Ambulatory Blood Pressure Monitors
Contents
1. 3 Ensure the accuracy of blood pressure measurements through proper cuff selection and application To select the proper cuff first measure the circumference of the limb at the point 5 where the cuff will be applied Match the limb measurement to the range of appropriate circumferences centimeters specified on each cuff refer to Table 2 D Table 2 Cuff Sizes Circumference Ranges and Part Numbers Limb Part Number Part Number J Quick Disconnect Luer Lock Pediatric Cuff 12 to 20cm 015 0118 01Q 015 0118 01 Small Adult Cuff 17 to 26 cm 015 0067 01Q 015 0067 01 Adult Cuff 24 to 32 cm 015 0068 02Q 015 0068 02 Large Adult Cuff 32 to 42 cm 016 0077 01Q 016 0077 01 Extra large Adult Cuff 38 to 50 cm 016 0109 01Q 016 0109 01 4 Position the cuff so that the center of the inflatable bladder is directly over the brachial artery The center of the bladder location is marked on the outside of the cuff Once the proper position is determined the cuff must be tightened to ensure that it is equally snug at the top and bottom edges and that it is not kinked This is especially important on larger arms Insert a finger between the cuff and the limb to ensure it is not too tight It may be necessary to wrap the cuff with its tail at an angle to achieve uniform tightness If the cuff is not equally snug at the top and bottom edges the number of readings available will be limit2. 1 3 Initializing the Monttor 2 onam RR a mee RAT ERES bbb ee peer kee 1 3 Connecting Directly to a Local Report 1 3 Connecting Directly to the PC Interface liliis RII 1 4 Connecting to the Base Station via Modem 1 4 Office Check Mode 2 0 ehm mace rns 1 7 Preparing the Patient and Precautions for Use eee 1 8 Using OCuff Support siete fb ei IIR E Gh be Pb dae 1 10 Correlating with Manual Readings ers 1 11 PatieritInstr ctioris lt o ses sme Ret ure a ee PEE EFE EE CY PUR E Ree 1 11 Data Transfer and Reports is eed tarnega RP RI bER REA Te REEL Lee E We WERE 1 12 se enkes pe Ux e eee ERREUR ERU ERE Se 1 12 Cleaning the Cuff and Carrying 1 13 Removing Installing the Bladder llli I 1 13 Event CodeS pee i UNA RIA Gene PEs oad wed Piana Roe Ova Se odes 1 14 Accuracy Checking ACCUlaCy 2 1 Required Equipment ES LI ees x ee ee a aati aus 2 1 Accuracy Procedure 22s ow reeds QAM eee KR ee Dee ee ale Ron a 2 2 Troubleshooting Problem Solving C
3. e Ambulatory Blood Pressure Monitors Operations Manual Event Codes The monitors display an event code whenever an event prevents the monitor from successfully completing a blood pressure measurement The two numerical digits of the event code indicate the reason the measurement was aborted The table below lists event codes that are displayed on the monitor as well as event codes that appear on the Event Code Report Monitor Report Condition 10 Excess movement artifact Frequent EC10 messages may indicate an air leak EC20 A A very large number of movement artifacts B Heart rate arrhythmia EC30 A Movement artifact at mean arterial pressure B Heart rate arrhythmia EC40 A Movement artifact at asystole B Heart rate arrhythmia EC50 A Movement artifact at diastole B Heart rate arrhythmia A Movement artifact EBD B Heart rate arrhythmia Systole was found to be above the highest cuff pressure However this result EC70 appears to be an error caused by motion artifact Therefore the cuff will not be inflated to a higher pressure on the next measurement attempt A Movement artifact EODD B Heart rate arrhythmia A Movement artifact di B Heart rate arrhythmia ECO1 EC11 Did not pump above the mean arterial level EC21 Did not pump above systolic pressure 91 Systole appears higher than the selected maximum cuff pressure limit 2 12 Did not reach
4. Connect to Quick Disconnect Fitting Cuff For use with 90207 Monitor amp Luer Fitting Cuff Can Remove Barb amp Tubing Lim to Sphygmomonometer Remove Quick i Disconnect Fitting Ambulatory Blood Pressure Monitors Operations Manual 3 Press START STOP on the monitor the monitor should read approximately 165 mmHg Compare the readings on the monitor and the manometer as the pressure bleeds down The monitor reading should be within three millimeters or 2 of the manometer reading whichever is greater the accuracy of the manometer Note If the monitor pressure values fall outside the allowed tolerance call your local Customer Service Representative or Spacelabs Medical for servicing At the end of the procedure the monitor displays an event code indicating that no dynamic blood pressure measurements were obtained 4 Disconnect the T tube splitter from the monitor Disconnect the air hose and sphygmomanometer Aoeinsoyv Troubleshooting Contents Problem Solving Checklist l l nes 1 nae ee Gd 2 Problem Solving Checklist Problem Monitor display is incorrect Possible Cause Data not retained Solution Replace backup battery Low or no power Check the batteries for a full charge if needed replace or recharge the batteries May be one of the following time out no reading due to air lea
5. prior to patient use e Use only recommended cleaning solutions or you may void the manufacturer s warranty e Harsh chemical agents degrade plastics and will compromise the safety of the device e Disconnect the equipment from the patient and the electrical supply before cleaning Do not allow liquid to enter the interior of the module or monitoring equipment Do not immerse the equipment or cables in water or cleaning solutions e Do not autoclave To clean the exterior of monitors modules and cables Prepare the cleaning solution according to the manufacturer s instructions Wetaclean cloth with the selected cleaning solution Remove excess liquid from the cloth and squeeze dry e Wipe exposed surfaces of the equipment and cables Remove any soap residue by gently wiping with a clean damp cloth Wipe dry with a clean dry cloth Use only the following recommended cleaning solutions Mild soap and water solution U S Pharmacopoeia USP green soap Sodium hypochlorite solution 1 10 dilution of household chlorine bleach in water Phenolic germicidal detergent 196 aqueous solution Glutaraldehyde 2 496 Cidex e Isopropyl alcohol 70 solution Note Over time repeated use of a chlorine bleach solution may cause some colors to fade e Ambulatory Blood Pressure Monitors Operations Manual Tape adhesive can be removed with Spacelabs Medical adhesive tape remover pads P N 392196 001
6. 9 BEEN Spacelabs Medical An OSI Systems Company Ambulatory Blood Pressure Monitors 90207 90217 Operations Manual 070 0137 03 Rev K 2005 Spacelabs Medical Inc All rights reserved Contents of this publication may not be reproduced in any form without the written permission of Spacelabs Medical Products of Spacelabs Medical are covered by U S and foreign patents and or pending patents Printed in U S A Specifications and price change privileges are reserved Spacelabs Medical considers itself responsible for the effects on safety reliability and performance of the equipment only if e assembly operations re adjustments modifications or repairs are carried out by persons authorized by Spacelabs Medical and e electrical installation of the relevant room complies with the requirements of the standard in force and e the equipment is used in accordance with the operations manual Spacelabs Medical will make available on request such circuit diagrams component part lists descriptions calibration instructions or other information which will assist appropriately qualified technical personnel to repair those parts of the equipment which are classified by Spacelabs Medical as field repairable Spacelabs Medical is committed to providing comprehensive customer support beginning with your initial inquiry through purchase training and service for the life of your Spacelabs Medical equipment CORPORATE OFFICES
7. Any event that prevents a successful blood pressure measurement other than a manual cancel is not counted as one of the five Office Check mode readings e Ambulatory Blood Pressure Monitors Operations Manual Reinstating Office Check Mode The Office Check mode may be reinstated in the 90217 and the 90207 monitors versions 2 14 and later To reinstate the Office Check mode without initialization of the monitor 1 Power ON the monitor 2 Press and hold the START STOP key when the version displays on the LCD 3 Release the START STOP key when ECOS displays on the LCD An EC13 will be logged to indicate the time at which the office Office Check was reinstated The Office Check mode will be enabled for five additional successful measurements Preparing the Patient and Precautions for Use Note Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by the American National Standard Electronic or automated sphygmomanometers The fifth Korotkoff sound was used to determine overall efficiency As in manual auscultatory methods accurate readings may not always be achieved under some conditions Patient movement the position of the cuff relative to the level of the heart extreme heart rates and blood pressures various arrhythmias and the subject s physiological condition and other factors may hi
8. Electroencephalogram EMG Electromyogram ESIS Electrosurgical Interference emg Suppression EXT External FECG Fetal Electrocardiogram FHR1 Fetal Heart Rate Channel 1 GND Gand FHR2 Fetal Heart Rate Channel 2 gnd HLO T hlo High Level Output Multiview Multi Lead Electrocardiogram SEE Noninvasive Blood Pressure N20 Nitrous Oxide sjoquAsS v xipuoddy Ambulatory Blood Pressure Monitors Operations Manual Symbol Description Symbol Description PRESS O5 Oxygen press Pressure PRS jaa Respiration SDLC Synchronous Data Link Control SPO2 SVO2 SpO2 Arterial Oxygen Saturation SpO as Measured by Pulse Oximetry Svo2 Mixed Venous Oxygen Saturation SaO 5 0 T1 Temperature 1 SYS T2 Temperature 2 sys y Temperature 3 T4 Temperature 4 aa Temperature UA Uterine Activity or Umbilical Artery VAC Vacuum Connection
9. international and safety symbols describes all symbols used on Spacelabs Medical products No one product contains every symbol Description Symbol Description HELP Key Keyboard Connection alt SPECIAL FUNCTIONS Key Mouse Connection g RECORD Key START STOP Key NORMAL SCREEN Key MONITOR SETUP Key START STOP STOP or CANCEL Key PREVIOUS ALARMS Key PREVIOUS MENU Key ON Power Connection to Mains CONTINUE Key ENTER Key OFF Power Disconnection from Mains ON Position for Push Button Power Switch OFF Position for Push Button Power Switch On Direction ON OFF Television Video Display Video Output ON Part of the Instrument Only 1 ex oa B OFF Part of the Instrument Only Symbol Ambulatory Blood Pressure Monitors Operations Manual Description Symbol Standby D Description STANDBY Key PAUSE or INTERRUPT Reset v T Slow Run Power Indicator LED Alarm Indicator Remote Control x Temporary Shut Off of Alarm Tone or Screen Indicators Indicator Local Control PRINT REPORT Key Partial ON OFF Normal Screen Indicator Out of Paper Recorder Paper Return to Prior Menu Clock Time Setting Key HELP Explain Prior Screen Key OTR Ly TREND TIMER Key Keypad Activate
10. monitor display is to be active or not Time of day 12 or 24 hour format Whether to display measurement systolic diastolic and heart rate Multiple or single cycle times If using a single cycle for the 24 hour monitoring period indicate the cycle interval and whether the tone is ON or OFF For multiple cycle times specify each cycle interval and whether the tone is ON or OFF for each cycle Any other information the base station operator may request The base station operator will enter the patient information in the computer 3 Prepare the monitor to receive the patient data from the base station Power ON the modem When instructed by the base station operator power ON the ABP monitor Note The modem link must be established within 10 to 20 seconds for the 90207 and within 45 seconds for the 90217 If this does not occur power the monitor OFF and then ON again to retry establishing the link When the transfer of information is complete the ABP monitor will beep Voice communication is restored after the monitor beeps Power OFF the monitor and disconnect the monitor from the modem Ifa direct connection between the monitor and the base station is used power OFF the monitor and then disconnect it from the ABP data interface unit To transfer readings from the monitor to the base station 1 Contact the base station by telephone for remote operation only 2 Askthe base station operator to read the monitor Giv
11. pressure cuff attached to the patient s arm This information is recorded in the monitors and can be transferred over a modem link or by direct connection between the monitors and one of the ABP analysis systems The monitors can be programmed to either activate or deactivate the following features Display the cuff pressure at each bleed step Display the systole diastole and heart rate at the end of each measurement Bleed to 40 mmHg rather than stopping at the diastolic value Beep before and after each reading Front Panel The 90207 and 90217 monitor front panels include the LCD display cuff hose connector and a START STOP switch Caution Ambulatory Blood Pressure Monitors Operations Manual Rear Panel The rear panels of both monitors contain program input and data output communication ports On the 90207 the power ON OFF switch is also located on the rear panel On the 90217 the ON OFF switch is located on the top panel Replacing the Batteries AA batteries provide the main power source for both monitors The 90207 monitor uses four batteries and the 90217 monitor uses three batteries These batteries should be replaced or recharged before the start of each patient monitoring session Use either alkaline or NiCad batteries The 90207 monitor uses a lithium battery P N 146 0008 xx to back up the monitor memory and should be replaced periodically The 90217 monitor backup battery should not require replace
12. the front strap to the top layer of the cuff material at the location where the hose exits the cuff Adjust the length of these straps to apply a minor amount of tension to hold the cuff in the correct position Ambulatory Blood Pressure Monitors Operations Manual Optional Accessories Table 3 Optional Accessories Accessories Part Number D Cuff Support Harness 015 0070 xx Service Manual 070 0502 xx Quick Disconnect Coupling 712 0794 00 Male Quick Disconnect to Luer Adapter 712 0773 00 Correlating with Manual Readings The monitor bleeds pressure in discrete steps not continuously using the oscillometric method of blood pressure determination If manual pressure readings are taken simultaneously with the monitor readings interpolation is required to accurately correlate monitor systolic and diastolic pressure values with the manual auscultatory pressures For systole record the first pressure at which a Korotkoff sound is heard Actual systolic pressure is somewhere between the pressure when the sound is heard and the previous higher pressure where no sound was heard The interval of uncertainty can be reduced by half by adding one half of the bleed step size 4 mmHg to the manual systolic pressure For diastole record the cuff pressure at which the last Korotkoff sound was heard Actual diastolic pressure is somewhere between that pressure and the next lower pressure The interval o
13. 0121 or 92506 1 Connect one end of the ABP interface cable to the serial port on the computer where the 90121 or 92506 software is installed 2 Connect the other end of the interface cable to the ABP monitor Refer to the 90121 ABP Report Management System Operations Manual P N 070 0529 xx or the 92506 ABP Report Management System Client Application Operations Manual P N 070 0932 xx for more information on the report management system Computer System with 90121 or 92506 ABP software cable to serial port ABP i Monitor Figure 1 2 PC interface direct connect configuration Connecting to the Base Station via Modem For a modem connection to a remote IBM XT AT PS2 or equivalent base station refer to Figure 1 3 cable to serial port to public base telephone NBE station network Monitor modem Figure 1 3 Modem connection configuration Note The actual initialization procedure is discussed in the 90121 ABP Report Management System Operations Manual P N 070 0529 xx and in the 92506 ABP Report Management System Client Application Operations Manual P N 070 0932 xx Ambulatory Blood Pressure Monitors Operations Manual Modem Speed and Compatibility Issues The 90207 and 90217 monitors operate Hayes compatible modems only You can identify your model type by plugging the communications cable into your 90207 90217 monitor and looking at the numbers on
14. Frequencies in Europe Attention Consult Operations or Service Manual for Description Warning Warning About Potential Danger to Human Beings Noninvasive Blood Pressure NIBP Neonate Caution About Potential Danger to a Device Fetal Monitor Connection Analog Fetal Monitor Connection RS 232 Digital Happy Face Magnifying Glass Physiological Monitor Connection RS 232 Digital Sad Face Compression E J File Cabinet List of Rooms 5 Arrows Printer Eo Recycle j Service Message ATEX Latex free 8 Do Not Reuse Single Use Only Radio transmitting device elevated levels of non ionizing radiation Batch Code REF Reusable Catalog Number Ambulatory Blood Pressure Monitors Operations Manual Symbol Description Date of Manufacture Symbol Description Nellcor Oxisensor Il Compatible NV X Novametrix Compatible Abbreviations used as symbols are shown below Symbol Description Symbol Description Access Codes 1 Through 32 AIR i ANT 1 Diversity Antenna System 1 Arr1 Arrhythmia Net 1 ANT 2 Diversity Antenna System 2 ArrNet2 Arrhythmia Net 2 CH EEG EMG or ECG Channel ch EEG Channels CH1 CH2 CH3 CH4 Centimeters of Water EMG Channel CH5 DIA Cardiac Output dia Diastolic co ECG EEG ecg Electrocardiogram eeg
15. Questions and concerns about cleaning issues should be directed to a Spacelabs Medical field service engineer Cleaning the Cuff and Carrying Pouch Small soiled or stained areas may be cleaned by gentle scrubbing with a sponge or cloth soaked in a mild soap and water solution The cuff wrap with the air bladder removed and the pouch are machine washable on delicate cycle only Do not wash them in large commercial type washers or with bed linens or gowns Ensure that the carrying pouch is dry before re use Removing Installing the Bladder To remove the bladder follow the steps listed below 1 Using fingers only fold or roll up the bladder inside the cuff Do not use pencils pens or other hard objects because these may damage the bladder 2 Remove the bladder through the hose exit opening Once the bladder is removed mate together the hook and loop surfaces of the velcro attachment before washing Re install the bladder into the cuff wrap in reverse order Make certain that all folds in the bladder are removed and that the long end of the bladder fits into the long end of the cuff refer to Figure 1 4 OPENING FOR OPENING FOR RIGHT ARM LEFT ARM ij BLADDER shown inserted into cuff wrap for left arm application Figure 1 4 Bladder configuration Note The cuff hose can exit from either opening in the cuff depending on whether you plan a right arm or left arm application
16. Recorder for Graphics START NIBP Key Indoor Use Only Auto Mode NIBP P9oaroowh ro oc Output el No Output Terminated Ambulatory Blood Pressure Monitors Operations Manual o lt i Description Description Data Input Output Input Output Select Program Options Input Reset Menu Keys C3 Waveform Parameter Keys 2 Monitor Setup am A Set Initial Conditions Menu Return Unit to Monitor Mode Arterial Pulse 2 B Access Special Function Menu 2 3 3 1 Serial Port 1 2 Serial Port 2 External marker push button t connection SDLC SDLC Port Electrocardiograph or Defibrillator Synchronization 5 v Gas Exhaust Foot Switch Enlarge Zoom x Delete PCMCIA Card Event Keep Dry Fragile Handle with Care 12 200 m gt ex Environmental Shipping Storage Altitude Limitations Environmental Shipping Storage Temperature Limitations This Way Up Environmental Shipping Storage Humidity Limitations SIoquuAsS v xipuoddy Ambulatory Blood Pressure Monitors Operations Manual Symbol Description Description E Open Padlock Closed Padlock dh Down Arrow Up Arrow x Hard Drive 2 Power Indicator LED N Antenna Mermaid Connector Microphone Omnidirectional Microphone V Y
17. U S A Spacelabs Medical Inc 5150 220th Ave SE Issaquah WA 98029 Telephone 425 657 7200 Telephone 800 522 7025 Fax 425 657 7212 Authorized EC Representative UNITED KINGDOM Spacelabs Medical Ltd Basepoint Business Centre Metcalf Way Crawley West Sussex RH11 7XX Telephone 44 0 845 6017224 Fax 44 0 845 6017225 BirthNet Clinical Browser Data Shuttle Flexport Intesys Mermaid MOM Multiview PCIS PCMS PrintMaster Quicknet Sensorwaich TRU CAP TRU CUFF TruLink Ultralite Ultraview Ultraview Care Network Ultraview Clinical Messenger Ultraview Digital Telemetry Ultraview SL Uni Pouch UCW Varitrend and WinDNA are trademarks of Spacelabs Medical Inc Other brands and product names are trademarks of their respective owners Caution US Federal law restricts the devices documented herein to sale by on the order of Only physician N Before use carefully read the instructions including all warnings and cautions Table of Contents Contents Page Operation OVEIVICW Rada aaah om poke aie ae Guus c e Ree I RB EROR Am LR 1 1 ABP Monitor bbe hoochie eed boda eee Mee P eb ede 1 1 Replacing the Batteries 2 5 sic rho Rae REND ROUEN Rund X E ionad 1 2 Main Battery m mr 1 2 Lithium Battery Replacement 90207
18. complete data EC28 Diastole above 200 mmHg EC38 Pulse pressure less than 16 mmHg EC48 A Movement artifact at mean arterial pressure B Heart rate arrhythmia 58 A Movement artifact at diastole B Heart rate arrhythmia EC68 Division by zero 9 19 Contradictory instructions sent to hardware e g pump ON and valve open EC29 Diastolic pressure value cannot be obtained from the data available 90207 Systolic pressure cannot be obtained from the data available EC39 90217 Algorithm could not process input data quickly enough resulting in an input queue overflow 90207 Mean arterial pressure cannot be obtained from the data available EC49 90217 This monitor must be initialized EC59 Heart rate value cannot be obtained from the data available EC69 Heart rate value cannot be obtained from the data available Bleed steps were too small This may be caused by a partially obstructed air EC79 hose All blood pressure attempts following this message are inhibited Attempts can be enabled by powering the monitor OFF and then ON Ambulatory Blood Pressure Monitors Operations Manual Monitor Report Condition EC99 Unexpected or contradictory data such as a negative cuff pressure LLL EC16 Low battery detected prior to start of measurement Low battery detected after measurement started Usually caused by the pump EC26 drawing enough current to lower the battery vol
19. d 5 5 amp Invalid bleed size The monitor has automatically changed the bleed size to EC45 EC45 8 mmHg An unexpected loss of power possibly caused by a removal of the batteries 5 amp EC55 during a blood pressure measurement b hardware overpressure or c a EC55 hardware time out Frequent EC55 messages would indicate a malfunction which requires service 90207 5 amp EC65 Equipment malfunction Return to Spacelabs Medical for service EC65 90217 Extremely large artifact 5 amp EC75 EC75 Equipment malfunction Return to Spacelabs Medical for service e Ambulatory Blood Pressure Monitors Operations Manual Monitor Report Condition 5 amp EC85 EC85 Equipment malfunction Return to Spacelabs Medical for service Cuff pressure baseline is out of limits The monitor should correct the baseline 5 amp EC95 automatically within 10 minutes or it can be reset by initializing the monitor EC95 If initialization does not correct the condition the monitor must be returned to Spacelabs Medical for calibration ECO7 EC78 Clogged connector filter EC08 Too few data entries to accurately determine blood pressure This message may EC18 indicate that the cuff is not being worn by the patient taken off but left connected to the monitor The message may also indicate that motion artifacts cause the majority of the in
20. d E Audio Output Speaker Network Connection Gas Sampling Port Activate Telemetry Recorder Universal Serial Bus Gas Return Port Remote Alarm Nurse Alert Nurse Call Battery Status Low Battery HOR Battery Replace only with the appropriate battery Replace only with the appropriate battery signs may be reversed I All batteries should be disposed of properly to protect the environment Lithium batteries should be fully discharged before disposal Batteries such as lead acid Pb and nickel cadmium Ni Cd must be recycled Please follow your internal procedures and or local provincial laws regarding disposal or recycling Caution hazardous voltages To reduce risk of electric shock do not remove the cover or back Refer servicing to a qualified field service engineer U S A DANGER High Voltage International Symbol Ambulatory Blood Pressure Monitors Operations Manual Description Symbol Protective Earth Ground Description Functional Earth Ground gt Replace Fuse Only as Marked Power supply jack polarity signs may be reversed Fuse Equipotentiality Terminal l Alternating Current Direct Current gt IEC 60601 1 Type B equipment The unit displaying this symbol contains an adequate degree of protection against electric shock Both Direct and Alterna
21. e the following information to the operator Patient s name Patient ID number Any other information the base station operator may request The base station operator will enter the patient information in the computer If the monitor is in a remote location the operator turns the base station modem ON 3 Prepare the monitor to transfer data to the base station e Power ON the modem When instructed by the base station operator power ON the ABP monitor for remote operation only Note The modem link must be established within 10 to 15 seconds for the 90207 and within 45 seconds for the 90217 If this does not occur power OFF the monitor and return to step 1 Ambulatory Blood Pressure Monitors Operations Manual When the transfer of information is complete the ABP monitor will beep Voice communication is restored after the monitor beeps Power OFF the monitor Disconnect the monitor from the modem Modem Indicator Lights Modem indicators at the local modem are lit flashing or unlit depending the stage of operation When the monitor is powered ON the RD Receive Data and SD Send Data lights will flash for several seconds The OH On Hook indicator becomes lit when the monitor starts communicating with the remote modem When the modems connect the CD Carrier Detect is lit The SD and RD lights flash as data is being transferred After the transmission is complete and the monitor is power
22. ed OFF the HS TR and MR indicators will always remain lit at the local modem Setup Test Note Verify that the cable connections are secure Power ON the ABP monitor It will display 9999 While the monitor is being read or initialized the digits will change to indicate that communication is taking place between the monitor and the analysis system When communication is complete the digits will no longer change Office Check Mode The monitor automatically enters an Office Check mode for the first five measurements immediately following initialization This allows you to verify the performance of the monitor on an individual patient without the need for re initialization to reset the display features While in the Office Check mode the monitor operates as follows Displays the cuff pressure on each bleed step Displays systole diastole and heart rate at the end of the measurement Bleeds one step below the diastolic value as determined by the monitor Terminating Office Check Mode For the 90207 monitor versions earlier than 2 14 press the START STOP key twice to cancel each of the remaining readings The Office Check mode is terminated when the sum of the canceled and successful measurements equals five For the 90217 and the 90207 monitors versions 2 14 and later press the START STOP key twice to cancel a single blood pressure reading The Office Check mode is terminated when a blood pressure reading is canceled
23. ed and the monitor may indicate that the cuff is improperly applied Caution Avoid compression or restriction of pressure in the NIBP patient connector tubes Check that operation of the equipment does not result in prolonged impairment of circulation Do not apply cuff to areas of breached or injured skin This product contains natural latex rubber components to which some people may be allergic These components include the bladder and the first four inches of tubing extending from the cuff Note e Use only Spacelabs Medical cuffs with this monitor Using other manufacturer s cuffs may result in inaccurate readings even if the manufacturer s recommended size is observed Ifthe cuff is too small pressure readings be falsely high if a cuff is too large it produces a falsely low reading The bladder can be positioned in the cuff for either the left or right arm Once the cuff is applied the arm should be relaxed at the patient s side To avoid reading errors due to hydrostatic pressure differences the level of the cuff on the arm should be near the level of the heart Ambulatory Blood Pressure Monitors Operations Manual 5 Lead the hose up the arm with the cuff and place it across the back of the patient Drape the hose so it does not cause the patient discomfort and is not pinched shut by too tight a radius The following graphic displays the most common positions for the cuff hose ALTERNATIVE 1 C
24. f uncertainty can be reduced by half by subtracting one half of the bleed step size 4 mmHg from the manual diastolic pressure Patient Instructions If the cuff becomes uncomfortable during a reading make certain that the patient knows how to terminate the readings by pressing the STOP key on the front of the monitor If the cuff slips out of place make certain that the patient knows how to correctly reposition the cuff for successful readings If the cuff is not properly positioned event codes may appear on the monitor Note The patient should make every effort to keep the monitor dry However there is no hazard if the monitor does get wet If this occurs power the monitor OFF and return it to Spacelabs Medical for service Ambulatory Blood Pressure Monitors Operations Manual Data Transfer and Reports Warning After monitoring is complete connect the monitor to either a PC Direct or Base Station interface to transmit patient data and generate blood pressure reports Refer to the 90121 ABP Report Management System P N 070 0529 xx the 92506 ABP Report Management System Client Application P N 070 0932 xx or the 90239 ABP Report Generator P N 070 0399 xx Operations Manuals for more details Note Any pulse rate obtained from the ABP cuff should be used only as a guideline for the heart rate Cleaning Disinfecting Visually inspect the monitor air hose and pressure cuff for dirt debris frayed or worn areas etc
25. hecklist errana te m mh 3 1 sinus 3 2 Appendix A Symbols Operation Contents OV6GtVIOW 2 ee c ur ace RR EC UR woe dade dal ate eden ee ee eal CR da 1 Preparing the Patient and Precautions for 8 Data Transfer and Reports 12 Event Codes 5 adesse RODA RR CIR I HR RT CRUS ERR Re ER Ro al A 14 Overview The Spacelabs Medical Models 90207 and 90217 Ambulatory Blood Pressure ABP monitors are small lightweight battery powered monitors designed to take blood pressure and heart rate measurements for 24 or 48 hours or for longer periods of time These measurements are recorded in the monitors and may be transferred to an ABP Analysis System FT1000A FT2000A or equivalent the personal computer PC interface the base station or a report generator for data analysis report printing and archiving Each monitor and base station can operate in a Direct Connect mode when both units are in the same location or in a Remote Connection mode using modems ABP Monitor The monitors have the following features Four digit liquid crystal display LCD Battery powered Serial communications port Power ON OFF switch Reading START STOP button Blood pressure cuff The monitors are carried in pouches that are strapped and or belted to the side of the patient Blood pressure and heart rate measurements are taken using a blood
26. initial cuff pressure The cuff may have been improperly applied or there may be an air leak EC22 Overpressure EC32 Overpressure EC42 No cuff attached Ambulatory Blood Pressure Monitors Operations Manual Monitor Report Condition EC52 Kinked hose EC62 Cuff applied too loosely EC82 Kinked hose ECOS Patient canceled reading by pressing STOP key No retry attempt is made following an code The Office Check mode has been reinstated No retry attempt is made EC13 following EC13 code EC04 Blood pressure measurement not completed in the maximum time allowed ECOA Occasional EC04 messages may result from excessive patient movement Frequent EC04 messages would indicate an improperly applied cuff or a monitor malfunction which requires service where n 2 1 to 9 Indicates that one or more of the blood pressure results have ECn4 been corrupted and subsequently recovered Frequent occurrence of this message would indicate a malfunction that requires service 5 The individual blood pressure result has been corrupted and cannot be recovered EC15 Equipment malfunction Return to Spacelabs Medical for service EC25 Monitor failed to initialize Please initialize 90207 At least one of the blood pressures or time readings obtained before the event EC35 code is erroneous Interpret all readings with caution 90217 The monitor needs to be reinitialize
27. k in the system improper cuff size cuff not properly attached to the monitor Isolate cause and correct Monitor displays LLL and alarm sounds Low main battery condition Power OFF the monitor immediately Replace batteries within 60 seconds after removal to continue monitoring Monitor displays event code Lbb during Low backup battery condition Replace backup battery before self testing continuing 90207 only Cuff placed on the patient too Reposition the cuff tightly Cuff too tight Air pump staying on too long Return monitor to Spacelabs Medical for service Cuff too loose Incorrect time displayed Cuff placed on the patient too loosely Reposition the cuff Air pump not staying on long enough Batteries removed for more than one minute 90207 only Return monitor to Spacelabs Medical for service Re initialize monitor e Ambulatory Blood Pressure Monitors Operations Manual Servicing There is a 12 month warranty on this product Field service for the ABP monitor is limited to replacing batteries and accessories If other repair is required return the monitor to Spacelabs Medical Contact your Spacelabs Medical Customer Service Representative for shipping details Caution Any attempt to perform service or repair to the monitor will result in cancellation of the warranty Appendix A Symbols The following list of
28. ment Main Battery Replacement Note If the main batteries must be replaced during patient monitoring this replacement must be accomplished within one minute to ensure successful resumption of the test 90207 only 1 Power the monitor OFF and remove the door over the battery compartment 2 Replace the AA alkaline or NiCad batteries being careful to observe polarities The monitor will not operate if the alkaline nickel cadmium or lithium batteries are incorrectly installed If the monitor is going to be stored for an extended period of time remove the batteries to prevent the possibility of leakage or discharge Spacelabs Medical is not responsible for product damage incurred as a result of AA battery leakage In the event your monitor has been damaged by a leaking battery contact the battery manufacturer for any recoverable repair or replacement costs Spacelabs Medical will assist you in determining those costs Gently replace the battery cover and secure the latch Power the monitor ON Check that the LCD display is ON If there is no display power the monitor OFF and review the problem solving checklist in Troubleshooting on page 3 1 Ambulatory Blood Pressure Monitors Operations Manual Lithium Battery Replacement 90207 only The lithium battery is located in the battery compartment under a pry off cover to the right of the AA batteries 1 Power the monitor OFF and remove the door over the bat
29. nder an accurate reading Vibration such as that in a moving automobile is an environmental problem that may affect readings When some of the above factors prevent an accurate reading an event code is provided to indicate the reason for the missed blood pressure reading When only a single blood pressure parameter systole diastole or mean arterial pressure is obscured and the other two parameters are measured the obscured parameter may be replaced with a computed value If such a value is computed in the 90217 monitor it appears on the report in angle brackets e g value On the monitor display dashes are displayed instead of the estimated value The ratio used in the formula is determined by the previous successful measurements of the pressure rather than a fixed ratio Consult a physician for interpretation of pressure measurements After the monitor has been initialized prepare the patient for monitoring as follows 1 Power ON the monitor wait for the monitor to perform self tests When the LCD displays the current time the monitor is ready for operation 2 Strap the monitor to the patient s hip opposite the side on which the cuff is worn Secure the monitor using the patient s own belt or the ABP pouch strapped over the opposite shoulder When using the shoulder strap use the belt supplied with the monitor or the patient s belt to provide additional security Ambulatory Blood Pressure Monitors Operations Manual
30. onnect the hose to the monitor Verify proper monitor operation by taking one or more blood pressure readings Push the START STOP key to begin a measurement Spacelabs Medical recommends taking three readings in the office so that the patient becomes comfortable with operation of the monitor and the measurement process 8 Show the patient how to enter information in the Patient Diary Make sure the patient knows what to do if the cuff becomes very uncomfortable during a measurement if it slips out of place or if event codes are displayed on the monitor screen refer to Patient Instructions on page 1 11 Also ensure that the patient knows how to care for the monitor 9 When you are satisfied that the monitor is operating properly the remaining measurements in the Office Check mode may be canceled Refer to Office Check Mode on page 1 7 Using Cuff Support Note Keeping the blood pressure cuff in place is very important both for patient comfort and for the accuracy of the readings This becomes particularly challenging when the arm has considerable taper as is often the case with obese patients 1 Putthe large loop of the support around the opposite arm Once the cuff is successfully applied to the patient adjust the length so that the junction of the straps fits well back on the shoulder towards the neck 2 Fasten the rear short strap to the rear of the armpit Be careful to clip to the material only and not to the bladder 3 Fasten
31. tage Lbb The report does not print an event code for this condition which is a low backup battery Contact Spacelabs Medical for replacement of the battery Contents Checking 1 Checking Accuracy Accuracy of the monitor pressure readings should be checked annually Recalibration is necessary only if the monitor is not within the accuracy limits Required Equipment A full size mercury sphygmomanometer or aneroid gauge Note Ensure the mercury sphygmomanometer or aneroid gauge is calibrated and indicates 0 with no pressure T tube P N 016 0040 00 A pressure cuff and a rigid cylinder sized to fit the pressure cuff Ambulatory Blood Pressure Monitors Operations Manual Accuracy Procedure To check the accuracy of the monitor 1 Disconnect the cuff hose from the monitor Connect the T tube splitter to the monitor pneumatic connector and the sphygmomanometer 2 Wrapthe pressure cuff around the rigid cylinder and then fasten the cuff Connect the cuff hose to the remaining connection on the T tube splitter The test setup should appear as shown below 712 0039 01 CALIBRATION KIT TO SPHYGMOMONOMETER ili pe 4 MONITOR TO CUFF CYLINDER For use with 90207 Q Monitor amp Quick Disconnect Cuff Can Connect Somes to to 90207 4Q Sphygmomonometer ABP Monitor
32. tery compartment uoneagodo 2 Remove the pry off cover and note the polarity of the battery and socket indicators 3 Remove the old lithium battery by carefully prying it out Curved forceps are recommended 4 Install the new lithium battery and replace the pry off cover The underside of this cover is divided into two unequal sized compartments Install the cover with the smaller compartment oriented over the lithium battery 5 Gently replace the battery compartment cover and secure the latch Note Once the lithium battery has been completely discharged it is considered non hazardous and may be safely discarded Initializing the Monitor The ABP monitors must be initialized prior to the start of patient monitoring Initialization specifies the monitoring period patient information time format measurement interval monitor tone ON OFF during selected periods event code display and whether or not to display pressure values To initialize the monitor connect it to one of the following analysis systems Connecting Directly to a Local Report Generator For a direct connection to the 90207 or to the 90217 monitor place the monitor into the chute on the Report Generator Model 90239A or equivalent as displayed in Figure 1 1 Figure 1 1 Report Generator Ambulatory Blood Pressure Monitors Operations Manual Connecting Directly to the PC Interface For a direct connection to a PC compatible computer via a Model 9
33. the display The acceptable modem types and maximum speeds of 90207 90217 monitors are summarized below Table 1 90207 90217 Acceptable Modem Speeds Model Type Max Speed Display older 90207 1200 1200 only 9999 90207 Q 1200 any Hayes 1999 9999 older 90217 up to 9600 up to 9600 2999 9999 90217 Q 9600 any Hayes 0999 9999 Connection Procedure 1 Set the switches on the modem if you are using an older 90207 monitor with 1200 modem as follows 2 Connect the serial port cable P N 012 0096 00 between the monitor and the modem Note If call waiting or call forwarding are options on a telephone used to transfer data ensure that both are deactivated Otherwise modem communications may be interrupted In addition telephone systems such as CBX or PBX can cause interference with the modem or the Switch Number Setting at Monitor Site down up down down down up up down CO O1 A GC N up 4 modem can cause interference with the switching system Ambulatory Blood Pressure Monitors Operations Manual To initialize the monitor for remote connection 1 Contact the base station by telephone for remote operation only 2 Askthe base station operator to initialize the monitor Give the following information to the operator Patient s name Patient ID number Whether
34. ting Current AC DC Input A Amperes Hertz V Volts Watts IEC 60601 1 Class Il equipment double isolated The unit displaying this symbol does not require a grounded outlet IEC 60601 1 Type BF equipment which is defibrillator proof The unit displaying this symbol contains an F type isolated floating patient applied part which contains an adequate degree of protection against electric shock and is defibrillator proof IEC 60601 1 Type BF equipment The unit displaying this symbol contains an F type isolated floating patient applied part providing an adequate degree of protection against electric shock IEC 60601 1 Type CF equipment The unit displaying this symbol contains an F type isolated floating patient applied part providing a high degree of protection against electric shock and is defibrillator proof Loop Filter IEC 60601 1 Type CF equipment The unit displaying this symbol contains an F type isolated floating patient applied part providing a high degree of protection against electric shock Adult NIBP sjoquAS v xipuoddy Ambulatory Blood Pressure Monitors Operations Manual Symbol Description S A Tp ligt ETL Laboratory Approved Description Canadian Standards Association Approved Note Risk of Explosion if Used in the Presence of Flammable Anesthetics Note Operates on Non Harmonized Radio
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