety Characteristics csset eene nnne 5 38 erue cea re 38 Gas Module 3 39 Agency Compliance 40 cT 5 40 Gas Module Il and Gas Module SE n eit te E PU RR 5 40 5 41 Electromagnetic Capability
89. 5 7 cm IEC 0012 00 1261 10 3 Lead Snap 24 61 0 cm IEC 0012 00 1261 11 3 Lead Snap 40 101 6 cm IEC 0012 00 1261 12 3 Lead Pinch Clip 18 45 7 AAMI 0012 00 1262 07 3 Lead Pinch Clip 24 61 0 AAMI 0012 00 1262 08 3 Lead Pinch Clip 40 101 6 cm AAMI 0012 00 1262 09 3 Lead Pinch Clip 18 45 7 cm IEC 0012 00 1262 10 3 Lead Pinch Clip 24 61 0 cm IEC 0012 00 1262 11 3 Lead Pinch Clip 40 101 6 cm IEC 0012 00 1262 12 Spectrum Operating Instructions 0070 10 0648 02 Optional Accessories ECG Lead Wires 5 Lead DESCRIPTION 5 Lead Snap 18 45 7 cm AAMI Accessories PART NUMBERS 0012 00 1261 01 5 Lead Snap 24 61 0 AAMI 0012 00 1261 02 5 Lead Snap 40 101 6 cm AAMI 0012 00 1261 03 5 Lead Snap 18 45 7 cm IEC 0012 00 1261 04 5 Lead Snap 24 61 0 cm IEC 0012 00 1261 05 5 Lead Snap 40 101 6 cm IEC 0012 00 1261 06 Snap Extended Leg 3 40 3 101 6 cm 2 60 2 152 4 cm AAMI 0012 00 1261 13 Snap Extended Leg 3 40 3 101 6 cm 2 60 2 152 4 cm IEC 0012 00 1261 14 5 Lead Pinch Clip 18 45 7 cm AAMI 0012 00 1262 01 5 Lead Pinch Clip 24 61 0 cm AAMI 0012 00 1262 02 5 Lead Pinch Clip 40 101 6 cm AAMI 0012 00 1262 03 5 Lead Pinch Clip 18 45 7 cm IEC 0012 00 1262 04 5 Lead Pinc
90. 8 02 53 Parameter Menus and Monitoring MESSAGE PROBLEM NIBP Retry REASON measurement has been attempted but no reading was possible and the retry limit has not been reached Operations SOLUTION Retry will be attempted Check for leaks and quality of peripheral pulses Decrease patient movement Switch cuff to another limb Unable To Measure An unsuccessful measurement cycle has been completed Switch cuff to another limb Decrease patient movement Press START to retry Be prepared to auscultate BP manually Contact Mindray Customer Support NIBP Cuff Overpressure The hardware overpressure limit has been exceeded Power cycle unit If message reappears contact Mindray Customer Support NIBP Cuff Overpressure Press STOP to clear The hardware overpressure limit has been exceeded Press STOP to clear the hardware overpressure If message reappears contact Mindray Customer Support NIBP Check Calibration The software has detected that the overpressure transducer is out of calibration Have the unit calibrated If problem persists contact Mindray Customer Support Unable to obtain a BP Patient movement Cuff or hose NOT attached leaking HR irregular arrhythmia present Blood pressure is out of range Improper cuff size brand Wait until patient is calm or gently hold limb Check all connections Check Patient and notify Phys
91. CO runs are completed use Edit CO Runs to choose the runs to be computed in the CO Average Runs that have green waveform data and a check mark VY in the box will be included in the average Runs that have red waveform data and an X mark X in the box will be excluded from the average 7 Select the Accept Average key to accept and store the CO Average 8 display Cardiac Index CI the patient weight and height must be entered via the CO Setup Menu or the Patient Menu 0070 10 0648 02 Spectrum Operating Instructions EPM Cardiac Output Troubleshooting MESSAGE PROBLEM CO value higher lower than expected REASON Computation constant incorrect for PA catheter type injectate temperature and injectate volume Catheter may be kinked or not in proper position Parameter Menus and Monitoring SOLUTION Check computation constant and enter correct data Notify physician No measurement Unable to measure Unstable temperature temperature or temperature out of range Time elapsed for measurement Check injectate temperature Flush PA catheter Discard bolus fluid Check patient Wait for Ready or Inject when Ready message to appear Rebolus when ready CO Signal Under Range Appears if the CO curve is not sufficient for a CO calculation or if a curve is not detected within thirty 30 seconds Rebolus if necessary CO Out of Range Irregular curve Appears if t
92. EC 60601 2 25 Gas Module II and Gas Module SE The Gas Module Il and Gas Module SE were 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 The Gas Module Il and Gas Module SE have been certified by CSA 0070 10 0648 02 Spectrum Operating Instructions Appendix Electromagnetic Capability 5 14 3 Gas Module 3 The Gas Module 3 was designed to comply with the following industry standards EN 60601 1 IEC 60601 1 UL 60601 CSA Standard C22 2 No 601 1M90 EN 60601 1 1 IEC 60601 1 1 EN 60601 1 4 IEC 60601 1 4 ISO 21647 The Gas Module 3 has been certified by CSA 5 15 Electromagnetic Capability 5 15 1 Spectrum The Spectrum meets the requirements of IEC 60601 1 2 EN 60601 1 2 NOTE NOTE TABLE 5 1 The Spectrum needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below Portable and mobile RF communications equipment can affect the Spectrum See tables 5 1 through 5 4 that follow GUIDANCE AND MINDRAY DS USA DECLARATION ELECTROMAGNETIC EMISSIONS The Spectrum is intended for use in the electromagnetic environment specified below The customer or the user of the Spectrum should assure that it is used in such an environment EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions Group 1 The Spectrum uses RF ener
93. ECG electrode patches may need to be repositioned and the ECG lead viewed may need to be adjusted until the optimum ECG tracing is obtained Arrhythmia Algorithm The Spectrum uses an arrhythmia algorithm to monitor ECG waveform data The algorithm creates ECG waveform templates based on a patient s normal ECG data and uses them to analyze newly received data The algorithm verifies that data is free from noise and artifact and that it does not deviate from the patient s normal ECG rhythms A normal ECG waveform typically includes consistent spacing between R waves a sharp and well defined QRS complex and an ECG baseline that is free of noise and artifact ST deviation Depression or Elevation lt lt SO Point ST Point S lt q gt 40 to 80 msec ST Segment FIGURE 2 30 Sample Waveform Noise and Artifact The presence of noise or artifact in an ECG waveform makes the accurate detection and classification of heart beats difficult To best optimize performance all leads should be free of noise Some of the causes of ECG noise include poor skin preparation improperly attached electrodes dried electrode gel defective lead wires and patient movement The algorithm uses several techniques to differentiate a patient s QRS complexes from noise sources If noise levels are too high for a particular lead a message is posted and the data is dropped from analysis until the signal quality
94. Expired Inspired and Respiration Rate monitoring utilizing a small lumen FilterLine Microstream capnography that is acquired via a nasal cannula non intubated or through an adapter set for use in a breathing circuit intubated Microstream can be used on adult pediatric and neonatal patients To begin monitoring Microstream CO 1 Connect one end of an exhaust line to the exhaust port on the Spectrum and the other end to the hospital gas scavenging system 2 Select or AUTO as the Resp Source in the Resp Menu CAUTION Vacuum negative pressure should not exceed 1 mmHg at the Spectrum Pump Exhaust fitting Excessive scavenge vacuum may result in an Occlusion message or damage to the Spectrum s internal pump The scavenging system must be on during calibration 3 Open input door and connect the proper FilterLine to the Monitor Connect the opposite end to the patient WARNING When monitoring with a Spectrum the maximum sampling rate at the nasal cannula is 58 ml min This device should not be used on patients whose breathing could be impaired by this vacuum flow rate WARNING When monitoring CO connection from the exhaust port of the Spectrum to the hospital s waste gas scavenging system is recommended to prevent exposure of hospital personnel to the patient s respiratory sample NOTE Ensure all tubing connections are secure Ensure that the nasal cannula is away from all sources of
95. External Parameter Module from the Spectrum Spectrum Operating Instructions 0070 10 0648 02 1 21 External Parameter Modules Optional General Product Description 1 10 2 External Parameter Module Front View FIGURE 1 17 Front View of EPM 1 Module Connector EB1 This module bus port connects the External Parameter Module to the port on the Spectrum 2 Module Latches These latches secure the module to the Spectrum 3 Guide Pins These pins guide the EB1 connector into the EMI port on the Spectrum 1 22 0070 10 0648 02 Spectrum Operating Instructions General Product Description External Parameter Modules Optional 1 10 3 Left Side View with External Parameter Module oe AL f FIGURE 1 18 Left Side View with External Parameter Module 1 T2 Connector This connector mates with either the YSI series 400 or 700 temperature probes The monitor automatically detects which probe is connected 2 IBP3 Connector This connector is used for the Channel 3 Pressure Transducer connection 3 ZERO ALL IBP Key Press this key to zero all invasive blood pressure simultaneously This key operates the same as the ZERO ALL IBP key on the monitor keypad 4 IBP4 Connector This connector is used for the Channel 4 Pressure Transducer con
96. HR Spo Resp 1 2 iem nr BPM RPM mH mig SE T 60 5 9 19 6 69 119 70 Date 1 3 70 0 40 60 5 9 19 7 amp 69 1197 70 Tine 12 40 03 MM 0 39 60 55 9 1097 60 69 1197 78 0 39 6 55 8 109 amp 69 1197 70 0 38 e 5 109 amp 69 1197 780 0 38 6a 5 1057 60 69 1197 70 0 38 6 5 m 9 amp 69 119 78 6 55 14 19 amp 69 1197 70 FIGURE 2 65 Sample Printout List Trend Format Spectrum Operating Instructions 0070 10 0648 02 2 111 Printing Optional Operations Event 4 14 00 4 14 00 4 14 00 As14j00 Rame 14 1500 SSO 16 00 _ ID 4 6i i Bed 2 Date 1 2 70 Time 10 04 30 PM N 1 2 70 1 2 70 1 2 70 1 2 70 1 2 70 1 2 70 1 2 70 172770 8 2 5 2202 2208 2204 22x05 ID _ UN E29 Bed Fraas ea Date 1 2 70 Time 10 05 36 PM ioo i 7 FIGURE 2 67 OxyCRG Trend Format Calculations IV Drug and Hemodynamic printouts are initiated in the respective menu by using the Navigator Knob and scrolling to the Print function The printout data will include patient demographic data date time of printout data used to calculate the information and the calculated data Drug Calculations will include the patient weight IV fluid infusion rate and medication concentration 12 lead ECG To print 12 lead ECG data and interpretation to internal recorder View 12 ECG
97. IBP display time out CO amp PAWP Timeout 15 30 45 mins 1 2 15 min Select to change CO and 4 hr PAWP timeout Enable EPM No Yes No Select to enable or disable the External Parameter Module Temperature units EG F USA Select to change C All others temperature units Weight Units lbs kg lbs USA Select to change weight kg All others units Height Units Ft inches cm Ft inches USA Select to change height cm All others units CO Units mmHg kPa mmHg Select to change CO units Copy monitor defaults Select to copy the monitor to card defaults and settings to a data transfer card Copy monitor defaults Select to copy the monitor from card defaults and settings from a data transfer card inserted into PCM2 SetUp Serial Port 1 None Visa with None Select to set up a serial admit DIAP output protocol port An Accutorr Gas item enabled in SetUp Module PatientNet 1 2 Serial Port 1 will be Vigilance removed from the selections in SetUp Serial Port 2 SetUp Serial Port 2 None Visa with None Select to set up a serial admit DIAP output protocol port An Accutorr Gas item enabled in SetUp Module PatientNet 2 Serial Port 2 will be Vigilance removed from the selections in SetUp Serial Port 1 1 Visa with admit and PatientNet will not be available as menu choices if WMTS Enabled is set to Yes or if Enable Network is set to Wired in the System Information menu HX Lo 0070 10 0648 02 A
98. INTERVAL or MARK EVENT key press The time stamp will be that of the trigger causing the trend entry The NIBP measurement and NIBP heart rate will be automatically removed from the display after a predetermined time interval The NIBP timeout interval is 15 minutes by default and can be set to a different value through the Installation Menu Automatic Interval NIBP Measurements There are two modes available for automatic NIBP measurements They are the Interval Mode and the Timer Mode The Interval Mode allows you to set the interval between measurements For example if the interval is set to 10 minutes and the START key is pressed at 10 12 the measurements will be taken at 10 12 10 22 10 32 etc The Timer Mode allows you to set an interval that is synchronized with the real time clock For example if the timer is set to 30 and the START key is pressed at 10 12 the measurements will be taken at 10 12 10 30 11 00 11 30 etc 1 Select the Interval Mode or the Timer Mode in the Monitor Setup Menu 2 Press INTERVAL until the desired time displays The choices are OFF Continuous 1 2 5 3 5 10 15 20 30 60 and 120 minutes and 4 hours 3 Press START to begin taking interval measurements NOTE If the monitor is in the interval mode when it is turned ON no measurement will be taken until the START key is pressed Automatic Adjustment in the Interval Mode In the Interval Mode the unit adjusts the inflation pressure accordin
99. If the cuff is over pressurized the cuff will automatically vent to atmosphere and the NIBP message window will alternately read Cuff Over Pressure and Unable to Measure Cuff Inflation Time IF the cuff pressure does not attain 20 mmHg within 40 seconds of the start of inflation or if the target pressure is not reached within another 60 seconds then the cuff is vented and the Retry or Unable to Measure message will display in the NIBP message window START and STOP Functions The START and STOP functions have the following effects on the timed measurement sequence Interval or Timer Mode INTERVAL is set and you press START An unscheduled measurement is made Taking this unscheduled measurement does not affect the timing of the interval cycle therefore the scheduled measurements will be taken as if there were no interruptions Only one measurement is taken for each measurement cycle therefore if the unscheduled measurement coincides with the scheduled measurement it counts as the scheduled measurement INTERVAL is set and you press STOP during the measurement 1 The cuff deflates and interval measurements are suspended 2 INTERVAL is set and you change the interval 3 The measurement cycle is reset with the new interval A measurement will be taken after you press the START key NIBP Auto Time Out Functions The NIBP data will time out on the display under the following conditions When the elapsed time exceeds the pre se
100. LAY START A UMTS STRIP STANDBY TRENDS INTERVAL co ME cor DISCHARGE FREEZE STOP PAWP Q Mur TREND EVENT FIGURE 1 1 The Mindray Spectrum Patient Monitor Spectrum Operating Instructions 0070 10 0648 02 Datascope Spectrum NORMAL SCREEN oM General Product Description General Product Description 1 1 General Product Description The Spectrum is a vital signs monitor intended for intrahospital use on human patients The Spectrum is a three 3 to eight 8 trace monitor The unit has many features and functions yet is easy to use through an integrated keypad Navigator Knob and an intuitive menu system The Spectrum has a 12 1 inch color display and comes standard with 3 or 5 lead ECG Masimo SET SpO Non invasive Blood Pressure Respiration Continuous Temperature and IV Drug Calculations The Spectrum may be configured to suit your department by adding software and hardware optional features Optional software features include ST and Arrhythmia analysis Optional hardware features include View 12 ECG Analysis Module which includes ST Arrhythmia and 12 lead interpretation Up to 4 Invasive Blood Pressure Channels MicroStream Anesthetic Gases Nellcor Oxismart and OxiMax SpO a second temperature source dual trace recorder and Cardiac Output A comprehensive calculation package including hemodynamic calculations is available if the Spectrum is equipped with an External Parameter M
101. LL ALARMS MUTED FOR XX XX mins is displayed in the message area of the Remote View Menu The XX XX in the message is a digital timer for the mute time remaining NOTE If Permanent is selected from the Remote Mute All For list ALL ALARMS MUTED PERMANENTLY is displayed in the message area of the Remote View Menu If a new bed is chosen while all remote alarms are permanently muted the permanent mute condition will continue for the new bed Alarm Mute icon resembling a crossed speaker is displayed in the numeric tiles and in the Numeric Data Area If Remote Mute All is selected again the audio alarm tones are re enabled NOTE The Remote Mute All selection silences only the alarms indicated in the Remote View Menu It does not silence the primary patient s alarms or alarm sounds at the remote location 5 Remote Print this selection sends a print request to the remote monitor The printout will be as configured in the Print Setup menu of the remote monitor NOTE When a Remote Print is requested there is no indication that the printout was completed as requested The user should verify the successful print at the printer Remote View Message Area The Message Area shown in FIGURE 2 10 displays status and alarm messages as follows f more than one message is being received they are alternately displayed All arrhythmia alarms priority one and priority two alarms generate the appropriate audio alerts at
102. LUME AMOUNT Aminophylline Theophylline Y mg 500 m 500 mg Diltiazem Cardizem N mg 125 m 125 mg Dobutamine Dobutrex Y mcg 250 500 mg Dopamine Inotropin Y mcg 250 ml 400 mg Epinephrine Adrenalin N mcg 250 Img HCL Esmolol HCL Brevibloc Y mcg 500 m 5000 mg Fentanyl Citrate Sublimaze Y mcg 100 ml 5 mg Heparin Sodium Heparin N units 250 ml 12 500 units Inamrinone Inocor Y mcg 250 ml 500 mg Lactate Insulin Regular Humulin N units 100 ml 100 units Isoproterenol Isuprel HCL N mcg 500 m 2 mg Labetalol HCL Normodyne N mg 200 m 200 mg Lidocaine HCL 7 Xylocaine HCL N mg 500 m 2000 mg Lorazepam Ativan N mg 500 m 40 mg Midazolam Versed Y mg 125 m 125 mg HcLl2 Milrinone Primacor Y mcg 200 ml 20 mg Lactate Nicardipine Cardene N mg 250 ml 25 mg HCL Nitroglycerin Tridil mcg 250 ml 50 mg Nitroprusside Nipride Y mcg 250 ml 50 mg Sodium Norepinephrine Levophed N mcg 250 ml 4 mg Phenylephrine Neosynephrine N mcg 250 ml 10 mg Procainamide Pronestyl N mg 500 ml 2000 mg HCL Propofol Diprivan Y mcg 50 ml 500 mg Vasopressin Pitressin N units 250 ml 250 units 1 Gahart B and Nazareno A 2002 Intravenous Medications St Louis Mosby 2001 2 Algozzine G Algozzine R and Lilly D Critical Care Intravenous Infusion Drug Handbook St Louis Mosby 2002 2 94 0070 10 0648 02 Spectrum Operating Instructions Operations Calculations 2 5 2 Hemodynamic Calculations Hemodynamic calculations are a set of va
103. NICATIONS EQUIPMENT AND THE GAS MODULE SE OR GAS MODULE 3 The Gas Module SE and Gas Module 3 are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Gas Module SE or 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 SE or 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 IN METERS m W ACCORDING TO FREQUENCY OF TRANSMITTER 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz 1 2 x JP 12x 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
104. No routine calibration is required The module should initially be calibrated after 1200 operating hours then once a year or after 4 000 operating hours whichever comes first 5 18 0070 10 0648 02 Spectrum Operating Instructions Appendix 5 2 8 Spectrum Operating Instructions Cardiac Output Patient Parameter Specifications The Spectrum is capable of providing thermal dilution Cardiac Output in Adult and Pediatric modes only Performance Requirements Cardiac output range Cardiac output resolution Cardiac Output Repeatability Accuracy Blood Temperature Measurement Range Accuracy Resolution Injected Temperature Measurement Range Accuracy Resolution Modes of Operation Injectate volume 0070 10 0648 02 0 2 20 0 liters minute 0 1 liters minute 2 or 0 2 liters minute from the mean value whichever is greater as measured using electronically generated flow curves 5 or 0 2 liters minute whichever is greater as measured using electronically generated flow curves 17 5 43 C 63 5 F 109 4 F Exclusive of probe errors 0 2 C 0 4 0 1 C 0 1 F 0 1 30 0 C 30 2 F 86 F Exclusive of probe errors 0 2 C 0 4 F 0 1 C 0 1 F Auto Start Manual Start 3 5 lO cc Special Functions Appendix 5 3 Special Functions 5 3 1 ST Segment Analysis Performance Requirements Enabling Enabled in Adult and Pediatric
105. Off 2 0 10 0 Off 1 0 6 0 8 0 ET kPa Off 2 0 10 0 Off 1 0 6 0 8 0 Insp mmHg Off 5 30 10 Insp Off 1 0 4 0 Insp kPa Off 1 0 4 0 Spectrum Operating Instructions 0070 10 0648 02 Alarms Operations HIGH LOW PARAMETERS ADULT PED NEONATE ADULT PED NEONATE Off Off Off Off Off Off 40 100 40 100 40 100 10 60 10 60 10 60 Insp Off Off Off 18 60 18 60 18 60 40 100 40 100 40 100 ET N20 Off Off Off Off Off Off 10 80 10 80 10 80 5 70 5 70 5 70 Insp N2O 10 80 10 80 10 80 Off Off Off 5 70 5 70 5 70 Apnea Delay 10 60 10 20 10 20 seconds 30 15 15 CCO 1 Off Off Off Off 1 0 20 0 1 0 20 0 1 0 20 0 1 0 20 0 CCI I min m Off Off Off Off 1 0 20 0 1 0 20 0 1 0 20 0 1 0 20 0 SvO Off Off Off Off 10 99 10 99 10 99 10 99 Alarm Parameters Gas Module PARAMETERS HIGH LOW nsp Hal Off 2 10 Off 0 5 5 ET Hal Off 2 10 Off 0 5 5 nsp Iso Off 2 10 Off 0 5 5 ET Iso Off 2 10 Off 0 5 5 nsp Enfl Off 2 10 Off 0 5 5 ET Enfl Off 2 10 Off 0 5 5 nsp Sevo Off 2 10 Off 0 5 5 ET Sevo Off 2 10 Off 0 5 5 nsp Des Off 2 20 Off 0 5 10 ET Des Off 2 20 Off 0 5 10 All Gas Module alarms are in units of and increment in units of 0 5 2 98 0070 10 0648 02 Spectrum Operating Instructions Operations Alarms Alarm Violations Spectrum alarm violations ar
106. Once the Patient Key has been entered communication with the EMR system must be verified Since the Panorama Gateway can be purchased with ADT messaging only Results messaging only or ADT messaging with Results messaging this verification differs as follows ADT messaging For a Panorama Gateway that has ADT messaging verify that communication with the EMR system has been established as follows e After entering the Patient Key in the Patient Menu select Normal Screen to close the menu f demographics information corresponding to the following fields was not part of the Patient Key but is entered into the EMR system these fields in the Patient Menu should auto populate upon re opening the menu First name Last name Bed e Date of Birth Gender n addition the Firs Name and Last Name should populate in the upper right of the display If the fields do not auto populate verify that the Patient Key has been correctly entered and that the patient demographics have been entered in the EMR system If the fields still do not auto populate contact the EMR administrator Results messaging For facilities with a Panorama Gateway that has Results messaging verify that communication with the EMR system has been established by checking the charting system to ensure that vital signs data has been uploaded If the charting system is not displaying the information contact the EMR administrator Spectrum Operating
107. Operating Instructions Datascope Spectrum Datasco pe mindray Spectrum mindray NORTH AMERIC 0070 01 0555 02_revC_Spectrum ops color indd 1 3 10 10 5 33 36 PM Operating Instructions Datascope Spectrum NORTH AMERICA Abbott is a US registered trademark of Abbott Laboratories Capnoline is a trademark of Oridion Medical Ltd DRYLINE is a trademark of Artema Medical AB Durasensor is U S registered trademark of Nellcor Puritan Bennett Inc Edwards is a U S registered trademark of Edwards Lifesciences Corporation FilterLine is a US registered trademark of Oridion Medical Lid INCS is a U S registered trademark of Masimo Corp LNOP is a US registered trademark of Masimo Corp Masimo SET is a U S registered trademark of Masimo Corp Max Fast is US registered trademark of Nellcor Puritan Bennett Inc Medico is a registered trademark of Oridion Medical Ltd Microstream is a U S registered trademark of Oridion Medical Ltd Navigator is a U S trademark of Mindray DS USA Nellcor is US registered trademark of Nellcor Puritan Bennett Inc NIV Line is a trademark of Oridion Medical Ltd Oxiband is a US registered trademark of Nellcor Puritan Bennett Inc OxiMax is a US registered trademark of Nellcor Puritan Bennett Inc Oxisensor is a U S registered trademark of Nellcor Puritan Bennett Inc Oxismart is a US registered trademark of Nellcor Puritan Be
108. PLIANCE 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 for input 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 gt 95 lt 5 gt 95 Mains power quality should be that of short dip in Ur for dip in Ur for a typical commercial or hospital interruptionsand 0 5 cycle 0 5 cycle environment If the user of the Gas voltage Module SE or Gas Module 3 variations on 40 60 40 60 requires continued operation during power supply dip in Ur for dip in Ur for power mains interruptions it is input lines IEC 5 cycles 5 cycles recommended that the Gas Module 61000 4 11 SE or Gas Module 3 be powered 70 30 70 30 from an uninterruptible power supply dip in Ur for dip in Ur for or a battery 25 cycles 25 cycles lt 5 Ur 95 lt 5 Ur gt 95 dip in Ur for dip in Ur for 5 sec 5 sec Power frequency 3 A m 3 A m P
109. Pressure Cuff or Monitor Sudden changes in blood temperature such as those caused by bolus drug administration may cause a CO or CI value to be computed To avoid falsely triggered curves inject as soon as possible after the Inject when Ready message is displayed Some pacemakers may contain a respiratory sensor that may produce artifact on an ECG waveform During the decontamination process do not get the LpH SE Germicidal detergent into any vent openings The monitor display provides data and waveform information over its entire area Do not cover any part of the monitor display with tape or labels The 2 4 GHz radio optionally used in this device must be at least 20 cm away from the user and or patient during normal operating conditions Replace sealed lead acid batteries with Mindray P N 0146 00 0043 ONLY Replace lithium ion batteries with Mindray P N 0146 00 0069 ONLY 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 Contamination with N5O or Anesthetic Agent in the air surrounding the Gas Module 3 may cause significant measurement errors Spectrum Operating Instructions 0070 10 0648 02 xiii Introduction Notes Notes NOTE This unit is not designed to be used with a peripheral pulse sensor SpO is a standard function in this monitor and may be used to obtai
110. Product Description 24 Caution LED LED used to indicate that an alarm has been tripped The CAUTION Priority 2 LED is yellow 25 Battery Charging LED A green LED located below the battery icon indicates that the battery charger is active The charger will not always be active when AC power is present It is dependent on the battery type sealed lead acid vs lithium ion and battery charge condition The LED is not an indication of the condition of the batteries or their charge level Charged batteries must be installed in the monitor to ensure uninterrupted operation while switching from AC to battery power 26 AC Power LED A green LED beside the Battery Charging LED that is used to indicate that the unit is connected to the AC Power within the facility 0070 10 0648 02 Spectrum Operating Instructions General Product Description Display 1 4 Display The display of the Spectrum provides menus waveforms parameter information and messages The Spectrum includes a display setup function that allows customization of the display Preferred setup details can be programmed and saved Main Menus Message 2 Area A Patient Monitor Setup Print Setup Parameters Functions 11 01 04 2 05 PM i JONES ERIC Adult 1 02 55 Zr 258 2 1 3 0 99 et JH 128 79 amp 25 8 Ki 20 insp NM mmHg 0 lo 2 13 23 8 8o 3 oom
111. RG PA PAD PAO PaO PAWP PB PECO PEEP PIP PVC gt PVR PVRI Qs Qt RCW RCWI RVSW RVSWI Glossary Fraction of inspired oxygen Hemoglobin Intra aortic balloon pump Intracranial pressure label for invasive blood pressure Invasive Blood pressure Isoelectric point reference point on ECG waveform for ST analysis Left atrium label for invasive blood pressure Left Cardiac Work feature of hemodynamic calculations Left Cardiac Work Index feature of hemodynamic calculations Left ventricle label for invasive blood pressure Left Ventricular Stroke Work feature of hemodynamic calculations Left Ventricular Stroke Work Index feature of hemodynamic calculations Mean arterial pressure Minute Volume Non invasive Blood Pressure Oxygen Availability Oxygen Availability Index Oxygen Extraction Ratio Oxygen cardiorespirogram this trend feature is for pediatric and neonatal patients It graphs selected parameters for comparisons and evaluation Pulmonary artery label for invasive blood pressure Pulmonary artery diastolic Partial pressure of alveolar oxygen Partial pressure of arterial oxygen Partial pressure of arterial carbon dioxide Pulmonary Artery Wedge Pressure Atmospheric pressure Partial pressure of end tidal CO Positive End Expiratory Pressure Peak Inspiratory Pressure Premature Ventricular Contractions Partial pressure of venous oxygen Pulmonary Vascular Resis
112. SCHARGE key to enter into its Installation Mode 4 From the Spectrum Installation Menu set Enable EPM to Yes and then select Save Current 5 Restart the Spectrum to enter normal monitoring mode 6 From the Patient menu of the main screen set Patient Size to either Adult or Pediatric 7 Open the Cardiac Output Menu shown in FIGURE 2 52 in one of the following three ways by choosing CO from the Parameters Menu by pressing the C O key on the front panel keypad by pressing the C O key on the EPM keypad Open the CO Setup Menu by choosing CO Setup Menu from the Cardiac Output Menu Cardiac Output Menu Normal Screen Measuring Averaged Data Comp Constant 0 632 3 Injectate Temperature 0 0 C CO 43 l min d CI 2 3 minim Select to return to normal screen FIGURE 2 52 Cardiac Output Menu Spectrum Operating Instructions 0070 10 0648 02 2 81 Parameter Menus and Monitoring Operations 2 4 11 1 2 2 82 CO Setup Menu CO Setup Menu Previous Menu Height 120 0 in 2 304 8 cm Weight 155 Ibs 70 5kg Auto Start Off Computation Constant 500 CO Time 30 sec Scale 1 CO Source Module Select to return to previous menu FIGURE 2 53 CO Setup Menu Auto Start With the EPM there are two modes of operation Auto Start and Manual To choose the desired mode of operation open the CO Setup Menu shown in FIGURE 2 53 and set Auto Start
113. Select Printer is set to Laser Laser Local or Laser Remote NOTE Station 12 lead ECG data will not print remotely to the Central 2 To print 12 lead ECG data to the laser printer the View 12 ECG Analysis Module must be installed and enabled 3 Enter the Patient s Date of Birth and Gender via the Patient Menu to print the 12 lead interpretation 4 Press the VIEW key to display View All ECG mode 5 Press the STRIP key to print 12 lead ECG to the destination of choice Printer Recorder Troubleshooting MESSAGE PROBLEM Recorder Report Appears Totally Blank Local Printer Door Open REASON Thermal paper may be installed incorrectly up side down The printer door is not closed SOLUTION Remove paper and re install with paper feeding off of the spool from the bottom Close the printer door Local Printer Out Of Paper Printer out of paper Replace with a new roll of paper Printer Busy Printer received multiple print requests at one time Wait until the printer is not busy Local Printer Unable To Print The system has detected an unrecoverable printer failure Power cycle unit If message reappears contact Mindray Customer Support Check Laser Printer No print on Alarm Trends not printing Laser printer is busy disconnected out of paper or has a fault condition Alarm printing not active Print Trend not pressed No Trends displayed No paper Check laser p
114. Spectrum the CO tile will be removed from the display 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring CO Cl SO KX Cont l min l min m Vigilance 5 4 2 7 85 Source FIGURE 2 54 Example CO tile with Continuous Cardiac Output from Vigilance The setup and patient connections for the Vigilance must be completed as instructed in the Edwards Vigilance Monitor Operator s Manual To display Vigilance cardiac output measurements at the Spectrum the two devices must be physically configured as follows the Spectrum must be equipped with an optional Comm Port that contains serial port interface SP1 and or SP2 the two devices must be interfaced using the Vigilance PC Interface cable serial port to serial port P N 0012 00 1275 01 as described in step 1 of the following section 2 4 11 2 1 Vigilance CO Setup 1 Both ends of the Vigilance PC Interface cable are identical Before it is connected ensure that the Vigilance and the Spectrum are powered OFF Connect one end of the cable to the Spectrum at a serial port SP1 or SP2 that is located on the optional Comm Port Connect the other end of the cable to the Vigilance at the COM 1 port 2 Power ON the Vigilance and then power ON the Spectrum while holding down the DISCHARGE key to enter into its Installation Mode 3 Seta serial port to Vigilance and then select Save Current 4 Restart the Spectrum
115. Storage Altitude Operating Temperature Operating Humidity Operating Altitude Shipping Shock Vibration Drop Impact Spillage and Ingress of Fluids 0070 10 0648 02 20 C to 60 C 10 to 95 non condensing 1250 to 9 889 feet ASL 1060 hPa to700 hPa 795 mmHg to 525 mmHg 5 C to 40 C 15 to 95 non condensing 1250 to 9 889 feet ASL 1060 hPa to 700 hPa 795 mmHg to 525 mmHg ISTA shipping procedure 1A 15 g 11 ms half sine shock pulse tested per IEC 60068 2 27 Sinusoidal Vibration per IEC 60068 2 6 1 g or 0 07 mm 57 62 Hz crossover frequency 10 to 500 Hz 10 sweep cycles in each axis Random Vibration per IEC 60068 2 34 0 02 g2 Hz 20 500 Hz low degree of reproducibility 9 minutes per axis PB 296 892 section 3 3 for Class Ill devices ECRI PB 296 892 section Allll 3 2 for Class 3 devices Non Protected Equipment IPXO as specified in IEC 529 Spectrum Operating Instructions Appendix 5 13 2 Spectrum Operating Instructions Gas Module 3 Transport and Storage Temperature Transport and Storage Humidity Operating Temperature Operating Humidity Operating Altitude Shipping Shock Vibration Drop Spillage and Ingress of Fluids 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
116. TS W TO FREQUENCY OF TRANSMITTER 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz 1 2 x JP 1 2 x JP 2 3 x JP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the 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 0070 10 0648 02 Spectrum Operating Instructions Appendix Electromagnetic Capability 5 15 2 Gas Module SE and Gas Module 3 The Gas Module SE and Gas Module 3 meet the requirements of IEC 60601 1 2 EN 60601 1 2 NOTE NOTE TABLE 5 5 The Gas Module SE and Gas Module 3 need special precautions regarding EMC and need to be installed and put into service according to the EMC information provided below Portable and mobile RF communications equipment can affect the Gas Module SE and Gas Module 3 See tables 5 5 through 5 8 that follow GUIDANCE AND MINDRAY DS USA DECLARATION ELECTROMAGNETIC EMISSIONS The Gas Module SE and Gas
117. TX Pediatric single patient adhesive sensors 20 0600 00 0122 LNCS INF L Infant single patient adhesive sensors 20 Box 0600 00 0123 LNCS NEO L Neonatal single patient adhesive sensors 20 0600 00 0124 LNCS NEO PT L Neonatal preterm patient adhesive sensors 20 0600 00 0125 LNC 4 SpO Patient cable 4 0012 00 1652 LNC 10 SpO Patient cable 10 0012 00 1599 LNC 14 SpO Patient cable 14 0012 00 1653 LNCS to LNOP PC series adapter 0012 00 1651 Masimo SET AC 1 LNCS adapter cable 0012 00 1656 LNCS Adult Pediatric starter kit one reusable Adult sensor 2 Adult and 1 0020 00 0154 Pediatric single patient adhesive sensor and one 3 1 m cable 0070 10 0648 02 Optional Accessories DESCRIPTION LNCS Neonatal disposable starter kit 2 Neonate and 2 Neonate PreTerm single patient adhesive sensors and one 3 1 m cable Accessories PART NUMBER 0020 00 0155 LNCS Adult Pediatric disposable starter kit 2 Adult and 2 Pediatric single patient adhesive sensors and one 3 1 m cable 0020 00 0156 4 1 2 3 Pulse Oximetry Nellcor Sp0 DESCRIPTION PART NUMBER Reusable sensor 0600 00 0051 SpO cable DOC 10 OxiMax 0012 00 1464 Disposable OxiMax Sensor Kit 2 adult 2 neonatal 0600 00 0103 Oximetry Nellcor OxiMax 505 Replacement sensors are available from Nellcor Puritan Bennett Phone 1 800 NELLCOR or WWW NELLCOR COM 4 1 3 Ori
118. Tissue damage or inaccurate measurements may be caused by incorrect sensor application or use such as wrapping too tightly applying supplemental tape failing to inspect the sensor site periodically or failing to position appropriately Carefully read the sensor directions for use the Spectrum Operating Instructions and all precautionary information before use Inaccurate SpO2 measurements may be caused by Incorrect sensor application or use e Significant levels of dysfunctional hemoglobins e g carboxyhemoglobin or methemoglobin ntra vascular dyes such as indocyanine green or methylene blue e Exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or excessive ambient light In such cases cover the sensor site with opaque material e Excessive patient movement e Venous pulsations e Electro surgical interference Placement of a sensor an extremity that has a blood pressure cuff arterial catheter or intra vascular line Nail polish or fungus In certain situations in which perfusion and signal strength are low such as in patients with thick or pigmented skin inaccurately low SpO readings will result Verification of oxygenation should be made especially in preterm infants and patients with chronic lung disease before instituting any therapy or intervention Many patients suffer from poor p
119. a analysis feature is intended to detect ventricular rhythms however due to physiologic differences in patient populations the Spectrum may occasionally sound a false alarm or may not recognize some arrhythmia patterns The Spectrum is capable of identifying ventricular arrhythmia patterns in Adult and Pediatric size patients Arrhythmia analysis may be enabled or disabled via the Arrhythmia Menu By default arrhythmia analysis is enabled Arrhythmia Menu Arrhythmia Menu Previous Menu Previous Menu Arrhythmia All On Arrhythmia All On Irregular HR On Y Tach 4 beats Y Tach 4 beats Tach Rate 120 bpm Tach Rate 120 bpm Asystole Delay seconds Asystole Delay 4 seconds Relearn Relearn ECG Noise Delay 5 seconds Select to return to previous menu Select to return to previous menu FIGURE 2 31 Arrhythmia Menu FIGURE 2 32 Arrhythmia Menu 3 5 lead 12 lead Arrhythmia alarm calls are classified as Priority 1 or Priority 2 Asystole Ventricular Tachycardia and Ventricular Fibrillation are classified as Priority 1 and the priority level cannot be changed by the user In addition these alarms will sound continuously until the user presses the MUTE or MUTE ALL key regardless of whether the patient s condition has improved The other arrhythmia alarms listed below are classified as Priority 2 by default The characteristics and priority level of the PVC min alarm can be changed at the user s discretion
120. al batteries installed AC Mains Power Source Input Voltage 100 240 VAC x 10 Line Frequency 50 or 60 Hz 3 Hz Current 1 2 0 7 Amps Battery Power Sealed Lead Acid P N0146 00 0043 Battery Type Sealed Lead Acid Number of Batteries 2 the unit is capable of operation with one battery for the sole purpose of changing batteries while in the normal operating mode Minimum Battery Run Time 1 hour and 20 minutes from two fully charged new batteries at 25 C for the following conditions ECG SpO and NIBP running at the 15 minute interval Battery Recharge Time 16 hours maximum Charging Method Parallel and independent Time to Shutdown from Low Battery gt 10 minutes but 20 minutes after indication with 2 new fully charged batteries 0070 10 0648 02 Spectrum Operating Instructions Appendix Power Supply 5 7 1 2 Lithium Ion Battery P N 0146 00 0069 Battery Type Number of Batteries Minimum Battery Run Time Battery Recharge Time Charging Method Time to Shutdown from Low Battery Spectrum Operating Instructions 0070 10 0648 02 Lithium ion 2 the unit is capable of operation with one battery for the sole purpose of changing batteries while in the normal operating mode 4 hours and 30 minutes from two fully charged new batteries at 25 C for the following conditions ECG 5 and NIBP running at the 15 minute interval 5 hours maximum Parallel and independe
121. alarm attributes Use the Navigator Knob to access these menus 4 Parameter Areas The parameter area contains the digital data for each available parameter 5 Battery Indicator When batteries are installed and the monitor is functioning on battery power the battery indicator provides a visual reference for the approximate charge level of the batteries See the following examples Full Battery Low Battery No Battery Present Lithium Ion batteries only If the monitor is configured for lithium ion batteries when there are no batteries installed the battery indicator will be displayed with an X through it as shown in the example When the battery charge is low but not below the cutoff voltage the battery indicator will begin to flash and a low pitched double beep will be generated every minute NOTE When the battery indicator begins to flash less than 15 minutes of operating time remains depending upon the number of functions that are operational NOTE The internal recorder may not be operational when the battery charge is low 6 Message Area A This message area is located above the ECG waveform window Messages regarding the ECG heart rate and alarm status are displayed here 7 Message Area B This message area is located below the last row of parameter tiles Messages regarding NIBP IBP printer status SpO CO and Gas Module are displayed here 8 Ra
122. and height must be entered via the CO Setup Menu or the Patient Menu Auto Start Off Manual Mode 1 Connectthe proper Cardiac Output cable and PA catheter Open the CO Setup Menu and set Auto Start to Off From the PA catheter package insert verify the correct computation constant for the catheter type injectate volume and injectate temperature Set the Computation Constant as necessary if it is different than the monitor s factory default of 0 500 Return to the Cardiac Output Menu 2 When a stable baseline blood temperature is obtained the Ready message will be displayed Select Start CO Run or the C O key on the Monitor or Module and the Inject Now message will be displayed Proceed with a bolus injection NOTE You have a maximum of 30 seconds in which to inject following Start CO Run If no injection is detected within this time interval the display returns to Ready until you choose to resume the measurement sequence 3 Once a bolus is injected the CO curve appears Measuring message is displayed and the resultant CO measurement is displayed NOTE If a measurement is compromised as indicated by an Irregular Curve or Injectate Temp Error alert message the curve will be displayed in Red and an X mark will be displayed in the box 4 Note the injectate temperature and verify that the correct computation constant was set 5 Subsequent CO runs can be performed as desired when the Ready message reappears 6 When sufficient
123. and or shock hazard WARNING Do not reuse disposable devices vi 0070 10 0648 02 Spectrum Operating Instructions Warnings Introduction WARNING Compressed gasses are considered Dangerous Goods Hazardous Materials I 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 I A T A Dangerous Goods Regulations and or the Code of Federal Regulations 49 Transportation Parts 171 180 for further information WARNING Route cables neatly Ensure cables hoses and wires are kept away from patient s neck to avoid strangulation Keep floors and walkways free of cables to reduce risk to hospital personnel patients and visitors WARNING Do not use a damaged or broken unit or accessory WARNING Inaccurate Cardiac Output measurements may be caused by Incorrect placement or position of the catheter e Excessive variation in pulmonary artery blood temperature Clot formation on the thermistor Anatomical abnormalities for example cardiac shunts e Excessive patient movement e Repeated intermittent flushes of cold fluid through the fluid lumens of the catheter Use of a manual pump such as the Abbott Blood Set with Pump and CAIR clamp
124. anel Medical Grade Wall mount Accessories PART NUMBERS 0160 00 0093 04 Wall mount adjustable VHM Flat Panel 0436 00 0210 Wall mount flush Flat Panel 0040 00 0368 Serial Port SP1 DESCRIPTIONS Cable Serial Port to Gas Module 12 30 48 cm PART NUMBERS 0012 00 1276 01 Cable Serial Port to Gas Module 72 182 88 0012 00 1276 02 Coble Interface Vigilance PC Serial Port to Serial Port Cable Serial Port to VISA 10 3 05 m 0012 00 1275 01 0012 00 1299 01 Ethernet CS1 DESCRIPTIONS CAT 5 Ethernet Cable Patch STP 6 1 83 PART NUMBERS 0012 00 1274 01 CAT 5 Ethernet Cable Patch STP 25 7 62 m 0012 00 1274 02 CAT 5 Ethernet Cable Patch STP 50 15 24 0012 00 1274 03 CAT 5 Ethernet Cable Patch STP 1 0 30 0012 00 1274 04 CAT 5 Ethernet Cable Patch STP 2 0 61 0012 00 1274 05 CAT 5 Ethernet Cable Patch STP 3 0 91 0012 00 1274 06 CAT 5 Ethernet Cable Patch STP 10 3 05 m 0012 00 1274 07 Laser Printer Laserjet 4200N 0992 00 009 1 04 Paper Laser Printer View 12 0683 00 0503 ECS HUB 12 Port 0992 00 0085 01 CAT 5 Ethernet Cable Crossover STP 3 0 91 m 0012 00 1392 05 CAT 5 Ethernet Cable Crossover STP 6 1 83 m 0012 00 1392 06 CAT 5 Ethernet Cable Crossover STP 10 3 05 m 0012 00 1392 07 CAT 5 Ethernet Ca
125. ansducers including Masimo SET LNOP and LNCS Patient Dedicated Adhesive Sensors and Masimo SET PC Series Patient Cables Use of other oxygen transducers may cause improper oximeter performance Masimo SET Sensors Masimo SET provides a family of sensors suitable for a wide variety of clinical settings and patients Specific sensors have been developed for neonates infants children and adults All sensors are indicated for continuous non invasive monitoring of arterial oxygen saturation SpO and pulse rate all sensors are non sterile and usable during patient movement The Adult Reusable Finger Sensors can also be used for spot check applications if needed sensors are intended for single patient use only unless indicated as reusable All tended for single patient ly unless indicated as reusable Nellcor SpO CAUTION When equipped with Nellcor 5 use only Nellcor oxygen transducers including Nellcor Oxisensor and OxiMax patient dedicated adhesive sensors Use of other oxygen transducers may cause improper oximeter performance Nellcor Sensors Nellcor provides a family of sensors suitable for a wide variety of clinical settings and patients Specific sensors have been developed for neonates infants children and adults Oxisensor and OxiMax oxygen transducers are sterile adhesive sensors with optical components mounted on adhesive tape Oxiband oxygen transducers and the Duraform oxygen transducer system a
126. art pressure The patient size selection should be matched to the actual patient before monitoring begins Setting up Patients 1 Turn the monitor on using the ON OFF switch Ensure the previous patient s data has been removed from the monitor by discharging previous patient 2 Connect the patient to the monitor apply appropriate accessories such as ECG electrodes NIBP cuff SpO2 probe CO Fiterline etc 3 Enter patient information into the Spectrum via the Patient Menu check patient size 4 lf desired press the START key to initiate a non invasive blood pressure measurement Spectrum Operating Instructions 0070 10 0648 02 Getting Started Operations How to Set the Clock Date and Time The date and time are set in the Monitor Setup Menu 1 Using the Navigator Knob highlight Monitor Setup Press the Navigator Knob to open the menu 2 Use the Navigator Knob to select Advanced Setup then select either Date or Time 3 Turn the Navigator Knob to select new setting Once the desired choice is highlighted press the Navigator Knob 4 This setting is saved when Yes is selected via the confirmation prompt NOTE Patient trend data is cleared if the Time and or Date are changed on the monitor If the Spectrum is connected to a Panorama Central Station the Time and Date settings of the Central Station will be acquired by the Spectrum in one of three ways as follows the Time and or Date are changed on
127. 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 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 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted 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 SE or Gas Module 3 are used exceeds the applicable RF compliance level above the Gas Mod ule SE or 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 SE or Gas Module 3 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Spectrum Operating Instructions 0070 10 0648 02 5 47 Electromagnetic Capability Appendix 5 48 TABLE 5 8 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMU
128. asurement taken every 5 minutes In 1 minute mode after 10 minutes the NIBP interval automatically switches to measurements taken once every 10 minutes Reports have been made of nerve injury occurring during use of automatically cycled blood pressure cuffs CAUTION Tissue damage or inaccurate measurements may be caused by incorrect sensor application or use such as wrapping too tightly applying supplemental tape failing to inspect the sensor site periodically or failing to position appropriately Carefully read the sensor directions for use the Spectrum Operating Instructions and all precautionary information before use CAUTION Inaccurate SpO measurements may be caused by Incorrect sensor application or use Significant levels of dysfunctional hemoglobins e g carboxyhemoglobin or methemoglobin Intra vascular dyes such as indocyanine green or methylene blue Exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or excessive ambient light In such cases cover the sensor site with opaque material Excessive patient movement Spectrum Operating Instructions 0070 10 0648 02 xi Introduction Precautions CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION e Venous pulsations e Electro surgical interference Placement of a sensor an ex
129. atient data command fields are not supported f Status Byte O e g Status Byte 1 e h Status Byte 2 3 The following bits of Status Byte 1 are not supported e Bit 1 SpO Uncalibrated e Bit 2 5pO Alarm Overlapped Bit 3 SpO2 RAM Test Failure Bit 4 SpO2 ROM Test Failure Bit 5 SpO OFFSET Mismatch e Bit 6 SpO FILTER Mismatch Bit 7 SpO System Test in Progress 4 The following bits of Status Byte 2 are not supported Bit 1 NIBP indicating Motion Artifact Bit 2 through 7 not used Vigilance Interface The Spectrum supports the Vigilance IFMout communications protocol in accordance with Edwards Lifesciences specification ELS 1291 0070 10 0648 02 Spectrum Operating Instructions Appendix Communication Protocols Module Bus Communication Protocol The Spectrum supports the Enterprise Module Serial Protocol Specification 0060 00 0991 Alarm Delay Time to Remote Equipment The alarm delay time from the Spectrum to remote equipment is lt 2 7 seconds measured at the Spectrum signal output connector Spectrum Operating Instructions 0070 10 0648 02 5 29 Power Supply 5 7 5 7 1 5 711 5 30 Appendix Power Supply Power Source The Spectrum will auto select its power source from those available The monitor will use the following priority in choosing the power source 1 AC Mains Power 2 Internal battery power The monitor will operate from AC Mains power with or without the intern
130. atient status SpO Too Much Light Masimo SET Only There is too much ambient room light for the sensor to function properly Minimize the room light around the patient Check sensor SpO Unrecognized Sensor Masimo SET Only The sensor is not recognized by the Monitor Replace the sensor with a Mindray recommended sensor SpO Communication Error SpO Board Fault The monitor and the SpO modules are not communicating properly Masimo SET board failed to operate properly Power cycle unit If problem persists contact Mindray Customer Support See Proper Service Menu Suggestion 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring MESSAGE PROBLEM SpO Sensor Fault REASON Defective Sensor SOLUTION Replace Sensor SpO Motion Nellcor Only Motion is detected Decrease patient motion check sensor SpO Check Sensor Nellcor Only The SpO module has sensed a poor connection or a bad sensor Reconnect the same sensor If problem persists replace sensor Unable to obtain SpOs reading Patient has poor perfusion Sensor not on Patient Cables loose not connected Ambient light Switch limbs Notify physician Reapply sensor Check connections switch cable Switch limbs and cover sensor with opaque material No SpO waveform Waveform not selected to Display
131. aveform area Ventricular Fibrillation V FIB Alarm A V FIB alarm is activated when a fibrillated waveform P QRS or T waves can no longer be identified is detected V FIB is defined as irregular disorganized electrical activity of the heart The V FIB detection algorithm runs in parallel to the beat detection algorithm and continuously examines the incoming data The V FIB alarm is a Priority 1 alarm event that produces e Alarm Priority 1 visual and audio alarm indicators A V FIB text message above the ECG1 waveform area Ventricular Tachycardia V TACH Alarm A V TACH alarm is activated as follows The range of the rate is between 100 to 180 beats per minute AND The V TACH lethal arrhythmia alarm is activated when the configured number of consecutive PVCs is reached The range for the V TACH threshold is 3 15 beats per minute A V TACH alarm is a Priority 1 alarm event that produces Alarm Priority 1 visual and audio alarm indicators A V TACH text message above the ECG1 waveform area 24 2 5 Non Lethal Arrhythmia Alarms A Non Lethal Arrhythmia is an arrhythmia that is most likely not life threatening to a patient Bigeminy Bradycardia Couplet Irregular Heart Rate Pause PVC min Run Trigeminy and Ventricular Rhythm V Rhythm alarms are classified as non lethal arrhythmia alarms With the exception of PVC min all other Non Lethal Arrhythmias are Alarm Priority 2 The Alarm P
132. aves scrolling from the left side of the display All waves will be restarted 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring The Print Wedge menu selection will begin a continuous printout of the top two waveforms on the Wedge Menu By default these waveforms are ECG1 and PA To stop the Wedge printout select Print Wedge again The Wedge Setup menu selection opens the Wedge Setup Menu This menu allows you to make the following changes to the waveforms displayed on the Wedge Menu 1 Change the parameters displayed in the upper and lower waveform windows 2 Change the scale of the PA waveform 3 Change the speed of the waveforms displayed The monitor also allows you to use the PA Diastolic PAD reading as PAWP NOTE Please check hospital policy concerning the use of PAD as a Wedge To use the Pulmonary Artery Diastolic reading as PAWP select Accept PAD as Wedge from the PA Menu A confirmation prompt will appear This menu selection will not be available if the PA Diastolic value is invalid or the pressure channel in use has not been zeroed 2 4 10 2 PAWP Troubleshooting MESSAGE PROBLEM REASON SOLUTION Unable to Wedge Improper catheter position Check PA catheter notify physician Catheter against wall or blood Flush catheter notify physician vessel PA catheter in Catheter in too far Notify physician immediately Spontaneous Wedge Overwedging or Balloon overinf
133. ayed ST data is different depending on the ECG cable in use When using a 3 or 5 lead ECG cable the displayed ST data is updated approximately every 10 seconds NOTE The ST algorithm has been tested for accuracy of the ST segment data The significance of the ST segment changes must be determined by a clinician ST Minitrends or Average ST data may be displayed in any of the available waveform areas ST Minitrends are graphical displays of ST deviations The data can be displayed at intervals of 15 30 or 60 minutes selectable via the ST Setup Menu The ST scale is also adjustable with selections of 2 5 mm 5 mm or 10 mm 2 42 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring Average ST is an on screen display of both the learned ST complex and the current ST complex superimposed to show changes in ECG morphology over time The learned ST complex will appear in white with the current ST complex appearing in the ECG waveform color If the ECG waveform is white then the learned complex will appear in green With a 3 lead cable ST Minitrends and Average ST will display the ST data from 1 With a 5 lead cable ST Minitrends and Average ST will display the ST data from 1 ECG2 and ECG3 With a 12 lead ECG cable ST Minitrends and Average ST will display the ST data from the 3 ECG leads with the greatest deviation 2 4 2 7 1 ST Analysis Setup ST analysis begins when the featu
134. be triggered only by the source identified in the Heart Rate data tile In some circumstances the pulse rate displayed in the SPO data tile may differ from the heart rate displayed in the heart rate data tile When the Spectrum detects SPO pulse rate is in violation of the set heart rate limits the pulse rate data will flash over a red background but the audio alarm will not sound B Heart Rate Fault Alarm The Heart Rate Fault Alarm occurs if the selected heart rate source is no longer able to detect a heart rate This alarm is only active if a low heart rate limit is set The Spectrum may display a message to help identify the cause of the alarm e g Lead Off Sensor Off The Heart Rate Fault Alarm is a priority 1 alarm Spectrum Operating Instructions 0070 10 0648 02 2 99 Alarms Operations C Apnea Alarm The Apnea Alarm is active when respiration is being monitored The Apnea Alarm will be triggered if respiration is not detected for a time period longer than set in the Alarm Setup menu The Apnea Alarm can be set as a Latched or Non latched alarm via the Advanced Setup menu When Apnea Latch is set to Off the Apnea Alarm will silence and cancel itself if patient breathing is again detected When Apnea Latch is set to On default the Apnea Alarm will not be silenced unless the operator acknowledges the alarm by pressing the MUTE or MUTE ALL keys The visual Apnea Alarm indications wi
135. beled CS1 Module Bus labeled MB1 Remote Display labeled RD1 Future Use The CS1 MB1 SP1 Comm Port supports the following connections Ethernet Communication labeled CS1 Module Bus labeled MB1 Serial Communication Channel labeled SP1 The RD1 NC1 SP1 Comm Port supports the following connections Remote Display labeled RD1 Future Use Nurse Call labeled NC1 Serial Communication Channel labeled SP1 The SP1 NCI SP2 Comm Port supports the following connections Nurse Call labeled NC1 2 Serial Communication Channels labeled SP1 and SP2 5 36 0070 10 0648 02 Spectrum Operating Instructions Appendix 5 12 External Parameter Module Physical Characteristics External Parameter Module Physical Characteristics Mounting The External Parameter Module mounts atop the monitor A means of quick disconnect is provided It does not require a tool yet requires more than one action in order to prevent accidental disconnect Connecting disconnecting the external module from the Monitor will not disturb monitor operation Maximum Size 11 0 wide x 2 3 high x 5 0 deep Maximum Weight 175 lbs Power The module receives power from the monitor Spectrum Operating Instructions 0070 10 0648 02 5 37 Environmental and Safety Characteristics 5 13 5 13 1 5 38 Appendix Environmental and Safety Characteristics Spectrum Transport and Storage Temperature Transport and Storage Humidity Transport and
136. ble Crossover STP 20 6 10 m 0012 00 1392 08 4 1 10 Base Station Accessories DESCRIPTION PART NUMBERS Base Station kit with 110V line cord BASESTATION1 10 Base Station kit with 220V line cord BASESTATION220 Base Station kit with 240V line cord BASESTATION240 Base Station 110V line cord 0012 25 0001 Base Station 220V line cord 0012 25 0002 Base Station 240V line cord 0012 25 0003 Base Station power supply 0014 00 0070 Base Station mounting kit 0386 00 0259 Base Station Operator s manual multilanguage 0073 00 1292 4 10 0070 10 0648 02 Spectrum Operating Instructions Miscellaneous Accessories Optional Accessories DESCRIPTIONS PART NUMBERS Recorder Chart Paper 10 Rolls 0683 00 0422 02 Battery Lithium lon 0146 00 0069 Battery Sealed Lead Acid 0146 00 0043 AC Power Cord 120V 0012 25 0001 AC Power Cord 220V 0012 25 0002 AC Power Cord 240V 0012 25 0003 Cable Assy DPD Defibrillator 8 20 32 cm 0012 00 1301 01 Cable Assy DPD Defibrillator 10 3 05 0012 00 1301 02 Cable Assy Analog Output ECG only 15 4 57 CABLEANALOGOUT Cable ECG IBP to IABP interface for Software Version L 04 and above 0012 00 1650 01 6 pin 4 6 m Transfer Card 0996 00 0094 01 Extended Trend Card 0996 00 0052 01 Abbreviated Operator s Manual 0070 00 0574 02 12 Lead ECG Physician s Reference Guide English Version 0070 00 0524 01 12 Lead ECG Physician s Reference
137. c Dia and Mean blood pressures Invasive Blood Pressure measurement is an option for the Spectrum IBP1 Normal Screen Label IBP1 Zero Scale to 160 mmHg Grids Color LE Change to IBP1 Select to return to normal screen FIGURE 2 49 IBP Menu IBP1 IBP2 IBP3 IBP4 waveforms may be labeled according to the site of insertion The labels are identified in the following table LABEL DEFINITION Art Arterial Blood Pressure UA Umbilical Artery Pressure LV Left Ventricular Pressure PA Pulmonary Artery Pressure CVP Central Venous Pressure ICP Intracranial Pressure LA Left Atrial Pressure RA Right Atrial Pressure Spectrum Operating Instructions 0070 10 0648 02 2 75 Parameter Menus and Monitoring Operations 2 4 9 1 Measuring IBP 1 Plug the pressure transducer cable into the IBP port s on the left side panel or into the IBP port s on the External Parameter Module 2 The IBP1 and IBP2 waveforms will appear by default as the fourth and fifth waveform on the display with its associated data to the right of the waveform The waveform may be moved to another location or turned off by accessing the Display Setup Menu The IBP3 and IBP4 waveforms and or data will not appear unless the External Parameter Module has been enabled and a location has been designated in the Display Setup Menu NOTE The arterial pressure catheter should not be used on a limb that is being utilized
138. ccessories IBP TRANSDUCERS PART NUMBERS P1OEZ Miniature Reusable 0682 00 0085 P23XL 1 Transducer Reusable 0682 00 0084 Cable Interface Transducer 0012 00 1245 4 1 9 Comm Port Accessories Comm Port Comm Port 2 CSI MB1 RDI 0998 00 0178 03 Comm Port 3 RD1 SP1 0998 00 0178 05 Comm Port 4 CSI SP1 0998 00 0178 04 Comm Port 5 SP1 NC1 SP2 0998 00 0178 06 Spectrum Operating Instructions CS Ethernet Port MB Module Bus SP Serial Port RD Remote Display NC Nurse Call Nurse Call NC1 DESCRIPTIONS Unterminated Cable 9 2 7 m PART NUMBER 0012 00 1277 02 Remote Display RD1 DESCRIPTIONS Cable 6 1 83 m VGA Extension Male D to Female D PART NUMBERS 0012 00 0852 01 Cable 25 7 62 VGA Extension Female to Unterminated 0012 00 0852 02 Cable 50 15 24 VGA Extension Female to Unterminated 0012 00 0852 03 Cable 100 30 48 VGA Extension Female to Unterminated 0012 00 0852 04 Cable 10 3 05 m VGA Male to Male 0012 00 0994 0 1 Cable 25 7 62 VGA Male to Male 0012 00 0994 02 Cable 50 15 24 m VGA Male to Male Cable 75 22 86 VGA Male to Male 0012 00 0994 03 0012 00 0994 04 Display 19 0 LCD Flat Panel Medical Grade Desktop 0160 00 0093 03 0070 10 0648 02 4 Optional Accessories Remote Display RD1 DESCRIPTIONS Display 19 0 LCD Flat P
139. ccutorr will not be available as a menu choice if WMTS Enabled is set to Yes Vigilance will only be available as a menu choice if it has been installed Country language and system information are not affected by restoring defaults Spectrum Operating Instructions Operations Installation Mode MENU TITLE ON SCREEN MENU CHOICES DEFAULT ACTIONS COMMENTS WMTS Enabled No Yes No Set to YES to enable the use of the Panorama Instrument Radio 608 Re boot in demo mode Yes No Set to YES to start the monitor in demonstration mode on next power up Normal monitoring will resume after cycling power in demonstration mode Restore factory Select to restore factory defaults defaults System Information Select to setup owner s screen Options Select to add view options 1 Visa with admit and PatientNet will not be available as menu choices if WMTS Enabled is set to Yes or if Enable Network is set to Wired in the System Information menu 2 Accutorr will not be available as a menu choice if WMTS Enabled is set to Yes 3 Vigilance will only be available as a menu choice if it has been installed 4 Country language and system information are not affected by restoring defaults Spectrum Operating Instructions 0070 10 0648 02 2 5 Installation Mode Operations 2 2 2 System Information Menu System Information Previous Menu Property of Location Departm
140. cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theo retically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electro magnetic site survey should be considered If the measured field strength in the location in which the Spectrum is used exceeds the applicable RF compliance level above the Spectrum should be observed to ver ify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Spectrum b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Spectrum Operating Instructions 0070 10 0648 02 43 Electromagnetic Capability Appendix 5 44 TABLE 5 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE SPECTRUM The Spectrum is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Spectrum can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Spectrum as recommended below according to the maximum output power of the communications equipment RATED MAXIMUM OUTPUT POWER P OF TRANSMITTER SEPARATION DISTANCE d IN METERS m ACCORDING IN WAT
141. ct any non isolated accessories to the Spectrum or to the ECG or invasive pressure channel inputs when connected to a patient Insure that the total chassis leakage currents of all connected units does not exceed 300pA Use an IEC 60601 1 approved isolation separation transformer if required Do not simultaneously touch the patient and any piece of electrical equipment if any cover has been removed from the equipment WARNING The AC line cord and interface cables i e non patient cables may utilize the same ground Therefore removal of the AC line cord does not necessarily isolate the Spectrum if non patient interface cables are attached WARNING 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 WARNING Do not incinerate battery possible explosion may occur WARNING Do not put MPSO Multiple Portable Socket Outlets i e Multiple outlet extension cords used with the Spectrum or its accessories on the floor Connect only Spectrum accessories to the same MPSO as the Spectrum Do not overload the MPSO WARNING Do not connect other equipment to the same MPSO with the Spectrum as it may increase system leakage current WARNING Reliably attach Potential Equalization connector to the safety ground when interconnecting Spectrum with other medical or non medical electrical equipment to minimize the risk of excessive leakage current
142. cted and the Installation Menu is properly configured CO Source enables the user to choose between either device as the source for CO A detailed description of this configuration is provided in the CO from both Vigilance and EPM section Vigilance Cardiac Output Troubleshooting MESSAGE PROBLEM REASON SOLUTION CO Check Vigilance This message is displayed when an Refer to the Edwards Vigilance alert or alarm status has been sent Monitor Operator s Manual or from the Vigilance to the Spectrum contact Edwards Lifesciences Corporation for assistance Within the USA 800 424 3278 Outside the USA 949 250 2500 0070 10 0648 02 Spectrum Operating Instructions Operations 2 4 11 Parameter Menus and Monitoring CO from both Vigilance and EPM If switching between Vigilance CO and EPM CO is desired proceed as follows 1 Setup the EPM as described in steps 1 and 2 of the EPM CO Setup section 2 Setup the Vigilance as described in step 1 of the Vigilance CO Setup section 3 Power ON the Vigilance and then power ON the Spectrum while holding down the DISCHARGE key to enter into its Installation Mode 4 Set Enable EPM to Yes set a serial port to Vigilance and then select Save Current 5 Restart the Spectrum to enter normal monitoring mode 6 From the Patient menu of the main screen set Patient Size to either Adult or Pediatric 7 Open the Cardiac Output Menu shown in FIGURE 2 52 in one of the following three
143. curacy rounded to 4 digits The SPO accuracy during motion conditions is not specified for the LNOP ear or LNCS sensors 5 14 0070 10 0648 02 Spectrum Operating Instructions Appendix 5 2 6 2 5 2 7 5 2 7 1 Spectrum Operating Instructions Patient Parameter Specifications Nellcor SpO Performance Requirements Sensor Compatibility Nellcor types D 25L N 25 1 20 D 20 OxiCliq A OxiCliq N OxiCliq P OxiCliq Oxiband A N Oxiband P I OXI 1 2 3 A N OXI 1 2 3 P I DS 100A DY S Max Fast Saturation Accuracy Sensor D 25L D 20 1 20 N 25 OxiCliq A OxiCliq N OxiCliq P OxiCliq I Oxiband A N Oxiband P I OXI 1 2 3 A N OXI 1 2 3 P I DS 100A DY S Max Fast Pulse Rate Range and Accuracy Range 20 to 249 bpm Update Rate Every 2 seconds CO Performance Characteristics Accuracy 70 to 100 2 digits Below 70 unspecified 70 to 100 3 digits Below 70 unspecified Accuracy 3 bpm The Spectrum is capable of providing measurements from either an Oridion MediCO capnography module or an Oridion capnography module The performance is in accordance with the requirements of EN 864 MediCO or ISO 21647 2004 MiniMediCO MediCo Microstream Only in monitors with serial numbers below MS05000 Range 0 99 mmHg Accuracy specification of the measured partial pressure is according to the following table
144. d T Blood data have display priority over T2 data If all three 3 temperature sources are being used T2 data will not appear on the display although T2 alarms will still function and T2 data will appear on printouts and continue to accumulate in the Trend data Whenever two 2 temperatures are being displayed the difference between them AT may also be displayed To display AT in the Temperature Parameter Area 1 Ensure that two temperature sources are connected 2 Goto the Temperature Menu and select Display Delta then select Yes 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring 2 4 5 1 Temperature Troubleshooting MESSAGE PROBLEM REASON SOLUTION Temperature Probes not Poor contact from probes to body Check the body surface contact Working at the probe tip Reposition or apply thermoconductive gel Temperature not displayed Improper display setup Check display setup in Monitor Setup Menu and change as desired Cable not plugged in Check the cable 2 4 6 Respiration Menu Respirations or the amount of breaths per minute are measured by 2 methods in the Spectrum The first method is thoracic impedance through the ECG signal The second is by exchange via Microstream or via the Gas Module Resp Menu Normal Screen Resp Lead M Resp Source Auto Resp On Seale 3 Grid Off Color c Change to RespOrco Select to return to normal screen FIGURE 2 4
145. d choose from the available parameters 2 To print to the recorder select Local from the Print Setup Menu 3 Press the STRIP key to initiate printing 4 Press the STRIP key again to abort the printout Select printouts will also require the use of alternate menus or keys During an ECG waveform printout tic marks appear every one second for reference Spectrum Operating Instructions 0070 10 0648 02 2 109 Printing Optional Operations Printouts from the Recorder Print Formats The print format can be changed from Leader to Wave in the Print Setup Menu Leader will print all patient demographic data date time of printout waveform speed source of the printout and all patient parameter data prior to printing the waveform data Wave will print all patient demographic data date time of printout waveform speed and source of the printout in the space prior to the waveform printing The patient parameter data will print above and below the waveform area Wave format is not available if the speed of the upper printed waveform is less than 25 mm sec The waveform speed can be set via the Monitor Setup Menu Strip Printing When the STRIP key is pressed a 16 second strip is printed This strip consists of data 8 seconds prior to and 8 seconds after the printout is initiated The source of the printout is indicated on the strip as Key Name ARTHUR IAN Date 2 5 82 ECG Filter ST ID 233 433 8600 Time 10 15 14 ST Mod
146. d 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 fan dust filter should be checked and cleaned on a regular basis at least once every two months Locate fan on front panel Remove the filter by pulling the dust filter cover Remove the dust from the filter let the filter soak in a mild detergent solution Rinse the filter and let dry completely before re installing CAUTION If the dust filter for the fan cannot be cleaned or is damaged replace it with part number 0378 00 0040 Use of another type of filter may decrease the cooling effectivity and cause damage to the Gas Module 3 The Water Trap Reservoir must be checked and emptied whenever changing patients or if NOTE NOTE it is more than half full To remove the water trap push the water trap latch to the right The water trap is spring loaded and will pop out An Air Leak message will be displayed The monitor will suspend sampling Detach the reservoir from the water trap assembly by pulling it down carefully Empty the reservoir and rinse
147. 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 USA s option at the factory or at an authorized Mindray 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 Mindary DS USA has any authority to bind Mindray DS USA 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 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 freight prepaid to Mindray DS USA Mahwah New Jersey 07430 Mindray DS USA shall not have any respons
148. dams dee ade ene t AA Rea RE ee oh Arrhythmia Algorithm Arrhythmia Alarms Arrhythmia Analysis Optional ST Analysis Optional Relearning ST or Arrhythmia Analysis 12 ead ECG Optional ECG Troublesh otifig Non Invasive Blood Pressure Measurements NIBP ssssssss eene 2 48 Manual NIBP Measurements i ree rel erem Bett ree bue Rest rE eee nauta 2 48 Spectrum Operating Instructions 0070 10 0648 02 i Table of Contents Automatic Interval NIBP Measurements eme emere 2 50 NIBP Troubleshooting eret ee rtt eie eene eel det iode ie ea eee ede ea ph cds 2 53 SpO5 Pulse Oximetty 2 55 Masimo SE Ras ro EN E E E T 2 57 o MIT m IL D E 2 57 SpO Troubleshooting and Menu Performance Considerations 2 58 Temperature MENU ooo NIU Det Fesser 2 60 Temperature Troubleshooting 2 61 Respiration s otio AEEA eb t ide ste 2 61 Thoracic Impedance ee 2 61 Microstream CO Monitoring Optionall tette effe ite det aee Pee Pete 2 62 Microstream CO Menu tentent tte tene tette tereti 2 63 Respiration and CO Troubleshoo
149. ding is affected by storage and handling conditions These conditions are Ultraviolet Light We recommend storing the recordings in a filing cabinet within a few days of printing Long term exposure to natural or artificial U V sources is detrimental e Storage Temperature and Humidity Keep the recordings in a cool and dry area for a longer lasting image Extreme temperature and humidity above 80 F 26 C and 80 Humidity should be avoided Solvent Reactions Do not store the recordings in plastic bags acetate sheet protectors and similar items made from petroleum products These products emit a small amount of vapor which will over a period of time deteriorate the image on the chart paper Adhesive Tape Never place adhesive tape over recordings The reaction between the adhesive compound and the chemical thermal paper can destroy the image within hours e Archives We recommend that if long term archives are required make a photocopy of the recordings as back up Under normal office filing conditions the recordings should retain acceptable image quality for about 5 years 3 4 0070 10 0648 02 Spectrum Operating Instructions User Maintenance Care and Cleaning of Gas Module 3 9 Care and Cleaning of Gas Module 3 9 1 Gas Module II and Gas Module SE WARNING Do not clean the Gas Module while it is on and or plugged 1 The Gas Module enclosure may be cleaned with a mild soap and water solution or ammoniate
150. dio Icon M If a Panorama Instrument Radio 608 is installed and WMTS Enabled is set to Yes in the Installation Menu this icon will be displayed 9 Panorama Icon or This icon will display in one of two possible formats as follows Ifthe Spectrum 608 radio is sending data but it is not being displayed at a Panorama Central Station then this icon will display the number 1 Ifthe Spectrum data is being displayed at a Panorama Central Station then this icon will display the capital letter V 1 10 0070 10 0648 02 Spectrum Operating Instructions General Product Description Rear View 1 5 Rear View 3 I nme H MSA 0000000 0 1 J 0 0 0000000 _0000000 0 0 00000000 C Gir FIGURE 1 4 Rear Panel 1 AC Receptacle Insert an AC power cord into this connector 2 Equipotential Lug Provides Equipotential grounding of hospital equipment 3 Soft Grip Handle Used for carrying the monitor 4 Main I O Connector Port DM1 Area dedicated for the use of an optional communication port 5 Expansion Slot Used for connecting an optional Panorama Instrument Radio 608 6 External Parameter Module Port EM1 Port used to connect the External Parameter Module to the Spectrum Spectrum Operating
151. dion CO Accessories DESCRIPTION PART NUMBERS Filterline Set short term Adult Pediatric box of 25 0683 00 0470 25 Filterline Set High Humidity Infant Neonatal box of 25 0683 00 0490 25 Filterline Set High Humidity Adult Pediatric box of 25 0683 00 0469 25 Smart Capnoline Oral Nasal Cannula Pediatric box of 25 0683 00 0495 25 Smart Capnoline O2 CO Oral Nasal Cannula Adult box of 25 0683 00 0496 25 Smart Capnoline O2 CO Oral Nasal Cannula Pediatric box of 25 0683 00 0498 25 Smart Capnoline Plus O2 CO Oral Nasal Cannula with tubing 0683 00 0516 25 Adult Intermediate box of 25 Smart Capnoline Plus O5 CO Oral Nasal Cannula with connector 0683 00 0517 25 Adult Intermediate box of 25 NIV Line Adult box of 25 0683 00 0506 25 NIV Line Pediatric box of 25 0683 00 0507 25 Capnoline Adult box of 25 0683 00 0508 25 Capnoline H Pediatric box of 25 0683 00 0509 25 Capnoline Infant Neonatal box of 25 0683 00 0510 25 Capnoline H Adult box of 25 0683 00 0511 25 Capnoline Pediatric box of 25 0683 00 0512 25 Calibration Gas 0075 00 0033 01 CO Exhaust Connector Male 0008 00 0332 01 4 4 0070 10 0648 02 Spectrum Operating Instructions Accessories Optional Accessories 4 1 4 4 1 4 1 4 1 4 2 Gas Module Accessories Gas Module II and Gas Module SE DESCRIPTION PART NUMBERS Calibration Gas 0075 00 0028 Calibration Gas Regulator 0119 00 0166 Gas Mo
152. displayed use the 2 4 6 4 Display Setup Menu to select RESP or to be displayed as desired 12 If desired the waveform scale can be changed through the CO9 Menu CAUTION treated as biohazardous waste Respiration and CO Troubleshooting MESSAGE PROBLEM Resp Waveform Too Large REASON Scales set inappropriately Microstream waste and CO FilterLine should be SOLUTION Change lead selection Change Respiration scale Resp Waveform Too Small Patient breathing is shallow or patient is turned on side Scale set inappropriately Change lead selection Change respiration scale False Apnea Alarm No Resp Waveform or Rate Displayed Apnea delay may be improperly set Patient may be having frequent episodes of CVA Scale size may be too low Respiration turned Off Patient connected using ESIS choke cable Cable not connected Choose an other apnea delay Reposition electrodes to better detect respirations Change Respiration scale Turn respiration On Off will be displayed in Resp window Check that proper patient cable is used Use Mindray non ESIS patient cable Check cable FilterLine Disconnected The FilterLine is not connected to the monitor Connect the FilterLine Warming Up The sensor has not reached its operating temperature The monitor was just turned on Wait for the message to go
153. dule Rolling Stand Kit 0040 00 0232 01 Gas Module Wall Mount Kit 0040 00 0232 02 Y Power 120V 0012 00 1081 01 Y Power 220V 0012 00 1081 02 Y Power 240V 0012 00 1081 03 Dust Filter 0378 00 0040 Nasal Cannula 7 2 1 m box of 10 0683 00 0424 10 Nasal Cannula CO2 O 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 Sample Line Patient 10 3 1 box of 10 0683 00 045 1 10 Water Trap Assembly box of 10 0202 00 0129 Gas Scavenging Adapter Assembly Quick Connect 0997 00 0923 Gas Scavenging Adapter Assembly Luer 0997 00 0984 Spectrum Gas Module Mounting Kit 0040 00 0287 03 Gas Module 3 DESCRIPTION PART NUMBERS Calibration Gas 0075 00 0028 Calibration Gas Regulator 0119 00 0166 Mounting Bracket Gas Module to Spectrum 0040 00 0299 02 includes 4 screws Part Number 0212 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 Spectrum 0436 00 0160 requires 4 screws Part Number 021 1 04 4010 Y Power Cord 120V 0012 00 1081 01 Y Power 220V 0012 00 1081 02 Y Power 240V 0012 00 1081 03 Cable Gas Module to Spectrum Serial Port short 0 3 m 0012 00 1276 01 Cable Gas Module to Sp
154. e If not permanent loss of capacity may occur as result of sulfation Charge retention at 20 is 6 months to 83 Lithium Ion Storage of the lithium ion batteries depends on temperature time period and the degree of cell charging state After 6 months of storage at 23 C fully charged lithium ion batteries have a retention capacity of 93 Spectrum Operating Instructions 0070 10 0648 02 3 3 Recorder Paper Replacement User Maintenance 3 7 Recorder Paper Replacement The instructions below describe the replacement of recorder paper Use only recommended recorder paper Mindray part number 0683 00 0422 XX This ensures that the print quality is acceptable and reduces print head wear 1 Open recorder door by pressing the paper eject button 2 Remove empty paper spool 3 Insert new paper roll between the two rounded tabs of the paper holder with the sensitive shiny side of the paper facing the print head at the top of the recorder paper feeding off of the spool from the bottom 4 Unroll approximately 4 inches of paper 5 Align the paper across the top of the roller 6 Holding the paper in place close recorder door 7 To ensure that the paper is aligned properly and has not been pinched in the door pull the loose edge out a couple of inches If the paper jams open the door and return to step 5 3 8 Care and Storage of Thermal Chart Paper Thermal Chart Paper is chemically treated and the permanency of a recor
155. e Delta Bed 4 383 B Speed 25 mm s ST V5 44 1 mm Trace II 1 cm mV Sources Keg ST II 42 7 mm Resp ECG II 8 RPM ST V4 42 8 mm HR ECG TU BPM 5 2 X 1 137 72 94 mmHg Temp 85 9 2 35 13 22 mmHg Insp Et mmHg NIBP 137 7 88 103 mmHg 02 Et 7 Insp X Interval Off N20 Et 7 Insp X ET 1 min Agent Et Insp X FIGURE 2 63 Sample Printout Single Waveform Name ARTHUR IAN Date 2 5 82 EGG Filter ST ID 233 433 8600 Time 18 14 08 ST Mode Delta Bed 4 303 B Speed 25 mm s ST V5 4 2 mm Trace II 1 cm m Source Key ST V4 42 9 mm Vi 81 cm mV Resp ECG II 10 RPM ST V6 42 9 mm HR ECG 79 BPM 5 2 97 1 137 72 94 mmHg Temp 86 1 F 2 35 13 22 mmHg CO2 Insp 7 Et mmHg NIBP 137 7 88 103 mmHg O2 Et Insp Interval Off N20 Et Insp X ET min Agent Et Insp X FIGURE 2 64 Sample Printout Two Waveforms Continuous ECG Printing If a realtime continuous printing of ECG data is required press the CONT ECG key Press CONT ECG again to abort printing 2 110 0070 10 0648 02 Spectrum Operating Instructions Operations Printing Optional Printing Frozen Waveforms When waveforms are frozen by pressing the FREEZE key the recorder will print an 8 second strip of Wavef
156. e ESIS Capability 3 or 5 lead 12Jead I Il Ill aVR aVL aVF V1 V2 V4 V5 3 or 12 lead ST Analysis Arrhythmia Analysis 12 lead ECG Interpretation Blood Pressure Non Invasive Blood Pressure Up to 4 channels of Invasive Blood Pressure Wedge Pressure with reference line Cardiac Output Mindray External Parameter Module EPM Edwards Vigilance Monitor 5 2 Temperature Masimo SET One YSI 400 700 channel Nellcor OxiMax Second YSI 400 700 channel Respirations Trend Lead selectable Impedance Tabular and Graphic trends with 120 entries OxyCRG trending 6 minutes Microstream CO Gas Module with Automatic Agent ID Extended trend display with up to 500 entries OxyCRG trending 12 hours Power Internal isolated power module Sealed lead acid batteries Lithium ion batteries Printing External Interfaces Mindray s Central Stations Gas Module IABP Systems Remote Displays Nurse Call Systems Serial Communications Internal recorder 12 ead ECG data to Laser Printer Edwards Vigilance Monitor Calculation IV drug calculations Hemodynamic calculations Other Soft Grip Handle Navigator Knob Dedicated keys Dual PCMCIA Ports Mounting kits Patient and monitor data transfer 5 Edwards Vigilance Monitor Spectrum Operating Instructions 0070 10 0648 02 Keys and Front Panel General Product Description
157. e the Spectrum uses the following formula Dose Ordered x Weight in kg x Solution Volume _ Infusion Rote ml hr Drug Amount For non weightbased Drug Infusion Rate the Spectrum uses the following formula Dose Ordered x Solution Volume _ Diag Ameti Infusion Rate ml hr 0070 10 0648 02 Spectrum Operating Instructions Operations Calculations Drug Calculator When Drug Calculator is chosen from the Patient Menu or the Functions Menu the Drug Calculator is displayed An example Drug Calculator that is set for a weight based drug is shown in FIGURE 2 56 Drug Calculator Normal Screen Drug Name Weight Drug Amount Solution Volume Dose kg min Dose Kg hr Print Units Print Table FIGURE 2 56 Drug Calculator set for a weight based drug Doparnine Inotropin 150 lbs 68 2 9 400 0 mg 250 ml 5 00 meg Kg min 300 00 meg kg hr Infusion Rate 12 79 ml hr Concentration 1600 0 meg ml Dose kg min Select to enter dosage of drug to be infused per minute based upon patient weight Please verify patient weight The following table describes the menu structure of the Drug Calculator Drug Calculator Menu Structure MENU TITLE ACTIONS ON SCREEN MENU CHOICES COMMENTS Normal Screen Select to return to normal screen Drug Name Weight See the GENERIC NAME and BRAND NAME columns of the table in the Adult Medication Choices subsection The Drug A
158. e ST Analysis selection in the ST Menu is On The Spectrum will learn the patient s QRS complexes one for a 3 lead cable 3 for a 5 lead or 12 lead cable These learned complexes will appear in the ST Menu with the monitor selected ISO and J ST points displayed Scroll to the ISO selection to adjust the isoelectric point on the learned QRS complex The isoelectric point is the area of the QRS complex following the P wave and before the start of the Q wave Adjust the ISO point by pressing the Navigator Knob and turning to adjust the white ISO reference line Press the Navigator Knob when the ISO point is satisfactory Scroll to the J ST point heading Adjust the J ST point by pressing the Navigator Knob and turning to adjust the orange and green J ST reference lines Press the Navigator Knob when the J ST points are satisfactory To adjust the ST pt scroll to the ST pt heading and press the Navigator Knob to display a list of ST measurement point settings Select the appropriate setting then press the Navigator Knob when the ST pt choice is satisfactory 2 4 2 8 Relearning ST or Arrhythmia Analysis The Spectrum initiates the learning process for ST measurements or Arrhythmia analysis after one of the following Unit Power Up Return to normal monitoring from Standby mode Enabling ST or Arrhythmia analysis The lead has been changed in ECG 1 waveform 3 lead only Patient Size is changed Whenever the Relearn function is
159. e classified by severity For priority 1 or Warning alarms The red alarm LED flashes The data in violation of the alarm flashes over a red background The priority 1 audio alarm sounds The priority 1 audio alarm is a pattern of 10 tones repeated every 10 seconds For priority 2 or Caution alarms The amber alarm LED flashes The data in violation of the alarm flashes over an amber background The priority 2 audio alarm sounds The priority 2 audio alarm is a pattern of 3 tones repeated every 30 seconds For both priority 1 and priority 2 alarms If there is no displayed digital data associated with the alarm a message will be posted in Message Area A that identifies the alarm If the Print on Alarm feature has been enabled and an alarm violation occurs The internal recorder will print a 2 wave 16 second strip The upper wave will be ECC and the lower wave will be that of the parameter associated with the alarm violation e Any other printing in process at the time of the alarm will be aborted Data in violation of an alarm will be printed within brackets bar will be printed along the top margin of the waveform area to mark the time the alarm was triggered A Parameter Alarms Individual alarm levels are adjustable for most of the parameters Spectrum is capable of monitoring In addition these alarms may be set by the user to either priority level 1 or 2 as desired NOTE The Heart Rate Alarm can
160. e ea nee dpa ern 3 2 ii 0070 10 0648 02 Spectrum Operating Instructions Table of Contents Sterilization and Cleaning of Reusable Bladderless Battery Replacement and Maintenance sss Battery Replacement e ater s Lege fetes tenuate Battery Maintenance OE ot e pine bes Ve odi Leto aede pie tete R cerder Paper Replacement ee HR RC PER OUR CO D E rst e btr RE aE AaS Care and Storage of Thermal Chart Paper m Care and Gleanitigiof Gas Module en tg iet ted tet ett boite ite ee pede ret esten Gas Module Il and i enne Gas Module Sest cse RO RI s Em m s Care and Cleaning of 3 and 5 lead ECG Cables and Leadwires Care and Cleaning of View 12 ECG Analysis Module A QA Optional Aecessories ORE REIR PUR TURO AERE erem cd y NIBP Accessories ERE eee rte ste ege edes dtd fs e o e E CO E i ede Oximetry Sensors arid ACCessories esc e eee d a gat eas n trae ce e eene fus atte Pulse Oximetry Masimo SET LNOP SpO Pulse Oximetry Masimo Sei LNCS SpO Pulse Oximetry Nellcor OxiMax SpO m Oridion GOs Accessorles o TR e en e e Iter e ae tus Gas Module Accessories ccccccscscec
161. e of the CO The units of measure for each parameter are CO l min CI min m NOTE If the CO amp PAWP Timeout setting in the Installation Menu is exceeded the CO and CI numeric data in the CO tile will be replaced by dashes and the time stamp will be removed 5 4 a CI 2 7 min m Q 3 06 PM Source Module FIGURE 2 51 Example CO tile with Intermittent Cardiac Output from the EPM Optimizing EPM CO Measurements 1 From the PA catheter package insert verify the correct computation constant for the catheter type injectate volume and injectate temperature If the computation constant is different than the monitor s factory default of 0 500 it must be changed 2 Verify proper PA catheter positioning 3 Purge system of air 4 Use correct injectate port 0070 10 0648 02 Spectrum Operating Instructions Operations 241111 Parameter Menus and Monitoring 5 Inject correct volume in smooth motion 6 Edit erroneous values from average EPM CO Setup 1 Ensure that the Spectrum is powered OFF 2 Connect the EPM to the Spectrum as follows a Align the 1 Module Connector on the EPM with the EM1 External Parameter Module Port on the rear of the Spectrum b Slide the EPM and the Spectrum together using the Guide Pins on the EPM to guide the EB1 connector into the EMT port The Module Latches on the EPM will secure it to the Spectrum 3 Power ON the Spectrum while holding down the DI
162. e stored If the Extended Trend option is installed a maximum of 12 hours of data may be stored When the maximum storage time has been reached the oldest data will be deleted from the database in order to allow storage of new data OxyCRG Mormal Screen Scroll Event Rescale Waves Clear Trends List Trend k Graph Trend 4 Select to return to normal screen FIGURE 2 61 OxyCRG Display Menu The general operation and format of the OxyCRG Menu items and display is the same as for Graph Trend display described previously Parameters Displayed The parameters displayed are Heart Rate from ECG source only SpO 5 condensed thoracic impedance respiration wave with digital rate data IBP1 and Temperature Transferring OxyCRG Data Between Different Spectrum Monitors OxyCRG data may not be transferred between monitors Spectrum Operating Instructions 0070 10 0648 02 2 107 Trends 2 7 4 2 108 Clearing Trend Data Operations To manually clear all trend data including List and Graph trends choose Clear Trends from the menu A confirmation prompt will appear Once cleared the data cannot be restored All trend data is automatically cleared when the patient is discharged from the monitor All trend data is also cleared if the monitor s displayed time or date is changed Removing the OxyCRG Display The OxyCRG Trend display does not automatically time out and must be manually re
163. ears when the Spectrum 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 Customer 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 Customer Support Not Ready For Calibration Appears when the Gas Module is unoble to initialize calibration Repeat calibration procedure If problem persists contact Mindray Customer 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 Customer Support Calibration Error Zeroing Error Appears when the Gas Module cannot perform a Zeroing during calibration Repeat calibration procedure If problem persists contact Mindray Customer Support 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring 2 4 9 IBP Invasive Blood Pressure Menu Optional Invasive Blood Pressure IBP is a direct measurement of the patient s arterial or venous blood pressure IBP utilizes a catheter that is inserted directly into a vein artery or other pressure access areas and is connected to a transducer for interpretation of Systolic Sys Diastoli
164. econds then the cuff is vented and a retry cycle is initiated up to 3 times Maximum Leakage The maximum allowed pressure drop with the bleed valves closed is 10 mmHg in 10 seconds as measured with a 500 cc volume at differential pressures of 250 mmHg 150 mmHg and 50 mmHg Reference ANSI AAMI SP10 1992 EN1060 3 1997 Vent Rate A volume of 500 cc when vented is reduced from a pressure of 260 mmHg to a pressure of 15 mmHg in a maximum of 10 seconds For Neonate from a pressure of 150 mmHg to a pressure of 5 mmHg in less then 5 seconds Reference EN1060 3 1997 Initial Conditions The NIBP will power up and go into a warm up state An NIBP Zero is performed automatically before the NIBP can be initiated An NIBP measurement will not initiate until the unit has been powered on for 20 sec in order to allow time for the Zero Afterwards it goes into an idle state Spectrum Operating Instructions 0070 10 0648 02 Patient Parameter Specifications Appendix 5 2 4 NIBP Start Pressure Settings and Ranges The Start Pressure is adjustable throughout the following ranges and is set to the following defaults USER SELECTABLE START DEFAULT PATIENT SIZE PRESSURE RANGE INCREMENT SIZE SETTING Adult Mode 100 280 mmHg 5 mmHg 180 mmHg Pediatric Mode 60 180 mmHg 5 mmHg 140 mmHg Neonatal Mode 40 120 mmHg 5 mmHg 100 mmHg NIBP Measurement Cycle There are two different modes of measurement operation manual and interval modes The ma
165. ection silences the audio portion of a remote alarm for the duration that is selected from the Remote Mute For list in the Remote View Setup Menu The factory default is 2 minutes While the audio alarm is silenced the visual alarm indicators remain displayed the message ALARMS MUTED FOR XX XX mins is displayed in the message area of the Remote View Menu The XX XX in the message is a digital timer for the mute time remaining ifa new remote alarm occurs during this time the current alarm will remain silenced while its digital timer continues to count down and the new alarm tone will sound an Alarm Mute icon resembling a crossed speaker is displayed in the numeric tile of each muted parameter and in the Numeric Data Area if one or more parameters in that area are muted If Remote Mute is selected again the digital timer is reset NOTE The Remote Mute selection silences only the alarms indicated in the Remote View Menv It does not silence the primary patient s alarms or alarm sounds at the remote location Spectrum Operating Instructions 0070 10 0648 02 Operations 4 Remote Mute All this selection silences the audio alarm tones of all remote alarms for the duration that is selected from the Remote Mute All For list in the Remote View Setup The factory default is 2 minutes While the audio alarms are silenced the visual alarm indicators remain displayed the message A
166. ectrum Serial Port long 1 8 m 0012 00 1276 02 Nasal Cannula 7 2 1 m box of 10 0683 00 0424 10 Nasal Cannula CO2 O 7 2 1 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 box of 25 0683 00 0524 25 For U S use only Spectrum Operating Instructions 0070 10 0648 02 4 5 Optional Accessories Accessories DESCRIPTION PART NUMBERS 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 Spectrum Gas Module Mounting Kit 0040 00 0287 03 Wall Mount 0436 00 0061 01 For US use only 4 1 5 Reusable Temperature Probes YSI 400 DESCRIPTION PART NUMBERS Adult Rectal Esophageal 0206 02 0001 Pediatric Rectal Esophageal 0206 02 0002 Skin Surface 0206 02 0003 YSI 700 DESCRIPTION PART NUMBERS Adult Rectal Esophageal 0206 00 0701 Skin Surface 0206 00 0709 4 1 6 Disposable Temperature Probes 400 Series Probes boxes of 20 DESCRIPTION PART NUMBERS Esophageal Stethoscope 12 Fr ES 400 12 0206 03 01 12 02 Esop
167. ed If CVA is detected the message CVA is displayed Status Messages that are supported by the Remote View are NOTE leads Off SpOs Sensor Fault SpO Check Sensor SpO Failure SpO Interference SpO Low Perfusion SpOz Motion 5 No Pulse SpO No Sensor 5 Pulse Search SpO Sensor Off Status Messages are not displayed if high priority alarms are alternately displaying Spectrum Operating Instructions 0070 10 0648 02 2 21 Parameter Menus and Monitoring Operations 2 4 24 1 2 4 2 Parameter Menus and Monitoring Each parameter s menu can be accessed from the Parameters menu or by selecting its menu target on the normal operating screen ECG Monitoring ECG is a continuous waveform of a patient s cardiac electrical activity The ECG waveform will display in the first waveform area of the Spectrum The quality of an ECG signal is directly affected by electrode site skin preparation electrode patch quality and ECG lead placement If artifact is present on the ECG waveform then the arrhythmia processing alarm processing and quality of the monitoring function may be affected The presence of artifact can prevent the monitor from establishing an accurate ECG reference waveform increasing the difficulty experienced in assessing the ECG rhythm Optimizing the ECG signal is imperative for accurate monitoring Use high quality e
168. ed above the ECG1 waveform area NOTE PVC min will not be displayed during periods of Ventricular Rhythms V TACH V FIB and Asystole Run Alarm The Run alarm is activated when the number of consecutive PVCs occur at a rate that equals or exceeds the user defined V Tach Rate The number of consecutive PVCs that constitute a Run is one beat less than the minimum used to identify V Tach The Run alarm is a Priority 2 alarm event that produces arm Priori visual and audio alarm indicators Al P 2 and audio al dicat A RUN text message above the ECG1 waveform area Trigeminy Alarm The Trigeminy alarm is activated when three or more cycles of one PVC coupled to two normal beats are detected This rhythm could also cause an Irregular HR alarm The Trigeminy alarm is a Priority 2 alarm event that produces Alarm Priority 2 visual and audio alarm indicators A TRIGEMINY text message above the ECG1 waveform area Ventricular Rhythm V Rhythm Alarm The V Rhythm alarm is activated when more than 2 consecutive PVCs occur at a rate that is less than the user defined V Tach Rate The V Rhythm alarm is a Priority 2 alarm event that produces Alarm Priority 2 visual and audio alarm indicators A VENTRICULAR RHYTHM text message above the ECG1 waveform area Spectrum Operating Instructions 0070 10 0648 02 2 39 Parameter Menus and Monitoring Operations 2 4 2 6 Arrhythmia Analysis Optional WARNING The arrhythmi
169. eecccessseeeeeeeceeesssseeeeeseeeessssseeeeeeeeeceessseeeeceseesessseeeeseceesssssseseeceenstsaees Gas Module Il and Gas Module SE cccccccccccccecccsssssseeeeeeceecesssseeeeceseessssseeeeeceeeessssseeeeeseceestssaaeeeess Gas Module 9 6st tret ete tmd iun edes bett cott tees eres aet Nerve t ban ha etui ds Reusable Temperature Probes ot TRA b dad ee edet att Rh eer ep Ee ee Disposable Temperature Probes ene Accessories ECG Cables ECG Leadwites seed b eo SR a RR REPE tdem 12 Lead ECG Accessories BMMMEEEEEEEEEEEEEEEEEEEEEMMMMMM Electrodesc ie es 5 s oot ble eedem reed tes deb da Comm PortACCessories s n Ive M atte te sette te dite Hd o eh ortas Base St ti n ACCessOFles eicere beet Petre ide mes etri err eed feb rao per ae Ede eei Miscellaneous Accessories 4 a tiae estre e Mounting Kits and Accessories Upgrade Kitsee RD Central Station Accessories esse eene ne nne ee enne nnne essen nene enn sess s External Parameter Module Accessories sssssss Renee ee nennen ne en nenne enne nennen nennen QE H A Salely Designations dote t te ti
170. eferenced to 10 Hz DC to 15 Hz minimum Maximum Propagation Delay 25 ms Sensitivity 1 V 100 mmHg 10 The Spectrum supports slaving of an IABP from Arterial Blood Pressure analog output Sync Pulse for Cardioversion Source The Sync Pulse is derived from the active ECG source Propagation Delay 35 ms maximum between QRS peak and the rising edge of the Sync Pulse Amplitude 2 Vp minimum into a 5 load Width 3 5 LEAD ECG 12 LEAD ECG 2 7 ms 9 11 ms Spectrum Operating Instructions 0070 10 0648 02 5 27 Communication Protocols 5 6 5 28 Appendix Communication Protocols DIAP Communication Protocol The Spectrum supports the Mindray Improved ASCII Protocol 0070 00 0307 with the following exceptions 1 The NIBP elapsed time is set to when the elapsed time is greater than 999 minutes 2 Though not specified in the protocol the alarm limit values are at the same resolution as the parameter value Example temperature is 10X therefore the alarm limit values are also 10X Gas Module The Spectrum supports the Gas Module Communication Protocol 0084 00 0025 ELAN Communication Protocol The Spectrum supports the ELAN Communication Protocol for communication to the Panorama Central Station 0084 00 0007 Accutorr Communication Protocol The Spectrum supports the Accutorr Communication Protocol 0070 00 0304 with the following exceptions 1 Baud Rate 9600 or 1200 2 The following Show p
171. eforms will print continuously These waveforms are the top two 2 waveforms appearing in the Wedge Menu The printed strip will be annotated with the waveform names and scales every 18 seconds Laser Printing 12 lead Printing 12 lead data to a laser printer is similar to the printing of the data to the recorder The data will print Landscape orientation to the laser printer to pre grid laser printer paper The printout will include in addition to the data on a recorder strip 10 second rhythm strip of Lead Il NOTE Printing 12 lead to a laser printer is not available when WM TS Enabled is set to Yes in the Installation Menu Date 2 26 02 Time 11 14 AM Patient DOUGH JOHN ID ER Male Date of Birth 3 10 1950 Vent rate 90 BPM SINUS RHYTHM PR int 140 ms RSR QR IN V1 V2 CONSISTENT WITH RIGHT VENTRICULAR CONDUCTION DELAY QRS dur 72 ms BORDERLINE ECG QT dTc 320 367 ms P QRS T axes 50 51 51 UNCONFIRMED REPORT peed 25 m s ECG Filter Monitor l aVR xp UE Eo 9 LO Li avi Lai LL mam s A asd b d OW ve 1m FIGURE 2 70 12 lead Laser Format Spectrum Operating Instructions 0070 10 0648 02 2 115 Printing Optional Operations 2 8 2 2 8 3 Printing 12 lead to the Laser Printer 1 To select the print destination for 12 lead ECG data select the Print Setup Menu and ensure
172. eft sternal border Place V3 brown chest lead midway between V2 and V4 on a straight line Place VA brown chest lead in the fifth intercostal space mid clavicular line Place V5 brown chest lead in the fifth intercostal space anterior axillary line Place V6 brown chest lead in the fifth intercostal space mid axillary line 0070 10 0648 02 FIGURE 2 19 View 12 Card Lead Placement IEC Place R red electrode under the right clavicle mid clavicular line within the rib cage frame Place L yellow electrode under the left clavicle mid clavicular line within the rib cage frame e Place F green electrode on the lower left abdomen within the rib cage frame e Place N black electrode on lower right abdomen within the rib cage frame e Place C1 white chest lead in the fourth intercostal space right sternal border Place C2 white chest lead in the fourth intercostal space left sternal border Place C3 white chest lead midway between C2 and C4 on a straight line e Place white chest lead in the fifth intercostal space mid clavicular line Place C5 white chest lead in the fifth intercostal space anterior axillary line Place C6 white chest lead in the fifth intercostal space mid axillary line 2 29 Parameter Menus and Monitoring 2 30 Lead II Monitoring The recommended lead placement for Lead II monitoring is as follows Operation
173. ent Contact Phone Accutorr Baud Rate DIAP Baud Rate Enable Network IP Address Subnet Mask ID Wireless IP Address Wireless Subnet Mask ID Laser Printer IP Address Network Name Device ID Select to return to previous menu FIGURE 2 2 System Information Menu This screen is accessed by rotating to the System Information selection on the Installation Menu and pressing the Navigator Control Knob Each item on this screen is accessed in the same manner as the other menus on the monitor Some items provide menu choices while others require information to be entered via a keypad like entry screen To enter information rotate to the desired letter or number and then press the Navigator Control Knob to select When finished rotate to the Previous Menu tag and press the Navigator Control Knob See the table that follows for descriptions of the System Information menu choices 2 6 0070 10 0648 02 Spectrum Operating Instructions Installation Mode MENU TITLE ON MENU SCREEN CHOICES DEFAULT TEXT STRINGS Previous Menu Select to return to Previous Menu Property Of Select to set up Property name Location Select to set up Location Department Select to set up Department Contact Select to set up Contact Phone Select to set up Phone 1200 9600 9600 Accutorr Baud Rate Select to change the Accutorr protocol baud rate DIAP Baud Rate 9600 19200 9600 Select to change the DIAP protocol ba
174. ent Parameter Specifications Tall T Wave Rejection Step Change Response Time Pacemaker Pulse Rejection Appendix When tested in accordance with ANSI AAMI EC 13 1992 Section 4 1 2 1c the heart rate meter rejects all T waves with amplitudes less than 120 of a 1mV 100 ms QRS and a T wave duration of 180ms and a QT interval of 350 ms When tested in accordance with ANSI AAMI EC 13 1992 Section 4 1 2 1f the response time of the heart rate meter to changes in heart rate is Less then 10 sec for step increase from 80 to 120 bpm Less then 11 sec for step decrease from 80 to AO bpm When tested in accordance with ANSI AAMI EC13 1992 Section 4 1 4 the heart rate meter rejects tall pulses of amplitude 2 0 mV to 700 mV and duration 0 1 ms to 2 ms with no tail When tested in accordance with ANSI AAMI EC 13 1992 Section 4 1 4 3 5 Lead ECG derived heart rate meter will reject all pacer pulses 2 0 mV to 700 mV and duration ms to 2 ms with 4 ms time constant tail of less than 2 0 mV NOTE 12 lead does not reject Pacemaker pulses with tails Heart Rate Averaging 0070 10 0648 02 3 5 12 Lead ECG The average heart rate is calculated as follows Mean R to R interval in the last 16 R to R intervals HR gt 48 bpm Mean R to R interval in the last 4 R to R intervals HR lt 48 bpm Spectrum Operating Instructions Appendix 5 2 2 Sensing Leads Default Sensing Lead Source
175. entricular beats in a row will constitute V Tach V Tach Rate 100 to 180 bpm Factory default is 120 bpm Use Navigator Control knob to select the heart rate threshold which must be reached to constitute V Tach Asystole Delay 3 to 10 seconds 3 5 lead Factory default is 4 seconds for 3 5 3 to 8 seconds 12 lead Lead and 3 seconds for 12 Lead Use Navigator Control knob to select the number of seconds with an absence of an R wave that will constitute asystole Relearn Use Navigator Control knob to select to relearn Arrhythmia and ST ECG Noise Delay 3 to 30 seconds Factory default is 5 seconds Use Navigator Control knob to select the number of seconds to delay the ECG Noise Alarm Only available with 3 lead or 5 lead 2 12 0070 10 0648 02 Spectrum Operating Instructions Operations Main Menus 2 5 5 Print Setup Menu Print Setup Menu Normal Screen Waveform 1 Waveform 2 Select Printer Print on alarm No Format Leader Print Every Off Select to return to normal screen FIGURE 2 6 Print Setup Menu Printing of Waveform Data The Print Setup Menu allows the user to set up waveforms for printing and gives the user the ability to change the print destination Waveforms may be printed at the time of an alarm by selecting Yes in response to Print on Alarm Waveforms may also be printed at regular intervals by selecting Print Every Available selections are 1 5 10 15 20 30 60 and
176. ering Pacemaker Pulse Display Rejection Enhancement Patient Parameter Specifications An ESU Interference filter provides greater than 90 dB attenuation at 500 kHz The ESU Filter may be turned off The 12 lead ECG function does not provide ESU interference filtering A Notch Filter is provided at 50 or 60 Hz The Notch Filter may be turned off Pacer signals from 2 mV to 700 mV RTI amplitude and 0 1 ms to 2 ms in duration and a maximum of 100 us rise time are rejected from the display when the Pacer Rejection Mode is On Pacer signals within the range 2 mV and 700 mV RTI amplitude with a maximum rise time of 100 us and with duration in the 0 1 ms to 2 0 ms range will be enhanced on the display when the Pacer Enhancement Mode is turned On ECG Systole Detector and Heart Rate Meter The ECG heart rate meter function is derived from the ECG waveform It provides a count of the number of R waves per minute that are detected in the ECG waveform ECG Derived Heart Rate Meter Performance Requirements NEONATAL RANGE BPM PEDIATRIC RANGE ADULT RANGE BPM BPM ECG SOURCE 3 5 lead ECG 30 to 350 30 to 300 30to 300 12Jead ECG 30 to 300 30 to 300 30 to 300 Resolution 1 bpm Accuracy 3 bpm or 3 at 30 to 250 bpm Trigger Indication Spectrum Operating Instructions 0070 10 0648 02 whichever is greater 5 251 to 350 bpm There is an audible beep on every beat captured Pati
177. erious 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 information is applicable Spectrum Operating Instructions 0070 10 0648 02 v Introduction Warnings Warnings WARNING Internal Electrical Shock Hazard This unit does not contain any user serviceable parts Do not remove instrument covers Refer Servicing to qualified personnel WARNING Trace Gas Hazard When using the optional Gas Module 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 exhaust output should be connected to a medical gas scavenging system WARNING Do not use this monitor 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 WARNING For continued protection against a fire hazard replace all fuses with the specified type and rating WARNING This unit uses a common isolation path for the ECG leads and the Invasive Pressure Channels Ensure that conductive parts of the ECG electrodes do not contact other conductive parts including earth ground Do not conne
178. eripheral perfusion due to hypothermia hypovolemia severe vasoconstriction reduced cardiac output etc These symptoms may cause a loss in vital sign readings The SpO sensor site should be checked at least every eight 8 hours every four 4 hours with the Adult re usable finger sensor Ensure proper adhesion skin integrity and proper alignment Exercise extreme caution with poorly perfused patients Skin erosion and pressure necrosis can be caused when sensors are not frequently monitored Assess the site every two 2 hours with poorly perfused patients and neonates When cleaning sensors do not use excessive amounts of liquid Wipe the sensor surface with a soft clorh dampened with cleaning solution Do not attempt to sterilize 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring 2 4 4 1 2 4 4 2 Masimo SET SpO Spectrum monitors equipped with Masimo SET SpO allow the user to adjust Sensitivity and Post Averaging Time The user should choose the sensitivity mode depending upon signal quality and patient motion In most cases the normal setting is appropriate If patient motion is limited high sensitivity can be used It is also possible to change the averaging time of the Saturation and Pulse Rate measurements The Post Average Time can be changed to 6 8 10 12 14 or 16 seconds CAUTION When equipped with Masimo SET SpO use only Masimo SET Oxygen Tr
179. extremity with an IV catheter or blood pressure cuff in place NOTE Ensure proper routing of patient cable to avoid entanglement and or strangulation pO Menu SpO Menu Normal Screen Normal Screen Sensor Off Audio Sensor Off Audio Off Sensitivity Mode Normal Grid Off Post Averaging Time 8 seconds Color cI Grid Off Change to Pleth Color I Change to Pleth Select to return to normal screen Select to return to normal screen FIGURE 2 37 SpO Menu Masimo SET FIGURE 2 38 SpO Menu Nellcor equipped unit equipped unit 3 The pleth waveform and digital value will be displayed by default in the second waveform and parameter area 4 Enter the Display Setup Menu to describe Pleth waveform and data in an alternate location 5 Set Sensor Off Audio in the SpO 2 Menu to the desired setting When set to Off the Spectrum will not give an audio beep When set to On the Spectrum will sound a series of 5 triple beeps Calibration The oximetry sub system incorporates automatic calibration mechanisms No other calibration is required Spectrum Operating Instructions 0070 10 0648 02 2 55 Parameter Menus and Monitoring Operations Auto Scaling The pleth waveform is automatically scaled and is not proportional to the patient s pulse volume There is no adjustment that can be made to the pleth waveform CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION 2 56
180. for any other medical procedure For example an IV Catheter NIBP Cuff or an SpO sensor 3 Connect catheter line with flushing device to a pressure transducer 4 Zero pressure transducer as follows a Open transducer vent to atmosphere b Press ZERO ALL IBP or individually zero pressure lines by opening individual IBP menus After the automatic zero process is complete the pressure display should indicate zeros NOTE If the transducer offset should exceed 120 mmHg it will not be possible to automatically zero the transducer Pressure values will be xxx and an Unable to Zero message will be displayed 5 Close the pressure transducer vent from atmosphere 6 Select the desired pressure scale in the IBP Menu 7 Zero and flush pressure line at regular intervals per standard hospital procedure NOTE Pressure transducers are protected against the effects of defibrillation electrocautery and cerebral perfusion Cerebral Perfusion Pressure CPP The monitor will calculate and display CPP under the following conditions The Hemodynamic Calculation option has been installed in the monitor One IBP channel has been labeled Art One IBP channel has been labeled ICP Display CPP located on the ICP parameter menu has been set to Yes PON NOTE CPP data will be displayed in the same parameter tile as the ICP data 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring
181. g to the previous reading of the systolic pressure After the first measurement in the timer mode the inflation pressure is the previous systolic 50 mmHg in the Adult Mode or Pediatric Mode and 40 mmHg in the Neonate Mode Suspension of NIBP Measurements 1 Press STOP to suspend an automatically timed measurement sequence or to end a measurement cycle already in progress deflate cuff 2 Press START to take an immediate measurement and resume a suspended timed measurement Sequence NOTE You can press STOP at any time to postpone a scheduled measurement or to terminate a measurement cycle already in progress 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring CAUTION Observe caution on all patients Neonates Pediatrics and Adults when NIBP is set to the Continuous Mode and the 1 minute interval When the NIBP continuous interval is selected the Spectrum will continually take back to back blood pressure readings As a safety precaution a limit is placed on continuous and 1 minute interval measurements In continuous mode after 5 minutes the NIBP interval will automatically switch to one measurement taken every 5 minutes In 1 minute mode after 10 minutes the NIBP interval automatically switches to measurements taken once every 10 minutes Reports have been made of nerve injury occurring during use of automatically cycled blood pressure cuffs NIBP Pressure Limit Fail Safe
182. gs pkg of 20 Adhesive tapes for Neonatal Y single patient adhesive sensors 0600 00 0065 pkg of 100 LNOP Il Neo Neonatal L single patient adhesive sensors for patients more 0600 00 0099 than 1 kg and less than 10 kgs pkg of 20 Adhesive tapes for Neonatal L single patient adhesive sensors pkg of 100 0600 00 0096 LNOP NeoPtPreterm neonatal Y single patient adhesive sensors for 0600 00 0046 01 patients less than 1 kg pkg 20 Posey wraps for Preterm neonatal Y single patient adhesive sensors 0600 00 0064 pkg of 12 LNOP II NeoPt L Preterm neonatal L single patient adhesive sensors for 0600 00 0098 patients less than 1 kg pkg 20 Posey wraps for Preterm neonatal L single patient adhesive sensors 0600 00 0097 pkg of 12 Adult Pediatric starter kit two adult and two pediatric single patient 0020 00 01 23 01 adhesive sensors and 3 66 m 12 cable Neonatal Y starter kit two neonatal and two preterm neonatal Y single 0020 00 0123 02 patient adhesive sensors and one 3 66 m 12 cable Clothing clips pkg of 5 0600 00 0084 Adhesive squares 12 cards 12 squares per card 0600 00 0085 Pulse Oximetry Masimo Set LNCS SpO DESCRIPTION PART NUMBER LNCS DC4 Adult finger reusable sensor 0600 00 0126 LNCS DC IP Pediatric finger reusable sensor 0600 00 0127 LNCS TC4 Reusable Adult Ear Sensor 0600 00 0128 LNCS ADTX Adult single patient adhesive sensors 20 Box 0600 00 0121 LNCS PD
183. gulator is on Repeat calibration procedure If problem persists contact Mindray Customer Support Spectrum Operating Instructions 0070 10 0648 02 2 73 Parameter Menus and Monitoring MESSAGE PROBLEM GM Uncalibrated REASON Appears after an unsuccessful calibration attempt of the sensor The numeric data for O will appear as and the 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 Customer Support GM N5O Uncalibrated Appears after an unsuccessful calibration attempt of sensor The numeric data for will appear as and waveform will be a flatline Ensure proper gas mixture is attached tightly and regulator is on Repeat calibration procedure If problem persists contact Mindray Customer Support GM Agents Uncalibrated Appears after an unsuccessful calibration attempt of the agent sensor 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 Customer Support GM Failed Appears when the Gas Module detects an unrecoverable error in its own operation Contact Mindray Customer Support Disconnected App
184. gy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The Spectrum is suitable for use in all establishments CISPR 11 other than domestic establishments and those directly Harmonie Class A connected to the public low voltage power supply Smissions EC network that supplies buildings used for domestic 61000 3 2 ERES Voltage Complies fluctuations Flicker emissions IEC 61000 3 3 0070 10 0648 02 5 41 Spectrum Operating Instructions Electromagnetic Capability Appendix TABLE 5 2 GUIDANCE AND MINDRAY DS USA DECLARATION ELECTROMAGNETIC IMMUNITY The Spectrum is intended for use in the electromagnetic environment specified below The customer or the user of the Spectrum should assure that it is used in such an environment IMMUNITY TEST Electrostatic discharge ESD IEC 61000 42 IEC 60601 TEST LEVEL 6 kV contact x8 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 transient burst 2 kV for power supply lines 1 2 kV for power supply lines 1 Mains power quality should be that of a typical commercial or hospital 61000 4 4 kV for input kV for input envir
185. h Clip 24 61 0 cm IEC 0012 00 1262 05 5 Lead Pinch Clip 40 101 6 cm IEC 0012 00 1262 06 Pinch Extended Leg 3 40 3 101 6 cm 2 60 2 152 4 cm AAMI 0012 00 1262 13 Pinch Extended Leg 3 40 3 101 6 cm 2 60 2 152 4 cm IEC 0012 00 1262 14 ECG Leadwires 12 Lead DESCRIPTION PART NUMBERS 12 Lead AAMI 0012 00 141 1 02 12 Lead IEC 0012 00 141 1 03 12 Long Lead AAMI 63 160 cm 0012 00 1588 12 Long Lead IEC 63 160 cm 0012 00 1587 Panorama Mobility Lead Wires DESCRIPTION 5 Lead Snap 24 61 0 AAMI PART NUMBERS 0012 00 1503 02 3 Lead Snap 24 61 0 cm AAMI 0012 00 1503 05 4 1 7 3 12 Lead ECG Accessories DESCRIPTION PART NUMBERS View 12 Domestic Kit VIEW 12DOMP2SP View 12 International Kit VIEW 1 2INTP2SP 4 8 0070 10 0648 02 Spectrum Operating Instructions Accessories Optional Accessories 4 1 7 4 Electrodes DESCRIPTION PART NUMBERS Neo Pre wired 3 Lead Combiner Clip 18 AAMI box of 100 Pks of 3 Ea 0681 00 0098 01 Radio Opaque Set Neo Pre wired 3 Lead Combiner Clip 18 AAMI box of 100 Pks of 3 Ea 0681 00 0098 02 Radio Translucent Set Disposable pre gelled ECG Electrodes foam base and Hydrogel 0681 00 0100 01 conductive adhesive 1 case of 600 10 boxes of 60 Disposable pre gelled ECG Electrodes foam base and Hydrogel conductive adhesive 1 case of 60 0681 00 0100 02 4 1 8 IBP A
186. h used to power the unit ON and OFF It is located on the front of the Gas Module SE and Gas Module 3 It is located on the back of the Gas Module Il Rear Panel A LJ SS o FIGURE 1 9 Gas Module Il and SE mindray W Gas Module 3 E anaw Bg Yomom CEE Manufactured in Sweden Ao Mindray OS USA Inc FIGURE 1 10 Gas Module 3 7 ACPower Input This input is used to attach the special Y Shaped Power Cord 8 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 9 Reference Port This port is used only to measure room air This port is not to be connected to anything Do not block this port 10 External Interface Port communication interface port used to connect the Gas Module to the Spectrum 11 Equipotential lug Provides Equipotential grounding of hospital equipment Spectrum Operating Instructions 0070 10 0648 02 1 17 Comm Ports General Product Description 1 9 Comm Ports NOTE Figures 1 12 to 1 15 depict four distinct sub models of the Comm Port that have different interface capabilities Only one sub model at a time can be connected to the Spectrum FIGURE 1 11 Comm Port 1 Comm Port to Main I O Connector DB1 This is the female connector that will engage the equivalent male connector when connected to the Spec
187. hageal Stethoscope 18 Fr ES 400 18 0206 03 0118 02 Esophageal Rectal 9 Fr ER 400 9 0206 03 0209 02 Esophageal Rectal 12 Fr ER 400 12 0206 03 0212 02 Skin SK 400 0206 03 0300 02 Instrument Cable 400 Series 0012 00 0975 0070 10 0648 02 Spectrum Operating Instructions Accessories Optional Accessories 4 1 7 4 1 7 1 4 1 7 2 ECG Accessories ECG Cables 3 5 Lead ECG Cables DESCRIPTION 10 3 1 m Straight 20 6 1 m Straight PART NUMBER 0012 00 1255 01 0012 00 1255 02 10 3 1 m Right Angle 0012 00 1255 03 20 6 1 m Right Angle 10 3 1 m Straight ESIS 0012 00 1255 04 0012 00 1255 05 20 6 1 m Straight ESIS 0012 00 1255 06 10 3 1 m Right Angle ESIS 0012 00 1255 07 20 6 1 m Right Angle ESIS 0012 00 1255 08 10 3 1 m Neonate Cable AAMI 0012 00 1265 01 10 3 1 m Neonate Cable IEC 0012 00 1265 02 Panorama Mobility Cable ESIS and Non ESIS DESCRIPTION Non ESIS 10 3 1 m AAMI Non ESIS 20 6 1 AAMI PART NUMBER 0012 00 1502 01 0012 00 1502 02 ESIS 10 3 1 m AAMI 001 2 00 1 502 03 ESIS 20 6 1 m AAMI ECG Leadwires ECG Lead Wires 3 Lead DESCRIPTION 3 Lead Snap 18 45 7 AAMI 001 2 00 1 502 04 PART NUMBERS 0012 00 1261 07 3 Lead Snap 24 61 0 AAMI 0012 00 1261 08 3 Lead Snap 40 101 6 cm AAMI 0012 00 1261 09 3 Lead Snap 18 4
188. he patient s right clavicle at the mid clavicular line within the rib cage frame Place the L yellow electrode under the patient s left clavicle at the mid clavicular line within the rib cage frame Place the F green electrode on the patient s lower left abdomen within the rib cage frame Place the N black electrode on the patient s lower right abdomen within the rib cage frame Place the C white electrode in one of the C lead C1 C6 positions depicted in the following section Spectrum Operating Instructions Operations Spectrum Operating Instructions View 12 Card Parameter Menus and Monitoring A View 12 card utilizes a 10 wire ECG lead set that can monitor 12 ECG vectors I VL Ul aVR aVL aVF V1 V2 V3 VA V5 and V6 simultaneously The recommended lead placement for a View 12 card is as follows FIGURE 2 18 View 12 Card Lead Placement Place RA white electrode under the right clavicle mid clavicular line within the rib cage frame Place LA black electrode under the left clavicle mid clavicular line within the rib cage frame Place LL red electrode on the lower left abdomen within the rib cage frame Place RL green electrode on lower right abdomen within the rib cage frame Place V1 brown chest lead in the fourth intercostal space right sternal border Place V2 brown chest lead in the fourth intercostal space l
189. he CO is out of the measurable range 0 2 l min to 20 0 l min Computation constant incorrect for PA catheter type injectate temperature and injectate volume Improper injection procedure Catheter may be kinked or not in proper position Patient movement during injection Measurement displayed if CO curve has multiple peaks failure to return to baseline or irregularities in curve Check computation constant and enter correct data Rebolus when ready Check hospital policy inject in a smooth and fluid bolus Notify physician Have patient lay still during bolus procedure Rebolus when ready Delayed Injection Injectate Temp Error Appears if the time between the start of the CO measurement and the onset of the temperature change is more than fifteen 15 seconds Appears when the temperature of the injectate is too warm gt 27 C or the difference between the injectate and the blood temperature is 8 C Rebolus when ready Ensure that the CO bolus is initiated within 15 seconds Check the temperature of the injectate Check injectate fluid insure fluid is not under warm lights near a warming blanket or another warm source Noisy Baseline Cardiac Output waveform baseline is unstable Rebolus when ready Measuring Appears once an injection is detected during the process of a CO run Injectate Temp Out of Range Appears when the temperature of the injectate is too
190. hile the Vigilance CO Menu is open will have no effect 9 PAWP Press this key to open the Pulmonary Artery Wedge Pressure PAWP Menu and measure the PAWP The key is active if a pressure channel has been labeled PA 10 LIMITS Press this key to display the Alarm Limits Menu The Alarm Limits Menu provides access to view or change alarm values 11 MUTE ALL Press this key to suspend audio alarms on all parameters The alarms remain suspended for a user selected amount of time This amount of time is set in the Alarms Setup Menu While the alarms are suspended an Alarm Mute icon is displayed next to each silenced parameter Also the message ALL ALARMS MUTED FOR XX XX mins displays XX XX is the time remaining in minutes and seconds Press this key again during the suspended alarm time to re enable the audio alarm If the suspend time was set to Permanent the message ALL ALARMS MUTED PERMANENTLY is displayed 12 MUTE Press this key to suspend audio alarms on all currently alarming parameters The alarms remain suspended for a user selected amount of time as set in the Alarms Setup Menu or until the alarm condition is no longer present Any new alarms that occur while the alarm tone is silenced will disable the silence and sound the alarm tone While the alarms are suspended an Alarm Mute icon is displayed next to each silenced parameter Spectrum Operating Instructions 0070 10 0648 02 1 5 Keys and Front Panel General Product
191. hythm A clinician has observed clinically questionable arrhythmia calls A Relearn must be initiated if Learning occurred during a Leads Off condition Spectrum Operating Instructions 0070 10 0648 02 2 41 Parameter Menus and Monitoring Operations 2 4 2 7 ST Analysis Optional ST Analysis is available for Adult and Pediatric patients only ST deviation Depression or Elevation ISO Point J Point ST Point 4 gt 40 to 80 FIGURE 2 33 ST Monitoring The depression or elevation of the ST segment is measured as the vertical distance between the isoelectric ISO point which provides the baseline and the ST point See figure above ST measurements are available on a maximum of three user selected ECG leads at a point situated 80 ms heart rate 120 bpm or less or 60 ms heart rate more than 120 bpm from the algorithmically determined end point of the QRS J Point In addition the user can also select from three 3 different settings for the ST measurement point 80 60 or 40 ms from the J point and independent of heart rate These measurements are valid only on normal beats Abnormal beats like ventricular beats are excluded from the analysis of the ST segment Ventricular paced beats are also rejected from the analysis of the ST segment because pacemaker tails distort the shape of the ST segment ST segment changes are continuously measured by the monitor but update of the displ
192. ibility in the event of loss or damage in transit Spectrum Operating Instructions 0070 10 0648 02 5 49 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 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 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 USA s option at the factory or at an authorized Mindray 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 has any au
193. ician Check Patient and verify BP with manual method Measure patient limb Use only properly sized Mindray accessories Reading too high or too low Incorrect cuff size Patient movement Measure Patient limb use correct cuff Wait until patient is calm or gently hold limb NOTE available NOTE cuff can distort BP measurement NOTE NOTE Cuff should be at heart level Always have an alternate method of BP verification On vasoconstricted patients failure to evacuate air from the The presence of an arrhythmia may increase the time required to complete a measurement and may cause measurement cycle to extend beyond a point where a measurement can be completed 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring 2 4 4 SpO Pulse Oximetry Pulse oximetry is a continuous and non invasive measurement of the amount of oxygen attached to the hemoglobin in red blood cells SpO is an estimation of arterial oxygen saturation SpO2 may be used interchangeably with The Spectrum comes standard with Masimo SET SpO Nellcor Oxismart or OxiMax SpO is an option SpO Measurements 1 Select the appropriate sensor for the patient 2 Attach the SpOs patient cable to the sensor and plug the other end of the patient cable into the 5 connector located on the left side panel of the monitor NOTE Do not place the sensor on an
194. id lens cleaner and a soft cloth DO NOT wipe a dry screen or use alcohol or solvents containing chlorinated hydrocarbon Spectrum Operating Instructions 0070 10 0648 02 3 1 Decontamination of Monitor User Maintenance 3 3 3 4 Decontamination of Monitor WARNING Perform the decontamination process with the unit powered down and power cord removed Decontamination of a unit that has come in contact with a biological material can be performed using LpH SE Germicidal detergent Apply a small amount of detergent to a disposable wipe paper based and wipe down the outside of the unit Discard the wipe appropriately After waiting 1O minutes use a clean dry wipe to dry the unit CAUTION During the decontamination process do not get the LpH SE Germicidal detergent into any vent openings Care and Cleaning of SpO Sensors NOTE Refer to the individual instruction sheets that are packaged with each sensor e Check sensors and cables daily for signs of damage Replace as required Sensors should be cleaned before and after each new patient e Wipe the patient contact area using a soft cloth with mild soap and water solution or isopropyl alcohol Hydrogen peroxide can be used to remove dried blood Allow the sensor to completely dry before using CAUTION When cleaning sensors do not use excessive amounts of liquid Wipe the sensor surface with a soft clorh dampened with cleaning solution Do not attempt to sterilize
195. igator Knob to set alarm limits as desired for currently monitored parameters 3 To save alarm limit settings as the default select Save Current from the Monitor Setup Menu NOTE Alarm Limits are not saved when the monitor is turned off unless you select Save Current from the Monitor Setup Menu 4 Tosetalarm limits for any parameter not currently monitored or to adjust the priority level of any alarm select Alarm Setup from the Alarm Limits Menu The Alarm Setup menu also provides options for setting alarm delay times and alarm muting features Alarm Limits Menu __ Alarm Setup Previous Menu Parameter High Set Limits Previous Show HR Limits Off HR Off Show SpO 2 Limits PVC min Off Mute For 2 min RUN 4 Mute All For 2 min ST Single Off Central Silence On 555 ys e ro Ys a NBP Dia Off ibid secon NIBP Mean Off ST Alarm Delay 30 seconds IBP 1 Sys Off IBP 1 Dia Off IBP 1 Mean Off IBP2 Sys Off Select to return to previous menu Low Off Off Off Off Off Off Off Off Priority MOM OM Mm Mm Om NON FIGURE 2 58 Alarm Setup Menu 0070 10 0648 02 Spectrum Operating Instructions Operations Alarms 2 6 2 Alarm Limits A separate table of alarm limit settings is maintained for each patient size When the patient size is changed the appropriate selections are automatically used See table below for alarm ranges Default settings appear i
196. ill be initiated if two ST leads have exceeded the set alarm parameters F Indications of Disabled or Silenced Alarms ALARMS OFF ICON If both high and low alarms are not set for a parameter an alarm off icon resembling a crossed bell will be displayed next to the numerical data for that parameter VOLUME The audio level of the alarm can be adjusted through the Monitor Setup Menu 2 100 0070 10 0648 02 Spectrum Operating Instructions Operations Alarms ALARM MUTE One or more alarms can be muted for a programmable length of time The following is a description of how to enable the different mute modes MUTE This key silences alarms on parameters for a programmed length of time default is 2 minutes or until the alarm condition is no longer present whichever is shorter Any new alarms that occur during the silenced period will disable the silence and the alarm will sound the tone An Alarm Mute Icon resembling a crossed speaker is displayed next to each muted parameter message and digital timer counts down in the upper message area Pressing MUTE again does not re enable audio alarms MUTE ALL This key suspends alarms on all parameters for a programmed period of time default is 2 minutes An Alarm Mute Icon resembling a crossed speaker is displayed next to each parameter message and timer appear in the upper message area showing the time remaining Pressing MUTE ALL at any time re enables audio alarm t
197. in Operation of the Spectrum below the minimum amplitude or value of PATIENT physiological signal may cause inaccurate results 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 Spectrum It can also cause delayed recovery after the discharge of a cardiac defibrillator The use of gas sampling accessories in Gas Module 3 other than specified by Mindray 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 on a Gas Module with the appropriate mounting brackets the Spectrum should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the Spectrum should be observed to verify normal operation in the configuration in which it will be used viii 0070 10 0648 02 Spectrum Operating Instructions Warnings Introduction WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING With the exception of stacking under a Spectrum with the appropriate mounting brackets the Gas Module 3 should not be used adjacent to or stacked with o
198. in preparation Repeat skin preparation and prior to application of electrode location procedures electrode tremors tense Apply fresh moist electrodes subject and or poor electrode Avoid areas of the torso that are placement very muscular 2 46 0070 10 0648 02 Spectrum Operating Instructions MESSAGE PROBLEM Intermittent Signal REASON Connections not tight and or properly secured Electrodes dry or loose Cable or lead wires damaged Parameter Menus and Monitoring SOLUTION Ensure proper connection Electrode to lead lead to cable cable to monitor Re prep skin and apply fresh moist electrodes Check with continuity tester Excessive alarms heart rate lead fault Electrodes dry Alarm limits set too close to patient s normal heart rate R wave wrong size Excessive patient movement or muscle tremor Re prep skin and apply fresh moist electrodes Readjust Must have a higher amplitude than the other ECG waves like the P and T waves Reposition electrodes and secure with tape if necessary Low Amplitude ECG Signal Gain set too low Electrodes dry old Skin improperly prepared This could be the patient s normal QRS complex Electrode could be positioned over a bone or muscle mass Readjust as required Set via the SIZE key Apply fresh moist electrodes Abrade skin Verify with a 12 lead electro cardiogram Move ECG patches closer towards
199. ing aligns and compares each new heart beat to reference templates that were previously stored in the system A beat typing algorithm classifies the beats f an incoming beat matches a template that has already been classified it is given the same label as the template The template parameters are updated with the features from this new beat The real time ECG analysis library incorporates ventricular ectopic beat detection as a part of arrhythmia analysis Beats are measured for compensatory pause QRS width QRS positive and negative areas and R wave positive and negative amplitudes This process uses multiple leads when available e A scoring algorithm is then applied to those measurements to determine whether or not a beat is ectopic Arrhythmia Alarms Arrhythmia alarms are activated based on the patterns in the patient ECG waveform rhythms Beat detection for a 5 lead wire set is determined by using a combination of leads Il and V When using a 3 lead wire set beat detection is determined by using the lead being viewed The following lethal and non lethal arrhythmia alarms may be detected by the arrhythmia algorithm NOTE Arrhythmia alarms are not available for the Neonate patient size Lethal Arrhythmia Alarms A lethal arrhythmia is an arrhythmia that can be life threatening to a patient if left untreated Ventricular Tachycardia V Tach Ventricular Fibrillation V Fib and Asystole alarms are classified as le
200. io Indicators An audio speaker is provided in order to annunciate alarms key depresses message tones and systole beep tones Audio alarms are in accordance with EN475 1995 Spectrum Operating Instructions 0070 10 0648 02 5 25 Information Display and Control Appendix Real Time Clock The Display Resolution for the Real Time minute Clock is The Accuracy of the Real Time Clock is 1 minute month 30 days 21 3 C The Real Time Clock has a dedicated independent power source that allows it to keep time whether or not the Spectrum has power provided 5 26 0070 10 0648 02 Spectrum Operating Instructions Appendix Input Output Communications 5 5 Input Output Communications ECG Analog Output Specification ECG analog output is disabled when 12 lead ECG analysis is enabled Bandwidth 3 dB referenced to 10 Hz Same as ECC Filter Setting Maximum Propagation Delay 25 ms Delay of QRS complex Sensitivity referenced to 10 Hz 1 V mV of input 10 Pacer Enhancement Pacer is summed at the output when pacer enhancement mode is turned ON Pacer amplitude signal is a minimum of 2 5 V Pacer width is 10 ms with a 5 tolerance Pacer rise and fall times is 100 us maximum The Spectrum supports slaving of an IABP for the ECG analog output only Arterial Blood Pressure Analog Output Specification Only in monitors with serial number prefix MS and software versions L X and higher Bandwidth 3 dB r
201. ire Lead Placement for a FIGURE 2 27 3 wire Lead Placement for a Pacemaker Patient Pacemaker Patient IEC Black Green FIGURE 2 28 5 wire Lead Placement for a FIGURE 2 29 5 wire Lead Placement for a Pacemaker Patient AHA Pacemaker Patient A pacemaker patient usually requires a different electrode patch placement configuration than a non pacemaker patient Do not place an ECG electrode directly over the pacemaker generator Place the electrode patches 3 5 inches away from the pacemaker generator area For example if the pacemaker generator is located in the right subclavian area relocate the Right Arm electrode closer in towards the center of the chest WARNING Pacemaker patients rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias Do not rely entirely upon rate meter alarms Keep pacemaker patients under close surveillance See the Appendix section of this manual for disclosure of the pacemaker pulse rejection capability of this instrument CAUTION Some pacemakers may contain a respiratory sensor that may produce artifact on an ECG waveform Spectrum Operating Instructions 0070 10 0648 02 2 33 Parameter Menus and Monitoring Operations 2 4 2 4 2 34 Using a Transcutaneous Electrical Nerve Stimulator TENS Since a TENS unit transmits electrical impulses avoid placing ECG electrode patches near the TENS electrodes
202. irst hour after entering measurement mode periodically for durations of typically 10 seconds at a rate which limits the total time consumed by SFMs to less than 2 of the time in which active measurements are taken Following the first hour after entering measurement mode periodically for durations of typically 10 seconds at a rate of at most once per hour f a change of 8 C from the last AZ is detected e f a pressure change of 20 mmHg relative to the last ambient pressure measurement less than the purge threshold for a period of 30 seconds is detected The module will be able to detect a real change in the ambient pressure and a pressure change due to partial blockage of the FilterLine The module prevents the triggering of an SFM in the following situations n case of purging until the end of this state During a breath absence period which follows a valid breath While waiting a minimum of 20 seconds for host SFM enable command After the 20 second opportunity given to the host to schedule the SFM passes the module schedules the SFM according to a priority determined by current conditions System Response Time The system response time with a standard length FilterLine which includes the delay time and rise time 10 to 90 in response to a step change in the concentration is 2 9 seconds typical Rise Time Adult and 190 msec maximum Neonatal Delay Time 2 7 seconds typical Pump Calibration Interval
203. is placed into Standby mode the message Viewed Monitor is Currently in Standby is displayed in the message area Spectrum Operating Instructions 0070 10 0648 02 2 17 Main Menus Operations Wave 1 Wave 2 Selectable Selectable Remote View Menu BED 4 Normal Screen Setup Remote Mute Remote Mute All Remote Print mmHg mmHg T1 9 Select to return B to normal screen ANT TT 2 CO l min ALL ALARMS MUTED PERMANENTLY x Message Area 9 Numeric Data Area FIGURE 2 10 Remote View Menu The Remote View Menu also provides the following menu choices Normal Screen Setup Remote Mute Remote Mute All and Remote Print 1 Normal Screen this selection removes the Remote View Menu from the display 2 Setup this selection opens the Remote View Setup Menu shown in FIGURE 2 11 This menu enables the user to configure the display and functionality of the Remote View Menu Remote View Setup Menu Previous Menu New Bed BED 4 Wave 1 l Wave 2 Pleth Remote Mute For 2 min Remote Mute All For Permanent Select to return to previous menu FIGURE 2 11 Remote View Setup Menu NOTE With the exception of the New Bed menu choice the current settings in the Remote View Setup Menu are saved when Save Current is selected from the Host Monitor There is one set of saved settings for each patient size NOTE The saved settings in the Remote View Setup Menu are tran
204. is re established If noise levels are too high the following will occur until the signal quality is re established Beat detection is suspended All rhythm calls are suspended 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring An ECG Noise message is displayed when ECG noise is detected in one or more ECG leads If ECG noise continues beyond the configured noise delay an alarm is triggered and ECG rhythm analysis is stopped Heart Rate Meter Heart Rate is computed using the 16 most recent R R intervals for heart rates above 48 beats per minute If the heart rate calculated using the last 4 beats is less than 48 beats per minute then this rate is used All detected beats are used to compute the heart rate A separate ventricular rate is used in the algorithm to determine rhythms like ventricular tachycardia and ventricular run Filtering Pacer Signals In order to prevent pacer pulses from being mistaken for QRS complexes they are removed from the ECG data that is sent to the arrhythmia algorithm for analysis Pacer pulses are shown on the Spectrum as exaggerated vertical lines ECG Amplitude The QRS detection threshold algorithm setting is fixed between 0 15 and 0 45 mV to avoid detecting noise spikes or P waves as valid beats Changing the display gain on the monitor does not affect the signal that is used by the algorithm for beat detection For optimal performance the leads
205. ivated when the measured variations in the RR interval over a period of time exceeds a preset limit established by the arrhythmia algorithm NOTE The Irregular Heart Rate alarm is not available when using a View 12 card The Irregular Heart Rate alarm is a Priority 2 alarm event that produces Alarm Priority 2 visual and audio alarm indicators An IRREGULAR HR text message above the ECC 1 waveform area Pause Alarm The Pause alarm is activated when no beat is detected during an interval that is greater than 1 8 R R and the next beat is not a PVC 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring NOTE The Pause alarm is only available when using a View 12 card The Pause alarm is a Priority 2 alarm event that produces arm Priori visual and audio alarm indicators Al P 2 and audio al dicat A PAUSE text message above the ECG1 waveform area PVC minute Alarm The High PVC alarm is activated when the number of PVCs detected per minute exceeds the configured threshold The PVC limit can be set to Off or 1 to 30 PVCs per minute The High PVC alarm has priority settings of 1 or 2 and behaves as follows If the High PVC alarm priority is set to 1 Alarm Priority 1 visual and audio alarm indicators are produced If the High PVC alarm priority is set to 2 Alarm Priority 2 visual and audio alarm indicators are produced AHigh PVC text message is produc
206. lable for Display Interval NOTE If the Display Interval remains set to Off while the Trend Entry Interval has been set to something other than Off the trend may appear to clear itself or to have disappeared This is because the trend has reached the maximum number of entries New interval data although not displayed is causing older trend entries to be deleted from the database Transferring List Trend Data Between Different Spectrum Monitors List and Graph Trend data along with patient name and demographics may be transferred between Spectrum monitors with a Mindray Transfer Card l Insert the Transfer Card into the PCM2 slot on the right side of the source monitor 2 Access the Functions Menu of the source monitor and select Copy patient data to card from the menu A status message will report completion of the transfer 3 Remove the card and insert it into the PCM2 slot of the receiving monitor 4 Access the Functions Menu of the receiving monitor and select Copy patient data from card A status message will report completion of the transfer NOTE If the source monitor is equipped with the Extended Trend option and the receiving monitor is not only the latest 120 trend entries will be transferred from the card NOTE If the latest trend data stored on the card has a time stamp newer than the time displayed on the receiving monitor data transfer will be prohibited This is possible when the time and date settings on the
207. lated Deflate balloon reinflate slowly dampened PAWP notify physician Spectrum Operating Instructions 0070 10 0648 02 2 79 Parameter Menus and Monitoring Operations 24 11 24111 2 80 Cardiac Output CO Optional Cardiac Output CO is the amount of blood ejected from the left ventricle each minute expressed in liters per minute l min Cardiac Index is the Cardiac Output divided by the patient s body surface area The following two optional interfaces can be used to measure CO the Mindray External Parameter Module P N 0998 00 0501 01X and 0998 00 0501 03X the Edwards Vigilance Monitor Vigilance CO can be monitored when Patient Size is set to either Adult or Pediatric and 1 When the Hemodynamics Option is installed and the EPM is enabled in the Installation Menu and or 2 When the Vigilance Option is installed and a serial port is set to Vigilance in the Installation Menu Cardiac Output cannot be monitored when Patient Size is set to Neonate External Parameter Module EPM Intermittent bolus CO can be monitored through a Mindray EPM If a tile has been set to display CO from the Display Setup Menu when measuring intermittent CO with the EPM the CO tile will be displayed as shown in the example of FIGURE 2 51 The 3 06 PM label shown in the example is a time stamp that indicates the time at which the displayed measurement occurred A Source label indicates the sourc
208. lectrodes designed to acquire the ECG with excellent base line stability recovery from defibrillation and minimum artifact from patient movement With the Spectrum ECG can be obtained by using a 3 Lead 5 Lead or 12 Lead ECG cable in conjunction with a lead set and skin electrodes For best performance and safety inspect the ECG cables and electrodes daily ECG Menu ECG Menu ECG Menu Normal Screen ECG Setup Menu ECG 1 1 Previous Menu ECG 2 Filter Monitor ECG 3 y HR Source Auto 4 aVR Pacer Reject Off ECG 5 avL Pacer Enhancement Off ECG 6 Notch Filter 60 Arrhythmia Menu M ESU Filter Auto ECG Cable Auto Detect ST Menu Grid Off ECG Sizes Menu Color ECG Setup Resp Menu aS Select to return to previous menu Select to return to normal screen FIGURE 2 12 ECG Menu FIGURE 2 13 ECG Setup Menu The ECG Menu provides the following choices Normal Screen ECG 1 ECG 6 Arrhythmia Menu Relearn ST Menu ECG Sizes Menu ECG Setup and Resp Menu 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring The Normal Screen selection returns the view to the normal screen The ECG 1 ECG 6 selections define the ECG labels for printing and trends The Arrhythmia Menu selection opens the Arrhythmia Menu The Relearn selection is only available if the ST or Arrhythmia options are installed and is used to manually initiate the learning
209. ll not be cancelled unless patient breathing resumes The Apnea Alarm is a priority 1 alarm D Arrhythmia Alarms Arrhythmia Alarms with the exception of the PVC Rate Alarm are identified in message Area Lethal Arrhythmia Alarms Asystole V Fib and V Tach are priority 1 alarms and in addition are latched Even after the alarming condition is resolved a latched alarm will continue until it is acknowledged by pressing the MUTE or MUTE ALL key on the front panel keypad If the alarm is acknowledged while the lethal condition still exists the audio portion of the alarm will be muted for the duration that is selected from the Mute For list in the Alarm Setup menu but the alarm message will remain in message area A If a new lethal condition occurs while the initial lethal alarm is muted the new lethal alarm will not break through and will be muted for the remainder of the mute duration If the lethal condition is resolved while the alarm is muted the alarm will be terminated Non lethal Arrhythmia Alarms are priority 2 alarms These alarms will silence and cancel automatically if the patient s condition is corrected The PVC Rate Alarm although considered non lethal may be set to either priority 1 or 2 E ST Alarms ST alarms can be set for either single lead alarm or dual lead alarm The ST single lead alarm will be initiated if one ST lead has exceeded the set alarm parameters The ST dual lead alarm w
210. lues that are used to determine the hemodynamic status of the patient The values that are necessary for these calculations are Patient Height Patient Weight Cardiac Output Heart Rate Mean Arterial Pressure Mean PA Wedge and Central Venous Pressure All manually entered values such as PAWP are denoted with an asterisk The following values are calculated and trended CI SV SVI SVR SVRI PVR PVRI LCW LCWI RCW RCWI LVSW IVSWI RVSW and RVSWI NOTE Calculated patient parameters contain more decimal places of accuracy than are displayed on the screen e g a CO of 2 4 may be a CO of 2 4492 Consequently attempts to verify the accuracy of the monitor s display using the following equations may produce results that are slightly different from the data computed by the monitor Hemodynamic Calculations ABBREVIATION UNITS DESCRIPTION FORMULA CI min m Cardiac Index CO BSA BSA 2 Body Surface Area Hi 725 cm x Ww1 425 kg x 0 007184 SV ml Stroke Volume CO HR x 1000 SVI m m Stroke Volume Index SV BSA SVR dyne sec cm Systemic Vascular Resistance ART mean CVP CO x 79 96 SVRI dyne sec cm m Systemic Vascular Resistance Index SVR x BSA PVR dyne sec cm Pulmonary Vascular Resistance mean PAWP CO x 79 96 PVRI 2 Pulmonary Vascular Resistance Index PVR x BSA LCW kg m Left Cardiac Work
211. m On color displays Priority 1 alarm data is shown in inverse video with red background Priority 2 alarm data is shown in inverse video with yellow background If data for a parameter is not available at the time of the trend entry the data field will be dashed If an NIBP reading could not be obtained or an invasive pressure channel was not zeroed at the time of the trend entry the data field will contain xxx Modification of Parameters Displayed The parameters displayed always include the currently active parameters and any others used since the time the patient was admitted to the monitoring system The default order of parameters displayed from top to bottom is HR NIBP SpO Resp CO IBP1 IBP2 IBP3 IBP4 ST1 ST2 ST3 STA ST5 ST6 ST7 ST8 579 ST1O ST11 ST12 T1 T2 TBlood AT Agent PVC min CO CI and To change the order of the parameters displayed select the Setup Menu from the Graph Trend Menu Once in the Setup Menu change the Format selection from Auto to Manual Select parameters to be displayed in each of the top 5 rows Modification of Trend Entry Conditions The Graph Trend data is the same as that stored for List Trends arranged graphically If data is not available for time period it appears as a gap in the Graph Trend Refer to the previous section List Trend for modification of trend entry conditions Transferring Graph Trend Data Between Different Spectrum Monitor
212. m Operating Instructions 0070 10 0648 02 5 51 Mindray s Responsibility Appendix This page intentionally left blank 5 52 0070 10 0648 02 Spectrum Operating Instructions co Glossary 6 1 Glossary of Terms AaDO gt ALVENT Art AvDO BSA Cl co CVA CvO5 CVP ECG EMR EPM etCO Spectrum Operating Instructions Alveolar Arterial Oxygen Difference Alveolar Ventilation Arterial label for invasive blood pressure Arteriovenous Oxygen Difference Body Surface Area Arterial Oxygen Content Pulmonary Capillary Blood Oxygen Content Cardiac Index Cardiac Output Carbon Dioxide Dynamic Compliance Cerebral perfusion pressure this is the calculated difference between cranial pressure and mean arterial pressure Cardiovascular Artifact this is any artifact in the respiratory waveform due to heartbeats also message will occur if heart rate and respiration rate are the same Venous oxygen content Central Venous Pressure label for invasive blood pressure Electrocardiogram Electronic Medical Records system This may include a Hospital Information System HIS and or a Clinical Information System CIS External Parameter Module End tidal A patient s carbon dioxide level measured at end expiration 0070 10 0648 02 Glossary of Terms FiO Hgb IABP ICP IBP ISO LA LCW LCWI LV LVSW LVSWI MAP MinVol NIBP O2AV OER OxyC
213. may cause significant measurement errors Check for a clean water trap Select or AUTO as the Resp Source in the Resp Menu Observe the capnogram on the monitor s display On Spectrum powerup Agent and numbers will display numbers will be displayed when a valid breath is detected NOTE The Gas Module Il and SE must be warmed up a minimum of two minutes for accurate and N50 readings five minutes for agent readings NOTE The Gas Module 3 must be warmed up a minimum of 45 7 8 seconds for ISO accurate O2 0 and agent readings If not already set use the Display Setup Menu to select the gas waveforms to be displayed If desired the gas waveform speed can be changed via the Monitor Setup Menu and the scale can be changed in the Gas Menu Gas Module 3 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 Verify that the appropriate water trap is properly installed and that the appropriate sampling line is connected DRYLINE Adult Pediatric water trap used with DRYLINE Adult Pediatric sampling line colorless Luer lock nut DRYLINE Neonatal water trap used with DRYLINE Neonatal sampling line blue Luer lock nut 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring 2 Verify that the water trap co
214. measurement interval that provides adequate venous drainage during cuff deflation Periodically inspect the limb bearing the cuff in order to detect venostasis f necessary move cuff to another limb to relieve single limb stress Cuff Size Using a narrow cuff gives erroneously high pressure readings If a standard cuff is applied to an obese patient or a patient with large biceps the extra tissue and fat will dissipate the applied pressure requiring an additional pressure increase to collapse the artery On the other hand over wrapping a slender arm gives erroneously low pressure readings because too much force per unit area is exerted This requires less pressure to collapse the artery Other Factors An accurate determination of blood pressure by the Spectrum can be difficult if cardiac rhythm is irregular Irregular cardiac rhythm changes the stroke volume from beat to beat This changing stroke volume may increase the time it takes the Spectrum to take a measurement The Spectrum makes up to four successive attempts to obtain a measurement If a measurement cannot be taken after four tries the numeric displays are zeroed User Verification of Spectrum Blood Pressure Measurements Regular service to blood pressure equipment will help insure accurate measurements Consult your Service Manual for appropriate information If you question the accuracy of the Spectrum check the blood pressure in the Spectrum with a manometer 0070 10 06
215. mic Vascular Resistance SVR Range 50 9999 dyne sec cm Resolution 1 dyne sec cm Systemic Vascular Resistance Index SVRI Range 50 5000 dyne sec cm m Resolution 1 dyne sec cm m Pulmonary Vascular Resistance PVR Range 1 1000 dyne sec cm Resolution 1 dyne sec cm Pulmonary Vascular Resistance Index PVRI Range 1 2000 dyne sec cm m Resolution 1 dyne sec cm gt m Left Cardiac Work LCW Range 0 1 100 0 kg m Resolution 0 1 kg m Left Cardiac Work Index LCWI Range 0 1 50 0 kg m m Resolution 0 1 kg m m Right Cardiac Work RCW Range 0 1 100 0 kg m Resolution 0 1 kg m Right Cardiac Work Index RCWI Range 0 1 50 0 kg m m Resolution 0 1 kg m m Spectrum Operating Instructions 0070 10 0648 02 5 23 Special Functions 5 24 Appendix Left Ventricular Stroke Work LVSW Range 1 500 gm m Resolution 1 gm m Left Ventricular Stroke Work Index LVSWI Range 1 500 gm m m Resolution 1 gm m m Right Ventricular Stroke Work RVSW Range 1 50 gm m Resolution 1 gm m Right Ventricular Stroke Work Index RVSWI Range 1 50 gmm m Resolution 1 gm m m Cerebral Perfusion Pressure CPP Range 30 300 mmHg Resolution 1 mmHg Reference Sources Source Kinney M Dunbar S Brooks Brunn J Molter N and Vitello Cicciu J AACN s Clinical Reference for Critical Care Nursing St Louis Mosby 1996 Source DuBois D Dubois EF A formula to estima
216. mmended because chlorine will chemically break down the urethane on the inside of the cuff Antimicrobial Definition Mindray bladderless cuffs are treated with an antimicrobial coating Antimicrobial technology effectively controls a broad spectrum of bacteria fungi algae and yeasts on a wide variety of treated substrates 3 6 Battery Replacement and Maintenance 3 6 1 Battery Replacement 1 Open battery compartment door on left side of unit by pressing the finger grip area and sliding the door to the left 2 Press the release button located on the right side of the installed battery This will eject the battery Slide out and remove battery 3 Slide in replacement battery until it clicks into place 4 Close battery compartment door by sliding the door to the right until it firmly clicks into place CAUTION Replace sealed lead acid batteries with Mindray P N 0146 00 0043 ONLY Replace lithium ion batteries with Mindray P N 0146 00 0069 ONLY 3 6 2 Battery Maintenance The batteries may be subject to local regulations regarding disposal At the end of the battery life dispose of the batteries in accordance with any local regulations NOTE Spectrum batteries may only be charged within a Spectrum monitor Do not attempt to use commercial rechargers Sealed Lead Acid Due to the self discharge characteristics of sealed lead acid batteries it is imperative that they are charged after 3 months of storage or unit not in us
217. modes only Absolute ST Deviation Range Delta ST Deviation Range Resolution Default ST Measurement Point User Selectable ST Measurement Points Default ISO Point User adjustable ISO Point Default J Point 5 20 0070 10 0648 02 3 5 lead ECG 9 9 mm to 9 9 mm 990 uV to 990 uV RTI 12 lead ECG 10 0 mm to 10 0 mm 1000 uV to 1000 RTI 12 ead ECG Only 20 0 mm to 20 0 mm 2000 pV to 2000 uV RTI 0 1 mm 10 uV 80 ms after J point for heart rates lt 120 bpm 60 ms after the J point for heart rates gt 120 bpm 40 60 and 80 ms after J point heart rate independent or 60 80 heart rate dependent Located between the P and Q waves 3 5 Lead ECG User adjustable from R peak 10 ms to R peak 200 ms in 8 ms increments 12 Lead ECG User adjustable from R peak 10 ms to R peak 200 ms in 8 ms increments The end of the QRS complex Spectrum Operating Instructions Appendix 5 3 2 Special Functions User Selectable J Point 3 5 Lead ECG User adjustable from R peak 10 ms to R peak 200 ms in 8 ms increments 12 lead ECG User adjustable from R peak 10 ms to R peak 200 ms in 8 ms increments Excluded Beots Ectopic beats and ventricular paced beats are excluded from ST measurement Invalid ST 3 and 5 lead modes ST data is invalidated when the paced rhythm Ventricular Rhythm or Ventricular Tachycardia persists for more than 45
218. moved to return to the normal waveform display To remove the OxyCRG Trend display choose Normal Screen from the menu press the NORMAL SCREEN key or press the TRENDS key once Trends Troubleshooting MESSAGE PROBLEM REASON No Trends displayed No Trend triggers set Trend page is scrolled 0070 10 0648 02 SOLUTION Go to the Monitor Setup Menu and set NIBP Trend Trend Interval or Alarm Trend as desired Use scroll button in Trend Menu to scroll to top of Trend Menu Spectrum Operating Instructions Operations Printing Optional 2 8 Printing Optional Spectrum data and waveforms may be printed to the following destinations internal recorder remote central station or to a laser printer 12 lead data only Print Setup Menu Mormal Screen Waveform 1 Waveform 2 Select Printer Print on alarm No Format Leader Print Every Off Select to return to normal screen FIGURE 2 62 Print Setup Menu 2 8 1 Internal Recorder Optional The Spectrum recorder can provide a printed record of all patient parameters It is a two trace thermal strip chart recorder with an integral paper spool The recorder uses plain white thermal paper 5 cm wide NOTE All grid patterns and data are printed by the recorder Operation of the Recorder 1 Select the waveforms to print to the recorder via the Print Setup Menu using the Navigator Knob To change the waveforms that appear select Waveform 1 or Waveform 2 an
219. mperature Performance Requirements Scale Range T1 T2 Delta T Resolution Accuracy Accuracy inclusive of 400 Series probes Accuracy inclusive of 700 Series probes Probe Excitation 400 Series Probe Excitation 700 Series 0070 10 0648 02 Celsius or Fahrenheit 15 C to 45 C 59 F to 113 F O Cto9 9 C 0 F to 9 9 F 0 1 C 0 1 F 0 1 C 15 C 45 C exclusive of probe errors 0 2 F 59 F 113 F exclusive of probe errors 0 1 C 25 C 42 0 2 C otherwise 0 2 F 77 F 108 0 4 F otherwise 0 2 C 15 45 0 4 F 59 F 113 lt 200 pA tip to sleeve lt 200 A tip to sleeve and 30 pA maximum ring to sleeve Spectrum Operating Instructions Appendix 5 2 6 5 2 6 1 Patient Parameter Specifications SpO Performance Requirements The Spectrum is capable of providing measurements via an OEM Masimo SET MS 3 OEM Nellcor MP 304 or OEM Nellcor NELL 3 pulse oximeter The function is in accordance with the requirements of EN 865 1997 The function is calibrated to display functional saturation Update Rate Every 2 seconds Masimo SET SpO Performance Requirements Sensor Compatibility LNOP and LNCS Series SpO Accuracy No motion conditions SATURATION RANGE PATIENT SIZE 70 TO 100 0 69 Adult Mode _ s2digis unspecified Pediatric M
220. n a plethysmograph waveform and heart rate NOTE The comparison testing conducted via the auscultatory method used both Phase 4 and Phase 5 Korotkoff sounds Reports of study findings for both the auscultatory method as well as the intra arterial methods are available by contacting Mindray Technical Support 800 288 2121 ext 8116 or 201 995 8237 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 Spectrum Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner The indications for use for the Spectrum Monitor include the monitoring of the following human physiological parameters ECG waveform derived from 3 5 or 12 lead measurements Heart Rate derived from selected sources ECG SpO IBP NIBP Pulse Oximetry ST Segment Analysis derived from 3 5 or12 ECG lead measurements Arrhythmia Detection derived from 3 5 or 12 ECG lead measurements Interpretation of Resting 12 lead ECG Non Invasive Blood Pressure NIBP Invasive Blood Pressure IBP up to four 4 channels Cardiac Output Respiration Rate waveform derived from ECG or CO inspired and end tidal microstream waveform Temperature up to two 2 channels Hemodynamic Calculations IV Drug Calculations The target populations are adult pediatric and neonate with the exception of
221. n bold text HIGH LOW PARAMETERS ADULT PED NEONATE ADULT PED NEONATE Heart Rate bpm Off Off Off Off Off Off Except France 60 250 100 300 100 350 30 120 30 150 30 200 Heart Rate bpm 120 150 175 30 50 70 France 60 250 100 300 100 350 30 120 30 150 30 200 PVC min Off 1 30 Run Off 4 8 ST Single Off 0 5 to 10 0 Elevation Off 0 5 to 10 0 Depression Lead mm ST Dual Off 0 5 to 10 0 Elevation Off 0 5 to 10 0 Depression Lead mm NIBP Sys mmHg Off Off Off Off Off Off 70 240 40 180 40 180 50 150 15 130 15 130 NIBP Mean Off Off Off Off Off Off mmHg 60 200 50 180 40 160 40 140 10 100 10 70 NIBP Dia mmHg Off Off Off Off Off Off 40 130 50 100 50 100 30 120 10 50 10 50 IBP Sys mmHg Off Off Off Off Off Off 5 300 5 240 5 180 0 150 0 130 0 130 IBP Mean mmHg Off Off Off Off Off Off 5 150 5 100 5 100 2 100 2 50 2 50 IBP Dia mmHg Off Off Off Off Off Off 0 140 0 100 0 70 0 120 0 100 0 50 SpO Off Off Off 50 99 5099 5099 80 100 80 100 80 100 85 85 85 Temp F Off 95 110 Off 80 100 Temp Off 35 43 Off 26 38 T blood Off 95 110 Off 80 100 T blood C Off 35 43 Off 26 38 Delta Temp F Off 2 10 Off 2 10 Delta Temp C Off 1 5 Off 1 5 Resp Rate rpm Off Off Off Off Off Off 10 100 15 150 30 200 5 30 5 40 5 50 ET CO mmHg OFf 20 80 Off 5 50 60 ET
222. n record the blood temperature SvO2 is measured by a spectrophotometric technique that uses light emitting diodes to transmit light in the red and infrared spectra through an optical fiber in a pulmonary artery catheter to the blood The Vigilance can be interfaced with the Spectrum This enables Vigilance CO T Blood and SvO data to be displayed and trended at the Spectrum as well as providing alarm control for these parameters The Spectrum uses T Blood data from Vigilance to derive AT which can also be displayed and trended as well as providing alarm control At the Spectrum the CO value is divided by the patient s BSA Body Surface Area to calculate and display a corresponding cardiac index Cl The BSA is determined from the patient s height and weight as entered in the Spectrum When measuring continuous cardiac output the CO tile on the main screen of the Spectrum will be displayed as shown in the example of FIGURE 2 54 The Cont label in the example CO tile indicates that the displayed measurements are continuous If the Vigilance is used for intermittent CO measurements an XX XX label will be displayed This label is a time stamp where XX XX the time at which the displayed measurements occurred A Source label indicates the source of the cardiac output The units of measure for each attribute are CO l min CI l min m SvO NOTE If the Edwards Vigilance Monitor is powered off or disconnected from the
223. n the gas sample when converting the gas readings to ATPD An increase in the ambient H30 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 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring Monitoring Anesthetic Gases O5 N20 and or CO NOTE To prevent moisture from entering the pneumatic system ensure that the Gas Module is always installed and operated in the horizontal orientation shown in all graphical depictions 1 Turn on the Gas Module and Spectrum and configure the Spectrum serial port to be used with the Gas Module Hold the DISCHARGE key in while powering unit on Set alarms as desired NOTE Sample line must be connected to Gas Module when turned on to avoid Air Leak message Gas Module II and SE 7 Foot Nasal Cannula CO5 O4 P N 0683 00 0452 10 wr 7 Foot Nasal Cannula P N 0683 00 0424 10 Adapter Straight ET P N 0683 00 0242 22 Gas Scavenging Adapter Assy P N 0997 00 0923 or 10 Foot Sample Line Patient P N 0997 00 0984 44 P N 0683 00 0451 10 Adapter Mask Elbow ET P N 0683 00 0242 12 7 Foot Nasal Cannula CO5 O4 P N 0683 00 0452 10 eo 7 Foot Nasal Cannula P N 0683 00 0424 10 ta 7 2 5 Meter Sample Line Patient Adapter Straight Tee 7 Adult Pediatric P N
224. nection Spectrum Operating Instructions 0070 10 0648 02 1 23 External Parameter Modules Optional General Product Description 5 C O Key Press this key to open the Cardiac Output Menu If the Cardiac Output Menu is already open and the Ready message is displayed pressing the C O key activates the CO run sequence NOTE Pressing this key will not open the Vigilance CO Menu 6 CO Connector port used to connect the Cardiac Output cable 1 24 0070 10 0648 02 Spectrum Operating Instructions General Product Description External Parameter Modules Optional 1 10 4 Rear View with External Parameter Module ec FIGURE 1 19 Rear View with External Parameter Module 1 Module Bus Port MB2 This is used for connection to future devices 2 Rear Module Hooks These two hooks secure the module to the Spectrum Spectrum Operating Instructions 0070 10 0648 02 1 25 External Parameter Modules Optional General Product Description This page intentionally left blank 1 26 0070 10 0648 02 Spectrum Operating Instructions 2 0 Operations 2 1 Getting Started The Spectrum comes with default factory settings which enable you to begin monitoring without setting any of the waveforms parameters alarms or functions However all of these settings can be changed for specific patient or departmental needs Certain operating characteristics are based on the selected patient size e g NIBP st
225. neral Product Description Gas Module Optional NOTE The following models are referenced in this manual Gas Module II Gas Module SE and Gas Module 3 When information is common to all models the generic name Gas Module is used Information that is unique to a specific model is identified accordingly Front Panel Gas Module SE FIGURE 1 8 Gas Module 3 1 Input Port This port is used to connect the sampling tubing to the Gas Module 2 Water Trap Assembly includes Water Trap Reservoir Gas Module Il and SE P N 0202 00 0129 e Gas Module 3 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 must be emptied and rinsed with water only whenever more than half full or whenever changing patients Refer to section 3 9 for more details 3 Dust Filter The Dust Filter P N 0378 00 0040 protects the Gas Module from airborne dust It should be removed and cleaned on a regular basis Refer to section 3 9 for more details 4 DustFilter Cover The Dust Filter Cover is removed to access the filter 0070 10 0648 02 Spectrum Operating Instructions General Product Description Gas Module Optional 1 8 2 5 Power Indicator Lamp This lamp illuminates when the Power Switch is in the ON position 6 Power Switch A switc
226. nistered 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 Spectrum requests Zeroing either on the automatic cycle or 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 Customer Support GM Uncalibrated Appears after an unsuccessful calibration attempt of the sensor The numeric data for will appear as and the waveform will be a flatline Ensure proper gas mixture is attached tightly and re
227. nnett Inc Panorama is U S trademark of Mindray DS USA PatientNet is U S registered trademark of GE Medical Systems Information Technologies Spectrum is a U S registered trademark of Mindray DS USA Velcro is a registered trademark of Velcro Industries B V View 12 is a US trademark of Mindray DS USA Vigilance is a US registered trademark of Edwards Lifesciences Corporation Copyright Mindray DS USA 2003 All rights reserved Contents of this publication may not be reproduced in any form without permission of Mindray DS USA 0070 10 0648 02 Spectrum Operating Instructions Table of Contents jo v Warnings Precautions and Notes 1r teet eR HE vores EIE ERR EHE ER EEE Warning vi Precautions ER DRE o edo ae ae e otav era cheek E REOR Cedo Hai nte soe E REOR To A x tote s due cL ton Indication For Use UM PCCKING e ost ee Mt aes Symbols and Descriptioris EEE A n ed e Xe doa xvi General Product Description Le ee e eee eee eese ee eee eee e ee eee eso eese osos eesseeeesseseeesseseesseceeessesese 1 General Product Description eee teni e a ee eee dene a eee eek edet tene hee 1
228. ns IBP Transducer Performance Excitation Transfer Function Zero Offset Range Zero Accuracy Linear Input Range Noise Drift Frequency Response IBP Heart Rate Meter Range Neonatal Range bpm Pediatric Range bpm Adult Range bpm Resolution Accuracy Trigger Threshold Step Change Response Time Spectrum Operating Instructions 5 Volts DC 2 Minimum load resistance is 300 ohms per transducer Compatible with 5 uV mmHg Volt nominal excitation transducers The transducer zero offset range is 120 mmHg The zero accuracy is x 1 mm Hg Is 30 to 300 mmHg after zeroing lt 0 5 mmHg RTI DC to 15 Hz 300 Q source impedance 0 15 mmHg per degree Celsius DC to 16 Hz 1 Hz 3 dB 30 to 350 30 to 300 30 to 300 1 bpm 3 bpm or x 376 at 30 to 250 bpm 5 bpm or x 576 from 251 to 350 bpm 18 mm 9 mmHg When tested using methods similar to ANSI AAMI EC13 1992 Section 4 1 2 1f the response time of the heart rate meter to changes in heart rate is Less then 10 sec for step increase from 80 to 120 bpm Less then 11 sec for step decrease from 80 to 40 bpm 0070 10 0648 02 5 11 Patient Parameter Specifications 5 2 5 5 12 Appendix Temperature Parameter Performance Characteristics The Spectrum is capable of providing temperature measurements from a maximum of 2 temperature channels used simultaneously as measured from YSI 400 or YSI 700 probes Te
229. nt gt 10 minutes but 20 minutes after indication with 2 new fully charged batteries with no CO and printer Data Storage 5 8 5 32 Appendix Data Storage Monitor Configuration Data Storage and Transfer Storage The monitor has the ability to store in non volatile memory the user selectable configuration There is one 1 configuration available for each patient size and the following information is saved e Alarm Values Display Configurations e NIBP Interval Parameter Settings scaling Trace Speed Printer Settings Trend Configurations Transfer Transfer of monitor configuration data to and from the Spectrum using a PCMCIA card inserted into PCM2 is provided while in installation mode The Transfer PCMCIA card has the ability to be write protected Patient Data Storage and Transfer Storage The current patient information and demographics is stored in non volatile memory The monitor is capable of storing in non volatile memory a maximum of 120 trend values for each active parameter and 6 minutes of OxyCRG data Extended Trend With the addition of a PCMCIA memory card inserted into PCM1 the monitor is capable of storing 500 list trend records for each active parameter and 12 hours of OxyCRG data The extended trend card is expected to be present at power up and never removed All trend data not on the extended trend card when installed is lost and not accessible Transfer Transfer
230. nt size FIGURE 2 3 Patient Menu The Patient Menu stores patient demographic data identification data and bed number The Patient Menu contains the following patient information Patient s Size Adult Pediatric or Neonate Gender Date of Birth First Name Last Name Identification Number Bed Number measurements of Height and Weight and IV Drug Calculations NOTE Changes that are made in the Patient Menu do not become effective until the menu is closed NOTE Verify monitoring settings when the patient size is changed 2 8 0070 10 0648 02 Spectrum Operating Instructions Operations Main Menus Entering a Patient s First Last Name ID Number and Bed Number To enter the patient s First Name Last Name ID Number and Bed Number complete the following steps gt NOTE NOTE Open the Patient Menu and scroll down through the menu using the Navigator Knob Select the patient data you wish to enter or change Press the Navigator Knob and a keypad will appear on the screen To enter Patient information highlight the appropriate characters When finished entering the data select Done and press the Navigator Knob to close the keypad The patient information will appear in the upper right hand corner of the display This data will also appear on printouts Although the Bed field can accept a maximum of 15 characters if a Spectrum 608 radio is communicating with a Panorama Central S
231. nt specified below The customer or the user of the Spectrum should assure that it is used in such an environment IMMUNITY TEST Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 IEC 60601 TEST LEVEL 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz COMPLIANCE LEVEL 3 Vrms 3 V m ELECTROMAGNETIC ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the Spectrum including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 1 2 x JP d 1 2x JP 80 MHz to 800 MHz 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 meters 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 vicinity of equipment marked with the following symbol e NOTE NOTE At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio
232. ntainer 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 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 2 4 8 1 Gas Monitor Calibration Accuracy verification of the Gas Module II and SE is recommended at six 6 month intervals or whenever gas readings appear to be in error 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 in the 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 approved precision calibration gas after calibration is performed Never use calibration gas that has expired or has a canister that is indicating low pressure The pressure indicator on the Mindray gas regulator must operate in the green zone during the entire calibration session NOTE The
233. nts GM Air Leak Appears when more than one anesthetic agent is detected by the system 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 Spectrum Monitor being on Message will disappear when a single agent is detected again Turn Gas Module and Spectrum Off Install check sample lines filters water trap and electrical connections Turn off Gas Module Turn on Gas Module and Spectrum Monitor GM Replace Trap Indicates residue build up on the water trap membrane that is decreasing air flow Replace water trap reservoir GM Occlusion Appears when the system detects an obstruction in the sampling line or the water trap bottle is full Empty and rinse water trap Change water trap if necessary Check sampling line and 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 Customer Support GM Zero In Progress GM Zero Error Appears when the system is zeroing all of it s channels This appears whether initiated by the user or is automatic Appears when the system has been unable to successfully zero the sensor This is normal operation Wait for message to clear Manually
234. nual mode requires the operator to initiate the measurement cycle The interval mode follows a configured plan of automatically initiated measurement cycles The Maximum Measurement Cycle Duration is 180 sec for Adult and Pediatric patients Reference EN60601 2 30 1995 The Maximum Measurement Cycle Duration is 90 sec for Neonatal patients Reference EN60601 2 30 1995 During a measurement if the initial cuff inflation pressure is found to be inadequate the unit will retry with a higher inflation pressure 50 x 10 mmHg in Adult mode and Pediatric mode 40 10 mmHg in Neonatal mode In interval mode only the unit will adjust the inflation pressure according to the previous systolic pressure After the first successful measurement is made the subsequent inflation pressure becomes 50 10 mmHg in the Adult mode and Pediatric Mode and 40 10 mmHg in Neonatal mode IBP Performance Characteristics The Spectrum is capable of providing invasive blood pressure IBP measurements from a maximum of 4 IBP channels that can be used simultaneously Each IBP channel provides three pressure readings systolic diastolic and mean pressures IBP Safety Requirements The IBP function meets the safety requirements of EN 60601 2 34 IBP Performance Requirements Accuracy 2mm Hg or 2 which ever is greater excluding transducer error 0070 10 0648 02 Spectrum Operating Instructions Appendix Patient Parameter Specificatio
235. ode 2 digits unspecified Neonatal Mode 3 digits unspecified During motion conditions SATURATION RANGE PATIENT SIZE 70 TO 100 0 69 Adult Mode 3 digits unspecified Pediatric Mode 3 digits unspecified Neonatal Mode 3 digits unspecified SpO Response Time The response time is 18 seconds to 95 of final step change of SpO value from 60 to 9576 at 75 bpm Post averaging time is set at 8 seconds Low Perfusion Performance LOW PERFUSION CONDITIONS PULSE 76 SATURATION PULSE RATE AMPLITUDE TRANSMISSION ACCURACY ACCURACY 0 0276 gt 5 2 digits 3 digits Spectrum Operating Instructions 0070 10 0648 02 5 13 Patient Parameter Specifications Appendix Pulse Rate Range and Accuracy ACCURACY DURING PULSE RATE NO MOTION MOTION PATIENT SIZE RANGE CONDITIONS CONDITIONS Adult Pediatric Neonate 30 to 235 bpm 3 digits 5 digits Update Rate Every 2 seconds Masimo SET Reference notes The Masimo SET MS 3 pulse oximeter with LNOP eAdt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70 to 100 SpO against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 6876 of the population The Masimo SET MS 3 pulse oximeter with LNOP eAdt sensors has been validated for motion accuracy in human
236. oduction CAUTION To assure successful triggering of a Mindray Intra Aortic balloon pump from the Spectrum monitor set the ECG Filter to Extended and set Pacer Enhancement to On Both of these settings are located in the ECG setup menu of the Spectrum CAUTION The Analog Output on the Spectrum supports triggering the Intra Aortic Balloon Pump IABP for 3 Lead and 5 Lead ECG cable monitoring only Invasive Blood Pressure triggering is not supported ECG analog output is disabled when 12 Lead ECG analysis is enabled CAUTION Removal of the View 12 ECG Analysis Module without first disabling the 12 lead ECG card may cause a temporary disruption in patient monitoring CAUTION Cuffs must be used with the correct Mindray hoses CAUTION Please consult a physician for interpretation of blood pressure measurements CAUTION A blood pressure measurement can be affected by the position of the patient and his her physiological condition as well as other factors such as patient movement CAUTION Observe caution on all patients Neonates Pediatrics and Adults when NIBP is set to the Continuous Mode and the 1 minute interval When the NIBP continuous interval is selected the Spectrum will continually take back to back blood pressure readings As a safety precaution a limit is placed on continuous and 1 minute interval measurements In continuous mode after 5 minutes the NIBP interval will automatically switch to one me
237. odule Digital displays are provided for Heart Rate Non invasive Blood Pressure NIBP Pulse Oximetry 5 Respiration Rate and Temperature T1 Optional digital areas provided for Invasive Blood Pressure up to four Anesthetic Agents O2 and ST and The optional internal recorder provides hard copies of all digital data and waveforms as well as trend information The Spectrum Monitor can be mounted on a rolling stand a wall mount bracket gas machine arm bedrail Gas Module or operated as a tabletop instrument The View 12 ECG Analysis Module for the Spectrum enables 12 lead acquisition continuous 12 lead ST analysis and arrhythmia analysis with print capability The View 12 ECG analysis module consists of a PCMCIA card for insertion into the Spectrum and a detachable leadwire set The Spectrum has the capability of interfacing with Mindray s Central Stations Gas Module IABP Systems Edwards Vigilance Monitor Remote Displays and Nurse Call Systems The Spectrum monitor is powered by an AC connection or internal batteries 0070 10 0648 02 Spectrum Operating Instructions General Product Description Key Features 1 2 FEATURES Display Key Features STANDARD 12 1 inch color liquid crystal display Automatic Sensor Detection and Waveform Display 8 trace erase bar refresh OPTIONAL External Remote Color Display ECG 3 or 5 lead 1 Il aVR aVL aVF V ECG Cascad
238. ones If MUTE ALL is set to Permanent the message All alarms muted permanently is displayed The time period for MUTE and MUTE ALL is adjustable via the Alarms Setup Menu 2 6 3 Alarm Troubleshooting MESSAGE PROBLEM REASON SOLUTION High or Low or No Alarm Alarm limits not set Go to Alarm Setup and adjust Sound alarms Alarm Mute All On time has Press MUTE ALL reactivate not expired alarms No Arrhythmia Arrhythmia option not installed Call Sales Rep to purchase option Alarm Sound Arrhythmia Alarms off Go to Monitor Setup Advanced Setup to activate alarm Monitor is in learning mode Wait until learning is concluded and monitor patient closely Alarms continue to Sound More than one alarm is active Press MUTE or MUTE ALL key to despite pressing MUTE silence Check Patient No Alarm printout with Print on Alarm is set to Off Go to Print Menu and set Print Alarm violation on Alarm to On Spectrum Operating Instructions 0070 10 0648 02 2 101 Trends Operations 2 7 2 7 1 Trends Three types of trend displays are available with the Spectrum All trends are accessed via the trends key and can be printed via the internal recorder List Trends The List Trend display allows the user to view a tabular list of stored patient vital signs and anesthetic gas data Press the TRENDS key to access this display A maximum of 120 time stamped entries may be stored If the Extended Trend option is installed a maximum of 500 time s
239. onment output lines output lines Surge 1 kV 1 kV differential Mains power quality should be that of IEC 61000 4 5 differential mode 2 kV a typical commercial or hospital mode 2 kV common mode environment common mode Voltage dips lt 5 Ur gt 95 lt 5 Ur 95 Mains power quality should be that of short dip in Ur for dip in Ur for 0 5 a typical commercial or hospital interruptions and 0 5 cycle cycle environment If the user of the voltage Spectrum requires continued variations on 40 60 40 60 operation during power mains power supply dip in for dip in for interruptions it is recommended that input lines IEC 5 cycles 5 cycles the Spectrum be powered from an 61000 4 11 uninterruptible power supply or a 70 30 70 30 battery dip in Ur for dip in Ur for 25 cycles 25 cycles lt 5 Ur gt 95 lt 5 Ur gt 95 dip in Ur for5 dip in Uy for 5 sec sec Power frequency 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 Ur is the A C mains voltage prior to application of the test level 0070 10 0648 02 Spectrum Operating Instructions Appendix Electromagnetic Capability TABLE 5 3 GUIDANCE AND MINDRAY DS USA DECLARATION ELECTROMAGNETIC IMMUNITY The Spectrum is intended for use in the electromagnetic environme
240. orm 1 and Waveform 2 data The source of the printout is indicated on the strip as Frozen Print on Alarm If a waveform is initiated by an alarm violation then the internal recorder will initiate a 16 second waveform strip To activate this feature go to the Print Setup Menu highlight the Print on Alarm selection and select Yes During an alarm printout the data for the parameter which violated the alarm will be printed in brackets and the portion of the waveform triggering the alarm will have a bar printed above If the recorder is printing a strip or trend data and an alarm is violated then the currently printing waveform will be aborted and the alarm waveform will be printed The source of the printout is indicated on the strip as Alarm Interval Printing To print waveform strips at regular intervals go to the Print Setup Menu highlight Print Every and select a time interval to print The selections are Off 1 5 10 15 20 30 minutes 1 hour and 2 hours The source of the printout is indicated on the strip as Periodic Trend Printing To print any trend data to the recorder press the PRINT TREND key while the trend is displayed To abort trend printing press the PRINT TREND key during the print The trends available for printing are List Trend Graph Trend and OxyCRG Trend List Trend prints digital data information while Graph Trend and OxyCRG print graphic representations of the data in the respective menus Tine
241. ower 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 Ur is the A C mains voltage prior to application of the test level 0070 10 0648 02 Spectrum Operating Instructions Appendix Electromagnetic Capability TABLE 5 7 GUIDANCE AND MINDRAY DS USA DECLARATION ELECTROMAGNETIC IMMUNITY The Gas Module SE and Gas Module 3 are intended for use in the electromagnetic environment specified below The customer or the user of the Gas Module SE or Gas Module 3 should assure that they are 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 SE or 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 6100043 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 meters m Field strengths from fixed RF transmitters
242. pendix 5 1 Safety Designations 5 1 1 Safety designations per IEC 60601 1 Standard Type of protection against electric shock Degree of protection against electric shock Supply Connection Mode of Operation Protection Against Hazards of Explosion Protection Against Ingress of Spectrum Operating Instructions Liquids 0070 10 0648 02 Class 1 with internal electric power source Where the integrity of the external protective earth ground in the installation or its conductors is in doubt the equipment will be operated from its internal electric power source batteries ECG IBP and Cardiac Output Type CF defibrillation protected NIBP Type BF defibrillation protected SpO and Temperature Type BF 100 240 Volt 50 or 60 Hz 1 2 0 7 Amps 12 VDC Sealed Lead Acid Internal Battery or 11 1 VDC Lithium lon Internal Battery Continuous Not protected Ordinary Not protected Ordinary Safety Designations Appendix Degree of electrical connection Equipment designed for direct electrical and between equipment and patient non electrical connection to the patient Degree of Mobility Transportable 5 2 0070 10 0648 02 Spectrum Operating Instructions Appendix 5 2 5 2 1 Patient Parameter Specifications Patient Parameter Specifications ECG ECG Safety Requirements The 3 5 lead ECG function is in accordance with the applicable requirements of EN 60601 2 27 The
243. place the complete DRYLINE Water Trap Assembly every month or more often if indicated on the monitor 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 Detach the reservoir from the filter housing by twisting and separating these two parts Empty the reservoir and rinse with water only Tightly re attach the reservoir to the filter housing Reinstall 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 NOTE NOTE Only the reservoir of the DRYLINE Water Trap Assembly may be cleaned and or disinfected 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 0070 10 0648 02 Spectrum Operating Instructions User Maintenance Care and Cleaning of 3 and 5 lead ECG Cables and Leadwires 3 10 Care and Cleaning of 3 and 5 lead ECG Cables and Leadwires Recommended cleaning method of ECG cables and leadwires is a cloth wipe using ordinary alcohol free hand soap or USP green soap tincture When disinfection is required a cloth wipe using disinfectants such as isopropyl alcohol chlorine bleach in water 1 10 mixture or 2 Glutaraldehyde solution i e Cidex is recommended
244. pt UN Up E E Graph Trends tee attt e e a e AE IR gae et PO OxyCRG Trends Trends Troubleshooting Printing Optional ee Internal Recorder 5 ptc te e e GG CR PRO 2 109 Printing 124ead fo the Laser Printer unice ede e ea t eee ene de he dr ea e 2 116 Printer Recorder Troubleshoofing etes dec p tar reo fee eet eb e hl edens 2 116 Connection to PatientNet Central Station 2 tenete 2 117 Connection to Panorama Central 2 118 Connection to Panorama 2 119 Monitor Display Troubleshooting ic aa E MEHR AY RED DAE TOU benches 2 120 User Maintenance eeeee eee eene e eee o rettet esee e eee eee e eee eee eese ees os eso sososssco esee esee eeeeeeeeeeeeeeeeeesee 3 Introduction ee tea bends 3 1 Care and Cleaning of Monitor 23 1 Deconiamination oFMORITOF sheasainn ER arate ean t etn vote ed et 3 2 Care and Cleaning of SpOs Sensors aestate eene Eee ehe tb eia et e Re Ee ebd a
245. pump from the Spectrum monitor set the ECG Filter to Extended and set Pacer Enhancement to On Both of these settings are located in the ECG setup menu of the Spectrum The Analog Output on the Spectrum supports triggering the Intra Aortic Balloon Pump IABP for 3 Lead and 5 Lead ECG cable monitoring only Invasive Blood Pressure triggering is not supported ECG analog output is disabled when 12 Lead ECG analysis is enabled ECG Lead Fault Messages A Lead Fault message will be displayed if an ECG lead becomes disconnected from the patient A Check Lead Connection message will be displayed if 3 lead or 5 lead ECG has an intermittent or poor connection NOTE NOTE If a 3 or 5 lead ECG cable and the View 12 ECG Analysis Module are both in use then Lead Fault messages refer to the 12 lead cable only When monitoring 12 lead ECG a Lead Fault message will not be displayed if Right Leg Lead RL or R becomes disconnected from the patient Symbols in Heart Rate Tile The following symbols can appear in the HR Parameter tile 2 24 Arrhythmia This indicates arrhythmia option is installed and active ST Analysis This indicates ST Analysis option is installed and active Pacemaker This indicates pacemaker rejection is On 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring 24 2 1 Skin Preparation Proper skin preparation is essential in obtaining an accurate ECG
246. re is turned on from the ST Menu By default ST data will appear in the Heart Rate Tile when using a 3 lead or 5 lead cable When using a 3 lead cable ST Analysis is performed on the lead chosen as ECG1 With a 5 lead cable ST Analysis is performed on the leads chosen as ECG 1 ECG 2 and ECG 3 on the ECG Menu To display ST data set a waveform to display any ECG wave ECG2 ECG3 etc or set any waveform to display Average ST or Minitrends then set Combine ST HR to OFF ST Menu Normal Screen ST Analysis On Combine ST HR On Relearn Iso JST ST pt 60 80 msec ST Setup Select to turn ST analysis on or off FIGURE 2 34 ST Menu When View 12 ECG Analysis Module is installed continuous 12 lead ST monitoring will be enabled when ST Analysis is set to On 12 lead ST analysis may be viewed in 2 modes Delta and Absolute Delta ST is the ST segment change between the learned ST segment and the present ST segment Absolute ST is the ST segment change between the O baseline point of the ST and the present ST segment To display 12 lead ST data in a tile set any waveform to display any ECG wave ST Minitrends or Averaged ST Spectrum Operating Instructions 0070 10 0648 02 2 43 Parameter Menus and Monitoring Adjusting the ISO and J ST Point l 2 Open the ST Menu by using the Navigator Knob to select the ST parameter heading ST Menu can also be accessed through the ECG Menu Insure th
247. re may affect NIBP performance and should be used with caution 2 Attach cuff hose to NIBP Connector 3 Apply the cuff to the patient To reduce errors the cuff should be adjusted for a snug fit Little or no air should be present within the cuff Be sure the cuff lies directly against the patient s skin No clothing should come between the patient and the cuff NOTE The NIBP cuff should not be placed on a limb that is being utilized for any other medical procedure For example an IV catheter or an SpO sensor 4 If not already selected select the Patient Size through the Patient Menu Choices are Adult Pediatric or Neonate 5 If necessary change the initial cuff inflation pressure through the NIBP Menu Initial cuff inflation pressures depend on the patient size setting The values for cuff inflation are identified in the following table PATIENT SIZE INITIAL CUFF DEFAULT MAXIMUM SETTING INFLATION VALUES SETTING INFLATION VALUES Adult 100 280 mmHg 180 mmHg 300 mmHg Pediatric 60 180 mmHg 140 mmHg 195 mmHg Neonate 40 120 mmHg 100 mmHg 150 mmHg 6 Press START to begin an NIBP measurement CAUTION Cuffs must be used with the correct Mindray hoses CAUTION Please consult a physician for interpretation of blood pressure measurements CAUTION A blood pressure measurement can be affected by the position of the patient and his her physiological condition as well as other factors such as patient movement
248. re reusable sensors that are applied with disposable adhesive The Durasensor DS 100A Adult Digit Oxygen Transducer is a reusable sensor with its optical components mounted in a plastic casing The Nellcor RS 10 and Max Fast oxygen transducers are adhesive sensors for application on the forehead or temples To order all Nellcor accessories and sensors call 1 888 744 1414 Selecting a Nellcor Sensor Sensors are designed for specific sites on patients with designated weight ranges To select the appropriate sensor consider the patient s weight level of activity adequacy of perfusion which sensor sites are available whether sterility is required and the anticipated duration of monitoring Spectrum Operating Instructions 0070 10 0648 02 2 57 Parameter Menus and Monitoring Operations NOTE Only Nellcor oxygen transducers should be used with the Spectrum monitors with Nellcor Oxismart or OxiMax pulse oximetry 2 4 4 3 SpO Troubleshooting and SpO Menu Performance Considerations To ensure optimal performance use an appropriate sensor apply it as directed and observe all warnings and cautions If excessive ambient light is present cover the sensor site with opaque material Failure to do so may result in inaccurate measurements Light sources that can affect performance include surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct
249. rinter Go to Print Setup Menu and set Print on Alarm to On Press PRINT TREND when trend window is open Use scroll feature to scroll to the top of the trend then press PRINT TREND Check Replace paper 0070 10 0648 02 Spectrum Operating Instructions Operations Connection to PatientNef Central Station 2 9 Connection to PatientNet Central Station The Spectrum can be connected to the PatientNet Central Stations via direct hardwire or telemetry connection using the Comm Port Access the Installation Menu and set a Serial Port to PatientNet to enable PatientNet The interface allows the Spectrum waveforms and data to be displayed at the PatientNet Central Station The interface also enables the Spectrum to Admit to Discharge from and print at the PatientNet Central Station NOTE Pressing the VIEW key does not affect the waveforms being transmitted to the Central Station NOTE See the PatientNet Operating Instructions for more details on PatientNet Operation NOTE See Administrative Guide for the PatientNet Central Station for more detail Spectrum Operating Instructions 0070 10 0648 02 2 117 Connection to Panorama Central Station Operations 2 10 Connection to Panorama Central Station The Spectrum will communicate with the Panorama Central Station via direct hardwire to an appropriate Comm Port or via a wireless network The Enable Network option in the System Information menu
250. riority for PVC min is user selectable between 1 and 2 Spectrum Operating Instructions 0070 10 0648 02 2 37 Parameter Menus and Monitoring Operations 2 38 NOTE Non lethal arrhythmia alarms are not latched alarms and can be acknowledged at any time To acknowledge a non lethal arrhythmia alarm press the MUTE key on the keypad Bigeminy Alarm The Bigeminy alarm is activated when three or more cycles of one PVC coupled to one normal beat are detected The Bigeminy alarm is a Priority 2 alarm event that produces arm Priori visual and audio alarm indicators Al P 2 and audio al dicat A BIGEMINY text message above the ECG1 waveform area Bradycardia Brady Alarm The Brady alarm is activated when the heart rate falls to a value 1076 lower than the user selected value for low heart rate alarm NOTE The Bradycardia alarm is not available when using a View 12 card The Brady alarm is an alarm event that produces arm Priori visual and audio alarm indicators Al P and audio al dicat A Brady text message above the ECG1 waveform area Couplet Alarm The Couplet alarm is activated when two consecutive PVCs are detected between normal beats The Couplet alarm is a Priority 2 alarm event that produces arm Priori visual and audio alarm indicators Al P 2 and audio al dicat A COUPLET text message above the ECG1 waveform area Irregular Heart Rate Alarm The Irregular Heart Rate alarm is act
251. romagnetic Emissions or decreased Electromagnetic Immunity of the Spectrum It can also cause delayed recovery after the discharge of a cardiac defibrillator Dispose of single use items in accordance with hospital policy To prevent condensation allow the Spectrum to warm up and dry if it is moved from a cold area to a warm one The Spectrum may not meet its performance specifications if stored or operated outside of specified temperature and humidity ranges Prior to use be sure the rail supporting the bed rail mounting hook can support the weight of the monitor Consult the bed manvfacturer s specifications if necessary Mindray cannot be responsible for injury or damage resulting from improper or inadequate support of the monitor Use recommended Mindray supplied power cords If a substitute is necessary use only hospital grade power cords Sudden changes in PA blood temperature such as those caused by patient movement or bolus drug administration may cause a CO or CI value to be computed To avoid falsely triggered curves you should inject as soon as possible after the INJECT message appears Line Isolation Monitor transients may resemble actual cardiac waveforms thus inhibiting heart rate alarms Check lead wires for damage and ensure good skin contact prior to and during use Always use fresh electrodes and follow proper skin preparation techniques 0070 10 0648 02 Spectrum Operating Instructions Precautions Intr
252. rs are red for priority 1 alarms yellow for priority 2 alarms and green if initiated by pressing the MARK EVENT key 2 102 0070 10 0648 02 Spectrum Operating Instructions Operations Trends Trend data in violation of an alarm is also highlighted according to the priority of the alarm On color displays the data is red for priority 1 alarms and yellow for priority 2 alarms If data for a parameter is not available at the time of the trend entry the data field will be dashed If an NIBP reading could not be obtained or an invasive pressure channel was not zeroed at the time of the trend entry the data field will contain xxx Modification of Parameters Displayed The parameters displayed always include the currently active parameters and any others used since the time the patient was admitted to the monitoring system The default order of parameters displayed from left to right is HR NIBP SpO2 Resp CO IBP1 IBP2 IBP3 IBPA T1 T2 TBlood AT Agent PVC CO Cl and When CO and CI data is obtained in continuous mode the label Cont will display next to the data entry in the CO and CI columns When CO and CI data is obtained in intermittent mode an XX XX label will display next to the data entry in the CO and CI columns This label is a time stamp where XX XX the time at which the trended data was recorded To change the order of the parameters displayed select the Setup Menu from the Lis
253. s FIGURE 2 20 Lead II Monitoring Place the RA white electrode under the patient s right clavicle at the mid clavicular line within the rib cage frame Place the LA black electrode under the patient s left clavicle at the mid clavicular line within the rib cage frame Place the LL red electrode on the patient s lower left abdomen within the rib cage frame Select ECG Lead II on the monitor Lead II is the direct electrical line between the RA white electrode and the LL red electrode 0070 10 0648 02 Red Yellow FIGURE 2 21 Lead Monitoring IEC Place the R red electrode under the patient s right clavicle at the mid clavicular line within the rib cage frame Place the L yellow electrode under the patient s left clavicle at the mid clavicular line within the rib cage frame Place the F green electrode on the patients lower left abdomen within the rib cage frame Select ECG Lead ll on the monitor Lead II is the direct electrical line between the R red electrode and the F green electrode Spectrum Operating Instructions Operations Parameter Menus and Monitoring Modified Chest Lead MCL Monitoring The recommended lead placement for MCL monitoring is as follows Red Yellow FIGURE 2 22 MCL Monitoring with a FIGURE 2 23 MCL Monitoring with a 3 wire Lead Set 3 wire Lead Set IEC Place the RA whi
254. s Graph Trend data is transferred together with List Trend and patient name and demographics Refer to the List Trend section for details Clearing Trend Data To manually clear all trend data including List and OxyCRG trends choose Clear Trends from the menu A confirmation prompt will appear Once cleared the data cannot be restored All trend data is automatically cleared when the patient is discharged from the monitor All trend data is also cleared if the monitor s displayed time or date is changed Removing the Graph Trend Display The Graph Trend display does not automatically time out and must be manually removed to return to the normal waveform display To remove the Graph Trend display choose Normal Screen from the menu or press the NORMAL SCREEN key 0070 10 0648 02 Spectrum Operating Instructions Operations 2 7 3 Trends OxyCRG Trends The OxyCRG Oxygen Cardiorespirogram display allows the user to view a continuously updated graphic summary of 5 specific patient vital signs This display is available for Neonate and Pediatric patient sizes only To access this display from the normal monitoring screen press the TRENDS key 3 times To access this display from the List Trends display press the TRENDS key twice To access this display from the Graph Trends display press the TRENDS key once This display may also be accessed from the other trend displays via menu selection A maximum of 6 minutes of data may b
255. s as this could result in incorrect measurement data Do not use DRYLINE Adult Pediatric sampling lines 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 Spectrum Operating Instructions 0070 10 0648 02 ix Introduction Precautions Precautions CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION Always place the monitor on a rigid flat surface or on approved mounts Do not block ventilation or speaker vents Never place fluids on top of this monitor In case of accidental spillage wipe clean immediately and have the monitor serviced to ensure no hazard exists This unit must only be operated with Mindray approved software To avoid possible damage to the Spectrum use only ECG cables and accessories available from Mindray Operation of the Spectrum below the minimum amplitude or value of patient physiological signal may cause inaccurate results Use of accessories transducers and cables other than those specified in the manual may result in increased Elect
256. s not selected from keypad after entering data Data not entered or entered incorrectly Contact Mindray Customer Support Enter proper patient data Go to the proper keypad enter data select Done when finished Follow instructions from How to Set the Clock Date and Time 0070 10 0648 02 Spectrum Operating Instructions z0 User Maintenance 3 1 Introduction This section of the manual outlines routine user maintenance guidelines The Spectrum Monitor is designed for stable operation over long periods of time Under normal circumstances the monitor should not require technical maintenance beyond that described in this section However routine maintenance calibration and safety checks are recommended at least once a year or more often as required by local statutory or hospital administration practice 3 2 Care and Cleaning of Monitor The monitor 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 monitor DO NOT apply large amounts of liquid DO NOT use abrasive cleaning agents or organic solvents WARNING Do not clean the monitor while it is on and or plugged in To prevent scratches on the screen carefully brush dust and dirt particles with a soft sponge moistened with cleaning solution or a fine soft hair brush DO NOT use abrasive cleaning materials Remove fingerprints and stains with a liqu
257. seconds and or during detected episodes of Asystole and Ventricular Fibrillation 12 lead mode ST data is invalidated when the paced rhythm or Ventricular Rhythm persists for more than 30 seconds and or during detected episodes of Asystole Ventricular Fibrillation and Ventricular Tachycardia Arrhythmia Analysis Arrhythmia analysis can be enabled in Adult and Pediatric modes Arrhythmia analysis will identify ventricular arrhythmia only Non lethal or all arrhythmia alarms are capable of being disabled The Spectrum will have the ability to make the following arrhythmia calls as applicable per ECG source 3 5 lead ECG includes the following Arrhythmia Calls Asystole Irregular Heart Rate Couplet PVCs per minute Run Bigeminy Trigeminy Ventricular Tachycardia Ventricular Fibrillation Ventricular Rhythm and Bradycardia 12 lead ECG includes the following Arrhythmia Calls Asystole Pause Couplet Ventricular Rhythm PVCs per minute Run Bigeminy Trigeminy Ventricular Tachycardia and Ventricular Fibrillation When the ECG source is 3 5 Lead PVCs per minute are invalidated and the PVC counter reset to O during periods of Ventricular Rhythm Ventricular Tachycardia Ventricular Fibrillation or Asystole When the ECG source is 12 Lead PVCs per minute are invalidated and the PVC counter is reset to O during periods of Ventricular Rhythm Ventricular Tachycardia and Ventricular Fibrillation During periods of Asystole the PVC co
258. sensors Use of other oxygen transducers may cause improper oximeter performance Vacuum negative pressure should not exceed 1 mmHg at the Spectrum Pump Exhaust fitting Excessive scavenge vacuum result in an Occlusion message or damage to the Spectrum s internal pump The scavenging system must be on during calibration Microstream waste and FilterLine should be treated as biohazardous waste When cleaning sensors do not use excessive amounts of liquid Wipe the sensor surface with a soft clorh dampened with cleaning solution Do not attempt to sterilize 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 Xii 0070 10 0648 02 Spectrum Operating Instructions Precautions Introduction CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION If the dust filter for the fan cannot be cleaned or is damaged replace it with part number 0378 00 0040 Use of another type of filter may decrease the cooling effectivity and cause damage to the Gas Module To avoid permanent damage do not expose metal components pins sockets snaps to disinfectants soaps or chemicals Only connect NIBP Luer fittings to Blood
259. sferable with the monitor defaults via a PCMCIA card 2 18 0070 10 0648 02 Spectrum Operating Instructions Operations Main Menus The following table provides a listing of the Remote View Setup Menu items Remote View Setup Menu MENU ITEM SELECTIONS FACTORY DEFAULT COMMENTS Previous Menu Select to return to previous menu New Bed All available beds on a single network This menu item provides a list of monitor devices that are available in the Mindray approved hardwired network and have Bed numbers assigned The chosen Bed displays at the top of the Remote View Menu Wave 1 All waveforms available on the remote monitor Only waveforms available on the remote monitor will be listed as selections for this menu item The menu selections for Wave 1 will not include the waveform that is currently selected as Wave 2 Wave 2 All waveforms available on the remote monitor Only waveforms available on the remote monitor will be listed as selections for this menu item The menu selections for Wave 2 will not include the waveform that is currently selected as Wave 1 Remote Mute For l min 2 min 5 min Select to choose duration of Remote Mute 10 min Remote Mute Permanent 1 min Select to choose duration of Remote Mute All All For 2 min 5 min 10 min These selections will not be available if the country chosen in the Installation Menu is France 3 Remote Mute this sel
260. spiration data through the ECG thoracic impedance technique Thoracic impedance is usually measured between the Right Arm and Left Arm electrode patches These patches should be placed on the chest directly across from each other to optimize the measuring of the neonate s chest movement The recommended lead placement for neonate monitoring is as follows FIGURE 2 24 Neonatal 3 wire Lead Placement Place the RA white electrode under the patient s right clavicle at the mid clavicular line within the rib cage frame Place the LA black electrode under the patient s left clavicle at the mid clavicular line within the rib cage frame Place the LL red electrode on the patient s lower left abdomen within the rib cage frame 0070 10 0648 02 FIGURE 2 25 Neonatal 3 wire Lead Placement IEC Place the R red electrode under the patient s right clavicle at the mid clavicular line within the rib cage frame Place the L yellow electrode under the patient s left clavicle at the mid clavicular line within the rib cage frame Place the F green electrode on the patients lower left abdomen within the rib cage frame Spectrum Operating Instructions Operations Parameter Menus and Monitoring Monitoring a Pacemaker Patient The recommended lead placement for monitoring a pacemaker patient is as follows Yellow FIGURE 2 26 3 w
261. ssed Rescale Waves Select to auto scale all waveforms Alarm Volume Variable from Mid Scale Displays a slide bar to adjust the setting Minimum to of the alarm volume Use the Navigator Control Maximum Knob to adjust the volume Beep Volume Variable from Off to Mid Scale Displays slide bar to adjust the setting Maximum of the systole beep volume Use the Navigator Control Knob to adjust the volume ECG Speed 6 25 12 5 25 25 mm sec Select to change trace speed of ECG amp 50 mm sec Pleth waveforms IBP Speed 6 25 12 5 25 25 mm sec Select to change trace speed of 50 mm sec pressure waveforms 0070 10 0648 02 Spectrum Operating Instructions Operations Main Menus Monitor Setup Menu Continued MENU ITEM SELECTIONS FACTORY DEFAULT COMMENTS Resp Gas Speed 3 125 6 25 12 5 12 5 mm sec Select to change trace speed 25 mm sec Advanced Setup Select to set these menu items Set Date Set Time Trend Interval NIBP Trend Alarm Trend Nurse Call Arrhythmia Menu NIBP Start Mode Apnea latch Advanced Setup Menu MENU ITEM SELECTIONS FACTORY DEFAULT COMMENTS Previous Menu Select to return to previous menu Set Date Select to change date Changing the date will clear the trend information A confirmation message will display Set Time Select to change time Changing the date will clear the trend information A confirmation message will display
262. t Trend Menu Once in the Setup Menu change the Format selection from Auto to Manual Select parameters to be displayed in each of the first 6 columns Modification of Trend Entry Conditions Trend entry conditions may be modified via the Advanced Setup Menu The Advanced Setup Menu is accessed from the Monitor Setup Menu Any combination of trend input triggers may be used TREND ENTRY TRIGGER DEFAULT COMMENT Interval Off Trend entries will occur at the selected time interval Alarm Off Trend entries will occur when an alarm violation occurs NIBP On Trend entries will occur whenever an NIBP measurement is made Filtering of List Trend Data Displayed Pressing the MARK EVENT key will cause a Trend Entry Data corresponding MARK EVENT key presses will be included in the displayed data If the Trend Entry Triggers for Alarms and or NIBP have been set to On this data will also always be included Spectrum Operating Instructions 0070 10 0648 02 2 103 Trends 2 104 Operations Trend entries triggered by the Interval setting above may be filtered out from the displayed List Trend data To change the amount of interval entries displayed select Setup from the List Trend Menu From the Setup Menu select Display Interval and set as desired The choices available for the Display Interval depend on the setting of the Trend Entry Interval setting above If the Trend Entry Interval is set to Off there will be no choices avai
263. t s left clavicle at the mid patient s left clavicle at the mid clavicular line within the rib cage frame clavicular line within the rib cage frame Place the LL red electrode on the Place the F green electrode on the patient s lower left abdomen within the patient s lower left abdomen within the rib cage frame rib cage frame Spectrum Operating Instructions 0070 10 0648 02 2 27 Parameter Menus and Monitoring 2 28 Operations Standard 5 wire Lead Sets A 5 wire lead set can monitor seven ECG vectors I Il Ill aVR aVL aVF and V simultaneously The recommended 5 wire lead placement is as follows White Black Yellow Green Brown Black White V Lead E position Green Red FIGURE 2 16 5 wire Lead Placement Place the RA white electrode under the patient s right clavicle at the mid clavicular line within the rib cage frame Place the LA black electrode under the patient s left clavicle at the mid clavicular line within the rib cage frame Place the LL red electrode on the patient s lower left abdomen within the rib cage frame Place the RL green electrode on the patient s lower right abdomen within the rib cage frame Place the V brown electrode in one of the V lead positions V1 V6 depicted in the following section 0070 10 0648 02 FIGURE 2 17 5 wire Lead Placement IEC Place the R red electrode under t
264. t time out in the installation mode f a measurement is unsuccessful the display values are replaced with XX and a tone sounds Spectrum Operating Instructions 0070 10 0648 02 2 51 Parameter Menus and Monitoring Operations 2 52 Indirect BP Measurements and Associated Errors Place the patient in a supine position to obtain true physiological pressure If the cuff is not at the patient s heart level the pressure values obtained will not reflect the true physiological pressure Instead the readings will be decreased by 1 86 mmHg for every inch the cuff is placed above the heart level and increased by 1 86 mmHg for every inch the cuff is placed below the heart level This effect is due to hydrostatic pressure Blood weight influences blood pressure readings The value of the weight of blood depends on where the measurement is taken with respect to the heart When the patient is supine on a flat surface the arm is near enough to the heart level that no adjustment of the NIBP readings is necessary Recommendations for Automatic Blood Pressure Measurements The following practices are recommended when making automatically cycled blood pressure measurements Position and support the limb in such a way as to minimize stretching of and weight exertion on affected nerves Avoid cuff placement that applies pressure on the ulnar nerve Cuff tubing should not exit the cuff over the course of the ulnar nerve at the elbow Select a
265. tamped entries may be stored When the maximum number of entries has been reached the oldest entry will be deleted from the trend record in order to allow storage of a new entry List Trend Normal Screen Time SpO IBP 1 2 1 mmHg mmHg F Scroll a 17 57 500150 4 987 Seroll o deis b W 1256 95 oc 987 Event 17 54 97 110 60 80 110 60 80 100 1 Clear Trends 1253 98 110 60 80 110 60 80 993 10 Graph Trend 17 51 t 110 60 80 110 60 80 98 7 Setup 81750 100 14 50 150 14 50 150 100 1 s Select to return to normal sereen FIGURE 2 59 List Trends The left side of the List Trend display contains menu items for scrolling and access to other displays Trend data is listed from newest to oldest Use the vertical scroll feature to view older data Use the horizontal scroll feature to view all the columns of data NOTE When scrolling horizontally the first column of data remains displayed and does not scroll Scroll bars along the right and bottom sides of the trend display indicate the position of viewed data in relation to the rest of the database Upon reopening of the List Trend display the top of the trend screen will display the most recently viewed data The leftmost column of the List Trend display contains markers which indicate that the entry was triggered by an alarm violation or by pressing the MARK EVENT key These marke
266. tance feature of hemodynamic calculations Pulmonary Vascular Resistance Index feature of hemodynamic calculations Arteriovenous Shunt percent Right Atrium label for invasive blood pressure Right Cardiac Work feature of hemodynamic calculations Right Cardiac Work Index feature of hemodynamic calculations Right Ventricular Stroke Work feature of hemodynamic calculations Right Ventricular Stroke Work Index feature of hemodynamic calculations 0070 10 0648 02 Spectrum Operating Instructions Glossary 5 SV SVI 5 gt SVR SVRI UA Vd VOl Wedge Spectrum Operating Instructions Glossary of Terms Oxygen Saturation Stroke volume feature of hemodynamic calculations Stroke Volume Index feature of hemodynamic calculations Mixed venous oxygen saturation Systemic Vascular Resistance feature of hemodynamic calculations Systemic Vascular feature of hemodynamic calculations Tidal Volume Umbilical Artery label for invasive blood pressure Dead Space Oxygen Consumption Oxygen Consumption Index Pulmonary Artery Wedge Pressure This term is used interchangeably with PAWP 0070 10 0648 02 6 3 0070 10 0648 02 Rev L October 14 2010 Mindray DS USA Inc 800 MacArthur Boulevard Mahwah NJ 07430 USA Dom Customer Service 1 800 288 2121 Intl Customer Service 1 201 995 8000 e Dom Fax 1 800 926 4275 e Intl Fax 1 201 995 8680 www mindray com Mindray Medical Ne
267. tation only the first 5 characters will be displayed in the Bed field at the Central Station Also since Remote View requires selecting a Bed a unique number for each bed should be used The following standard format for this demographic is recommended Start the string with a room that has a fixed number of digits For example if the maximum number of digits that is used in numbering the rooms is 4 then for room 102 a leading zero would be added to get the Ath digit 0102 Follow the room with a letter to identify the particular bed within the room For example a room with 2 beds would have bed A and bed B e An example of a complete Bed Bed B in room 513 in a facility where the maximum number of digits that is used in numbering the rooms is 4 would be identified as 0513B If the monitor is communicating with the EMR Electronic Medical Records system through a Panorama Gateway any changes to patient demographics made at the monitor will not be sent to the EMR system For further explanation refer to section 2 11 Connection to Panorama Gateway Entering a Patient s Date of Birth To enter the patient s Date of Birth complete the following steps 2 gt Spectrum Operating Instructions Open the Patient Menu and scroll down through the menu using the Navigator Knob Select Date of Birth from the menu Press the Navigator Knob and a pop up window will emerge with day month and
268. te electrode under the Place the R red electrode under the patient s left clavicle at the mid patient s left clavicle at the mid clavicular line within the rib cage frame clavicular line within the rib cage frame Place the LA black electrode on the e Place the L yellow electrode on the right sternal border at the fourth right sternal border at the fourth intercostal space within the rib cage intercostal space within the rib cage frame frame Place the LL red electrode on the Place the F green electrode on the patient s lower left abdomen within the patient s lower left abdomen within the rib cage frame rib cage frame Select ECG Lead for MCL monitoring Select ECG Lead for MCL monitoring Lead is the direct electrical line between Lead is the direct electrical line between the RA white electrode and the LA black the R red electrode and the L yellow electrode electrode Select ECG Lead Il for MCL monitoring Select ECG Lead II for MCLg monitoring Lead Il is the direct electrical line between Lead Il is the direct electrical line between the RA white electrode and the LL red the L red electrode and the F green electrode electrode Spectrum Operating Instructions 0070 10 0648 02 2 31 Parameter Menus and Monitoring 2 32 Neonatal Electrode Placement Using a 3 wire lead set ECG lead placement on a neonate is usually directed towards Operations obtaining the best possible re
269. te the approximate surface height and weight be known Arch Intern Medicing 1916 17 863 71 Source Baxter Healthcare Corporation Model COM 2 Cardiac Output Computer Operations Manual Software Version 2 2 Santa Ana 1989 0070 10 0648 02 Spectrum Operating Instructions Appendix 5 4 Information Display and Control Information Display and Control Front Panel Display Indicators and Controls The front of the monitor will provide a keypad display rotary push knob and four LEDs Front Panel Display DISPLAY TYPE SIZE MINIMUM RESOLUTION Color active matrix TFT liquid crystal 12 1 inch diagonal 800 x 600 pixels Anti Glare Anti Reflection Filter The display is fitted with an anti glare anti reflection filter Rotary Knob The rotary knob is 16 position per revolution optical encoder with an integral push button switch LED Indicators Alarm Indicators Visual alarm indicators are in accordance with EN475 1995 red LED will flash at 1 4 2 8 Hz 84 times minute at 50 duty cycle during a warning alarm high priority A yellow LED will flash at a rate of 0 4 0 8 Hz at a 50 duty cycle during a caution alarm medium priority If a warning and caution alarm are in force simultaneously only the red LED is activated Power Indicators A green AC Mains LED is illuminated whenever the unit is connected to AC Power A green Battery Charging LED is illuminated constantly when the batteries are charging Aud
270. thal arrhythmia alarms These alarms automatically default to Alarm Priority 1 NOTE Lethal arrhythmia alarms are latched alarms Even after the alarming condition is resolved a latched alarm will continue until it is acknowledged by pressing the MUTE or MUTE ALL key on the front panel keypad If the alarm is acknowledged while the lethal condition still exists the audio portion of the alarm will be muted for the duration that is selected from the Mute For list in the Alarm Setup menu but the alarm message will remain in message area A If a new lethal condition occurs while the initial lethal alarm is muted the new lethal alarm will not break through and will be muted for the remainder of the mute duration If the lethal condition is resolved while the alarm is muted the alarm will be terminated 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring Asystole Alarm An Asystole alarm is activated when no QRS complexes are detected for the configured time period in the absence of Ventricular Fibrillation For 3 Lead and 5 Lead ECG The time period range for an Asystole alarm is user selectable from 3 to 10 seconds For 12 Lead ECG The time period range for an Asystole alarm is user selectable from 3 to 8 seconds The Asystole alarm is a Priority 1 alarm event that produces e Alarm Priority 1 visual and audio alarm indicators An Asystole text message above the 1 w
271. the host monitor and the associated alarm text messages are displayed in the Remote View Message Area Refer to section 2 4 2 5 Arrhythmia Alarms for the specific arrhythmia alarm text messages that can be displayed 2 20 0070 10 0648 02 Spectrum Operating Instructions Operations Main Menus NOTE The Lethal Arrhythmia alarms V Tach V Fib and Asystole are latched alarms Even after the alarming condition is resolved at the remote monitor a latched alarm will continue at the host monitor until it is acknowledged by selecting Remote Mute or Remote Mute All from the Remote View Menu If the alarm is acknowledged while the lethal condition still exists the audio portion of the alarm will be muted for the duration that is selected from the Remote Mute For list or the Remote Mute All For list of the Remote View Setup Menv but the alarm message will remain in the Remote View Message Area If a new lethal condition occurs while the initial lethal alarm is muted the new lethal alarm will not break through and will be muted for the remainder of the mute duration If the lethal condition is resolved while the alarm is muted the alarm will be terminated Only alarm text messages for parameters that are not currently displayed in a Wave 1 or Wave 2 numeric tile or in the Numeric Data Area are displayed in the Remote View Message Area f Apnea is detected the message Respiratory Apnea alarm is display
272. ther 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 The arrhythmia analysis feature is intended to detect ventricular rhythms however due to physiologic differences in patient populations the Spectrum may occasionally sound a false alarm or may not recognize some arrhythmia patterns Ensure that the ECG lead wires are neatly secured in a manner that will prevent them from encircling the patient s neck creating a strangulation hazard Perform the decontamination process with the unit powered down and power cord removed 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 airway 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 trap
273. therlands B V e Box 26 3870 CA Hoevelaken The Netherlands Tel 31 33 25 44 911 Fax 31 33 25 37 621 Mindray UK Limited 3 Percy Road St John s Park e Huntingdon Cambridgeshire PE29 652 e United Kingdom Tel 01480 416840 Fax 01480 436588 Mindray Medical France SARL Europarc Cr teil 123 Chemin des Bassins 94035 Cr teil Cedex France Tel 0 1 45 13 91 50 Fax 0 1 45 13 91 51 Mindray Medical German GmbH Zwischen den B chen 4 64625 Bensheim Germany Tel 49 6251 17524 0 Fax 49 6251 17524 20 Mindray Medical International Ltd e 2813 Office Tower Convention Plaza No 1 Harbour Road Wanchai Hong Kong Tel 852 2793 5596 Fax 852 2344 8824 0002 08 8918
274. thority to bind Mindray DS USAto 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 makes no warranty whatever in regard to trade accessories such being subject to the warranty of their respective manvfacturers A condition of this warranty is that this equipment or any accessories which are claimed to be defective be returned when authorized by Mindray freight prepaid to Mindray DS USA Mahwah New Jersey 07430 Mindray DS USA 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 50 0070 10 0648 02 Spectrum Operating Instructions Appendix Phone Numbers and How To Get Assistance 5 17 5 18 Phone Numbers and How To Get Assistance Mindray DS USA maintains a
275. ting essssssssseeee eme eene 2 64 Gas Monitoring with Gas Module ssssssssssesseeeeeeeeeenmen emere een 2 66 Gas Module 3 Pr use Test 45 77 d sedute eot t eer e te e edet dade t P tede 2 68 Gas Monitor Calibration et et ode ee eee ox aen eben dodo 2 69 Gas Module Treubleshooting E PR D tends 2 72 IBP Invasive Blood Pressure Menu Optional mee enn 2 75 Measuring IB Det Ca ost roc tides ee bestie Madea de crit e deu Coste 2 76 IBP tee ern ne etd ode aee De aga ae ee ek ode 2 77 Pulmonary Artery Wedge Pressure PAWP esses emere eene nene nennen 2 78 Measuring PAWP PAWP Troubleshooting Cardiac Output CO Optional reete een eie et ei ERR e ea ee eta e e 2 80 External Parameter Module EPM eene enne 2 80 Edwards Vigilance Monitor Vigilance tenens 2 86 CO from both Vigilance andERM 5 qe te dee et ee foto ee da 2 89 en dM A 2 90 Drug Calculation Sie Os 2 90 Hemodynamic Calculationis e dete eene io eaa ei ede ee oa ena ee 2 95 ense n a a Alarm limits
276. to enter normal monitoring mode 5 From the Patient menu of the main screen set Patient Size to either Adult or Pediatric 6 Open the Vigilance CO Menu by choosing CO from the Parameters Menu or by pressing the C O key on the front panel keypad NOTE The C O key on the EPM keypad does not function when the Spectrum is configured to monitor Vigilance cardiac output measurements Spectrum Operating Instructions 0070 10 0648 02 2 87 Parameter Menus and Monitoring Operations 2 4 11 2 2 2 4 11 2 3 2 88 Vigilance CO Menu The Vigilance CO Menu enables the user to e set the patient height and weight to be used in calculating cardiac index Cl NOTE Other menus also use patient height and weight data When this data is changed in any menu it is automatically updated in the other menus e choose the source for cardiac output access the Hemodynamics Calculations Menu a description of the Spectrum Hemodynamics Calculation method is provided in section 2 5 2 choose the color of the data that will display in the CO tile Vigilance CO Menu Normal Screen Height 120 0 in 304 8 cm Weight 155 Ibs 70 5 kg CO Source Vigilance Hemo Cales Menu Color c M g Select to return to normal screen FIGURE 2 55 Vigilance CO Menu CO Source As noted in the introduction to the Cardiac Output section CO can also be measured through an EPM If both the EPM and the Vigilance are conne
277. tremity that has a blood pressure cuff arterial catheter or intra vascular line Nail polish or fungus In certain situations in which perfusion and signal strength are low such as in patients with thick or pigmented skin inaccurately low readings will result Verification of oxygenation should be made especially in preterm infants and patients with chronic lung disease before instituting any therapy or intervention Many patients suffer from poor peripheral perfusion due to hypothermia hypovolemia severe vasoconstriction reduced cardiac output etc These symptoms may cause a loss in vital sign readings The SpO sensor site should be checked at least every eight 8 hours every four 4 hours with the Adult re usable finger sensor Ensure proper adhesion skin integrity and proper alignment Exercise extreme caution with poorly perfused patients Skin erosion and pressure necrosis can be caused when sensors are not frequently monitored Assess the site every two 2 hours with poorly perfused patients and neonates When equipped with Masimo SET 5 use only Masimo SET Oxygen Transducers including Masimo SET LNOP and LNCS Patient Dedicated Adhesive Sensors and Masimo SET PC Series Patient Cables Use of other oxygen transducers may cause improper oximeter performance When equipped with Nellcor SpO use only Nellcor oxygen transducers including Nellcor Oxisensor and OxiMax patient dedicated adhesive
278. trum FIGURE 1 12 CS1 MB1 SP1Comm Port 2 Ethernet Connector CS1 Ethernet connection port used for networking connections or devices requiring ethernet x s TM communication such as the Panorama Central Station or a Laser Printer 3 Module Bus Connector MB1 Port used for future enhancements 4 Serial Port Connector SP1 SP2 Proprietary serial port used to connect to the PatientNei Central Station Gas Module Edwards Vigilance Monitor or other devices 1 18 0070 10 0648 02 Spectrum Operating Instructions General Product Description Comm Ports FIGURE 1 13 RD1 NC1 SP1 Comm Port 5 Remote Display Connector RD1 Port used to connect a color remote display to the Spectrum monitor 6 Nurse Call Connector NC1 Port used to connect a nurse call cable to the Spectrum monitor dM an et EXE Dl lt MBI RDI amp 5 FIGURE 1 14 CS1 MB1 RD1 Comm Port NC1 gt gt 5 2 lt gt FIGURE 1 15 SP1 NC1 SP2 Comm Port Spectrum Operating Instructions 0070 10 0648 02 1 19 External Parameter Modules Optional General Product Description
279. ud rate Enable Network No Wired No Select to enable Panorama communications IP Address 2 Select to set up IP Address Subnet Mask 10 2 Select to set up Subnet Mask ID Wireless IP Address Select to set up Wireless IP Address Wireless Subnet Mask ID Select to set up Wireless Subnet Mask ID Laser Printer IP Address Select to set up laser printer IP Address Network Name 2 Select to set up Network name Device ID Spectrum Operating Instructions 1 Ifa serial port is set to Visa with admit or PatientNet or if WMTS Enabled is set to Yes in the Installation Menu Enable Network will not be available as a menu choice 2 _ Refer to the Panorama Service Manual for information on network settings 3 Device ID is an information field that displays a unique factory defined device ID number It is not user selectable 0070 10 0648 02 2 7 Operations 2 3 Main Menus The Main Menus of the Spectrum are always displayed at the top of the screen and are accessed using the Navigator Knob The Main Menu headings are Patient Monitor Setup Print Setup Parameters and Functions 2 3 1 Patient Menu Patient Menu Normal Screen Patient Size Adult Gender Unspecified Date of Birth Unspecified First name Last name ID Bed Height Unspecified Weight Unspecified Drug Calculator Select to enter or change patie
280. unter is reset to Spectrum Operating Instructions 0070 10 0648 02 5 21 Special Functions 5 3 3 5 3 4 5 3 5 5 22 Appendix ECG Interpretation The Spectrum equipped with 12 lead ECG and in adult mode only is capable of providing interpretive rhythm and condition statements in accordance with 0070 00 0524 XX Interpretive statements are disabled in adult modes for ages less than 18 years old Calculations The Spectrum has the ability to calculate and display intravenous IV drug infusion rate and concentration based upon patient weight and drug dosage Drug Infusion Rate Units ml hr Range 0 to 9999 ml hr Resolution 0 01 ml hr Drug Concentration Units mcg ml mg ml g ml units ml or mU ml Range 0 1 100 Resolution 0 1 References Source Chulay M Guzzetta C Dossey B AACN Pocket Handbook of Critical Care Nursing Stamford Appleton amp Lange 1997 Source Vallerand A and Deglin J Davis s Guide to IV Medications 3rd Edition Philadelphia F A Davis Company 1996 Hemodynamic Calculations The Spectrum will have the ability to calculate and display the following Hemodynamic parameters Cardiac Index CT Range 0 1 20 0 min m2 Resolution 0 1 I min m Stroke Volume SV Range 1 1000 ml Resolution ml 0070 10 0648 02 Spectrum Operating Instructions Appendix Special Functions Stroke Volume Index SVI Range 0 1 500 0 ml m Resolution 0 1 ml m Syste
281. using the exact same electrode site during reapplication If an electrode becomes wet with fluid change the electrode patch 2 26 0070 10 0648 02 Spectrum Operating Instructions Operations Parameter Menus and Monitoring 2 4 25 Lead Placement The computerized arrhythmia algorithm works best when the patient s R wave is significantly larger than the P wave or the T wave If the R wave is not significantly larger than other lower voltage waves on the ECG tracing the computer may have some difficulty in identifying the appropriate waves On some patients electrode patch placement and or the viewed ECG lead may need to be adjusted in order to obtain a significant R wave This section outlines lead placement according to the guidelines of the American Heart Association AHA and the International Electro Technical Commission IEC Standard 3 wire Lead Sets A 3 wire lead set can monitor one of three ECG vectors I Il or Ill The recommended 3 wire lead placement is as follows Red Yellow CN Green FIGURE 2 14 3 wire Lead Placement FIGURE 2 15 3 wire Lead Placement IEC Place the RA white electrode under the Place the R red electrode under the patient s right clavicle at the mid patient s right clavicle at the mid clavicular line within the rib cage frame clavicular line within the rib cage frame Place the LA black electrode under the Place the L yellow electrode under the patien
282. ut high frequency electrosurgical noise from the ECG waveform The Disable selection is not saved with the Save Current function and will be reset when the monitor is power cycled This function is not supported in 12 lead mode ECG Cable Auto Detect 3 lead This menu item is used to manually set the mode of 5 lead operation for the chosen ECG cable type NOTE When using Mindray cables the Auto Detect selection will automatically detect the cable type and switch the mode of operation accordingly Grid On Off Select to turn the ECG grid On or Off Color List of 16 colors Select to change the display color for all ECG waves and for the HR and ST parameters Spectrum Operating Instructions 0070 10 0648 02 2 23 Parameter Menus and Monitoring WARNING CAUTION CAUTION NOTE CAUTION CAUTION Operations Ensure that the conductive parts of ECG electrodes do not contact other conductive parts including earth ground To avoid possible damage to the Spectrum use only ECG cables and accessories available from Mindray Line Isolation Monitor transients may resemble actual cardiac waveforms thus inhibiting heart rate alarms Check lead wires for damage and ensure good skin contact prior to and during use Always use fresh electrodes and follow proper skin preparation techniques This device is not intended for direct cardiac application To assure successful triggering of a Mindray Intra Aortic balloon
283. very 1 mmHg above 38 mmHg At sea level Accuracy applies for respiration rates of up to 80 RPM For respiration rates above 80 RPM accuracy is 4 mmHg or 12 of the reading whichever is greater for EtCOz values exceeding 18 mmHg This is tested according to and is compliant with EN 864 and ISO 21647 To achieve the specified accuracies for respiration rates above 60 respirations minute the Microstream FilterLine H Set for Infant Neonatal p n 006324 must be used Above 55 degrees C module temperature 1 mmHg or 2 5 whichever is greater has to be added to the tolerance of the accuracy specs Accuracy in the presence of interfering gases The accuracy specification is maintained to within 4 of the values indicated in the table above in the presence of interfering gases according to ISO 21647 clauses 51 101 3 and 101 1 Flow Rate 50 ml min 7 5 15 ml min flow measured by volume Respiration Rate Range O 150 RPM Respiration Rate Accuracy Respiration Rate O to 70 RPM 71 to 120 RPM 121 to 150 RPM Accuracy 1 RPM 2 RPM 3 RPM Spectrum Operating Instructions 0070 10 0648 02 5 17 Patient Parameter Specifications Appendix Self Maintenance SFM Interval Self Maintenance SFM is performed only during measurement mode The module performs one or more of the following Ambient pressure measurement Auto zero AZ e Flow test SFM is triggered under the following conditions During the f
284. warm gt 27 C or the difference between the injectate and the blood temperature is 8 C Check injectate fluid insure fluid is not under warm lights near a warming blanket or over chilled in the ice bath Spectrum Operating Instructions 0070 10 0648 02 Parameter Menus and Monitoring Operations 2 4 11 2 MESSAGE PROBLEM REASON SOLUTION Inject When Ready Appears if Auto Start is enabled Bolus when ready stable temperatures are detected Ready Appears if Auto Start is not enabled Press START when ready and stable temperatures are detected Inject Now Appears once START has been Bolus when ready pressed before bolus is initiated Please Wait Appears after fluid bolus is initiated and Wait until message disappears Cardiac Output is being calculated Edwards Vigilance Monitor Vigilance For questions regarding the use and maintenance of the Edwards Vigilance Monitor refer to its operator s manual or contact Edwards Lifesciences Corporation for assistance Within the USA 800 424 3278 Outside the USA 949 250 2500 The standard Edwards Vigilance Monitor measures both intermittent and continuous cardiac output as well as T Blood It can also be optionally configured to measure continuous mixed venous oxygen saturation SvO Intermittent CO uses the bolus thermodilution method while continuous CO uses a pulmonary artery catheter to introduce small pulses of energy into the blood and the
285. will be XXX These channels will appear as XXX in the normal run mode as well Repeat procedure from step 1 If problems persist contact Mindray Customer Support For Gas Module 3 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 0070 10 0648 02 71 Parameter Menus and Monitoring Operations 2 4 8 2 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 minutes for the device to warm up GM Agent Warming Up Does not apply to Gas Module 3 This message appears after the GM Warming Up message disappears It indicates that the Agent ID Bench is warming up and readings will not be available Wait for the message to go away It takes up to five minutes from power up for the Agent ID Bench 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 Customer Support GM Mixed Age
286. with water only Re attach the reservoir to the assembly tightly Re install the whole unit into the Gas Module making sure the latch is set Check that the Air Leak message disappears and monitoring resumes Do not disinfect or open the water trap If an occlusion message appears it may be necessary to replace the water trap assembly P N 0202 00 0129 The Water Trap Assembly must be replaced every two months Spectrum Operating Instructions 0070 10 0648 02 3 5 Care and Cleaning of Gas Module 3 9 2 User Maintenance Gas Module 3 WARNING Do not clean the Gas Module while it is on and or plugged 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 NOTE potential infection hazard Re
287. ynamic Calculation option has been installed on the monitor and one of the available invasive pressure channels has been labeled PA The Wedge Menu be opened from the PA Menu or by pressing the PAWP key on the monitor keypad Wedge Menu Normal Screen Measure h 1 li E MASA T Reset Waves Print Wedge Wedge Setup P Em TIN Hemo Cales Menu 9 Select to freeze display and measure PAWP with a reference line Select Measure again when complete FIGURE 2 50 Wedge Menu Measuring PAWP NOTE To ensure accurate wedge pressure readings rezero the PA pressure channel and check the PA catheter for integrity kinks and or leaks prior to measurement 1 Open the PAWP Menu by pressing the PAWP key or by selecting Wedge Menu from the PA Menu NOTE Follow manufacturer s suggested procedures and hospital policy for PAWP balloon inflation 2 Inflate balloon watch PA waveform for wedge waveform 3 Once a satisfactory wedge waveform is detected press Measure to freeze the waveforms within the PAWP Menu 4 Use the Navigator Knob to adjust the reference line to the estimated Wedge measurement 5 Press the Navigator knob to return to PAWP Menu choices 6 Press Accept to enter the PAWP measurement onto the Hemodynamic Calculations Menu and post the measurement in the PA parameter tile or select Measure to further adjust the reference line The Reset Waves menu selection will restart the w

Operating Instructions

Contents

Download Pdf Manuals

Related Search

Related Contents