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WA LXi User Manual

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1. 810 0409 XX Always use accessories with strict adherence to the manufacturer s directions for use WARNING Do not operate the monitor in the presence of magnetic resonance imaging MRI or hyperbaric chambers WARNING Do not operate the monitor in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide or in oxygen enriched environments or in any other potentially explosive environment WARNING It is the clinician s responsibility to set or verify alarm limits appropriate to each patient WARNING Never allow any liquid to enter any monitor connector If a connector does come in contact with liquid 1 Remove the monitor from service 2 Use warm dry air to dry the connector 3 Thoroughly test and verify operation before returning the monitor to service 6 Chapter 1 General Information Welch Allyn Vital Signs Monitor 300 Series A WARNING Do not connect more than one patient to a monitor WARNING f the monitor is dropped or damaged it must be thoroughly tested by a qualified service person before it is returned to service WARNING Periodically check all cords and cables for damage wear or fraying replace as needed WARNING The monitor contains no operator serviceable parts other than the replaceable paper roll WARNING If the battery shows any signs of damage leakage or cracking it must be replaced immediately by a qualified service person and only with a battery approved by Welch
2. 90 mmHg 12 kPa Blood Pressure Accuracy e Blood pressure measurement meets or exceeds ANSI AAMI SP10 2002 for manual electronic or automated sphygmomanometers e Blood pressure accuracy is validated for pressure measurement using the upper arm only with the patient seated e M Blood pressure is validated against manual auscultatory readings for adults and children older than 3 years e Blood pressure is validated against intra arterial readings for children 3 years and younger Blood Pressure Determination Time 20 45 seconds typical 165 seconds maximum Overpressure Cutoff 295 to 330 mmHg 39 3 to 44 kPa Systolic Range Adu 30 to 260 mmHg 4 to 34 5 kPa Pediatric 30 to 160 mmHg 4 to x 21 3 kPa Neonate 25 to 120 mmHg 3 3 to 16 kPa Diastolic Range Adu 20 to 235 mmHg 2 7 to 31 3 kPa Pediatric 15 to 130 mmHg 2 to 17 3 kPa Neonate 10 to 105 mmHg 1 3 to 14 kPa MAP Adu 20 to 255 mmHg 2 7 to 30 kPa Pediatric 15 to 140 mmHg 2 to 18 7 kPa Neonate 10 to 110 mmHg 1 3 to 14 7 kPa Pulse Rate Range 30 to 220 bpm Pulse Rate Accuracy 3 bpm or 3 Note NIBP specifications are tested by Welch Allyn using the BIO TEK BP Pump NIBP Monitor Tester 14 Chapter 7 Reference Welch Allyn Vital Signs Monitor 300 Series Characteristic Specification Notes Temperature Temperature 80 F to 110 F Measurement Range 26 7 C to 43 3 C Tem
3. GCOnneeuoni Ea aeu oui oL ALI Ao os hes ir e cote cM Mer AD quf 11 Connecting AC FONET un end wae Whee DOR E eO UR EN Y eR ER 11 Connecting the NIBP Cuff Hoses ito les cds DE rd 13 Connecting the Temperature Probe Cable o o ooooooooo 14 Connecting and Disconnecting the SpO Sensor Cable 15 Power On Power on Self Test and Power Off oo oooooooooo oo eee 17 Configuring Operating ParameterS YF eee 18 How to Use the Menu System LLLFF eee 18 ChangingtheTimeandDate FF ees 22 Changing the Patient Type nnana anaana ee 24 MAP Measurement Enable and Disable V ua 25 Changing the NIBP Measurement Units LV YY Y 26 Changing Temperature Type and Measurement Units 27 Changing the Volume of the Pulse Tone o o o ooooooo ooooooo 28 Selecting Stream or Batch Printing FFF ua 29 3 Patient Monitoring cassie Yu ERREUR e Uu eas 31 Monitoring Blood Pressur amp u ee pe a ee eed Pay FWD TD ON 31 WarningS NIBP 3 4 nu mt Ret st A en a Ms A e 31 NIBP Pr parati nis acu sey Gyd e wots SL FD TEG ODAU yN UR A 32 Manual NIBP Measurement 34 Automatic NIBP Measurement 0 0 0 0 0 00 ccc Fa 35 Monitoring Pulse Rate eo wet lt eee DAN bh gy 38 Monitoring PO vrs eateries om E Sotelo e e e RR aC e 39 iv Contents Welch Allyn Vital Signs Monitor 300 Series Warnings and Cautions SpO3 1
4. When the monitor detects a nonrecoverable equipment problem it does the following e Displays an error code in the SYS window and shuts off the display to all other windows e Stops patient monitoring e Stops the pump and opens the air valve e Activates the Nurse Call relay if connected e Produces an audible tone e Shuts down as soon as is pressed or one minute has elapsed Response For both recoverable and nonrecoverable equipment alerts respond as follows 1 Press amp to immediately silence the alert tone 2 Determine what caused the alert and correct the problem 56 Chapter 4 Alarms and Alerts Alarm Indicators The monitor alarm indicators are as follows Welch Allyn Vital Signs Monitor 300 Series Event Audible Indicator Visual Indicator Patient Alarm Equipment Alert Nonrecoverable Error Equipment Alert Recoverable NIBP Equipment Alert Recoverable Sp0 after valid reading Three short tones in quick succession followed by a short silence and then two short tones in quick succession followed by a long silence repeated until action is taken Three short tones in quick succession followed by a short silence and then two short tones in quick succession followed by a long silence repeated for one minute or until power is shut off Two short tones Two short tones Two short tones Flashing display of the violating value For a MAP violation the monitor
5. 96 EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Eguipment WEEE Note f the monitor or the battery is contaminated this directive does not apply For more specific disposal information see www welchallyn com weee or contact Welch Allyn Customer Service Outside the EU When the monitor or the battery reaches end of life recycle it locally according to national state and local regulations or return it to Welch Allyn 2 I Reference Battery Operation Battery Low Warning When the battery charge is low a warning tone sounds and the Low Battery indicator a4 flashes continuously From the time 44 comes on the battery has enough charge remaining to perform at least one of the following over the next hour 20 NIBP cycles 30 minutes of SpO monitoring 20 predictive temperature determinations a single printing of 99 stored data sets To avoid a shutdown of the monitor due to battery failure plug in and connect the AC power adapter Battery Failure If the monitor continues to run on battery power after 4 comes on the battery eventually fails Battery failure is indicated by the following LA flashes continuously A short tone repeats continuously Pressing amp does not suppress this tone The message LOW BATTERY is displayed in the message window An error code is displayed in the systolic window SYS for 10 seconds and then all monitor displays a
6. Allyn part number 008 0634 XX or equivalent that has been adapted to your Nurse Call system This cable can be built or customized by a biomedical engineering department or other appropriate technical resource using the specification described on Nurse Call on page 81 WARNING Although the Nurse Call option enables remote notification of an A alarm condition it is not intended to replace appropriate bedside patient surveillance by trained clinicians Note When a patient alarm occurs pressing YY silences the monitor alarm tone and the Nurse Call alarm for 90 seconds but does not suspend the visual alarm indicator on the monitor 60 Chapter 4 Alarms and Alerts Welch Allyn Vital Signs Monitor 300 Series Error Codes Error Code Description Blood Pressure C01 NIBP cycle cancelled by operator C02 Unable to calibrate Either the cuff is being moved excessively during the calibration or the NIBP unit is not working C03 Inflation too rapid Check for hose constriction Verify patient type setting C04 Inflation too slow Check for hose leak Verify patient type setting C05 Excessive noise or air leak Check patient condition cuff placement and connection Limit patient motion C06 Pressure measurement outside monitor range C10 Cuff pressure was too high Check the patient s condition Sp0 Sensor problem Check patient condition and sensor position contact Ver
7. Insert the probe into the probe well Note You can replace any components of the thermometer including the probe well Use only Welch Allyn parts as listed in the Parts and Accessories Guide 52 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series 53 4 Alarms and Alerts WARNING f you turn off any alarm limits while responding to an alarm verify A alarm limits before you resume patient monitoring Responding to a Patient Alarm WARNING If a patient alarm and an equipment alert occur at the same time A take care of the patient alarm first A patient alarm occurs when a vital sign measurement falls outside of programmed limits During a patient alarm the monitor sounds the alarm tone a repeating series of intermittent short tones and flashes the associated numerics in the appropriate window The alarm also activates the Nurse Call relay if the Nurse Call cable is connected Respond as follows 1 Press amp to immediately silence the alarm tone e For SpO related alarms the alarm resumes 90 seconds later if the alarm condition has not been corrected e For NIBP related alarms the alarm is reset e For MAP related alarms the MAP measurement readings are displayed in flashing text on the message display 2 Check the patient and provide appropriate care 54 Chapter 4 Alarms and Alerts Welch Allyn Vital Signs Monitor 300 Series Responding to an Equipment Alert WARNING If a patient al
8. NIBP Pediatric Low Systolic Alarm 75 mmHg NIBP Pediatric High Diastolic Alarm 00 mmHg NIBP Pediatric Low Diastolic Alarm 35 mmHg NIBP Pediatric High MAP Alarm 110 mmHg NIBP Pediatric Low MAP Alarm 50 mmHg NIBP Neonatal High Systolic Alarm 120 mmHg NIBP Neonatal Low Systolic Alarm 50 mmHg NIBP Neonatal High Diastolic Alarm 70 mmHg NIBP Neonatal Low Diastolic Alarm 30 mmHg NIBP Neonatal High MAP Alarm 80 mmHg NIBP Neonatal Low MAP Alarm 35 mmHg SpO Adult High Alarm SpO Adult Low Alarm 85 SpO Pediatric High Alarm SpO Pediatric Low Alarm 85 Sp0 Neonatal High Alarm 95 Sp0 Neonatal Low Alarm 85 Temperature Scale 9F Fahrenheit predictive Pulse Rate Adult High Alarm 120 beats per minute Pulse Rate Adult Low Alarm 50 beats per minute Pulse Rate Pediatric High Alarm 150 beats per minute Pulse Rate Pediatric Low Alarm 50 beats per minute Pulse Rate Neonatal High Alarm 200 beats per minute Pulse Rate Neonatal Low Alarm 100 beats per minute Pulse Tone Volume 03 Print Control Batch Time of day Display 24 hour 83 Limited Warranty This product is sold by Welch Allyn under the warranties set forth in the following paragraphs These warranties are extended only to the end user with respect to the original purchase of this product directly from Welch Allyn or from Welch Allyn s authorized distributors For two years from the date of the or
9. NIBP measurement results are displayed in the SYS DIA and pulse rate windows Directions for Use Chapter 3 Patient Monitoring 35 e f MAP is enabled MAP results are displayed in the message window Note If the SpO sensor is attached and generating valid pulse rate data then the displayed pulse rate is derived from the SpO sensor reading The measurement display persists for two minutes or until another NIBP cycle is initiated If an error is detected an error tone sounds and an error code appears in the SYS window Automatic NIBP Measurement Automatic NIBP measurements repeat continuously at programmed intervals Note The interval is the time from the beginning of one measurement cycle to the beginning of the next measurement cycle To set up an automatic NIBP measurement do the following 1 Attach the cuff to the patient s arm 2 Press SZ to set the measurement interval The two dashes in the message window indicate that automatic measurement is turned off Y min 3 To set an interval press A or W to cycle through the options which include ST and a range of intervals 1 3 4 5 10 15 30 45 60 90 120 and 240 minutes Note The ST interval selection works differently from the other intervals For information on using these settings please refer to STAT Measurement on page 38 36 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series 4 To select the currently
10. Used Probe Cover Do not touch the used probe cover 1 Position the probe over an appropriate disposal receptacle 2 While holding the probe securely push the probe cover ejector button blue or red to remove the probe cover into the disposal receptacle Predictive Temperature Measurement Note Verify that the temperature measurement type is set to predictive The display is either 9F or 9C the letter M is notilluminated To set up for predictive temperatures please refer to the procedure described in Changing Temperature Type and Measurement Units on page 27 To take a predictive temperature follow these steps Directions for Use Chapter 3 Patient Monitoring 45 Oral Predictive When used correctly the monitor produces an accurate oral temperature measurement in less than 6 seconds Note For oral temperatures use only the oral probe blue ejection button and the blue probe well 1 Remove the temperature probe from the probe well The temperature probe runs a self test displaying 188 8 for a few seconds When it is ready for use the temperature window clears and then OrL appears in the temperature window 2 Load a new probe cover by inserting the probe into a probe cover and pressing the probe handle down firmly The probe handle moves slightly to engage the probe cover Caution Use only Welch Allyn probe covers The use of any other probe cover or A failing to use a probe cover can produce measur
11. a e All display windows are blanked other than the message window and the SYS window e The message window displays HIGH ALARM e The SYS window displays the current alarm setting for the upper limit of systolic blood pressure This setting is a numeric blood pressure level or it is indicating that no alarm is set for the selected vital sign For the selected vital sign do one of the following e Leave the limit unchanged or e Press A or Y as needed to change the limit to another value or to to disable the alarm Press to accept the displayed alarm limit and advance to the next vital sign The display moves to the next window for example from SYS HIGH to SYS LOW or from SYS LOW to DIA HIGH To continue changing alarm limits repeat from step 2 to return to normal operation do nothing for 10 seconds To set the MAP alarm limits if MAP is enabled Continue from step 3 until you have cycled through all of the display windows that is until you have cycled through SpO2 LOW The display moves to the message window which displays the current MAP high alarm limit as follows MAP 7 XXX mmHg or MAP 7 XXX kPa MAP XXX mmHg or MAP XXX kPa 58 Chapter 4 Alarms and Alerts Welch Allyn Vital Signs Monitor 300 Series 6 Change or accept the MAP high alarm limit as described above from step 2 7 Press 4 to step to the MAP low alarm limit 8 Change or accept the MAP low alarm limit The range of hig
12. and printer status 8 Chapter 1 General Information Welch Allyn Vital Signs Monitor 300 Series Status Indicators NIBP Measurement Units Temperature Units Pulse kilopascals kPa Amplitude Indicator OF degrees Fahrenheit millimeters of mmHg C degrees Celsius mercury Temperature Type M monitored Patient type neonate and pediatric 2 adult 2 alarms not silenced alarms silenced Battery Status charged power power charging is off is on LA discharged Directions for Use Chapter 1 General Information Function Controls Up Down Power On Off OSO a 9 Power Power Review SetNIBP Start Stop NIBP SetAlarm Silence Alarms is on is off Data Interval AUTO button Limits Alarms Silenced 9 10 Chapter 1 General Information Connections AN Nurse Call Cable Connector Sp0 SpO Sensor Cable Connector RS232 Cable o Connector ess DC Power Cable Connector 8V 740mA Welch Allyn Vital Signs Monitor 300 Series Temperature Probe Cable Connector For information on the connections refer to the following AC Power Adapter Connecting AC Power on page 11 Temperature Probe Connecting the Temperature Probe Cable on page 14 Sp0 Sensor Connecting and Disconnecting the SpO Sensor Cable on page 15 NIBP Cuff Hose Connecting the NIBP Cuff Hose on page 13 Nurse Call Cable Nur
13. displayed interval press any button other than A or W Ten seconds after you select an interval and assuming that safe venous return pressure SVRP has been maintained for at least 30 seconds the monitor starts the first automatic NIBP cycle and the following occurs e The cuff inflates to the default pressure level e The SYS window dynamically displays the current cuff pressure e f MAP is enabled the MAP measurement value alternates with the time display in the message window Note f a MAP alarm occurs the MAP is displayed steadily in the message window When the NIBP cycle ends a tone sounds and the monitor displays the measurement results including pulse rate in the min window If the SpO sensor is attached to the patient the pulse rate is derived from the SpO sensor The measurement display persists until one of the following occurs e the next cycle begins if the monitor is still in automatic NIBP mode e two minutes pass Wis pressed again Note If the first cycle does not produce a measurement the monitor retries the measurement using a target pressure calculated from the results of the previous cycle Directions for Use Chapter 3 Patient Monitoring 37 The automatic NIBP cycles continue until one of the following occurs e The monitor reaches the 5 minute limit for a STAT measurement The current cycle continues to completion even if it goes beyond the 5 minute limit e The monitor halts becaus
14. ees 39 SpOs Monitoring Procedire u eg tio 40 Monitoring Temperatures rss E eR em RE Re em eda a 42 Warnings and Cautions Temperature V Y eee 42 Setting the Temperature Measurement Typ I Y au 43 loading a Probe Covers ie li eese Deis 44 Ejecting a Used Probe Covers sujan ed I A e E a d deese d a d 44 Predictive Temperature Measurement FF o 44 Monitored Temperature Measurement llle 50 Thermometer and Probe Cleaning Procedure ooo 51 Removable Probe Well Cleaning Procedure o ooooooooooo o 51 4 ATanmsand AlertS dass eR tr MEE Qc RG ot 53 Responding t a Patient Alarm ss suec s ll ara EA 53 Responding to an Equipment Alert FF yd 54 Recoverable Temperature NIBP or SpO Alert Not Escalated 54 Recoverable SpO Alert Escalated YYF Y Y a 54 Recoverable NIBP Alert Escalated FFFFF a 54 Nonrecoverable Alerts FF FF eee 55 Alarm IndicatOES 2 mee wha ot nb ra a tt dde aa 56 SOUND AOS oo A SY Sd y DN CN dd NO 56 Nurse Callias ed canoa Sd Sd Y Y Ad a era 59 Error GOdeSu sc al Ae ie S ANM 60 5 Reviewing Patient Data FR 61 Displaying Stored Patient Data nne sarasini eee 61 Printing Patient Data ais a dr el yda do ydd e di 61 To Start and Stop Printings sodes a erc Qe E NEW ee e 62 Batch Prin ungee ee osos A A bad eae EET Se Y y 62 tea PRINTINGE ce a eta MEI aro tentad
15. setting refer to How Changing the Patient Type Affects MAP Defaults on page 38 4 To select the displayed state and return to normal operation either do nothing for 10 seconds or press any button other than A or W If you press a function button such as Y the monitor returns to normal operation with that function amp activated For information about MAP measurements see Patient Monitoring on page 31 26 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series Changing the NIBP Measurement Units Default setting mmHg To change the NIBP measurement units 1 Depress Y for 3 seconds SET HOUR XX appears in the message window 2 Press 8 repeatedly until BP Units mmHg or BP Units kPa appears in the display window 3 Press A or W as needed to display the desired NIBP measurement units 4 To select the displayed units and return to normal operation either do nothing for 10 seconds or press any button other than A or W If you press a function button such as amp the monitor returns to normal operation with that function e activated Y min i For information on NIBP measurements see Patient Monitoring on page 31 Directions for Use Chapter 2 Setup 27 Changing Temperature Type and Measurement Units Default setting F Fahrenheit predictive To change the temperature type and the temperature measurement units 1 2 3 With the monitor on press 9 repeatedly
16. software remains with Welch Allyn or its vendors For information about any Welch Allyn product call Welch Allyn Technical Support USA 41315 685 4560 Australia 61 29 638 3000 800 535 6663 800 074 793 Canada 800 561 8797 China 86 216 327 9631 European Call Center 353 46 906 7790 France 33 15 569 5849 Germany 49 747 792 7186 Japan 81 33 219 0071 Latin America 1 305 669 9003 Netherlands 31 15 750 5000 Singapore 6b 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Reorder Part Number 810 2252 XX Manual Part Number 810 2223 01 Rev A 2 2006 Welch Allyn 8500 SW Creekside Place Beaverton Oregon 97008 7107 www monitoring welchallyn com Printed in USA C E ora a a IE Contents 1 General Information o cra aa id 1 About This Manual ba tas tl tt e a MW 1 Intended USE 5 ua e a ers d bd AS RIS AA ANF a 1 SVITIBO S cm YN sene Anand eor iet an plis 2 Product OVervie Wi Y lu eae ee E GG WYD IR 4 Warnings and Cautioni Si ea oue y em pas suite plex sede pex GG pois 5 General Warnings kd seo or HE al A Ov eia la a A e nA IR AR ed 5 General Cautions on Vete vta a of Bee ee dete e de 6 Displays Indicators Controls and Connections eee 7 Numeric Measurement and Message DisplayS o ooooocoooo 7 Status dicto Suc osse hne PIS at das bi 8 Function GontrolSs auo terc A a ta A DEP ee Sad ee e 9 CONNECTIONS A A AN 10 2 SOLUD 2 eb AAA ae 11
17. the directions supplied with the sensor To adjust the volume of the SpO pulse tone see Changing the Volume of the Pulse Tone on page 28 42 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series Monitoring Temperature Warnings and Cautions Temperature A WARNING To ensure patient safety and to obtain accurate and reliable temperature results read this section thoroughly before using the temperature instrument WARNING Always put a single use probe tip cover on the probe tip before taking a temperature measurement Failure to use a probe tip cover can cause patient discomfort patient cross contamination and erroneous temperature readings WARNING Use only Welch Allyn single use disposable probe covers The use of any other probe cover can cause patient cross contamination and erroneous temperature readings WARNING Never re use a probe cover WARNING Using a probe at the wrong site produces inaccurate measurements and can cause patient injury e Use only oral probes identified by a blue ejection button at the top of the probe to take oral and axillary temperatures e Use only rectal probes identified by a red ejection button at the top of the probe to take rectal temperatures WARNING Use only the oral probe well with the oral probe and use only the rectal probe well with the rectal probe Using the wrong probe well can result in patient cross contamination WARNING Always verify direc
18. until TEMP MODE appears in the display window One or two green LEDs to the right of the temperature window illuminate to indicate the selected temperature type Press A or W as needed to cycle to the desired display F Fahrenheit Predictive F M Fahrenheit Monitored C Celsius Predictive C M Celsius Monitored To select the displayed units and return to normal operation either do nothing for 10 seconds or press any button other than A or W If you press a function button such as amp the monitor returns to normal operation with that function activated For information on temperature measurements see Patient Monitoring on page 31 28 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series Changing the Volume of the Pulse Tone Default setting 03 The pulse tone can be set from level 00 volume off to level 05 volume on full To adjust the volume of the SpO pulse tone do the following 1 Press repeatedly until VOLUME XX appears in the display window and the pulse tone sounds continuously Y min i 2 Y min 3 To set the displayed volume level and return to normal operation either do nothing for 10 seconds or press any button other than A or W If you press a function button such as O the monitor returns to normal operation with that function activated Note Changing the volume of the pulse tone has no effect on the volume of the alarm tones Directions for Us
19. 28 days or up to 44 gestational weeks Pediatric 2 29 days through 12 years Adult 2 13 years and older Default setting ADULT Follow these steps to change the patient type setting 1 Press The current patient type sat amp or amp appears below the DIA window and NEONATE PEDIATRIC or ADULT appears in the message window 2 Press A or W to display at amp or amp 3 To select the displayed patient type and return to normal operation either do nothing for 10 seconds or press any button other than A or W If you press a function button such as amp the monitor returns to normal operation with that function gt activated Y min Changing the patient type has the following effects e Alarm limits are reset to the default limits for the new patient type e Cuff inflation target pressure is reset to the default for the new patient type If you cycle through the patient types but do not change the setting the alarm limits and the cuff inflation target pressure settings do not change Directions for Use Chapter 2 Setup 25 MAP Measurement Enable and Disable Default setting MAP ENABLED for neonate MAP DISABLED for adult and pediatric 1 Depress 9 for 3 seconds SET HOUR XX appears in the message window 2 Press E repeatedly until MAP ENABLED or MAP DISABLED appears in the display window 3 Press A or W to enable or disable MAP measurement Note If you change the MAP enabled disabled
20. 4877 m 557 ft to 16 000 ft Shipping altitude 615 m to 12 300 m 2000 ft to 40 000 ft Storage temperature 20 C to 50 C 4 F to 122 F Relative humidity 15 to 90 non condensing Directions for Use Chapter 7 Reference 81 Nurse Call Switch current 1A maximum Switch voltage 30V ac dc maximum Isolation 1500 Vrms Alarm relay Energized during patient alarm Cable Welch Allyn part number 008 0634 XX customized to connect to the local Nurse Call system Cable properties e 10 feet 3 meters long e Not shielded e One end not terminated to be customized on site e One end terminated with a connector which mates to the Nurse Call connector shown below on the monitor 4 not connected 1 Black Normally Open wie 2 Red Arm 3 Green Normally Closed 82 Chapter 7 Reference Welch Allyn Vital Signs Monitor 300 Series Factory Default Settings Function Value Blood pressure measurement units mmHg Patient type Adult Automatic NIBP Interval 15 minutes MAP Adult and Pediatric Disabled MAP Neonate Enabled NIBP Adult High Systolic Alarm 220 mmHg NIBP Adult Low Systolic Alarm 75 mmHg NIBP Adult High Diastolic Alarm 10 mmHg NIBP Adult Low Diastolic Alarm 35 mmHg NIBP Adult High MAP Alarm 20 mmHg NIBP Adult Low MAP Alarm 50 mmHg NIBP Pediatric High Systolic Alarm 145 mmHg
21. 7 E equipment alert 54 erasing patient data 67 error codes 60 F factory defaults 82 Fahrenheit units selecting 27 FDA 73 indicators description 8 intended use 1 86 Index intravenous infusion warning 31 K kPa units selecting 26 M maintenance 69 manual reorder number ii MAP alarm 36 58 measurement data reviewing 61 units setting 26 mmHg units selecting 26 monitor configuration 18 setup 18 onitored temperature 43 50 onitoring blood pressure 31 pulse rate 38 Sp02 39 temperature 42 3 3 N neonatal see also patient type defined 24 icon 4 NIBP 31 automatic 35 cycle ending 37 manual 34 preparation 32 STAT 38 nurse call connector location 59 O operating parameters setting 18 oral temperature 45 P paper replacing 68 Welch Allyn Vital Signs Monitor 300 Series patient alarm 53 patient data reviewing 61 patient type and alarm limits 58 and cuff size 32 and MAP enable disable 25 38 changing 24 selecting 19 setting 24 status indicator 8 pediatric see also patient type defined 24 icon 4 power 11 power on self test 17 predictive temperature 43 printer output 63 replacing paper 68 printing patient data 29 programmed limits 53 R READING message 61 rectal temperature 49 reorder manual part number ii review 61 S safety warnings and cautions 5 setup 11 software license agreem
22. Allyn WARNING Always recycle batteries according to local regulations Never dispose of batteries in refuse containers WARNING Do not use the monitor on patients who are linked to a heart machine or a lung machine WARNING Do not use the monitor on patients who are experiencing convulsions or tremors General Cautions A Caution f the accuracy of any measurement is in doubt verify the patient s vital sign by another method If the monitor is not measuring accurately have it inspected by a gualified service person Caution Be sure that the monitor is securely located on a flat surface or properly suspended by means of appropriate mounting eguipment Caution Do not autoclave the monitor Caution Do not place cups glasses or other fluid containers or vessels on the monitor Directions for Use Chapter 1 General Information 1 Displays Indicators Controls and Connections This section describes the measurement displays status indicators function controls and connections of the monitor Numeric Measurement and Message Displays SYS DIA and Sp02 Displays systolic and diastolic blood pressure and SpO or Aa a ia related alarm thresholds and min ra a al error codes See Error Codes thresholds and error codes on page 60 Message window Displays the current date and time MAP measurements and alarm thresholds Displays configuration settings error codes software version numbers
23. P NIB P notation can include error information C01 C02 C03 C04 C05 C06 C10 NIBP cycle cancelled by operator Unable to calibrate Cuff inflation to rapid Excessive cuff inflation time Excessive noise or air leak Measurement out of range Cuff overpressure Error Legend If any error indicators appear in the printed data the monitor prints an error legend The error legend contains a two line header followed by a brief explanation of each error type encountered in the data The illustration below shows the error legend for a batch of data containing at least one temperature P error at least one NIBP C04 error and no other errors Footer The Error Codes P Loss of tissue contact C04 Excessive inflation time printout footer consists of a line containing the monitor serial number a line containing the monitor software version two separator lines and four blank lines Unit S N JA736455 S W Ver 1 00 00 00005 Directions for Use Chapter 5 Reviewing Patient Data 67 Erasing Patient Data All patient vital sign data is erased when the monitor is powered off or when you change the time and date settings You can also erase data at any time during normal monitor operation Erasing Data Before Changing the Date and Time If you attempt to change the date and time the monitor prompts you to confirm that you also want to erase all stored patient data Note You cannot change the date and t
24. The monitor menu system contains three sets of menus settings configuration and service Settings Menu Access the settings menu by pressing the menu button W while in normal operation Then press 2 repeatedly to reach the setting of interest Settings Menu Patient Type nak 2 Ba Power Off all values saved except target inflation pressure Temperature Units Temperature Type F C M No action for 10 seconds or Press any button other than O A Y Pulse Tone Volume Directions for Use Chapter 2 Setup 19 Use the settings menu to select and set the following parameters Patient Type aak Target Pressure Temp Modes oF F M C C M Pulse Tone Volume Neonate Term birth through 28 days or up to 44 gestational weeks Pediatric 29 days through 12 years Adult 13 years and older The initial cuff inflation pressure set individually for each patient type Fahrenheit Predictive Fahrenheit Monitored Celsius Predictive Celsius Monitored From 0 silent to 5 loudest To change a settings parameter 1 Select the parameter as indicated above 2 Change the value by pressing A or W 3 Setthe displayed new value either by doing nothing for 10 seconds or by pressing any button other than A or W If you press a function button such as e the monitor returns to normal operation with that function activated 20 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series Config
25. Vital Signs Monitor 300 Series Welch Alltyn Print Directions for Use Software version 1 2X WelchAllyn Advancing Frontline Care ii Welch Allyn Vital Signs Monitor 300 Series Copyright 2005 Welch Allyn All rights are reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Welch Allyn Welch Allyn assumes no responsibility for any injury to anyone or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or statement of intended use published in this manual Welch Allyn and Flexible Monitoring are registered trademarks of Welch Allyn FlexNet is a trademark of Welch Allyn Nellcor is a registered trademark of Nellcor Puritan Bennett Inc Software in this product is Copyright 2005 Welch Allyn or its vendors All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and ownership of the
26. arm and an equipment alert occur at the same time A take care of the patient alarm first Recoverable Temperature NIBP or SpO Alert Not Escalated Most recoverable equipment alerts are not escalated to the level of patient alarms When an unescalated alert occurs take the necessary steps to correct the eguipment problem and then resume patient monitoring For an unescalated equipment alert for Temperature NIBP or SpO the monitor does the following e Beeps once e Displays an error code Cxx in the relevant window Temp SYS DIA or SpOs Recoverable SpO Alert Escalated An SpO equipment alert is always escalated immediately to the level of a patient alarm if it occurs when both of the following conditions exist e SpO monitoring has begun and the monitor has recorded an SpO2 measurement e An SpO or Pulse Rate alarm limit has been set See Responding to a Patient Alarm on page 53 Recoverable NIBP Alert Escalated An NIBP equipment alert is escalated to the level of a patient alarm whenever both of the following conditions exist e Two consecutive NIBP equipment alerts occur while the monitor is taking automatic NIBP PR measurements e Alarms are enabled See Responding to a Patient Alarm on page 53 Note For information about a battery alert see Battery Low Warning on page 71 and Battery Failure on page 71 Directions for Use Chapter 4 Alarms and Alerts 55 Nonrecoverable Alerts
27. as carboxyhemoglobin or methemoglobin the presence of concentrations of some intravascular dyes sufficient to change the patient s usual arterial pigmentation patient movement patient conditions such as shivering and smoke inhalation painted nails poor oxygen perfusion anemia or low concentrations of hemoglobin hypotension or hypertension Severe vasoconstriction shock or cardiac arrest venous pulsations or sudden and significant changes in pulse rate proximity to an MRI environment moisture in the sensor excessive ambient light especially fluorescent wrong sensor or sensor too tight WARNING If there is any question of the accuracy of an SpO5 measurement verify the measurement using another clinically accepted measurement method 40 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series A WARNING Do not use the SpO sensor as an apnea monitor WARNING During prolonged continuous SpO monitoring check the sensor site often in compliance with the sensor manufacturer s directions Inspect the patient s skin integrity and circulation and relocate the sensor if necessary Tissue damage can result from improper or prolonged sensor attachment e Use only sensors and accessories recommended by Welch Allyn e Donot use damaged sensors or cables e Do not use a sensor with exposed optical components e Do not immerse or wet the sensor Caution Some sensors might not work with some patients If after 20 s
28. asurements three minutes of monitoring is recommended For axillary measurements five minutes of monitoring is recommended WARNING Do not exceed the recommended measurement periods of three A minutes for oral and rectal measurements and five minutes for axillary measurements During a monitored measurement the temperature is displayed dynamically throughout the measurement period Unlike a predictive measurement the monitor does not indicate the end of any elapsed time for a monitored measurement To select the temperature measurement type 1 Press Y repeatedly until TEMP MODE appears in the display window 2 Press A or Y to cycle to the option you wish to select Fahrenheit predictive Celsius predictive oF p C p Fahrenheit monitored Celsius monitored OF C M M 3 To set the temperature measurement type and return the monitor to normal operation do nothing for 10 seconds or press any button other than A or W If you press a function button such as the monitor returns to normal operation with that function activated 44 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series Loading a Probe Cover 1 Holding the probe handle with your thumb and two fingers on the indentations of the probe handle withdraw the probe from the probe well 2 Insert the probe into a probe cover and press the probe handle down firmly The probe handle moves slightly to engage the probe cover Ejecting a
29. bled disabled setting again Enabling and Disabling MAP Measurement See MAP Measurement Enable and Disable on page 25 STAT Measurement If the selected interval is STAT the monitor takes repeated NIBP measurements for 5 minutes starting a new cycle each time the cuff deflates below safe venous return pressure SVRP for two seconds Current cuff pressures are not dynamically displayed during a STAT reading The message window displays the NIBP reading from the previous cycle until the current cycle finishes Before the first cycle finishes the display reads 0 Monitoring Pulse Rate The monitor displays the pulse rate at the end of all NIBP or SpO5 measurements It displays NIBP pulse information only if no SpO reading is available If the SpO gt sensor is connected to the patient during the measurement period the pulse amplitude indicator rises and falls in rhythm with the monitored heart rate The higher the display rises the stronger the measured pulse however the height of the indicator display is not mathematically proportional to the volume of the pulse Directions for Use Chapter 3 Patient Monitoring 39 Monitoring Sp0 Warnings and Cautions Sp0 A WARNING Always follow the manufacturer s instructions for care and use of the SpO sensor WARNING The accuracy of the SpO5 measurement can be affected by any of the following the presence of significant amounts of dysfunctional hemoglobin such
30. d lead acid 6V 4 Ah battery with external recharge capability The battery charges to at least 90 capacity in 12 hours The AC power adapter when connected simultaneously operates the monitor and charges the battery it charges the battery more rapidly if it is not simultaneously operating the monitor Using a new fully charged battery the monitor can be operated continuously for at least 8 hours of Adult NIBP monitoring at 3 minute intervals with simultaneous and continuous monitoring of temperature and SpO values In other words a new fully charged battery supports at least 165 Adult NIBP readings at 3 minute intervals while simultaneously and continuously monitoring and displaying temperature and SpO values Leakage Current For maximum patient electrical isolation connect a computer to the monitor only when the monitor is not connected to a patient or when the computer is outside the patient field running on battery power Directions for Use Environmental EMC Compliance Chapter 7 Reference 77 The monitor complies with all applicable and required standards for electromagnetic interference It does not normally affect nearby equipment and devices It is not normally affected by nearby equipment and devices It is safe to operate the monitor in the presence of high frequency surgical equipment However it is good practice to avoid using the monitor in extremely close proximity to other equipment Gu
31. d vital sign the time is printed on the same row as the temperature reading Time Sys Dia MAP PR SpO2 mmHg BPM NO E LLL UE 21 45 125 eol 90 72 98 21 52 125 69 30 72 98 Temp 99 2F NOR ORL 22 12 Temp 110 0F NOR ORL Directions for Use Chapter 5 Reviewing Patient Data 65 Range and Alarm Flags Flag characters f and 4 indicate a data value that falls outside of a defined range or violates a programmed alarm threshold In the illustration above 694 indicates a diastolic pressure value below the programmed alarm limit and 110 0F indicates a temperature value above the monitor s temperature measurement limit Temperature The temperature notation includes information about the type and location of the measurement and can include error notation Type F Fahrenheit C Celsius NOR Normal predictive MON Monitored Location OrL Oral Oral probe AP Axillary Pediatric Oral probe AA Axillary Adult Oral probe rEC Rectal Rectal probe Error P Discontinuity in tissue contact during the measurement period The displayed temperature measurement is not necessarily accurate C20 Broken or missing temperature probe Pulse Rate The pulse rate notation does not include error information SpO2 SpO gt notation can include error information C7 Malfunctioning sensor Sensor error 66 Chapter 5 Reviewing Patient Data Welch Allyn Vital Signs Monitor 300 Series NIB
32. ded to change XX to the current hour Press 2 once to set the hours and change the display to SET MINUTE XX Press A or V as needed to change XX to the current minute Press ME once set the minutes and to change the display to SET YEAR XX Press A or W as needed to change XX to the current year Press 8 once to set the year and change the display to SET MONTH XXX Press A or W as needed to change XXX to the current month Press 2 once to set the month and change the display to SET DAY XX 10 Press A or W as needed to change XX to the current day Directions for Use Chapter 2 Setup 23 11 To save the displayed time and date settings either do nothing for 10 seconds or press any button other than A or W If you press a function button such as e the monitor returns to normal operation with that function e activated You cannot change the date and time while memory contains stored vital signs data If you attempt to change the date and time setting while data is stored the guestion ERASE DATA appears in the message window If you confirm the data erasure the monitor erases the data from memory and returns you to the date set function If you select NO the stored data is retained in memory and the monitor returns to normal operation 24 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series Changing the Patient Type The age range for each patient type is defined as follows Neonatal 9 Term birth through
33. ditional equipment to the signal input part or A signal output part of this monitor configures a medical system and is responsible for verifying that the system complies with the requirements of the system standard IEC 60601 1 1 Directions for Use Chapter 1 General Information 5 Warnings and Cautions All operating and service personnel must be familiar with the information presented here and with other warnings and cautions which appear throughout this document Warning and caution labels can appear on the monitor the packaging the shipping container or in this document General Warnings A WARNING Many environmental variables including patient physiology and clinical application can affect the accuracy and performance of the device The clinician must verify all vital signs information prior to patient intervention WARNING The monitor is for use only by medical clinicians Although this document might illustrate medical monitoring techniques the monitor must be used only by trained clinicians who know how to take and interpret a patient s vital signs WARNING During defibrillation keep the defibrillation discharge paddles away from any conductive parts that might already be in contact with the patient WARNING For the safety of patients and to ensure the best product performance and accuracy use only accessories and supplies recommended or supplied by Welch Allyn for the monitor as listed in Products and Accessories
34. e Chapter 2 Setup 29 Selecting Stream or Batch Printing Default setting BATCH For monitors configured with the optional thermal printer 1 Press and hold for three seconds 2 Press 8 until the message window reads PRINT BATCH or PRINT STREAM 3 Press A or W to alternate between PRINT BATCH and PRINT STREAM display 4 To set the displayed printing method and return to normal operation do nothing for 10 seconds or press any key other than A or W If you press a function button such as the monitor returns to normal operation with that function amp activated For information on using the printer see Patient Monitoring on page 31 30 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series 31 3 Patient Monitoring Monitoring Blood Pressure Warnings NIBP A WARNING To ensure safe and accurate NIBP measurements use only cuffs and hoses approved by or supplied by Welch Allyn WARNING Never use an adult or pediatric monitor setting or cuff for an NIBP measurement on a neonatal patient Adult and pediatric inflation limits can be excessive for neonatal patients even if a neonatal cuff is used WARNING NIBP readings may be inaccurate for patients experiencing moderate to severe arrhythmia WARNING When patients are being monitored frequently or monitored for a prolonged period regularly remove the cuff to inspect it and to inspect the patient s cuffed extremity for ischemia purp
35. e Y is pressed e The monitor halts because of an alarm alert or error condition e The interval code is changed to If an error is detected during the measurement an error tone sounds and an error code appears in the SYS window Note The latest NIBP measurement is displayed until one of the following occurs e the next NIBP cycle starts e an alarm alert or error occurs e the monitor shuts down MAP Measurement MAP is available for adult pediatric and neonatal patients The monitor is set at the factory to enable MAP display and alarm limit checking for neonatal patients and to disable those functions for adult and pediatric patients If MAP is enabled the monitor displays MAP readings in the message window at the end of NIBP measurements 38 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series How Changing the Patient Type Affects MAP Defaults When you cycle power to the monitor the monitor stores all current settings before shutting down It then uses these saved settings when it powers up again This does not affect the factory default settings Whenever you enable or disable MAP for a given patient type Adult Pediatric Neonatal the current enabled disabled setting becomes the default powerup setting for that patient type For example If the monitor is set to Neonatal and you set MAP Disabled MAP Disabled becomes the default setting for neonatal patients until you change the ena
36. econds A a properly functioning sensor fails to discern a pulse do the following 1 Adjust or reposition the sensor If the failure continues 2 Use a different type of sensor Sp0 Monitoring Procedure 1 Verify that the SpO sensor cable is connected to the monitor 2 Attach the SpO finger clip sensor to the end of the patient s index finger as shown below The sensor can be attached to the patient when the monitor is on or off and during an NIBP cycle WARNING Do not use an SpO finger clip sensor and a blood pressure cuff A simultaneously on the same limb To do so will result in inaccurate pulse rate and perfusion readings and could cause erroneous pulse rate alarms Directions for Use Chapter 3 Patient Monitoring 41 Within a few seconds the pulse amplitude indicator reflects the rate and strength of the pulse Within less than 20 seconds the SpO window displays the SpO5 measurement and a numeric pulse rate value appears in min Note During an SpO measurement the displayed pulse rate is derived from the SpO sensor Otherwise the pulse rate is derived from NIBP Detaching the sensor during an SpO5 measurement triggers an alarm If alarms are set for SpO or pulse rate a condition of no pulse for between 5 and 10 seconds causes an alarm If SpO5 is being measured continuously on a patient over an extended period change the location of the sensor at least every three hours or as indicated by
37. ement errors or inaccuracies 3 Place the probe tip under the patient s tongue on either side of the mouth and deep in the rear sublingual pocket Sublingual pockets 4 Have the patient close his her lips around the probe Caution f the patient bites the probe the probe can be damaged 46 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series 5 Hold the probe in place to assure continuous contact with the oral tissue until the measurement is complete Rotating segments appear in the temperature window indicating that the measurement is in progress Note The probe must remain in steady contact with the sublingual pocket throughout the measurement period otherwise the monitor fails to accurately predict the temperature During the measurement period the temperature window displays a walking box a box with the sides illuminated sequentially When the temperature prediction is complete the monitor sounds three short tones and displays the temperature reading which persists for one minute 6 Eject the probe cover by pressing the ejection button hygienically dispose of the probe cover 7 Return the probe to the probe well If the monitor cannot make a predicted measurement within 60 seconds It switches to monitored temperature measurement and continues to monitor the patient s temperature See Monitored Temperature Measurement on page 50 Caution Do not monitor temperature cont
38. ement within 60 seconds it switches to making a monitored temperature measurement See Monitored Temperature Measurement on page 50 Caution Do not monitor temperature continuously for more than 5 minutes Note fa probe position error occurs during the temperature determination the temperature display alternates between the measured temperature and P WARNING If the probe becomes contaminated follow the instructions under A Thermometer and Probe Cleaning Procedure on page 51 Directions for Use Rectal Predictive Chapter 3 Patient Monitoring 49 When used correctly the monitor produces an accurate rectal temperature measurement in less than 13 seconds Note For rectal temperatures use only the rectal probe red ejection button and the 1 ao B o wm red probe well Remove the temperature probe from the probe holder The temperature probe runs a self test displaying 188 8 for a few seconds When it is ready for use a double tone sounds the temperature window clears and then rEC appears in the message window Load a probe cover onto the probe Apply a thin coat of waterbased lubricant to the tip of the probe cover Separate the patient s buttocks with one hand Insert the probe tip 1 5 centimeter 5 8 inch inside the rectal sphincter Tilt the probe slightly to ensure good tissue contact and keep the buttocks separated throughout the duration of the measurement A WARNING Use extreme care to avo
39. ent guidance Electrostatic discharge 26 kV contact 6 kV contact Floors should be wood concrete or ESD 8 kV air 8 kV air ceramic tile If floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at least 3096 Electrical fast 2 kV for power supply 2 kV for power supply Mains power quality should be that of a transient burst lines lines typical commercial or hospital IEC 61000 4 4 1 kV for input output 1 kV for input output environment lines lines Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of a IEC 61000 4 5 2 kV common mode 2 kV common mode typical commercial or hospital environment Voltage dips short lt 5 U lt 5 U Mains power quality should be that of a interruptions and gt 95 dip in U gt 95 dip in U typical commercial or hospital voltage variations on for 0 5 cycle for 0 5 cycle environment If the user of the VSM 300 power supply input 40 U 40 U Series monitor requires continued lines 60 dip in U 60 dip in 4 operation during power mains IEC 61000 4 11 for 5 cycles for 5 cycles interruption it is recommended that the 70 U 70 U monitor be powered from an 30 dip in U4 30 dip in 4 uninterruptible power supply or a battery for 25 cycles for 25 cycles lt 5 U lt 5 U gt 95 dip in U gt 95 dip in U for 5 sec for 5 sec Power frequency 50 60 3 A m 3 A m Power frequency magnetic fields should Hz magnetic
40. ent ii specifications temperature 73 SpO2 cable connection 15 measuring 39 STAT interval 38 storage 69 stored data 61 stream printing 29 62 T temperature monitoring 42 operating monitor 80 parameters setting 43 Directions for Use probe cable connection 14 trademarks ii V vital signs alarms 53 blood pressure 31 pulse rate 38 SpO2 39 temperature 42 W warnings general 5 NIBP 31 Sp02 39 temperature 42 Index 87 88 Index Welch Allyn Vital Signs Monitor 300 Series
41. ess specified by Welch Allyn customer service Welch Allyn 8500 S W Creekside Place Beaverton Oregon 97008 7107 USA Telephone 503 530 7500 or 800 289 2500 Facsimile 503 526 4200 Welch Allyn shall not be otherwise liable for any damages including but not limited to incidental conseguential or special damages No express or implied warranties extend beyond the warranties defined in this document Welch Allyn makes no warranty of merchantibility or fitness for a particular purpose 84 Limited Warranty Welch Allyn Vital Signs Monitor 300 Series Index 85 A AC power connecting 11 adult see also patient type defined 24 icon 4 alarm high and low 57 MAP 36 58 patient 53 range limits 58 responding to 53 setting 56 tone 53 alert responding to 54 autoclave 6 axillary temperature 47 B batch printing 29 62 battery charge before using 12 charging 11 failure 71 low charge warning 71 low power indicator 12 blood pressure automatic 35 manual 34 monitoring 31 buttons description 9 C CAL message 34 cautions NIBP 31 Sp02 39 temperature 42 CE certification 2 Celsius units selecting 27 charging the battery 11 classification 73 cleaning 69 configuration 18 connections location 10 controls description 9 CSA certification 2 cuff positioning 33 pressure preset 32 selecting 32 D data erasing 67 default values 82 displays description
42. f these cases printing stops immediately Note If the monitor is configured for Stream printing but printing is disabled you can press and hold Y for 3 seconds to immediately start a Batch print job When this Batch job ends the monitor is still configured for Stream printing Stream Printing Alternatively a clinician can choose to print a continuous stream of vital signs where the measurement information is printed as soon as the results of each cycle are recorded When the monitor is configured for stream printing and while it is in normal operating mode press amp to immediately begin stream printing Stream printing continues until one of the following occurs Directions for Use Chapter 5 Reviewing Patient Data 63 is pressed again the monitor prints an error log if any errors occurred and a footer and then printing stops e Anonrecoverable error condition is detected printing stops immediately e A battery failure condition is detected Printing is suspended as long as the battery failure continues if the AC power adapter is connected before the monitor shuts down printing resumes Printer Output The printer standard report consists of a header patient information patient data table heading date time range and alarm flags and measurement readings an error legend and a footer If the monitor receives a print reguest and no data is available it prints only the header and footer Header weilch Al
43. field be at levels characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment Note U is the AC mains voltage prior to application of the test level Directions for Use Chapter 7 Reference 79 Guidance and manufacturer s declaration electromagnetic immunity The VSM 300 Series monitor is intended for use in the electromagnetic environment specified below The customer or the user of the monitor should assure that it is used in such an environment Immunity test IEC 60601 test Compliance Electromagnetic environment guidance level level Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 Portable and mobile RF communications equipment should be used no closer to any part of the VSM 300 Series monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 Vims 3Vims d 1 2 JP 150 kHz to 80 MHz 3 V m 3 V m d 1 2 JP 80MHz to 800 MHz 80 MHz to 2 5 GHz d 23 P 800MHzto2 5 GHz where P is the maximum output power rating of the transmitter in watts 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
44. h and low alarm limits for each vital sign is shown here Alarm Limits for Vital Signs Vital Sign Low Limit Default High Limit Default Resolution Systolic mmHg Neonatal 30 110 50 35 115 100 5 mmHg 0 5 kPa Pediatric 35 150 75 40 155 145 5 mmHg 0 5 kPa Adult 35 250 75 40 255 220 5 mmHg 0 5 kPa Diastolic mmHg Neonatal 15 95 30 20 100 70 5 mmHg 0 5 kPa Pediatric 20 120 35 25 125 100 5 mmHg 0 5 kPa Adul 25 225 35 30 230 110 5 mmHg 0 5 kPa Mean Arterial Pressure mmHg Neonatal 15 100 35 20 105 80 5 mmHg 0 5 kPa Pediatric 20 130 50 25 135 110 5 mmHg 0 5 kPa Adul 25 245 50 30 250 120 5 mmHg 0 5 kPa Pulse Rate beats per minute Neonatal 35 210 100 40 215 200 5 bpm Pediatric 35 210 50 40 215 150 5 bpm Adult 35 210 50 40 215 120 5 bpm SpO Neonatal 50 98 85 51 99 95 196 Pediatric 50 98 85 51 99 196 Adult 50 98 85 51 99 1 Directions for Use Chapter 4 Alarms and Alerts 59 Nurse Call The monitor can be connected to a Nurse Call system through a customized cable that connects to the Nurse Call connector When the cable is connected and operational the monitor immediately notifies the Nurse Call system when a patient alarm occurs Nurse Call Cable Connector To connect the monitor to a Nurse Call system you must have a cable Welch
45. id any risk of bowel perforation During the measurement period the temperature window displays a walking box a box with the sides illuminated sequentially When the measurement is complete the monitor sounds a tone and displays the measurement in the temperature window The monitor displays the temperature reading for one minute Note fa probe position error occurs during the temperature determination the 6 7 8 temperature display alternates between the measured temperature and P Remove the probe Eject the probe cover by pressing the ejection button and hygienically dispose of it Return the probe to the probe well A WARNING f the probe becomes contaminated follow the instructions under Thermometer and Probe Cleaning Procedure on page 51 50 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series Monitored Temperature Measurement l Caution Do not monitor temperature continuously for more than 5 minutes Note Verify that the temperature measurement type is set to monitored The letter M to the right of the temperature display window and below F or C is illuminated 9 The procedures for monitored and predictive temperature measurements are the same with the following exceptions For monitored measurements e The monitor must be set to take a monitored temperature See Changing Temperature Type and Measurement Units on page 27 e The monitor displays
46. idance and manufacturer s declaration electromagnetic emissions The Vital Signs Monitor 300 Series monitor is intended for use in the electromagnetic environment specified below The customer or the user of the monitor should assure that it is used in such an environment Emissions test RF em CISPR RF em CISPR issions 11 issions 11 Harmonic emissions IEC 61 000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 Compliance Group 1 Class B Class A Complies Electromagnetic environment guidance The Vital Signs Monitor 300 Series monitor uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Vital Signs Monitor 300 Series monitor is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 18 Chapter 7 Reference Welch Allyn Vital Signs Monitor 300 Series Guidance and manufacturer s declaration electromagnetic immunity The Vital Signs Monitor 300 Series monitor is intended for use in the electromagnetic environment specified below The customer or the user of the monitor should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environm
47. ify SpO and pulse rate using an alternative method C7 The sensor is broken missing or incompatible Contact customer service Temperature C20 The probe is broken or missing or the probe well is missing Contact customer service The temperature probe has poor tissue contact General C13 Battery failure Use the AC power adapter E20 E50 Internal failure Contact customer service 61 9 Reviewing Patient Data You can review stored patient data either by viewing it on the monitor or by printing it Displaying Stored Patient Data 1 Press 9 to display the most recent stored set of patient vital signs data e The monitor interrupts the dynamic display of any current vital sign measurement e The message READING appears in the message window with a data set sequence number and the time of the displayed reading During a patient data review if MAP is enabled this display alternates every two seconds with the MAP display 2 Press A or W to cycle through the stored measurement data sets The monitor stores 99 measurement cycles 3 To return to normal operation press any button other than A or W If you press a function button such as 2 the monitor returns to normal operation with that function e activated Printing Patient Data Note The information in this section pertains only to monitors configured with the optional thermal printer The printer provides a way t
48. iginal delivery to the buyer one year tor remanufactured monitors the Vital Signs Monitor 300 Series is warranted to be free from functional defects in materials and workmanship and to conform in all material respects to the description of the product contained in the directions for use and other labeling of the product This warranty is valid only under the following conditions e The product is properly operated under conditions of normal use in accordance with applicable safety and regulatory reguirements e The product is configured modified adjusted and repaired only by Welch Allyn or by persons expressly authorized by Welch Allyn in accordance with Welch Allyn s service procedures and e The product has not been damaged by misuse negligence or accident For a period of 90 days unless otherwise specified this same warranty is made for any accessories provided by Welch Allyn Under the above warranties Welch Allyn s sole and exclusive obligation and buyer s sole and exclusive remedy is limited to the repair or replacement at the discretion of Welch Allyn free of charge of products found to be defective during the warranty period Warranty claims must be made not more than seven days after expiration of the warranty period by calling the customer service number shown below to obtain a returned material authorization number RMA and returning the product with the RMA documentation transportation charges prepaid to the addr
49. ime without also erasing all stored patient data To erase patient data press AY the monitor erases the data and enables the date time adjustment For information on changing the time and date settings see Changing the Time and Date on page 22 Erasing Data During Normal Operation To erase patient data during normal operation press and hold E for three seconds When the monitor prompts for confirmation press to confirm or W to cancel When the erasure is complete the monitor returns automatically to normal operation If you cancel the erasure you can then press any button other than A or W to return to normal operation 68 Chapter 5 Reviewing Patient Data Welch Allyn Vital Signs Monitor 300 Series Replacing the Printer Paper Supply Note Use only the thermal paper part number 7052 25 supplied by Welch Allyn The use of any other paper can result in poor printer performance To replace the printer paper supply follow these steps 1 Press to open the printer door 2 Insert a new roll of paper Note The paper roll must be installed as shown in the illustration below If the paper roll is not installed correctly the printer will not print 3 Thread the end of the roll over the roller and through the slot in the printer door as shown 4 With one hand pull lightly on the paper to take up any slack With the other hand close the printer door by pushing it down and into place until it click
50. inuously for more than 5 minutes Note A probe position error P indicates that the probe was moved after making tissue contact If a probe position error occurs during the temperature determination the temperature display alternates between the measured temperature and P WARNING If the probe becomes contaminated follow the instructions under A Thermometer and Probe Cleaning Procedure on page 51 Directions for Use Chapter 3 Patient Monitoring 41 Axillary Predictive When used correctly the monitor produces an accurate axillary temperature measurement in less than 15 seconds for adults and in less than 13 seconds for pediatric patients Note For axillary temperatures use only the oral probe blue ejection button and the blue probe well Use Axillary Pediatric AP measurements for patients up to 17 years old Use Axillary Adult AA measurements for patients 18 years old and older 1 Remove the temperature probe from the probe holder The temperature probe runs a self test displaying 188 8 for a few seconds When it is ready for use the temperature window clears and then OrL appears in the temperature window 2 Press A or VY to change the display to AP or AA 3 Load anew probe cover by inserting the probe into a probe cover and pressing the probe handle down firmly The probe handle moves slightly to engage the probe cover Caution Use only Welch Allyn probe covers The use of any other probe cover or A faili
51. l Signs Monitor 300 Series monitor The series includes the following models Model Features Model Features 53000 Standard NIBP Pulse Rate and MAP 53N00 Standard Nellcor SpO5 5300P Standard Printer 53NTO Standard Nellcor SpO Temperature 530T0 Standard Temperature 53NOP Standard Nellcor SpO Printer 530TP Standard Temperature Printer 53NTP Standard Nellcor SpO Temperature Printer All operators must read and understand this manual before using the monitor All technicians and other service personnel must read and understand this manual before attempting to set up configure troubleshoot or service the monitor All information in this manual including the illustrations is based on a monitor configured with the Temperature SpO and Printer options If your monitor configuration lacks any of these options then some information in this manual does not apply Intended Use The VSM series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure pulse rate body temperature noninvasive functional oxygen saturation of arteriolar hemoglobin SpO2 and body temperature in normal and axillary modes of neonatal pediatric and adult patients The most likely locations for patients to be monitored are general med surg floors general hospital and alternate care environments This device is available for sale only upon the order of a phy
52. ly Vital Signs Monitor Patient Information Patient Name Patient ID Physician Procedure Comments Patient Data The contents of the Patient Data block reflect the configuration of the monitor that is with or without the SpO option and with or without the temperature option For a single cycle all data except temperature is printed on one line the temperature data if it exists is printed on a second line If the data for a single parameter is not available nothing is printed in the space provided for that parameter The patient data is displayed in a table consisting of a table heading the current date and rows of patient vital sign data 64 Chapter 5 Reviewing Patient Data Welch Allyn Vital Signs Monitor 300 Series Table Heading The Table Heading contains some or all of the following column headings depending on monitor configuration Time Sys Dia MAP PR SpO2 or or or Date DD MMM YYYY Time The recording time is printed for each record in the form hh mm using a 24 hour clock at the beginning of the first line of the record In the illustration below the first record 21 45 contains systolic and diastolic pressure MAP pulse rate and SpO2 readings the second record 21 52 contains systolic and diastolic pressure MAP pulse rate and temperature and the third record 22 12 contains only a temperature reading When temperature is the only recorde
53. nd of the package or shipping ll crate up Protect the monitor from exposure to rain U Fragile contents handle with care 4 _ Do not subject the monitor to altitudes outside cu aen these limits 90 Do not expose the monitor to relative humidity above this limit x Limit stacking to this number of units 5 E wem o not expose the monitor to temperatures 122 F N A outside these limits 20 C min HEF Directions for Use Table 3 Symbols Connectors Chapter 1 General Information 3 Temperature Probe Cable Connector Sp02 Sp0 Sensor Cable Connector E RS232 Cable Connector oeo AC Power Adapter Cable Connector 8V 740mA Nurse Call Cable Connector LN 07 NIBP Hose Connector Table 4 Symbols Printer Door Press to open the printer door lt A Load paper this direction The functions of the monitor front panel controls illustrated here are described in detail elsewhere in this document Table 5 Front Panel Controls aD Set alarm limits Power on off Silence alarms Print patient data Scroll up down Scroll forward back Increase decrease value The scroll icon appears as these two arrows in the documentation OK Review patient data Set an NIBP automatic measurement interval Start stop an NIBP cycle AUTO button e A Y Cycle to the next menu selections Chapter 1 General Informa
54. ng to use a probe cover can produce measurement errors or inaccuracies Note Be sure that nothing touches the probe tip before you place it in the axillary measurement site 4 Lift the patient s arm to fully expose the axilla Note Do not allow the probe tip to make contact with the patient until the probe is placed in the measurement site Any such contact can cause an inaccurate reading 48 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series 5 Place the probe tip as high as possible in the axilla and then bring the patient s arm down to make maximum contact with the probe tip Hold the patient s arm in this position keeping the patient as still as possible for the duration of the measurement Note Be sure that the probe tip is fully covered by the axilla and the arm and that it is not touching any clothing Do not attempt to take an axillary temperature reading through the patient s clothing During the measurement period the temperature window displays a walking box a box with the sides illuminated sequentially When the temperature prediction is complete the monitor briefly sounds a tone and displays the temperature reading which remains on the display for one minute 6 Remove the probe from the patient s axilla 7 Eject the probe cover by pressing the ejection button hygienically dispose of the probe cover 8 Return the probe to the probe well If the monitor cannot make a predicted measur
55. o Le b a iei du AS re Ei EE od 62 PrinterzQutp t 24 Las Seve p LP Hb e AUR Melee 63 Erasing Patient Data ne Vu me tte Pho we E RR RARE Y eas 67 Erasing Data Before Changing the Date and TiM e 67 Erasing Data During Normal Operation YY ooo 67 Replacing the Printer Paper Supply FF a 68 6 Operator Maintenances sa WR YRU RR OU DR 69 SC E a ARAN NF 69 SIO ddec ae ETE CMT 69 Recycling Monitor ComponentsS L L FI I LI FY uad 70 A E AN 70 Outside the Etc iaa A A EOE OR E oT TA WY IRE 70 Ts Reference td a ases a a A de lo 71 Battery Operations ee Di dd a ea a ea 71 Battery bow Warning a 2s casada puta il pA dub Dd Gyd ii 71 Battery Fallute aio rtp t melee de ae WIOL rc RR amp 71 Battery Replacement x sss RI E REDE Le E AL BER 72 Directions for Use Contents V Monitor Specification Ss x scs roce Ai Mae RG a ble RH E Onda 73 PE ITORMAN COs oc se bm rave a acer E et e eli eee 73 Physical evo eat Foros ados eo A Ebro ado Ns Che esu Ar Pra 75 Electrical ou 2 54 288 ad he Gy y Dd dd Fyd rd ius PEE 76 Environmental s 2 mm cete dert ub eu GWD 77 Nurse Gall iaa ttg aie redeo Saec e E e S eed e ee 81 Factory Default S ttigSs z ns eO Y A A A AYR 82 Limited Warranty uas aca ti peo x A acean lat Se s eee 83 vi Contents Welch Allyn Vital Signs Monitor 300 Series El General Information About This Manual This manual contains information about the Welch Allyn Vita
56. o pull the cable connector out of the connector port For information on SpO5 measurements see Patient Monitoring on page 31 Directions for Use Chapter 2 Setup 17 Power On Power on Self Test and Power Off When the battery is charged press to turn on the monitor The monitor runs a diagnostic self test each time it powers up e Ifall tested functions are working normally the various windows briefly display start up values 8 and and a short tone sounds twice 99 min e fthe self test fails an error code appears in the SYS window When the self test is complete the software version appears briefly in the message window followed by the current time of day Caution Always observe the monitor during powerup If any display fails to A illuminate properly or if an error code appears in the systolic window inform your biomedical engineering department immediately or call your nearest Welch Allyn Customer Service or Technical Support facility Do not use the monitor until the problem is corrected To shut off the monitor press Note Shutting off the monitor erases all stored patient data but does not erase settings or configuration parameters 18 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series Configuring Operating Parameters You can change several monitor operating parameters When changed these settings become the default powerup settings How to Use the Menu System
57. o so will result in poor battery performance and reduced battery life e While the monitor is charging the AC charging indicator flashes e When the monitor is 90 charged the AC charging indicator is steady To fully charge the battery leave the AC power adapter connected for a few more hours e After the monitor is fully charged for the first time the monitor can be powered by the AC power adapter or by the internal battery Directions for Use Chapter 2 Setup 13 Connecting the NIBP Cuff Hose Attach the hose to the monitor and the cuff as follows referring to the illustration below 1 Screw the hose connector onto the NIBP connector on the monitor 2 Connect the monitor hose connector to the mating connector on the cuff Threaded NIBP Hose Connector For information on NIBP measurements see Patient Monitoring on page 31 14 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series Connecting the Temperature Probe Cable Follow these steps to connect the temperature probe cable to the monitor 1 Locate the temperature probe connector port Don the back of the monitor 2 Holding the temperature probe cable connector with the spring tab on the right carefully insert it into the monitor temperature probe connector port The spring tab clicks out when the connector halves are fully and correctly mated 3 To disconnect the temperature probe cable depress the spring tab and withdraw the cable connec
58. o view and save patient vital signs data It can be configured to print all stored data as a single batch or to print a continuing stream of data as the data is recorded in memory See Selecting Stream or Batch Printing on page 29 62 Chapter 5 Reviewing Patient Data Welch Allyn Vital Signs Monitor 300 Series To Start and Stop Printing e f the monitor is not printing press to start printing e If the monitor is printing press amp to stop printing If the monitor is set to Stream printing the printer prints a footer before stopping Note The print button is not enabled during an NIBP cycle or during a nonrecoverable eguipment alert Batch Printing After a patient has been continuously monitored over some period a clinician can use the monitor s batch printing capability to print all of the measurements that were stored in the monitor s memory over the monitoring period When the monitor is configured for batch printing and while it is in normal operating mode press amp to print all readings stored in memory up to 99 cycles starting with the oldest measurement cycle and working forward The message PRINTING is displayed during the batch print and all monitor controls other than S and are disabled Batch printing continues until one of the following occurs e All stored data has been printed is pressed again e _ A battery failure condition e Anonrecoverable error condition is detected In any o
59. of equipment marked with the following symbol H Note 1 Note 2 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 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 theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Vital Signs Monitor 300 Series monitor is used exceeds the applicable RF compliance level above the Vital Signs Monitor 300 Series monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Vital Signs Monitor 300 Series monitor Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 80 Chapter 7 Reference Welch Allyn Vital Signs Monitor 300 Series Recommended separation distances between portable and mobile RF communications equipment and the Vital Signs Monitor 300 Series monitor The Vital Signs Monitor 300 Series monitor is intended for use in an electromagnetic environment in which radiated RF dis
60. othing for 10 seconds or press any button other than A or W If you press a function button such as the monitor returns to normal operation with that function activated Note Target pressure is a nominal starting point If it is too low to take a measurement the monitor takes another measurement using a higher initial pressure Selecting a Cuff You can tell whether the cuff size is appropriate by putting the cuff on the patient and then inspecting the fit If the edge marking lies somewhere between the two range markings then the fit is correct You can also find the correct cuff by measuring the circumference of the patient s arm at the biceps Cuff Size Circumference Circumference Cuff Size Circumference Circumference inches centimeters inches centimeters Neonate 1 1 3 2 2 3 3 5 6 Small Child 4 9 6 6 12 4 16 8 Neonate 2 1 6 2 8 42 741 Child 6 2 8 4 15 8 21 3 Neonate 3 2 1 3 6 5 4 9 1 Small Adult 7 9 10 6 20 0 27 0 Neonate 4 24 46 69 117 Adult 10 0 13 5 25 3 34 4 Neonate 5 35 59 8 9 15 0 Large Adult 12 6 17 1 32 1 43 4 Infant 3 9 5 2 9 8 13 3 Thigh 16 0 21 7 40 7 55 0 Directions for Use Positioning the Cuff Chapter3 Patient Monitoring 3 For the most accurate measurement do the following 1 Position the cuff on the bare arm midway between the shoulder and the elbow Typical cuff positions are shown in this illustration Neonatal Ad
61. perature Calibration 0 2 F 0 1 C meets or exceeds ASTME1112 00 EN12470 3 2000 Accuracy Temperature predictive oral 4 seconds Determination Time typical axillary 10 seconds rectal 15 seconds Sp0 Pulse Rate Range 20 to 250 bpm Pulse Rate Accuracy 3 bpm 3 digits Low perfusion Sp0 Accuracy 70 100 2 digits Adult and pediatric 70 100 3 digits Neonate Pulse Oximetry SpO 1 to 100 Saturation Range Note SpO specifications are published by the SpO5 component manufacturer and tested by Welch Allyn using the BIO TEK Index 2 SpO simulator Directions for Use Physical Characteristic Specification Dimensions height width depth Weight Color Temperature Probe Oral Axillary Rectal 6 6 inches 16 8 cm 10 0 inches 25 4 cm 6 0 inches 15 2 cm Approximately 5 4 Ibs 2 4 kg Blue Red Chapter 7 Reference 15 Characteristic Specification Support Self supporti Mountable with available accessories to the following IV po Mobi Wall ng on rubber feet e e stand Portability Recessed ca ry handle Mounted on a pole or mobile stand can be rolled from patient to patient 16 Chapter 7 Reference Welch Allyn Vital Signs Monitor 300 Series Electrical Power Requirements The medical rated isolation AC power adapter connected to the AC supply must supply 8 volts DC and 0 74 amperes Battery The monitor uses a supplied seale
62. re blanked An error signal 2 short tones sounds once 72 Chapter7 Reference Welch Allyn Vital Signs Monitor 300 Series Battery failure causes the immediate suspension of all monitoring and print functions If the wall charger is not plugged in then the monitor shuts off 15 minutes after the battery discharge reaches failure level If automatic NIBP is selected and if the wall charger is plugged in before the monitor shuts down then automatic measurement cycles resume as soon as the battery voltage rises above the failure threshold Battery Replacement When the battery has reached end of life replace it with an identical battery from Welch Allyn reorder number 501 0015 XX Caution Always recycle batteries according to local regulations Never dispose A of batteries in waste receptacles Directions for Use Monitor Specifications Chapter 7 Reference 13 The monitor is an FDA Class ll non critical device and according to Council Directive 93 42 EEG Annex IX a Class IIB device Performance Characteristic Specification General Recovery from Defibrillation Per IEC 60606 2 30 1999 E The monitor returns to normal function within 1 minute after Discharge the discharge of a cardiac defibrillator Actual recovery time 0 seconds NIBP Cuff Pressure Range O to 300 mmHg 0 to 40 kPa 160 mmHg 21 3 kPa 120 mmHg 16 kPa Initial Cuff Inflation Adult Factory Default Pediatric Neonate
63. repeatedly flashes the MAP numerics in the message display Flashing display of the violating value for one minute or until power is shut off Continuous display of the error code in the appropriate window Continuous display of the error code in the appropriate window Flashing display of the last SpO and Pulse Rate followed in some cases by a Patient Alarm tone Setting Alarms During patient monitoring an alarm occurs when a measurement falls outside the programmed alarm limit Alarms can be set or turned off for the following vital signs e Systolic high and systolic low e Diastolic high and diastolic low e Pulse rate high and pulse rate low e SpO high and SpO low e MAP high and MAP low Directions for Use Chapter 4 Alarms and Alerts 57 Note For patient safety all alarms are reset to the factory default levels whenever the patient type is changed This means that you must either accept the default alarm limits or set new limits every time you change patient type ag 2 or Q The high alarm for any vital sign is always higher than the low alarm for the same vital sign For example the alarm limit for systolic high is always higher than the alarm limit for systolic low A reading that exactly reaches the alarm threshold without crossing the alarm threshold does not qualify as an alarm condition Set alarms for systolic and diastolic blood pressure pulse rate and SpO as follows 1 Press
64. s Note Be certain that the paper does not catch in the printer door 69 Operator Maintenance This chapter describes the operator maintenance procedures Cleaning Wipe the monitor with a cloth slightly dampened with warm water and a mild detergent or appropriately diluted nonstaining disinfectant solution Caution Never wet the monitor or immerse it in fluid of any kind Never allow AN water to enter any connector ports Caution Never immerse any monitor components such as the NIBP hose or cuff the temperature probe or the SpO sensor Wipe the NIBP hose and any reusable cuffs with a damp cloth moistened in a mild detergent solution Wipe the temperature probe with a cloth dampened with alcohol warm water or an appropriately diluted nonstaining disinfectant solution Clean the SpO sensor with a cloth dampened with 70 alcohol or bleach diluted to one part in ten Storage For maximum monitor life and optimum performance store the monitor at room temperature in a dry environment For prolonged storage keep the monitor in the original container or in some other dust proof container Before storing the monitor verify that the printer contains paper 70 Chapter 6 Operator Maintenance Welch Allyn Vital Signs Monitor 300 Series Recycling Monitor Components Within the EU Do not dispose of this product as unsorted municipal waste Prepare it for reuse or separate collection as specified by Directive 2002
65. se Call on page 81 11 Setup This chapter describes the set up procedures for patient monitoring Connections Use the procedures described below to connect components to the monitor Connecting AC Power The monitor operates on DC power supplied by either the internal battery or the AC power adapter For information on the battery refer to Battery Operation on page 71 and Electrical on page 76 When the AC power adapter is connected it simultaneously powers the monitor and charges the internal battery When the AC power adapter is not connected the monitor operates on the internal battery Caution Use only the medical grade AC power adapter approved by Welch Allyn A Refer to the Welch Allyn Parts and Accessories Guide 810 0409 XX for ordering information Using an unqualified power adapter can have the following results e violation of isolation requirements e hazard to the patient e damage to the monitor e nullification of the product warranty 12 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series To use the AC power adapter 1 Plug the power adapter into the AC power source 2 Plug the power adapter connector into the monitor DC port AC Power Adapter Port Use the AC power adapter to fully charge the battery before using the monitor This can take up to 12 hours Caution Fully charge the battery before using the monitor for the first time A Failure to d
66. sician or licensed health care professional 2 Chapter 1 General Information Symbols Welch Allyn Vital Signs Monitor 300 Series The symbols illustrated on the following pages appear on the monitor or in this document Table 1 Symbols Certification and Operation the Canadian Standards Association International to comply with applicable U S and Canadian medical safety standards This device has been tested and certified by c Us Urgent alarm notification output to Nurse Call A system CE oua The CE Mark and Notified Body Registration Number signify that the device meets all essential requirements of the European Medical Device Directive 93 42 EEC Ao Recycle used batteries properly and in accordance with local regulations Do not dispose of batteries in refuse containers 5 28 46 SOUTH STREET wan Australian Registered Importer 5 Sealed lead acid battery 6V 4 Ah Pb 4 Recycle the monitor and battery separately from other disposables See Recycling Monitor Components on page 70 A Patient connections are Type BF and protected against defibrillation A WARNING Indicates conditions that could lead to illness injury or death Caution In this manual indicates conditions that could damage equipment or other property Caution On the product means Consult accompanying documentation Table 2 Symbols Shipping Storing and Environment t1 Keep this e
67. t probe cover to skin contact Do not take an axillary temperature through the patient s clothing WARNING Use extreme caution when taking rectal temperatures on children Insert the probe tip only 3 8 inch 1 cm to avoid risk of bowel perforation WARNING The thermometer case is not waterproof Do not immerse it in fluids or drip fluids onto it WARNING The thermometer consists of high quality precision parts Protect it from severe impact or shock Do not use the thermometer if you notice any signs of damage to the probe or the instrument If the thermometer probe is dropped or damaged remove it from service and have it inspected by a qualified service person WARNING Do not use the thermometer for any purpose other than those described in this document Doing so will invalidate the product warranty Directions for Use Chapter 3 Patient Monitoring 43 Setting the Temperature Measurement Type The monitor if configured with the temperature option can provide both predictive and monitored temperature measurements A predictive measurement is a one time measurement that takes only a few seconds It results in a single temperature reading which is displayed at the end of the brief measurement period The monitor sounds three short tones to indicate the end of a predictive measurement A monitored measurement s a continuous temperature monitoring used when the situation prevents accurate predictive measurement For oral and rectal me
68. the temperature continuously e The measurement continues until the probe is replaced in the probe holder Directions for Use Chapter 3 Patient Monitoring 51 Thermometer and Probe Cleaning Procedure 1 Wipe the thermometer regularly with a cloth dampened with warm water and a mild detergent solution Occasionally clean the thermometer and probe as necessary with either a 70 isopropyl alcohol or a 10 solution of chlorine bleach Caution Do not immerse or soak the thermometer or probe in any type of fluid Caution Do not use steam heat or gas sterilization on the thermometer or probe Caution Do not autoclave the thermometer or probe Removable Probe Well Cleaning Procedure 1 Remove the probe from the probe well remove the probe well from the monitor and unplug the thermometer cable connector from the monitor Clean the inner and outer surfaces of the probe well by swabbing with a cloth dampened with 7096 isopropyl alcohol or a 1096 solution of chlorine bleach The probe well can be immersed during cleaning Caution Do not use hard sharp or abrasive objects to clean the probe well M 2 7 BR o Caution Do not use steam heat or gas sterilization on the probe well Caution Do not autoclave the probe well Thoroughly dry all surfaces Reassemble the thermometer components Reconnect the thermometer cable to the monitor making sure it clicks into place Reinstall the probe well into the monitor
69. tion Welch Allyn Vital Signs Monitor 300 Series Table 6 Front Panel Displays and Indicators SYS Systolic pressure Temperature DIA Diastolic pressure Sp02 Arterial hemoglobin oxygen saturation Q min Pulse rate pulse Pulse strength amplitude indicator message MAP mean arterial pressure nad Neonatal window ec Degrees Celsius 2 Pediatric Degrees Fahrenheit Adult oF 2 M Monitored temperature Re AC power Battery charging flashing Battery charged steady CA Battery discharged Product Overview The monitor can monitor systolic and diastolic noninvasive blood pressure NIBP pulse rate and MAP mean arterial pressure Units configured with the appropriate options can also simultaneously monitor temperature and SpO and can continuously monitor pulse rate All vital sign measurements are displayed on the front panel of the monitor These measurements can also be printed using the optional integrated thermal printer The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals It can also be configured to provide an alarm activated Nurse Call function Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards IEC 60950 for data processing equipment IEC 60601 1 for medical equipment All such configurations must comply with system standard IEC 60601 1 1 Caution Anyone connecting ad
70. tor Temperature Probe Connector Port Temperature Probe Cable Connector For information on temperature measurements see Patient Monitoring on page 31 Directions for Use Chapter 2 Setup 15 Connecting and Disconnecting the SpO5 Sensor Cable To connect the SpO2 sensor cable 1 Locate the SpO sensor cable connector labeled SpO2 on the side of the monitor 2 Note the hole patterns of the connector halves and align the cable connector accordingly Note Verify that the sensor cable connector has slots on both sides If the cable connector has a slot on only one side then the sensor is not compatible with the monitor The SpO connectors are notched and flanged to ensure proper fit If the connectors do not join easily stop and verify the following e You have the correct SpO sensor e The cable connector is aligned correctly 3 Carefully insert the SpO cable connector into the SpOs monitor connector If you are using a sensor extension cable plug the sensor into the extension cable and plug the extension cable into the monitor 16 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series To disconnect the SpO cable refer to the instructions shown in the illustration below Note Always grasp the cable by the connector shoulder Do not pull on the cable itself Thumb presses the upper tab to free the connector Thumb and forefinger grasp the shoulder of the connector cable t
71. turbances are controlled The customer or the user of the Vital Signs Monitor 300 Series monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Vital Signs Monitor 300 Series monitor as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output meters power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 12 JP d 12 JP d 23 JP 0 01 0 12 012 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 23 10 3 8 3 8 73 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts w according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Other Environmental Specifications Characteristic Specification Operating Temperature Sp02 NIBP pulse rate and 10 C to 40 C temperature measurement 50 9F to 104 9F Operating altitude 170 m to
72. ult and Pediatric 2 Position the alignment mark on the cuff directly over the brachial artery Note Be sure that the cuff is neither too tight nor too loose When putting it on the patient wrap it so that you can comfortably fit two fingers between the cuff and the arm Be sure that the air hose has no kinks or twists During an NIBP measurement limit the movement of the cuff and the cuffed extremity If the cuff is not level with the heart add 1 8 mmHg to the displayed reading for each inch of elevation above the heart or subtract 1 8 mmHg from the displayed reading for each inch of elevation below the heart Always use the appropriate cuff size for each patient 34 Chapter 3 Patient Monitoring Welch Allyn Vital Signs Monitor 300 Series Manual NIBP Measurement Follow these steps to take a single NIBP measurement 1 Attach the cuff to the patient s arm 2 Press amp Note The monitor inflates the cuff The SYS window dynamically displays the current cuff pressure If the message CAL appears in the message window when you attempt to start an NIBP cycle it means that the NIBP measurement system is self calibrating to a zero baseline and is temporarily unavailable for up to 30 seconds The reguested NIBP cycle begins when the calibration is complete However the cuff must remain stationary for at least 15 seconds for the calibration to complete When the NIBP cycle is completed a tone sounds and the
73. ura or neuropathy WARNING To avoid the risk of intravenous line misconnection and possible introduction of air into a patient s blood do not fit the NIBP system with Luer Lock adapters WARNING Do not place the cuff on an extremity already being used for intravenous infusions or SpO monitoring WARNING Do not place the cuff where it can affect proper circulation WARNING NIBP measurements may be inaccurate in the presence of excessive motion artifact Caution Pulse rate measurements generated through the blood pressure cuff or through SpO2 are subject to artifact and might not be as accurate as heart rate measurements generated through ECG or through manual palpation 32 Chapter 3 Patient Monitoring NIBP Preparation Welch Allyn Vital Signs Monitor 300 Series Before you start any NIBP measurement always follow the steps described in these procedures e Changing the Target Pressure on page 32 e Selecting a Cuff on page 32 e Positioning the Cuff on page 33 Changing the Target Pressure Follow these steps to change the target pressure default initial pressure for cuff inflation for the current patient type 1 Press until the message window displays TARGET PRESSURE The SYS window displays the current setting for initial inflation pressure 2 Press A or Y to raise or lower the preset pressure value to the target level To set the displayed pressure level and return to normal operation either do n
74. uration Menu The configuration menu is accessed by pressing 8 and keeping it depressed for three seconds You then press 2 repeatedly until you reach the setting of interest Configuration Menu Set Time and Date Press and hold for 3 seconds MAP Enable Disable Power Off all values saved O NIBP Units mmHg kPa Press and hold for 3 seconds No action for 10 seconds Press any button other than 8 AV Directions for Use Use the configuration menu to select and set the following parameters Chapter 2 Setup Time and Date MAP Measurement Blood Pressure Measurement Units Print Mode hour minute year month day Enabled Disabled mmHg millimeters of mercury kPa kilopascals Batch Stream To change a configuration parameter 1 Select the parameter as indicated above 2 Change the value by pressing A or W 21 3 Setthe displayed new value either by doing nothing for 10 seconds or by pressing any button other than A or W If you press a function button such as returns to normal operation with that function activated the monitor 22 Chapter 2 Setup Welch Allyn Vital Signs Monitor 300 Series Changing the Time and Date Follow these steps to change the time and date settings of the monitor internal clock 1 2 3 4 5 6 7 8 9 Press and hold 2 for 3 seconds SET HOUR XX appears in the message window Press A or W as nee

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