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Spot Vital Signs LXi

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1. Blood Pressure Menu Options for available settings Changes the temperature options See Table 5 Temperature Menu Options for available settings Changes the Display Contrast options Use the left right navigation buttons to adjust Changes the manual parameters defaults See Table 6 Manual Parameters Menu Options for available settings Enables or disables available external devices See Table 7 External Devices Menu Options for available settings Saves the current patient reading at a preselected time interval or upon reguest See Table 8 Save Readings Menu Options for available settings Secures Spot LXi so unauthorized people cannot use the device or access data without enacting the proper key seguence Allows the user to select the default settings for the device and reset the unit to the default settings See Table 9 Change Local Defaults Options for available settings Displays the recent button presses errors measurements measurement sites battery state changes and patient reading send events Displayed information only operator cannot change Table 3 Date Time Menu Options Setting Description Date Format Date Time Format Time Displays the date in one of the following styles e mm dd yyyy example July 16 2005 07 16 2005 e dd mm yyyy example 16 July 2005 16 07 2005 Changes the date on the Display Window and in patient readings If a locati
2. Caution The position and physiologic condition of the subject can affect a blood pressure reading Temperature Cautions These cautions pertain to the Spot LXi temperature feature Sp0 Cautions Caution The Surelemp Plus feature only operates with the probe well in place Caution Do not use alkaline batteries in the Braun ThermoScan PRO 4000 Caution Biting the probe tip may result in damage to the probe These cautions pertain to the Spot LXi SpOs feature N Caution The pulse oximeter is calibrated to determine the percentage of arterial oxygen saturation of functional hemoglobin Significant levels of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin may affect the accuracy of the measurement Caution Some sensors may not be appropriate for a particular patient If at least 10 seconds of perfusion pulses cannot be observed for a given sensor change sensor location or sensor type for perfusion to resume Caution Physiological conditions medical procedures or external agents that may interfere with the pulse oximeter s ability to detect and display measurements include dysfunctional hemoglobin arterial dyes low perfusion dark pigment and externally applied coloring agents such as nail polish dye or pigmented cream Caution When selecting a sensor consider the patient s weight and activity level the adequacy of perfusion the available sensor sites the need for sterility and the anticipated duratio
3. Reading Full Action Manual or automatic If automatic Spot LXi saves readings at a preselected time interval For either option Spot LXi automatically saves the measured parameters into memory before automatically powering off when not used for 30 minutes Changes the amount of time before automatically saving the current patient reading Only available if Automatic Save Mode is enabled Auto Overwrite Ask Overwrite Do not Overwrite Spot LXi can save 50 patient readings in memory Upon reaching reading 51 the device may automatically overwrite reading 1 ask the user if he she wants to overwrite reading 1 or disable the ability to take another reading until at least one reading is erased Table 9 Change Local Defaults Options Setting Description Language English Dansk Nederlands Suomi Fran ais Deutsch Italiano Norsk Espa ol Portugu s Svenska or Chinese BP Units mmHg or kPa Temperature Units Height Units Weight Units Date Format Time Format Fahrenheit F or Celsius C Inches in or centimeters cm Pounds Ib or kilograms kg Displays the date in one of the following styles e mm dd yyyy example July 16 2005 07 16 2005 e dd mm yyyy example 16 July 2005 16 07 2005 Displays the time in one of the following styles e 12 hour example 5 00 PM e 24 hour example 17 00 35 Blood Pressure Operation Blood Pressure Cuff Selection Careful si
4. 11 power supply network that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Electromagnetic Immunity The Spot Vital Signs LXi is intended for use in the electromagnetic environment specified below The customer or user of the Spot Vital Signs LXi should assure that it is used in such an environment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 IEC 60601 Test Level 6 kV contact 8 kV air 2 KV for power supply lines Compliance Level 6 KV contact 8 kV air 2 KV for power supply lines Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096 Mains power guality should be that of a typical commercial or hospital environment 1 KV for input output 1 kV for input output lines lines Surge 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 5 2 KV common mode 2 KV common mode Directions for Use Specifications 61 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 gt 95 dip in 0 5 cycle 60 dip in 5 cycles 30 dip for 25
5. 9 to 107 69 F 35 5 to 42 C 20 5 F 20 25 C outside this temperature range 0 1 For C Approx 4 to 6 seconds Approx 12 to 15 seconds age 18 years and older Approx 10 to 13 seconds age 17 years and younger Approx 10 to 13 seconds Directions for Use Specifications 57 Sp0 Specifications Masimo Sensor Accuracy Guide Accuracy specified when used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules using PC series patient cables during no motion Numbers present 1 standard deviation Plus or minus one standard deviation represents 68 of the population SpO accuracy from 70 to 100 Pulse rate accuracy from 25 to 240 bpm Performance Measurement Range Sp 1 to 100 Pulse Rate 25 240 beats per minute BPM Perfusion 0 02 to 20 Accuracy Saturation 70 to 100 No Motion Adults Pediatrics 2 digits Neonates 3 digits Motion Adults Pediatrics 3 digi Neonates 3 digi nn Low Perfusion Adults Pediatrics 2 digits Neonates 3 digits Pulse Rate Accuracy Pulse Rate 25 to 250 bpm No Motion Adults Pediatrics Neonates 3 digits Motion Adults Pediatrics Neonates 5 digi n a Low Perfusion Adults Pediatrics Neonates z 5 digi Table 25 Masimo Sensor Accuracy Guide Saturation Accuracy Pulse Rate Accuracy Sensor Weight Range NoMotion Motion NoMotion Motion LNOP ADT gt 30 kg 2 3 3 bpm 5 bpm LNO
6. P 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 5 Note 1 At 80 MHz and 800 MHz 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 8 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 Spot Vital Signs LXi is used exceeds the applicable RF compliance level above the electrocardiograph should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the electrocardiograph Over the frequency range 150 kHz to 80 MHz field strengths should be
7. PC or any similar device WARNING Before using carefully read the sensor Directions for Use including all warnings cautions and instructions WARNING _Do not use a damaged sensor or pulse oximetry cable or a sensor with exposed optical components WARNING Incorrect application or a long duration of use of an SpO sensor may cause tissue damage Inspect the sensor site periodically as directed in the sensor s Directions for Use WARNING Certain ambient environmental conditions sensor application errors and certain patient conditions may affect SpO readings and pulse signal WARNING _Do not immerse the sensor or patient cables in water solvents or cleaning solutions the sensors and connections are not waterproof Do not use irradiation steam or ethylene oxide for sterilization WARNING The SpO in the Spot LXi device is not intended for use as an apnea monitor WARNING Consider the SpO an early warning device As a trend toward patient deoxygenation is indicated use laboratory instruments to analyze blood samples to completely understand the patient s condition Directions for Use A Introduction 9 WARNING _Tissue damage can be caused by incorrect application or duration of use of a Nellcor OxiMax sensor Inspect the sensor site as directed in the sensor Directions for Use WARNING Do not use the sensors during magnetic resonance imaging MRI scanning Induced current could potentially cause burns The MS board
8. Respiration Send Next Readin Probe cover storage area storage space for one box of probe covers Navigation button move throughout the options in the Navigation Window or to increase decrease parameter units SAN S1940 OGOIg Select button accepts the current option Power button controls power to the device Memory button recalls up to 50 most Blood Pressure Start Stop button recent readings Charging LED indicates initiates a new blood pressure cycle when device is plugged in and Pressing again aborts an active blood charging the battery pressure measurement 2 Controls Display Window and Connections Welch Allyn Spot Vital Signs LXi Figure 2 Spot LXi Front Panel with Braun ThermoScan PRO 4000 Thermometer Braun ThermoScan PRO 4000 thermometer store the probe covers toward the back of the thermometer housing remove the thermometer to access the covers SpO2 100 Pdient ID O1 23456789 gt Weight Heigh Respiration PULSE min lear Send Next Reading Navigation button move throughout the options in the Navigation Window or to increase decrease parameter units Power button controls power to the device Charging LED indicates when device is plugged in and charging the battery Spot Vital Enter Signs L Xi Charging LED indicates the thermometer battery is charging Select button accepts the current Memor
9. These warnings are specific to the SureTemp Plus thermometer option WARNING Use only Welch Allyn probe covers Using other manufacturers probe covers or no probe cover may produce temperature measurement errors and or inaccuracy WARNING _Always use a probe cover whenever coming into contact with a patient WARNING Long term continuous monitoring beyond three to five minutes is not recommended in any mode WARNING _ Oral axillary probes blue ejection button at top of probe and blue removable probe wells are used for taking oral and axillary temperatures only Rectal probes red ejection button and red removable probe wells are used for taking rectal temperatures only Use of the probe at the wrong site will result in temperature errors Use of the incorrect removable probe well could result in patient cross contamination WARNING _The thermometer connectors and probe are not waterproof Do not immerse or drip fluids on these items Should this occur dry the connectors and probe with warm air Check all functions for proper operation and accuracy WARNING Do not take an axillary temperature through patient s clothing Direct probe cover to skin contact is reguired WARNING Do not autoclave WARNING Use Welch Allyn single use disposable probe covers to limit patient cross contamination WARNING Incorrect insertion of probe can cause bowel perforation WARNING Washing hands greatly reduces the risk of cross contamination an
10. a 70 isopropyl alcohol solution or a 10 chlorine bleach solution Removable Probe Well Caution DO NOT use hard or sharp objects to clean the probe well This could damage the probe well and cause the device to not function properly Caution DO NOT use steam heat or gas sterilization on the probe well Caution DO NOT autoclave the probe well 1 Remove the temperature probe from Spot LXi see Temperature Probe on page 63 2 Grasp the well under the probe opening and pull up gently to remove it from the device 3 Swab the inner and outer surface of the probe well with a cloth dampened with a mild detergent solution 70 isopropyl alcohol or 10 chlorine bleach solution Immerse the probe well in mild detergent solution as necessary for cleaning 4 Dry all surfaces thoroughly before re assembling the device see SureTemp Plus on page 27 for reassembly instructions Braun ThermoScan PRO 4000 Thermometer Use a soft cloth slightly moistened with alcohol to clean the thermometer display and exterior Do not use abrasive cleaners Damage to the probe window or the presence of dirt or cerumen on the probe window can affect the accuracy of your temperature measurement To clean the window gently wipe it with a cotton swab slightly moistened with alcohol and immediately wipe dry with a clean cotton swab Allow to dry at least five minutes before taking a temperature Every month clean the Braun ThermoScan PRO 4000
11. brassards et ou les tubulures de Welch Allyn Utiliser les brassards et ou les tubulures d autres fabricants risque de provoquer des mesures inexactes de la pression art rielle MISE EN GARDE Si plusieurs mesures de pression art rielle sont prises sur le m me patient inspectez r guli rement le site du brassard et les extr mit s pour v rifier l absence de d isch mie de purpura et ou de neuropathie MISE EN GARDE Ne laissez pas un brassard sur le bras du patient pendant plus de 10 minutes s il est gonfl plus de 10 mm Hg Ceci pourrait faire mal au patient troubler la circulation sanguine et entra ner une l sion des nerfs p riph riques MISE EN GARDE Ne placez pas le brassard sur un membre servant une perfusion intraveineuse ou une zone dont la circulation est ou pourrait tre compromise MISE EN GARDE Un brassard trop serr risque d entra ner une congestion veineuse et la d coloration du membre MISE EN GARDE Ne pas serrer suffisamment le brassard ce qui emp che de le gonfler correctement risque de provoquer des erreurs MISE EN GARDE Ne pas changer le s connexion s de la tubulure du brassard de ce dispositif avec des connexions de type luer Ces derni res s utilisent g n ralement dans le cas d intraveineuses l utilisation de connexions de type luer sur les tubulures du brassard pr sente le risgue de voir la tubulure du brassard connect e par erreur au syst me d intraveineuse du patient ce gui peut entra
12. charging contacts within the Spot LXi housing with a swab slightly dampened with alcohol Sp0 Sensors Printer WARNING Do not immerse the sensor in water solvents or cleaning solutions the sensors and connections are not waterproof Do not use irradiation steam or ethylene oxide for sterilization Clean the reusable SpO sensor with a 70 isopropyl alcohol solution Do not immerse the sensor The printer label kit comes with a two step head cleaner Follow the directions provided with the cleaner Directions for Use Maintenance and Service 65 Battery Replacement Spot Vital Signs LXi A Caution Only use the Welch Allyn 4500 84 lead acid battery Using an incorrect battery will cause damage to the Spot LXi and void the warranty Caution Do not break the shrinkwrap around the battery If necessary replace the internal battery after heavy use or the battery no longer charges 1 Power off the Spot LXi and disconnect the AC power transformer cord 2 Remove the four screws holding the battery door using a phillips head screwdriver Remove the battery door to expose the battery 3 Tip the Spot LXi backward and slide the battery out Disconnect the one way connector and then attach a new battery to the connector as shown The one way connector ends only connect one way Do this as quickly as possibly to prevent loss of clock time Figure 10 Battery Removal and One way Connector One way connector 4 Slide
13. cycles gt 95 dip in 5 seconds gt 9590 dip in 0 5 cycle 60 dip in 5 cycles 30 dip for 25 cycles gt 95 dip in 5 seconds Mains power guality should be that of a typical commercial or hospital environment If t reguires continued opera he user of the Spot Vital Signs LXi ion during power mains interruptions it is recommended that the Spot Vital Signs LXi be powered from an unin erruptible power supply or battery Power freguency 3 Mm 3 Mm Power freguency magneti c fields should be at levels 50 60Hz magnetic field characteristic of a typical location in a typical commercial or hospital environment IEC 61000 4 8 Electromagnetic Immunity The Spot Vital Signs LXi is intended for use in the electromagnetic environment specified below The customer or user of the Spot Vital Signs LXi should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Environment Guidance Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Spot Vital Signs LXi including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 17 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 17 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 33
14. do not overtighten Table 19 Cuff Pops Off Possible Cause Corrective Action Inappropriate cuff size See Blood Pressure Cuff Selection on page 35 If cuff continues to pop off notify biomedical department or Welch Allyn Technical Support Cuff not applied securely Smooth hook and loop securely before inflating cuff Cuff applied inside out Table 20 Cuff Deflating Too Slowly Possible Cause Patient movement Re apply cuff Verify that the Welch Allyn label is facing away from arm Corrective Action and Explanation Have patient sit still Do not have arm tight against chest wall as respiration may affect speed and accuracy of blood pressure measurement Arrhythmia Check for regularity of heart rate palpate pulse or check device e Moderate to severe heart rate irregularities may make blood pressure difficult to measure accurately Small leak in pneumatic system Check cuff tubing and pressure hose for leaks Table 21 Temperature Malfunction Possible Cause Corrective Action and Explanation Error code displayed Probe is broken replace it Consult Service Manual Notify biomedical department or Welch Allyn Technical Support Low temperature readings Place probe in the most posterior sublingual pocket when in Oral Mode Verify the thermometer is in the correct mode No temperature displayed Place the temperature probe in holder prior to taking anoth
15. for a nominal charge and shipment is subject to availability Loaners are shipped pre paid however this charge is added to the service charges 70 Maintenance and Service Welch Allyn Spot Vital Signs LXi 11 Supplies and Accessories 71 Blood Pressure Table 29 Reusable Two Piece Blood Pressure Cuffs 1 per pack REF Size REF Size 4500 01 Child 4500 03 Large Adult 4500 02 Adult 4500 04 Thigh Table 30 Durable One Piece Blood Pressure Cuffs 1 per pack REF Size REF Size REUSE 07 2MO Infant REUSE 11 2MQ Adult REUSE 08 2MO Small Child REUSE 12 2MO Large Adult REUSE 09 2MO Child REUSE 13 2MO Thigh REUSE 10 2MO Small Adult Table 31 Disposable One Piece Blood Pressure Cuffs 20 per box REF Size REF Size SOFT 07 2M0 Infant SOFT 11 2MQ Adult SOFT 08 2M0 Small Child SOFT 12 2MQ Large Adult SOFT 09 2M0 Child SOFT 13 2M0 Thigh SOFT 10 2MQ Small Adult Table 32 Miscellaneous Supplies and Accessories REF Description REF Description 4500 30 Blood Pressure Hose 5ft 1 5M 5200 08 Calibration T Connector 72 Supplies and Accessorie Temperature S Welch Allyn Spot Vital Signs LXi Table 33 SureTemp Plus REF Description 02895 00 ureTemp Plus Oral Probe and Well 9 feet 2 7M 02895 10 ureTemp Plus Rectal Probe and Well 9 feet 2 7M 02894 00 02894 10 ureTemp Plus Rectal Well 06138 00 ureTemp Plus Temperature Calibra
16. le niveau d activit du patient le caract re ad quat de la perfusion le site de capteur disponible les besoins en mati re de st rilit et la dur e anticip e de la surveillance Directions for Use Introduction 19 Contents Checklist Possible Unpack the Spot LXi and any applicable accessories and then inspect for missing items Retain the shipping materials in the event of shipping damage or for return if necessary to Welch Allyn for repair or warranty service Report any signs of shipping damage to the carrier Report any missing or damaged items to the Welch Allyn Service Center near you All Spot LXi devices include the following components Spot LXi Device This device automatically measures and displays blood pressure pulse rate and temperature Directions for Use Manual Read this manual thoroughly before using Spot LXi Save this manual for reference Warranty Card This card validates the Spot LXi warranty Fill out the warranty card and mail it today Blood Pressure Cuff One cuff with connectors Other size cuffs are available separately Blood Pressure Hose Latex free pressure hose with connectors to attach various sizes of blood pressure cuffs to the Spot LXi AC Power Transformer and Cord Assembly Provides power to the Spot LXi and charges the internal battery Quick Reference Card Attach this quick operating guide to the device handle mobile stand or wall mount Attachments Spot LXi may in
17. le site occup par le capteur conform ment au mode d emploi de celui ci MISE EN GARDE N utilisez pas les capteurs pendant les scannages MRI imagerie par r sonance magn tique Le courant induit risque de provoquer des br lures ventuelles L oxym tre de pouls de la carte MS risque d avoir un impact sur l image MRI et l unit MRI risque d avoir un impact sur l exactitude des mesures d oxym trie MISE EN GARDE Acheminez avec soin les c bles du patient pour r duire le risque d emm lement o d tranglement du patient MISE EN GARDE Ne pas recouvrir le site du capteur de Nellcor OxiMax avec un mat riau opaque lorsque l clairage ambiant est fort risque d entra ner des mesures inexactes MISE EN GARDE L oxym tre de pouls ne saurait remplacer ou se substituer une analyse de l arythmie bas e sur l ECG Avertissements g n raux Les avertissements de ce manuel identifient les conditions ou pratiques qui si elles ne sont pas corrig es ou arr t es imm diatement risquent de provoquer des d faillances ou des endommagements des quipements ou encore des pertes de donn es Ces avertissements ont trait tout le dispositif du Spot Vital Signs LXi A Avertissement Si l exactitude d une mesure quelconque est en doute v rifiez le s signe s vital aux du patient par une autre m thode puis v rifiez que le dispositif fonctionne correctement Avertissement V rifiez que le dispositif est plac sur une surface fixe
18. less than 3 V m 62 Specifications Welch Allyn Spot Vital Signs LXi Recommended Separation Distances Between Portable and Mobile RF Communications Eguipment and the Spot Vital Signs LXi The Spot Vital Signs LXi is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Spot Vital Signs LXi can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications eguipment transmitters and the Spot Vital Signs LXi as recommended below according to the maximum output power of the communications eguipment Separation Distance According to Freguency of Transmitter m Rated Max Output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Power of Transmitter W d 1 17 P d 1 17 P d 2 33 P 0 01 0 117 0 117 0 233 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 73 100 11 70 11 70 23 30 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 propagat
19. the Select and Power buttons for 5 seconds The device enters the Internal Configuration Mode and the Configuration Menu screen appears on the display Figure 7 Internal Configuration Mode Menu Configuration Menu gt Version Manual Numbers Parameters External Batter i y Devices Location a R Identifier SAR OO Buttons Deate time Lockout Blood Pressure Defaults Temperature Event Log Contrast Select 3 Use the Navigation buttons to move through the menu options and then press the Select button to access the options or accept a change See the following tables for descriptions of the menu options 4 Press the Power button to exit the Internal Configuration Mode Internal Configuration Welch Allyn Spot Vital Signs LXi Table 2 Configuration Menu Options Setting Description Version Numbers Battery Location Identifier Date Time Blood Pressure Temperature Contrast Manual Parameters External Devices Save Readings Buttons Lockout Defaults Event Log Displays the software and hardware version numbers in the Spot LXi device Displays the battery level Allows the entry of the device s location e g the department name Follow the display prompts to enter up to 10 characters Changes the date and time formats or updates the actual date and time See Table 3 Date Time Menu Options for available settings Changes the blood pressure options See Table 4
20. thermometer until it clicks To release the housing insert the lock release pin into the lock release hole until the lock tab snaps back Figure 6 Spot LXi with Braun ThermoScan PRO 4000 Lock Lock release pin Lock tab Lock release hole Blood Pressure Hose and Cuff Identify and have available the Spot LXi blood pressure cuff and the blood pressure hose 1 Inspect the blood pressure hose notice that one end has a single gray connector fitting and the other end has two white fittings 2 Saueeze the side tabs on the gray connector and completely push the blood pressure hose connector into the blood pressure hose connection port until it clicks into place see Figure 5 on page 25 3 Twist the white connectors on the blood pressure hose and cuff connectors together Directions for Use Thermometer Controls Display Window and Connections 27 Spot LXi is available with either the SureTemp Plus thermometer or the Braun ThermoScan PRO 4000 thermometer SureTemp Plus SureTemp Plus is available with two probes and matching wells one for oral axillary temperatures blue ejection button and probe well and one for rectal temperatures red ejection button and probe well The rectal probe and well are accessory items that are sold separately see Temperature on page 72 WARNING Always use a probe cover whenever coming into contact with a patient A Caution The SureTemp Plus feature only operates with the pr
21. to 13 4 Large Adult REUSE 12 2M0 SOFT 12 2M0 32 0 to 43 0 12 6 to 16 9 Thigh REUSE 13 2M0 S0FT 13 2MO 40 0 to 55 0 15 7 to 21 7 To ensure pediatric blood pressure accuracy and safety the Child Reusable Two Piece Blood Pressure Cuff 4500 01 Infant Durable One Piece Cuff REUSE 07 2MO and the 36 Blood Pressure Operation Welch Allyn Spot Vital Signs LXi Infant Disposable One Piece Cuff SOFT O7 2MO are the smallest cuffs approved for use with young children and infants The child s arm must fit within the range markings on the cuff Blood Pressure Measurement The preferred blood pressure measurement site for adults and children is the upper arm Keep the patient s arm relaxed and motion free during measurement s Alternate blood pressure measurement sites include the thigh ankle or forearm WARNING Do not place the cuff on any extremity that is used for intravenous infusions or any area where circulation is compromised WARNING Using the same arm for cuff inflation and SpO measurement may cause inaccurate SpO results WARNING Excessive cuff tightness may cause venous congestion and discoloration of the limb WARNING Wrapping the cuff too loosely preventing proper inflation may result in errors WARNING The Spot LXi is not intended to measure blood pressure on neonatal patients The AAMI SP10 2002 standard defines neonates as children 28 days or less of age if born at term 37 weeks gestation or more ot
22. 01 1 1 WARNING For proper patient electrical isolation use only a Welch Allyn power supply 4500 101A to charge Spot Vital Signs LXi Do not use the manufacturer supplied charger for the weight scale while it is attached to Spot LXi NOTE while charging the Spot LXi it is acceptable to charge the Spot LXi printer with the power supply 713703 or BC1300M 6 Introduction Welch Allyn Spot Vital Signs LXi Blood Pressure Warnings These warnings pertain to the Spot LXi blood pressure feature A WARNING Spot LXi is not intended to measure BLOOD PRESSURE on neonatal patients The AAMI SP10 2002 standard defines neonates as children 28 days or less of age if born at term 37 weeks gestation or more otherwise up to 44 gestational weeks WARNING To ensure pediatric blood pressure accuracy and safety the Child Reusable Two Piece Blood Pressure Cuff 4500 01 Infant Durable One Piece Cuff REUSE 07 2MQ and the Infant Disposable One Piece Cuff SOFT 07 2M0 are the smallest cuffs approved for use with young children and infants The child s arm must fit within the range markings on the cuff WARNING Avoid compression of the blood pressure hose or cuff tubing of Spot LXi This may cause system errors to occur in the device WARNING Patients who are experiencing moderate to severe arrhythmias may give inaccurate blood pressure measurements WARNING Spot LXi does not operate effectively on patients who are experiencing convulsions o
23. 20 Label Paper 10 rolls and Cleaning Kit 4500 910 Barcode Scanner with Mounting Bracket 4500 925 Cable for Wired Connectivity 4500 927 USB 2 0 Cable Serial Cable Kit Service Contracts REF Description 4500 BTO Blood Pressure with Thermometry 4500 BTS Blood Pressure with Thermometry and SpO 75 76 Supplies and Accessories Welch Allyn Spot Vital Signs LXi 11 Warranty Spot LXi Welch Allyn warrants that the Spot Vital Signs LXi products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within one year after the date of purchase Neither the lamp or specula have an explicit warranty beyond out of box failures The date of purchase is 1 the date specified in our records if you purchased the Product directly from us 2 the date specified in the warranty registration card that we ask you to send to us or 3 the date of purchase of product from the authorized Welch Allyn distributor as documented from a receipt from said distributor This warranty does not cover damage caused by 1 handling during shipping 2 use or maintenance contrary to labeled instructions 3 alteration or repair by anyone not authorized by Welch Allyn and 4 accidents If a Product or accessory covered by this warranty is determined to be defective because of defective materials components or workmanship and the warranty claim is made within the warra
24. 22 to 110 lbs 20 10 to 50 kg LNOP NEO Neonatal sensor lt 22 Ibs 10 kg 20 LNOP NEOPT Soflouch neonatal preterm sensor lt 2 2 lbs 1 kg 20 Table 36 Reusable Sensor Catalog Description Weight Range Quantity LNCS DCI Finger sensor adult gt 66 lbs 30 kg 1 LNCS DCIP Finger sensor pediatric 10 to 50 kg 1 LNOP DCI Finger clip probe adult gt 66 Ibs 30 kg 1 LNOP DCIP Finger clip probe pediatric 10 to 50 kg 1 Table 37 Sensor Cables Catalog Description Weight Range Ouantity LNC 4 WA 4 foot cable with DB 9 connector for LNCS NA 1 LNC 10 WA 10 foot cable with DB 9 connector for LNCS NA 1 PC 04 4 foot cable with sensor connector NA 1 PC 08 8 foot cable with sensor connector NA 1 PC 12 12 foot cable with sensor connector NA 1 74 Supplies and Accessories Nellcor Accessories Table 38 OxiMax Adhesive Sensors Single Patient Use Welch Allyn Spot Vital Signs LXi Catalog Description Weight Range Quantity MAX AI MAX A Adhesive Sensor adult gt 66 Ibs 30 kg Case of 24 MAX PI MAX P Adhesive Sensor pediatric 22 to 110 lbs Case of 24 10 to 50 kg MAX II MAX Adhesive Sensor infant 6 5 to 44 Ibs Case of 24 3 to 20 kg MAX RI MAX R Adhesive Sensor adult nasal gt 110 Ibs 50 kg Case of 24 Table 39 OxiMax OxiCliq Sensors Reusable Cable with Adhesive Sensor Bandage Catalog Description Weight Range Quantity OC 3 OxiClig Sensor Cable 3 ft 91cm N A 1 OXI
25. CLIO PI OxiCliq P pediatric 22 to 110 lbs Case of 24 10 to 50 kg Table 40 OxiMax Resuable Sensors Catalog Description Weight Range Ouantity DS 100A Durasensor DS 100A finger clip sensor adult gt 88 lbs 40 kg OXI A N Oxiband OXI A N adult neonatal lt 6 5 lbs or gt 88 lbs lt 3 kg or gt 40 kg OXI P l Oxiband OXI P l pediatric infant 6 5 lbs to 88 Ibs 3 to 40 kg D YS Dura Y D YS multisite sensor gt 2 2 lbs 1 kg D YSE D YSE ear clip for Dura Y sensor gt 66 lbs 30 kg D YSPD PediCheck D YSPD pediatric spot check sensor 6 5lbs to 88 Ibs 3 to 40 kg Table 41 OxiMax Sensor Cables Catalog Description Weight Range Ouantity DOC 10 DOC 10 10 ft 3M N A 1 Directions for Use Supplies and Accessories Miscellaneous REF Description 4500 60 Mobile Stand 4500 62 Wall Mount 4500 84 Lead Acid Battery 705310 Directions for Use 700862 Ouick Reference Card 704432 Service Manual 4500 150E Training Video 4500 100 Carrying Case 4500 101A AC Power Transformer desktop transformer line cord not included 4500 400 Line Cord United States Canadian Japanese version 4500 402 Line Cord European version 4500 404 Line Cord United Kingdom version 4500 406 Line Cord Australian Version 4500 408 Line Cord South African version 4500 500 Printer with Mounting Bracket 4500 505 Printer Rechargeable Battery Pack 4500 510 Printer Paper 4 rolls 4500 5
26. Display Window and Connections 29 Charge the Spot LXi battery and printer battery if using for 6 hours before initial use Charge the device an additional hour if it includes a Braun ThermoScan PRO 4000 thermometer While Spot LXi is charging the charging LED flashes and the battery level indicator segments on the display continuously seguence When the battery is fully charged the charging LED is solid and the battery level indicator is steady with all segments continuously shown on the display If the device includes a Braun ThermoScan PRO 4000 thermometer the charging LED below the thermometer will illuminate orange as it is charging When the battery is fully charged the LED will power off If the Spot LXi has a mounted external printer that is connected via the cable the charging LED on the printer flashes orange and green when the Spot LXi is plugged into the AC main power source If the Spot LXi has a mounted external printer that is not connected via the cable the charging LED on the printer will not flash Note There is no hazard associated with leaving the battery in the device even if the device is not used for long periods of time A dead battery may result if the Spot LXi is left uncharged or shipped stored for a long period of a time If this occurs use the supplied transformer to plug the Spot LXi into the AC line Do not use the device for two hours In extreme cases the charge condition LED does not blink to i
27. GGDS 49 O E ado REE eae EEO FN YNI E wde NON 49 Event Causes and Corrective ACtIONS n os 0 0 0 0 ce eee 51 A UE eee eee hate bat ee ie De he wale at let 55 Performances cael ett te y de dd LEA ee ee 55 Blood Pressure Accuracy 55 Jemperature Specitication Ss nss tirader n s bu WR Peed pee GER eld 56 SpOs Specifications 57 Masimo Sensor Accuracy Guide 57 Mlasitno FatentS Mu en re Bose ith tds A lea A rdd nn a Dhak a 57 Nellcor Sensor Accuracy Guide 58 NellcorPatents oops e faced ee Uo DD unten YSU OD BD ae ynd ee PS 58 Mechanical a Uu as ta ydd deat te EU IAE 59 Directions for Use Contents vii Electrical a ed Y dh An YND AO RF GAD 59 BAM A ES 59 Environmental sez nsr acta ados Bt a dd be Cac til tie cu Din 59 AS 59 Guidance and Manufacturer s Declaration 60 Emissions and Immunity Information 60 10 Maintenance and Service 63 CIS AIA ueu a ee Da hep tee tens o YNO FE NHW FYD OADW Ny DD te ue 63 SO ai Gu rte E MAC eee 63 Blood Pressure Cutts au tics a GW ou a Dette UU A GN 63 Blood Pressure Hose and Cable 63 SureTemp Plus Thermometer 0 0 00 00 ce eee eee 63 Braun ThermoScan PRO 4000 Thermometer 64 SPORSENSOlS sistas Me w
28. P PDT 10 to 50 kg 2 3 3 bpm 5 bpm LNOP NEO lt 10 kg 3 3 3 bpm 5 bpm LNOP NEOPT lt 1 kg 3 3 3 bpm 5 bpm LNOP DCI gt 30 kg 2 3 3 bpm 5 bpm LNOP DCIP 10 to 50 kg 2 3 3 bpm 5 bpm Masimo Patents The Masimo sensors and cables are covered under one or more of the following U S A patents 5 758 644 5 823 950 6 011 986 6 157850 6 263 222 6 501 975 and other applicable patents listed at www masimo com patents htm 58 Specifications Nellcor Sensor Accuracy Guide Welch Allyn Spot Vital Signs LXi Accuracy specifications are based on controlled hypoxia studies with healthy non smoking adult volunteers over the specified saturation SpO range Pulse oximeter SpO readings were compared to SaO values of drawn blood samples measured by hemoximetry All accuracies are expressed as X digits This variation equals one standard deviation 1 SD which encompasses 68 of the population Table 26 OxiMax Sensor Models Single Patient Use Sensor Models Sp0 Range 70 to 100 MAX AI 2 MAX PI 2 MAX II 2 MAX RI 35 1 The accuracy specification has been determined between saturations of 80 to 100 Table 27 OxiCliq Sensor Models Single Patient Use Sensor Models Sp0 Range 70 to 100 OXICLIO PI 25 Table 28 Reusable Sensor Models Sensor Models Sp0 Range 70 to 100 D YS Infant to Adult 3 D YS and D YSE 35 D YS and D YS
29. PD 35 DS 100A 3 OXI A N Adult neonate Adult 3 Neonate 4 OXI P I Pediatric infant 3 Nellcor Patents Covered by one or more of the following US Patents 4 802 486 4 869 254 4 928 692 4 934 372 5 078 136 5 351 685 5 485 847 5 533 507 5 577 500 5 803 910 5 853 364 5 865 736 6 083 172 6 708 049 Re 35 122 and foreign equivalents Directions for Use Specifications 59 Mechanical Dimensions Height 10 63 27 cm Length Braun 8 20 32 cm Length SureTemp Plus 7 5 19 cm Depth 5 25 13 34 cm Weight 7 5 lbs 3 4 kg Mounting Self supporting on rubber feet Custom mobile stand Custom wall mount Portability May be hand carried when held by the rear handle Electrical Power Reguirements Patient rated transformer is connected to AC mains 100 240V 50 60Hz 0 4A or internal power 6Vdc 6Ah Battery Sealed lead acid with external charger The Spot LXi battery is 90 to 100 charged after 6 hours of charging The rechargeable batteries in the Braun ThermoScan PRO 4000 thermometer reguires an additional 1 hour to charge The battery automatically charges when Spot LXi is powered through the AC power transformer An operator can use the device while the battery is charging however the battery charges faster when the instrument is not in operation The external printer has a Ni Mh battery that includes a separate external printer charger 713703 or BC1300M Charge the external printer battery 6 hours befo
30. Spot LXi with the SureTemp Plus thermometer takes a temperature in either Normal or Monitor Mode The default setting is Normal Mode In the Normal Mode the SureTemp Plus thermometer predicts body temperature in the oral axillary or rectal modes The thermometer takes an oral reading in approximately 4 to 6 seconds a pediatric axillary reading ages 17 years and younger in approximately 10 to 13 seconds an adult axillary reading ages 18 years and older in approximately 12 to 15 seconds and a rectal reading in approximately 10 to 13 seconds Use the Monitor Mode when difficult situations prevent taking an accurate temperature in the Normal Mode A WARNING To ensure optimal accuracy always confirm that the correct mode is selected WARNING Use only Welch Allyn probe covers Using other manufacturers probe covers or no probe cover may produce temperature measurement errors and or inaccuracy WARNING Always use a probe cover whenever coming into contact with a patient Normal Mode Patient actions may interfere with accurate oral temperature readings Ingesting hot or cold liquids eating food chewing gum or mints brushing teeth smoking or performing strenuous activity may affect oral temperature readings for up to 20 minutes after activity has ended Probe contact with electrodes or bandages poor tissue contact taking an axillary temperature over clothing or prolonged exposure of axilla to ambient air can cause inaccu
31. Utilisez exclusivement les protections de sonde Braun ThermoScan avec ce thermom tre Lutilisation de protections de sonde d un autre fabricant ou la non utilisation d une protection de sonde risque de produire une prise de temp rature erron e et ou inexacte Si le thermom tre est utilis sans protection de sonde nettoyez la lentille see Braun ThermoScan PRO 4000 Thermometer on page 64 MISE EN GARDE Ne passez pas l autoclave MISE EN GARDE Le thermom tre n est pas tanche Ne l immergez pas et ne faites pas tomber de gouttes dessus Si cela se produisait s chez le thermom tre avec de l air chaud V rifiez ensuite qu il fonctionne et fournit des r sultats exacts Mises en garde relatives au Sp0 Ces mises en garde ont trait la fonction Spot LXi SpO A MISE EN GARDE Utilisez exclusivement Spot LXi et l option Masimo ou Nellcor SpO avec les capteurs et accessoires de la marque Masimo ou Nellcor respectivement Utiliser des capteurs ou des cables incorrects ou non approuv s risque d entra ner des performances incorrectes MISE EN GARDE Le capteur et les c bles d extension SpO sont destin s tre utilis s exclusivement pour les mesures d oxym trie du pouls N essayez pas de connecter ces c bles un PC ou un dispositif similaire MISE EN GARDE Avant d utiliser le capteur lisez attentivement son mode d emploi dont l ensemble des mises en garde avertissements et instructions MISE EN GARDE N ut
32. Welch Allyn Spot Vital Signs LXi Directions for Use WelchAllyn Advancing Frontline Care Welch Allyn Spot Vital Signs LXi Directions for Use WelchAllyn Advancing Frontline Care ii Welch Allyn Spot Vital Signs LXi Copyright 2010 Welch Allyn All rights are reserved To support the intended use of the product described in this publication the purchaser of the product is permitted to copy this publication for internal distribution only from the media provided by Welch Allyn No other use reproduction or distribution of the publication or any part of it is permitted without written 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 Spot Vital Signs SureBP Technology and SureTemp are registered trademarks of Welch Allyn Braun ThermoScan is a registered trademark of the Braun Company LNCS is a trademark of and SET LNOP and Masimo are registered trademarks of Masimo Corporation Possession or purchase of a Masimo SpO eguipped device does not convey any express or implied license to use the device with unauthorized sensors or cables which would alone
33. aks in cord If connections are secure check electrical outlet for power Charging indicator is on if connections are good and the device is plugged into a working outlet If the battery is completely discharged the LEDs will not illuminate Allow the unit to charge at least 15 minutes before proceeding Replace the battery Verify that the AC power transformer connections are intact and that the charging indicator Is on If the connections are secure check the electrical outlet for power Plug the device into a known working electrical outlet Notify biomedical department or Welch Allyn Technical Support Possible Cause Corrective Action Barcode scanner does not read barcode Slowly adjust the distance and the angle between the scanner and the barcode while squeezing the scanner button Verify that the barcode is as flat as possible Poor barcode scanner connection Unplug and re plug in the barcode scanner into serial Port or Port Il beneath the Spot Vital Signs LXi handle Verify the power light illuminates on the barcode scanner Spot LXi has a low battery Look at the battery level indicator on the display window to confirm battery charge level If the battery level indicator shows no battery power then charge the battery page 29 54 Troubleshooting Welch Allyn Spot Vital Signs LXi 9 Specifications Performance This section describes normal ranges for Spot Vital Signs LXi Blood Pressure A
34. althometer retirez les deux vis hexagonales sur le c ble RS 232 avant de visser ce dernier sur le socle de la balance Directions for Use Introduction 17 Avertissements relatifs la pression art rielle Ces avertissements ont trait la fonction de pression art rielle du Spot LXi N Avertissement Minimisez les d placements des extr mit s et du brassard pendant les mesures de la pression art rielle Avertissement Si le brassard ne se trouve pas au m me niveau que le c ur notez la diff rence de lecture due l effet hydrostatique Ajoutez 1 80 mm Hg 0 2 kPa la valeur affich e pour chaque pouce 2 5 cm au dessus du niveau du c ur Soustrayez 1 80 mm Hg 0 2 kPa de la valeur affich e pour chaque pouce 2 5 cm au dessous du niveau du c ur Avertissement Pour obtenir des lectures exactes de la pression art rielle il est essentiel que le brassard soit d une taille appropri e et plac correctement Reportez vous Mesures avec un brassard a deux pi ces r utilisable Table 10 ou Mesures avec un brassard mono pi ce longue dur e Table 11 la page 35 pour de plus amples informations sur la taille Avertissement La position et la condition physiologique du sujet peuvent avoir un impact sur la mesure de la pression art rielle Avertissements relatifs la temp rature Ces avertissements ont trait la fonction de temp rature du Spot LXi A Avertissement La fonction SureTemp Plus ne fonctionne
35. an County Meath Republic of Ireland Tel 353 46 90 67700 Fax 353 46 90 67755 Related Publications Braun ThermoScan PRO 4000 User s Guide for models 450E0 45NEO 45MEO Masimo Directions for Use for models 45MTO 45MEO Nellcor Directions for Use for models 45NTO 45NEO 3 4 Introduction Welch Allyn Spot Vital Signs LXi Warnings and Cautions Familiarize all operating personnel with the general safety information in this summary Specific warnings and cautions are also found throughout this manual General Warnings A waming statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to patient injury illness or death These warnings pertain to the entire Spot Vital Signs LXi device A WARNING The information in this manual is a comprehensive guide to the operation of Spot LXi For best results read this manual thoroughly before using the device WARNING Spot LXi is designed for medical clinician use Although this manual may illustrate medical spot check technigues only a trained clinician who knows how to take and interpret a patient s vital signs should use this device WARNING Spot LXi is not intended for use in environments that are without health care practitioner supervision WARNING Spot LXi is not intended for continuous monitoring Do not leave the device unattended while taking measurements on a patient WARNING To ensure data int
36. bration Check Use the 9600 Plus Calibration Tester see Temperature on page 72 to check the SureTemp Plus or Braun ThermoScan PRO 4000 thermometer accuracy If the thermometer is out of calibration contact Technical Service Masimo SpO Calibration Check Use a Masimo approved SpO simulator Fluke Biotek or Clinical Dynamics SmartSat to check the SpO accuracy There is no way to change the calibration of the SpO module If the SpO is out of calibration contact Technical Service Nellcor SpO Functional Check Use a Nellcor SpO simulator SRC MAX to check the SpO funcationality There is no way to change the functionality of the SpO module If the SpO is not functioning properly contact Technical Service Product Disposal Do not dispose of this product as unsorted municipal waste Prepare this product for reuse or separate collection as specified by Directive 2002 96 EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment WEEE If this product is contaminated this directive does not apply For more specific disposal information see www welchallyn com weee or contact Welch Allyn Customer Service at 44 207 365 6780 Directions for Use Service Maintenance and Service 69 Caution Unauthorized repairs will void the warranty A Welch Allyn Service Center must perform all repairs on products under warranty Oualified electronics personnel or a Welch A
37. ccuracy Blood pressure accuracy meets or exceeds AAMI SP10 2002 standards for non invasive blood pressure accuracy 5 mmHg mean error 8 mmHg standard deviation Blood pressure accuracy is validated for pressure measurement using the upper arm only Cuff Pressure Range 0 to 300 mmHg Systolic Range 60 to 250 mmHg Diastolic Range 30 to 160 mmHg Blood Pressure Determination Time Typical 15 seconds Mean Arterial Pressure Range 40 to 190 mmHg Pulse Rate Range 25 to 240 bpm using Sp0 determination Pulse Rate Range 35 to 199 bpm using Blood Pressure determination Pulse Rate Accuracy using Sp0 Without Motion 25 to 240 bpm 3 digits determination With Motion normal physiologic range 55 to 125 bpm 5 digits Low Perfusion 25 to 240 bpm 3 digits Pulse Rate Accuracy 5 0 using Blood Pressure determination Overpressure Cutoff 315 mmHg 15 mmHg 1 Specification applies to device performance and was validated with Biotek and Nellcor simulators 55 56 Specifications Temperature Specifications Temperature Range SureTemp Plus Braun ThermoScan PRO 4000 Calibration Accuracy SureTemp Plus Braun ThermoScan PRO 4000 for displayed temperature ranges Display Resolution SureTemp Plus Predict Time Oral Adult Axillary Pediatric Axillary Rectal Welch Allyn Spot Vital Signs LXi 80 to 110 F 26 79 to 43 3 C 68 to 108 F 20 to 42 29 C 40 2 F 0 19 C Monitor Mode 0 4 F 20 29 C 95
38. clude the following items based on the model and accessories purchased SureTemp Plus Temperature Probe Well and Covers One oral temperature probe blue ejection button and well and one box of 25 single use disposable probe covers Braun ThermoScan PRO 4000 Thermometer and Covers One ear thermometer one box of 20 single use disposable probe covers one rechargeable battery pack and one lock release pin Barcode Scanner and Mounting Bracket Attach these items on the basket of the mobile stand or wall mount Pulse Oximetry SpO The finger clip SpO sensor and extension cable are for use with adult and pediatric patients Other sensors are available separately Printer Attach to the basket of the mobile stand or wall mount The printer comes with paper Rolls of paper and labels are available separately 20 Introduction Welch Allyn Spot Vital Signs LXi 21 Controls Display Window and Connections Drawings and text are representative of Spot Vital Signs LXi with all available options Your device may not include all functions based on the model purchased Controls Figure 1 Spot LXi Front Panel with SureTemp Plus Thermometer SureTemp Plus thermometer remove the probe to take a temperature Removable probe well store the temperature probe here when not in use remove to clean or replace to eliminate SpO2 gt PULSE y min cross contamination 100 Patient ID 0123456789 Weight Pain Height Clear
39. cm weight Ib or kg respiration rate pain level connectivity signal strength and battery charge level Figure 4 Display Window Connectivity indicator shows the status of Spot LXi sending a wireless reading Reading sent indicates a successful wireless send reading attempt Reading not sent indicates an unsuccessful wireless send reading 4 WEST Y X Location identifier shows where the device belongs If no location is entered this area displays the date attempt Clock shows the current time Systolic and Diastolic display if MAP is turned on the screen toggles between the systolic and diastolic values and the word MAP and the MAP value Temperature display and indicator shows the temperature in Fahrenheit or Celsius SpO display shows the percent saturation of arterial hemoglobin For devices with Sp0 only Navigation Window shows menu options error messages or temperature conversion SYS Reading number indicator mmHg shows what reading the device is on Spot LXi retains up to 50 readings in memory 21 2 Whom dE i 985 100 Patient ID 0123456789 DIA mmHg Battery level indicator shows the battery charge level Thermometer probe setting indicators shows temperature mode For devices with SureTemp 17 thermometer only Thermometer probe setting indicators shows Monitor Mode For devices with SureTemp Plus thermome
40. cond tube 4 Pusha female fitting into the third piece of 4 tubing and connect the opposite end of the tubing to the T connector 5 Twist the blood pressure tubing fitting that connects to the right blood pressure cable connection port to the female fitting and connect the opposite end of the blood pressure tubing to the blood pressure cable connection port Verify that all connections are tight Figure 11 Blood Pressure Calibration Tubing Connections Right blood pressure cable connection Bulb and valve Accurate calibrated pressure meter or sphygmomanometer Right female fitting 6 Enter the Internal Configuration Mode see Internal Configuration on page 31 68 Maintenance and Service Welch Allyn Spot Vital Signs LXi 7 Press the Navigation button to highlight Blood Pressure on the display and press the Select button 8 Press the Navigation button to highlight BP Calibration Check on the display and press the Select button 9 Press the Select button to close the valve 10 Verify that the pressure meter is on and the thumb screw valve is closed Inflate the device manually to about 250 mmHg 11 Drop the pressure to 200 mmHg wait 15 seconds for stabilization and take a reading 12 Repeat for 150 mmHg 50 mmHg and O mmHg all measuring downscale 13 If the calibration at any point is outside of 3 mmHg call Welch Allyn Technical Service for assistance Temperature Cali
41. correctly in the ear canal the ExacTemp light flashes When the thermometer detects an accurate measurement the ExacTemp light is continuously on a long beep signals the end of the measurement and the display shows the result b If the probe is positioned incorrectly in the ear canal or is moved during the measuring process the Exac Temp light goes out a sequence of short beeps sounds and the display shows an error message POS position error Press the ejector button to eject the used probe cover into the trash when you are finished taking the temperature Return the thermometer to its holder Spot LXi displays the patient s temperature and temperature scale in the Temperature Display area on the LCD see Display Window on page 24 42 Temperature Operation Welch Allyn Spot Vital Signs LXi 43 Pulse Oximetry Operation The following factors may cause inaccurate measurements during an SpO reading Patient is in cardiac arrest or shock Bright light Moisture in the sensor ncorrect sensor application or use Arterial occlusion proximal to the sensor ntravascular dyes such as indocyanine green e or methylene blue Fingernail polish if finger sensor is used Directions for Use Excessive patient movement Sensor is too tight Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line Poor patient perfusion Venous
42. cturer s charger while the weight scale is attached to the Spot LXi While charging the Spot LXi it is acceptable to charge the Spot LXi printer with the power supply 713703 or BC1300M Caution Always unplug the AC power transformer from the outlet before moving the mobile stand to a new location Caution The basket has a three pound weight limit Take care not to exceed this limit Caution Only use a 9V battery with the Healthometer scale Remove and discard the wall mounted power supply Caution When using the Healthometer scale remove the two hex nuts on the RS 232 cable as supplied before screwing the cable into the scale base 10 Introduction Welch Allyn Spot Vital Signs LXi Blood Pressure Cautions These cautions pertain to the Spot LXi blood pressure feature N Caution Minimize extremity and cuff motion during blood pressure readings Caution f the blood pressure cuff is not at heart level note the difference in reading due to the hydrostatic effect Add the value of 1 80 mmHg 2 kPa to the displayed reading for every inch 2 5 cm above heart level Subtract the value of 1 80 mmHg 2 kPa from the displayed reading for every inch 2 5 cm below heart level Caution Proper blood pressure cuff size and placement is essential to the accuracy of the blood pressure determination See Reusable Two Piece Cuff Measurements Table 10 or Durable One Piece Cuff Measurements Table 11 on page 35 for sizing information
43. d nosocomial infection WARNING _To ensure optimal accuracy always confirm that the correct mode is selected 8 Introduction Welch Allyn Spot Vital Signs LXi Braun Thermoscan PRO 4000 These warnings are specific to the Braun ThermoScan PRO 4000 thermometer option A Sp0 Warnings WARNING Keep the probe window clean dry and undamaged at all times to ensure accurate measurements To protect the probe window always keep the thermometer in the storage cover while transporting or when not in use WARNING Only use Braun ThermoScan probe covers with this thermometer Using other manufacturer s probe covers or no probe cover may produce temperature measurement errors and or inaccuracies If the thermometer is used without a probe cover attached clean the lens see Braun ThermoScan PRO 4000 Thermometer on page 64 WARNING Do not autoclave WARNING The thermometer is not waterproof Do not immerse or drip fluids on it Should this occur dry the thermometer with warm air Check for proper operation and accuracy These warnings pertain to the Spot LXi SpO feature A WARNING Only use Spot LXi with Masimo or Nellcor SpO option with Masimo or Nellcor brand sensors and accessories respectively Using the wrong or unapproved sensors or cables may cause improper performance WARNING The SpO sensor and extension cables are intended for use only for pulse oximetry measurements Do not attempt to connect these cables to a
44. e means to check the patient s vital signs and then check the Spot LXi for proper functioning 44 Pulse Oximetry Operation Welch Allyn Spot Vital Signs LXi Spot LXi measures a patient s SpO for up to 10 minutes After 10 minutes a C9 error code is displayed This error code means that the use has exceeded the 10 minute time limit 2 Check sensor sites periodically to assess circulation sensor positioning and skin sensitivity 3 Remove the sensor from the patient The SpO reading flashes for 8 seconds If the sensor is not reattached to the patient in 8 seconds the SpO596 and pulse rate flashing signalling that the measurement period has ended The device continues to display the last SpO reading 45 7 Manual Entries and External Device Operation Manual Entries Weight Height Respiration and Pain Level Users can manually enter weight height respiration rate and pain level parameters along with the Spot LXi readings if the specific parameter is turned on in the Internal Configuration Mode see Internal Configuration on page 31 The default for each manual parameter is on 1 Press the Navigation buttons until the cursor is in front of the parameter in the Navigation Window 2 Press the Select button The default parameter value appears and flashes above the Navigation button 3 Press the Navigation buttons to increase or decrease the value 4 Press the Select button to accept the value The Na
45. egrity save readings and clear the Spot LXi display between patients WARNING The Spot LXi is not defibrillator proof WARNING Spot LXi is not intended for use during patient transport WARNING This device is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide An explosion may result WARNING _To ensure patient safety use only accessories and supplies i e cuffs hoses temperature probes SpO sensors etc recommended for or supplied with Spot LXi Using unapproved accessories with Spot LXi can affect patient and or operator safety WARNING _ Take care to prevent water or other fluid from entering any connectors on the device Should this occur dry the connectors with warm air Check the accuracy of all operating functions WARNING Every three months inspect the blood pressure cuff SpO cable and other accessories for fraying or other damage Replace as necessary WARNING _Do not use Spot LXi on patients who are on heart lung machines WARNING Electric shock hazard There are no user serviceable parts inside Spot LXi other than battery replacement see Battery Replacement on page 65 An operator may only perform maintenance procedures specifically described in this manual For service refer the device to an Authorized Service Center WARNING This device is not intended for hand held use during operation Directions for Use Introduction 5 WARNING Do
46. er temperature Check the temperature probe connection to Spot LXi see SureTemp Plus on page 27 SureTemp Plus models only Loss of tissue contact The probe has lost contact with the patient s tissue Once you achieve proper contact Spot LXi continues the temperature measurement It is recommended that you take a new temperature reading Ambient temperature exceeds lower or upper measurement range limit Bring the device into the proper ambient temperature e Ambient temperature range limit is 50 F to 104 F 10 C to 40 C Directions for Use Table 22 Sp0 Malfunction Troubleshooting 53 Possible Cause Sensor in place but no SpO on display Corrective Action Insert the patient s finger completely into sensor Verify blood pressure and SpO5 measurements are not taken on the same extremity Verify the sensor cable is correctly plugged into Spot LXi see SpO2 Sensor on page 28 Verify you are using the correct sensor Use only Masimo or Nellcor SpO5 sensors and accessories with the Spot LXi with Masimo or Nellcor configurations respectively Table 23 Device Does Not Turn On Possible Cause Corrective Action Low battery Plug in the device Check connections between the Spot LXi and transformer then between the transformer and wall receptacle Device not powering up Table 24 Barcode ID does not scan Unplug Spot LXi from wall receptacle and check for bre
47. essure Readings Possible Cause Corrective Action and Explanation Incorrect cuff size Use Welch Allyn approved cuffs only Measure patient s arm circumference midway between elbow and shoulder see Blood Pressure Cuff Selection on page 35 to select correct cuff size Use reference markings on cuff to ensure correct cuff size Patient s arm position Ensure patient s arm is at heart level Arm movement during blood pressure cycle Keep arm still during blood pressure cycle Movement may cause inaccuracies from artifact Blood pressure taken over clothing Take blood pressure on a bare arm Arrhythmia Check for regularity of heart rate palpate pulse or check device e Moderate to severe heart rate irregularities may make blood pressure difficult to measure accurately Change in blood pressure between auscultatory reading and Spot LXi reading Incorrect reference Check blood pressure immediately before Spot LXi reading e Blood pressure is dynamic and changing It is normal for blood pressure to fluctuate 5 to 10 mmHg Use the correct Korotkoff sound to determine diastolic blood pressure e Many listeners incorrectly equate diastolic blood pressure with the disappearance of sound only phase 5 Spot LXi was developed using the American Heart Association recommendations which state that phase 5 be used unless sound continues to 0 mmHg in which case the change in the quality of sound
48. eturn the probe to the probe well To take a temperature in Rectal Mode WARNING Incorrect insertion of probe can cause bowel perforation WARNING Washing hands greatly reduces the risk of cross contamination and nosocomial infection A Caution To obtain accurate rectal temperatures use the temperature probe with the red ejection button and red probe well Verify that the rectal probe red ejection button and matching probe well are installed see SureTemp Plus on page 27 Spot LXi only operates in Rectal Mode if the red rectal probe and probe well are installed Hold the probe handle with your thumb and two fingers on the indentations of the probe handle and withdraw the probe from the probe well Verify the lowerbody icon in Spot LXi s temperature display area is flashing Insert the probe into a probe cover and press the probe handle down firmly The probe handle moves slightly to engage the probe cover Separate the patient s buttocks with one hand Use the other hand to gently insert the probe only 5 8 in 1 5 cm inside the rectum less for infants and children The use of a lubricant is optional Tilt the probe so that the tip is in contact with tissue Continue to separate the buttocks and hold the probe in place throughout the measurement process During the measurement process the temperature display area displays rotating walking segments The device beeps when the final temperature is reached T
49. he temperature display area displays the patient temperature temperature scale and measurement site The temperature is shown in degrees Fahrenheit and degrees Celsius for 5 seconds in the Navigation Window To switch to Monitor Mode leave the probe in place The Spot LXi automatically switches to Monitor Mode after approximately 30 seconds Once in Monitor Mode proceed to Step 6 on page 40 40 Temperature Operation Welch Allyn Spot Vital Signs LXi 7 Remove the probe after the temperature measurement is complete and firmly press the ejection button on the top of the probe to release the probe cover 8 Return the probe to the probe well and wash your hands Monitor Mode Monitor Mode displays the temperature of the probe as long as the probe remains in place at the measurement site and remains within the operating patient temperature range The patient s temperature will reach final eguilibrium in approximately three minutes in the oral and rectal sites and five minutes in the axillary site WARNING Long term continuous monitoring beyond three to five minutes is not recommended in any mode Note Spot LXi does not retain Monitor Mode temperatures in memory for recall To take a temperature in Monitor Mode 1 Verify that the correct probe oral axillary blue ejection button or rectal red ejection button and matching probe well are installed see SureTemp Plus on page 27 2 Hold the probe handle with your thumb and t
50. herwise up to 44 gestational weeks To initiate blood pressure measurements 1 Properly size the blood pressure cuff and position it around the patient s bare upper arm or alternate site as necessary with the artery index marker over the brachial artery Leave room between the cuff and the arm for two fingers Press the Blood Pressure Start Stop button Spot LXi inflates the cuff to the appropriate level measuring the blood pressure as the cuff is inflating aah The systolic display shows the pressure in the cuff as the blood pressure determination is in process Pressing the Blood Pressure Start Stop button at any time during a blood pressure determination aborts the measurement and rapidly deflates the cuff When complete Spot LXi displays the systolic diastolic and pulse rate measurements If you have enabled MAP in the Internal Configuration Mode Spot LXi also displays this value If Spot LXi is unable to determine a blood pressure while the cuff is inflating due to patient movement excessive noise or an arrhythmia the device will attempt to measure the blood pressure while deflating the cuff Note Spot LXi displays the pulse rate as determined from the blood pressure measurement method only if the SpO option is absent or disabled If the SpO function is operational all pulse rate determinations are a result of the SpO measurement method 3 s Temperature Operation Temperature Operation Mode Selection
51. if weight is enabled here if weight scale is enabled in the External Devices Menu you cannot manually enter the weight Pounds Ib or kilograms kg Changes the default patient weight displayed in the Navigation Window On or off On or off 34 Internal Configuration Welch Allyn Spot Vital Signs LXi Table 7 External Devices Menu Options Setting Description Information System Barcode Patient ID Barcode Clinician ID Reguired for Send Clear on Send Save Weight Scale Wireless Module Printer Printer Paper On or off You must enable this option to send patient readings wired or wirelessly On or off You must enable this option to send patient readings wirelessly On or off Yes or no You must enable this option to reguire the sign in of the clinician Only visible when Information System is on Yes or no You must enable this option to clear the Clinician ID after after sending or saving the measurements Disable to keep Clinician ID until power down On or off Spot Vital Signs LXi can connect to a scale and the weight will appear on the display window see Weight Scale on page 47 for details None or DPAC You must enable DPAC to send patient readings wirelessly The wireless radio is available as an accessory On or off Plain or labels Only available if the Printer is enabled Table 8 Save Readings Menu Options Setting Description Save Mode Auto Save Interval
52. ilisez pas un capteur ou un c ble d oxym trie de pouls endommag et n utilisez pas un capteur dont les composants optiques sont expos s MISE EN GARDE Une application ou une dur e inappropri e d utilisation du capteur du SpO risque d entra ner l endommagement des tissus Inspectez r guli rement le site occup par le capteur conform ment au mode d emploi de celui ci MISE EN GARDE Certaines conditions de l environnement ambiant des erreurs d application du capteur et certaines conditions du patient risquent d avoir Un impact sur les mesures du SpO et sur le signal du pouls MISE EN GARDE N immergez pas le capteur ou les c bles du patient dans de l eau des solvants ou des solutions de nettoyage les capteurs et les connexions ne sont pas tanches N utilisez pas d irradiations de vapeur o d oxyde d ethyl ne pour la st rilisation MISE EN GARDE Le SpO du dispositif Spot LXi n est pas destin tre utilis en tant que moniteur d apn e MISE EN GARDE Consid rez le SpO comme un dispositif de mise en garde pr coce Si une tendance vers la d soxyg nation du patient est indiqu e utilisez des instruments de laboratoire pour analyser des chantillons sanguins afin de bien comprendre la condition du patient 16 Introduction A Welch Allyn Spot Vital Signs LXi MISE EN GARDE Une application ou une dur e inappropri e d utilisation du capteur du Nellcor OxiMax peut entra ner l endommagement des tissus Inspectez
53. ion is affected by absorption and reflection from structures objects and people 63 Maintenance and Service Cleaning WARNING Before performing any maintenance or service to the Spot LXi disconnect the AC power line from the electrical outlet Spot Vital Signs LXi Caution Prevent water or other fluids from entering any connectors If the connectors get wet dry them with warm air Check all measurement functions Caution Do not sterilize or autoclave the Spot LXi device As necessary clean the device with a cloth slightly dampened with either 70 isopropyl alcohol 10 chlorine bleach solution or mild detergent in water or use PDI Sani System Cloths Never immerse Spot LXi in any type of fluid Blood Pressure Cuff Refer to the Directions for Use provided with the blood pressure cuff for cleaning procedures Blood Pressure Hose and Cable Wipe the pressure hose with a damp cloth moistened in a mild detergent solution Do not immerse hose SureTemp Plus Thermometer Temperature Probe Caution DO NOT immerse or soak the probe in any type of fluid Caution DO NOT use steam heat or gas sterilization on the probe Caution DO NOT autoclave the probe Press down on the connector tab and slide the connector out of the port to remove the temperature probe 64 Maintenance and Service Welch Allyn Spot Vital Signs LXi Regularly wipe the probe with a cloth dampened with warm water and a mild detergent solution
54. lfunction Restart device If problem persists contact Technical Service E4 5 Temperature malfunction Restart device If problem persists contact Technical Service E4 6 Temperature malfunction Restart device If problem persists contact Technical Service E4 7 Cannot initialize thermometer If problem persists contact Technical Service E4 8 Thermometer needs to be calibrated Contact Technical Service E4 9 Probe well missing or installed improperly Reinstall probe well E5 0 Temperature heater error f problem persists contact Technical Service E5 2 Heatsink Failsafe Failure If problem persists contact Technical Service AM Device outside operating temperature Change ambient temperature range Av Device outside operating temperature Change ambient temperature range b Internal temperature malfunction Contact Technical Service bv Internal temperature malfunction Contact Technical Service Table 15 SpO Error Codes Code Description Corrective Action C8 Faulty SpO sensor Replace sensor C9 SpO time limit exceeded Remove sensor from patient E7 Internal SpO error Retake reading Directions for Use Troubleshooting 51 Event Causes and Corrective Actions Note Differences of up to 10 mmHg between manual and automatic readings are considered normal and occur for a number of reasons including intra patient BP variability observer hearing differences and auscultatory deflation rate Table 16 Inaccurate Blood Pr
55. llyn Service Center should repair products out of warranty Technical Assistance If you have an eguipment problem that you cannot resolve call the Welch Allyn Service Center nearest you for assistance Technical service telephone support is available on normal business days If you are advised to return a product to Welch Allyn for repair or routine maintenance schedule the repair with the service center nearest you Before returning a product for repair you must obtain authorization from Welch Allyn Service personnel will give you a Service Notification number Please note this number on the outside of your shipping box Returns without a Service Notification number will not be accepted for delivery Service Manual Spare Parts A Service Manual is available by request to qualified electronics personnel The Service Manual is a comprehensive guide to troubleshooting service and repair of Spot LXi see Miscellaneous on page 75 Also included with the Service Manual is a complete spare parts list Order spare parts from your local Welch Allyn Service Center Service Loaners Service loaners are provided on request if a Welch Allyn Service Center provides repair service Loaners for products repaired while under the original warranty or while under service contract are provided free of charge and are shipped within 48 hours of notification of need For service repairs outside of warranty or contract loaners are available
56. n Outre la batterie qui peut tre remplac e see Battery Replacement on page 65 aucune pi ce pouvant tre entretenue par l utilisateur ne se trouve l int rieur du Spot LXi Chaque op rateur ne peut effectuer que les proc dures de maintenance sp cifiquement d crites dans ce manuel Pour l entretien du dispositif consultez un centre d entretien agr 12 Introduction A Welch Allyn Spot Vital Signs LXi MISE EN GARDE Ce dispositif n est pas destin tre tenu la main pendant son fonctionnement MISE EN GARDE Ne passez pas l autoclave MISE EN GARDE Ce produit satisfait aux normes actuelles en vigueur concernant les interf rences lectromagn tiques et ne devrait ni affecter ni tre affect par les autres appareils Par mesure de pr caution vitez d utiliser ce produit tr s pr s d un autre appareil MISE EN GARDE Welch Allyn n est pas responsable de l int grit de l installation de support quelle qu elle soit Welch Allyn recommande au client de contacter son service d ing nierie biom dicale o son service de maintenance pour veiller ce tout accessoire d installation soit mont de mani re professionnelle et respecte les crit res de s curit et de fiabilit MISE EN GARDE Le Spot LXi est constitu de pi ces de pr cision de grande qualit Prot gez le des impacts et chocs importants Avant d tre utilis nouveau tout Spot LXi qui est tomb ou endommag doit tre v rifi pa
57. n of monitoring Directions for Use Introduction 11 Mises en gardes et avertissements Tout le personnel d exploitation doit conna tre les consignes de s curit g n rale de cette synth se Des mises en garde et avertissements sp cifiques sont galement donn s tout au long de ce manuel Mises en garde g n rales Les mises en garde de ce manuel identifient les conditions ou pratiques qui si elles ne sont pas corrig es ou arr t es imm diatement risquent de provoquer des blessures des maladies ou le d c s du patient Ces mises en garde ont trait tout le dispositif du Spot Vital Signs LXi MISE EN GARDE Les informations de ce manuel constituent un guide complet de l utilisation du Spot LXi Pour obtenir les meilleurs r sultats possibles lisez attentivement ce manuel avant d utiliser le dispositif MISE EN GARDE Le Spot LXi est con u pour usage clinique m dical Bien que ce manuel puisse illustrer des techniques de surveillance m dicale ponctuelle cet instrument ne doit tre utilis que par un clinicien form sachant comment prendre et interpr ter les signes vitaux du patient MISE EN GARDE Le Spot LXi n est pas destin tre utilis dans des environnement non supervis s par un professionnel de la sant MISE EN GARDE Le Spot LXi n est pas con u pour les surveillances en continu Ne laissez pas le dispositif sans surveillance lors de la prise de mesures sur un patient MISE EN GARDE Pour ass
58. ndicate a fast charge or the device loses the time and date stamp If this happens unplug the accessories and plug the Spot LXi into the AC line using the appropriate adapter If the Spot LXi still fails to indicate a fast charge unplug the AC adapter disconnect and reconnect the battery and plug in the AC adapter Leave unused for two hours Power On Off Press the Power button to turn the device on or off Upon each power up the display lights up a beep sounds and the Spot LXi displays the model and serial numbers If the internal self check is successful the display shows its normal functions see Figure 4 on page 24 with all values blank and the device is ready for operation If the self check fails an error code is shown in the Navigation Window Spot LXi automatically powers off when not used for 30 minutes Standby Mode The Standby Mode conserves battery power The device goes into Standby Mode if it is not used for two minutes Press any button to bring the Spot LXi out of Standby Mode 30 Controls Display Window and Connections Welch Allyn Spot Vital Signs LXi 31 Internal Configuration You can change several device operating parameters in the Internal Configuration Mode When changed these settings become the default powerup settings You will also see non changeable device configurations for technical service purposes To Enter the Internal Configuration Mode 1 Turn the Spot LXi off 2 Press and hold
59. ner l introduction d air dans le syst me circulatoire du patient 14 Introduction Welch Allyn Spot Vital Signs LXi Mises en garde relatives la temp rature Ces mises en garde ont trait la fonction de temperature du Spot LXi SureTemp Plus Ces mises en garde sont sp cifiques l option du thermom tre SureTemp Plus A MISE EN GARDE Utilisez exclusivement les protections Welch Allyn L utilisation de protections de sonde d un autre fabricant ou la non utilisation d une protection de sonde risque de produire une prise de temp rature erron e et ou inexacte MISE EN GARDE Toujours utiliser un embout lorsque la sonde est en contact avec le patient MISE EN GARDE La prise de temp rature en continu long terme c est dire au del de trois cinq minutes n est recommand e en aucun mode MISE EN GARDE Les sondes orales axillaires bouton d jection bleu au dessus de la sonde et le puits de sonde oral axillaire amovible bleu sont utilis s exclusivement pour les prises de temp rature orales et axillaires Les sondes rectales bouton d jection rouge et le puits de sonde amovible rouge sont utilis s exclusivement pour les prises de temp rature rectales l utilisation de la sonde dans un site incorrect entra ne des erreurs de temp rature L utilisation du puits de sonde amovible incorrect risque d entra ner une contamination crois e entre patients MISE EN GARDE Les connecteurs du thermom tre et la sonde ne
60. not autoclave WARNING This device complies with current required standards for electromagnetic interference and should not present problems to other eguipment or be affected by other devices As a precaution avoid using this device in close proximity to other eguipment WARNING Welch Allyn is not responsible for the integrity of any mounting installation Welch Allyn recommends that the customer contact their Biomedical Engineering Department or maintenance service to ensure professional installation for safety and reliability of any mounting accessory WARNING The Spot LXi consists of high quality precision parts Protect it from severe impact and shock A qualified service technician must check any Spot LXi that is dropped or damaged for proper operation prior to further use Do not use the Spot LXi if you notice any signs of damage Contact the Welch Allyn Customer Service Department for assistance WARNING Do not use an SpO finger clip sensor and a blood pressure cuff simultaneously on the same limb Doing so may result in inaccurate pulse rate and perfusion readings WARNING All signal input and output I O connectors are intended for connection of only devices complying with IEC 60601 1 or other IEC standards for example IEC 60950 as appropriate to the device Connecting additional devices to the Spot LXi may increase leakage currents To maintain operator and patient safety it is necessary to consider the reguirements of IEC 606
61. ntroduction 13 Mises en garde relatives la pression art rielle Ces mises en garde ont trait la fonction de pression art rielle du Spot LXi MISE EN GARDE Le Spot LXi n est pas destin mesurer la PRESSION ART RIELLE des nouveau n s La norme AAMI SP10 2002 d finit les nouveau n s comme les enfants g s de 28 jours au plus s ils sont n s terme 37 semaines de gestation minimum ou les enfants jusqu 44 semaines de gestation maximum MISE EN GARDE Pour assurer l exactitude et la s curit des mesures de pression art rielle p diatrique le brassard p diatrique deux pi ces 4500 01 le brassard pour nourrissons mono pi ce longue dur e REUSE 07 2MO et le brassard pour nourrissons mono pi ce usage unique SOFT 07 2MO sont les plus petits brassards approuv s pour les jeunes enfants et les nourrissons Le bras de l enfant doit tre compris entre les marques limites de plage d utilisation figurant sur le brassard MISE EN GARDE vitez de comprimer le flexible de pression art rielle ou la tubulure du brassard du Spot LXi Ceci risque de provoquer des erreurs syst me au niveau du dispositif MISE EN GARDE Les patients souffrant d arythmies l g res grave peuvent donner lieu des mesures inexactes de la pression art rielle MISE EN GARDE Le Spot LXi ne fonctionne pas efficacement sur des patients qui sont en crise de convulsions ou de tremblements MISE EN GARDE Utilisez exclusivement les
62. nts Welch Allyn Spot Vital Signs LXi Introduction This Directions for Use manual is a comprehensive guide designed to help you understand the capabilities and operation of your Spot Vital Signs LXi The information in this manual includes all options available with Spot LXi e g pulse oximetry barcode scanner printer mobile stand and wall mount The applicability of some sections of this manual depends on the configuration of your particular device Read this manual thoroughly before attempting to use the device Table 1 Available Versions of Spot Vital Signs LXi REF Description 45070 SureBP Technology with SureTemp Plus Thermometer 450E0 SureBP Technology with Braun ThermoScan PRO 4000 Thermometer 45MTO SureBP Technology with Masimo SpO and SureTemp Plus Thermometer 45ME SureBP Technology with Masimo SpO and Braun ThermoScan PRO 4000 Thermometer 45NTO SureBP Technology with Nellcor SpO and SureTemp Plus Thermometer 45NEO SureBP Technology with Nellcor SpO and Braun ThermoScan PRO 4000 Thermometer Intended Use The Spot Vital Signs LXi automatically measures systolic and diastolic pressure excluding neonates pulse rate temperature oral adult axillary pediatric axillary rectal and ear and pulse oximetry SpO as well as calculates Mean Arterial Pressure MAP Furthermore Spot Vital Signs LXi allows the entry of height weight respiration rate and pain level S
63. nty period described above Welch Allyn will at its discretion repair or replace the defective Product or accessory free of charge You must obtain a service notification number from Welch Allyn to return your Product before you send it to Welch Allyn s designated service center for repair Contact Welch Allyn Technical Support THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WELCH ALLYN S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECT OR CONSEOUENTIAL DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THE WARRANTY Accessories Refer to the manufacturer s Directions for Use for the Masimo and Nellcor finger sensor and cable warranty Refer to the Directions for Use provided with the Welch Allyn Blood Pressure Cuff for warranty information The SureTemp Plus probe is covered by a one year warranty and the SureTemp Plus probe well is covered by a 90 day warranty against original defects in material and workmanship Probe covers are intended for single use only 78 Warranty Welch Allyn Spot Vital Signs LXi The Braun ThermoScan PRO 4000 is covered by a three year warranty against original defects in material or workmanship The printer is covered by a one year warranty against original defects in material or
64. o es le tk nes cede AR Le on M Le RARE 28 AG Power Mansion Sa RUE gana eee ee 28 Bater ae du a etn A I O eee eae To 29 Power OMOT eu Gwg Ae E UDD TA Dh ND AA EW DEL DDO 29 StanabyVMOde ser 2 9 sd Ssh Mann me RAI NR or nd Md a no NL ane 29 3 Internal Configuration sx eta RA WYRE EG os dM AHA WD 31 4 Blood Pressure Operation 35 Blood Pressure Cuff Selection 35 Blood Pressure Measurement YY I FF FF Y ad 36 5 Temperature Operation a 37 Temperature Operation Mode Selection 37 Normal Mode unes a eh wn eal is Dares mue dn du 37 Monitor Mode sesira cialis end ota eh WAG O od Baa und EN 40 Temperature Measurement Range Indicators 40 EarslemoeraiUres pa Sn a EN FF estar My ddd a MR Sa 41 6 Pulse Oximetry Operation 43 7 Manual Entries and External Device Operation 45 ManUa bEntieS tii moe ceu Fedd a tes ls A e tut Lata as ee 45 Weight Height Respiration and Pain Level 45 Body Massilndexes oy 2 44 00 re ig iwn Ah dT eRe AR DG tds Bae 45 Memory Recalde bee A meee a Y A Sn SL 45 External DeViCeSt ase ue a Eny a wen o AD 46 PRINTER ss NENN HEN 4 POE SR Ne Be PIER So eT Minne 46 M lght SCale su cata gle me mal eM wh cd Ryd ded dy SAS 47 Barcode SCANNER 47 8 Troubleshooting erene ea AE
65. obe well in place 3 4 Align the probe well with the tabs facing up and down into the round opening of the SureTemp Plus housing on the right side of Spot LXi Push it into place Align the temperature probe connector with the SureTemp Plus thermometer connection port on the back of the Spot LXi see Figure 5 on page 25 You can only insert the connector into the port one way Press the tab on the connector and push it until it clicks into place Insert the temperature probe into the probe well Braun ThermoScan PRO 4000 A Caution Do not use alkaline batteries in the Braun ThermoScan PRO 4000 thermometer Open the package of rechargable batteries and follow the installation guide provided Open the box of probe covers as directed on the box and slide the box into the metal guides toward the back of the thermometer housing with the opening at the top and perforation facing forward Hold the Braun thermometer at a 45 angle then insert the probe and the top of the thermometer into the housing Lower the bottom portion of the thermometer into the housing until it snaps into place If you do not properly seat the thermometer it could fall out of the holder and become damaged Slide the thermometer housing into the thermometer slot on the right side of the Spot LXi device Push the lock tab forward to prevent the thermometer housing from falling out of Spot LXi see Figure 6 on page 26 To release the lock insert the l
66. ock release pin into the lock release hole 28 Controls Display Window and Connections Welch Allyn Spot Vital Signs LXi Sp0 Sensor Spot LXi is available with a wide variety of SpO sensors and ships with a reusable finger clip sensor All other sensors are accessory items that are sold separately see Pulse Oximetry on page 73 1 Align the shape and pin configuration of the extension cable connector to the SpO cable connection port on the left side of the Spot LXi device 2 Push the connector firmly into the SpO cable connection port until you hear it click into place see Figure 5 on page 25 3 Align the opposite end of the extension cable to the sensor cable connector and firmly push them together Note Use only Masimo or Nellcor SpO sensors and accessories with the Spot LXi with Masimo or Nellcor configurations respectively Ouick Reference Card Attach the Ouick Reference Card to the Spot LXi handle mobile stand or wall mount using the supplied plastic cable tie AC Power Transformer The operator can use the Spot LXi with AC or battery power after charging the battery 1 Insert the round transformer connector into the AC power connection port on the back of the Spot LXi see Figure 5 on page 25 2 Insert the line cord into the line connector on the transformer then plug the power cord on the transformer into the AC main power source to charge the battery Directions for Use Battery Controls
67. od Pressure Cautions anta O eho ida aed oe Set 10 Temperature Cautions ueu Bose i Ba Baro ting dl An ess A NR 10 SPOS CAUUONS 4 fest Big Dw bah ae Ae Bid da AG grd UU 10 Mises en gardes et avertissements 11 Mises en garde g n rales 11 Mises en garde relatives la pression art rielle 13 Mises en garde relatives la temp rature 14 Mises en garde relatives au SpOz 15 Avertissements g n raux 16 Avertissements relatifs la pression art rielle 17 Avertissements relatifs la temp rature 17 Avertissements relatifs au SpO2 LL 18 GonitentsicheckKliSt gt 45 eu en RAT CY CF WN faeces ca eue O 19 Possible Attachments ebu la fy 19 2 Controls Display Window and Connections 21 CONTO Ts a Me eke eh NN HN FUR HR RR WN 21 Display Window kr ses GA GYNI O GIDA NIN DH WG O AG OD IA 23 GOnneetiOn seis we Lime sait ARS of DAY GE ic Y Rydd rhy ney AY nei A 25 Braun ThermoScan PRO 4000 Lock 26 Blood Pressure Hose and Cuff 2 26 vi Contents Welch Allyn Spot Vital Signs LXi Thermometer o oa Ha A ed E a N eos Ceres 27 SPOS SENSOR sak bunau i elk het Ar ent GN DD er nee A 28 QUICK Reference Lard e d
68. ode Description Corrective Action C12 Device outside operating temperature Change ambient temperature range C13 Low battery level Charge battery E30 Internal malfunction Contact Technical Service E31 Internal malfunction Contact Technical Service E32 Internal malfunction Contact Technical Service E33 Internal malfunction Contact Technical Service E38 Date and time not set Set date and time see Date Time Menu Options on page 32 E42 Internal malfunction Contact Technical Service E44 Internal malfunction Contact Technical Service E45 Internal malfunction Contact Technical Service Table 13 Blood Pressure Error Codes Code Description Corrective Action C01 Blood pressure reading cancelled by user Retake blood pressure reading C02 Unable to release cuff pressure Check tubing for kinks and connection integrity C03 Inflation too quick Check tubing and connections C04 Air leak Check blood pressure cuff and tubing connections C05 Unable to determine blood pressure Check connections restrict patient movement CO6 Unable to determine blood pressure Check connections restrict patient movement C07 Internal NIBP error Device will power down E10 Cuff pressure limits exceeded Device will power down E11 Cuff pressure duration exceeded Device will power down E20 Internal NIBP error Device will power down 50 Troubleshooting Welch Allyn Spot Vital Signs LXi Table 14 SureTemp Plus Temperature Error Code
69. oe iad Mik act MR AN MU Y Boda o A MU 64 UR A CN CR ET NND FYN HN AN 64 Battery Replacement FY I RF eee 65 Spot Vital SINS Ani Den A Y GYT oid ede paw 4 65 Braun ThermoScan PRO 4000 65 PAN Mu LEARN es GYNI Yd Lacan NF den AE ADE e 66 CAlIB tION SLR YS du ta Mle oe do GA YD WG de 67 Blood Pressure Calibration Check 67 Temperature Calibration Check 68 Masimo SpO Calibration Check 2 0 0 0 0 00 00 68 Nellcor SpO Functional Check 68 Product DISpOSall ss uu A eee ada 68 SEWICE UE a Et MeN o A di ed A A re HR PLAN da 69 Technical ASSISTANCE eu ae a ltda FR dad e OG Bae A Wd ir 69 Service Manual Spare Parts 69 Service LOAN GIS vant Baw ke t O RC ROE CN 69 11 Supplies and Accessories 71 Blood Press re ser AE AN ND a Re 71 T Mperature tt A ne a a NY AD sn A 72 Pulse OXIME ar gares nanas A ee oa Eee See NG MAS 73 Masimo Accessories a asus ab oh aa ada al Wyd Lee Ty Bydd A WAG 73 NellcormAcCessoriGSu uu ais y Y Yg AW ne eh hae iin ee te edy RR 74 Miscellaneous cud en Ais Pea Y Vie deel Y gyn ddyn AF 75 SERVICE COMPACTS ueu Be acd Se ohn dB ADO NOG UL Seed 75 Warranty ua et et ee tae Bete a DD dy a AC 77 SPORLA 4e ts oh Y Y eine fe he Tee ae 77 ACCESO NOS at au ral AR A wd AM yo Ore nth eds Vale es rie 77 viii Conte
70. on is entered see Location Identifier in Table 2 Configuration Menu Options the date will not appear on the Display Window the location will Displays the time in one of the following styles e 12 hour example 5 00 PM e 24 hour example 17 00 Changes the time on the Display Window Directions for Use Internal Configuration 33 Table 4 Blood Pressure Menu Options Setting Description BP Calibration Check Blood Pressure Units Prepares the Spot LXi for calibration Only gualified personnel should verify the Spot LXi blood pressure calibration For more details see Calibration on page 67 mmHg or kPa Mean Arterial Pressure MAP On or off Table 5 Temperature Menu Options Setting Description Temperature Units Temperature Mode Fahrenheit F or Celsius C SureTemp Plus models only Oral Pediatric Axillary Adult Axillary and Last Mode In Last Mode the device takes the next temperature in the mode in which the previous temperature was measured Rectal Mode is available only when the rectal probe red ejection button and probe well are attached Table 6 Manual Parameters Menu Options Setting Description Height Height Units Height Default Weight Weight Units Weight Default Respiration Pain Level On or off Inches in or centimeters cm Changes the default patient height displayed in the Navigation Window On or off Even
71. or in combination with this device fall within the scope of one or more of the patents relating to this device Nellcor and Oxi Max are registered trademarks of Nellcor Puritan Bennett Inc Software in this product is Copyright 2008 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 software remain with Welch Allyn or its vendors For information about any Welch Allyn product call Welch Allyn Technical Support USA 1 800 289 2501 Australia 61 2 9638 3000 Canada 1 800 561 8797 China 86 21 6327 9631 European Call Center 353 46 90 67790 France 33 15 5695 849 Germany 49 695 098 5132 Japan 81 3 6383 0852 Latin America 1 305 669 9003 Netherlands 31 202 061 360 Singapore 65 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Manual Material No 705310 Rev F Printed in USA Welch Allyn 4341 State Street Road Skaneateles Falls NY 13153 USA European Regulator
72. ose his her lips Figure 9 Sublingual Pocket Location SUBLINGUAL POCKET b For axillary temperatures lift the patient s arm so that the entire axilla is easily seen and place the probe as high as possible in the axilla Do not allow the probe tip to come into contact with the patient until the probe is placed in the measurement site Any prior contact between the probe tip and the tissue with another material may cause inaccurate readings Verify that axillary tissue completely surrounds the probe tip and place the arm snugly at the patient s side Directions for Use 6 8 Temperature Operation 39 Firmly hold the probe in place and keep the tip of the probe in contact with the tissue throughout the measurement process During the measurement process the temperature display area displays rotating walking segments The device beeps when the final temperature is reached The temperature display area displays the patient temperature temperature scale and measurement site The temperature is shown in degrees Fahrenheit and degrees Celsius for 5 seconds in the Navigation Window To switch to Monitor Mode leave the probe in place The Spot LXi automatically switches to Monitor Mode after approximately 30 seconds Once in Monitor Mode proceed to Step 6 on page 40 Remove the probe after the temperature measurement is complete and firmly press the ejection button on the top of the probe to release the probe cover R
73. ot LXi with the Braun ThermoScan PRO 4000 thermometer takes a temperature in the ear The thermometer probe shape prevents insertion far into the ear canal which could perforate the tympanic membrane A WARNING Keep the probe window clean dry and undamaged at all times to ensure accurate measurements To protect the probe window always keep the thermometer in the storage cover while transporting or when not in use WARNING Only use Braun ThermoScan probe covers with this thermometer Using other manufacturer s probe covers or no probe cover may produce temperature measurement errors and or inaccuracies If the thermometer is used without a probe cover attached clean the lens see Braun ThermoScan PRO 4000 Thermometer on page 64 WARNING Do not autoclave WARNING The thermometer is not waterproof Do not immerse or drip fluids on it Should this occur dry the thermometer with warm air Check for proper operation and accuracy To take an ear temperature reading 1 2 Pull the bottom of the thermometer gently toward you to remove it from the housing Locate the probe cover box inside the thermometer housing Firmly push the probe tip into the probe cover box When the probe cover is in place the thermometer turns on automatically Listen for the ready signal beep and three dashes to appear on the thermometer display Fit the probe snugly into the ear canal and then push the Start button a If the probe is positioned
74. ou utilisez l un des accessoires de fixation en option Avertissement Ne placez pas de liquides sur ou proximit du dispositif Avertissement Nous recommandons d utiliser le dispositif dans les plages de temp rature op rationnelle indiqu es see Environmental on page 59 Le dispositif ne sera pas conforme aux performances sp cifi es s il est utilis hors de ces plages de temp rature Avertissement Pour une isolation lectrique appropri e du patient utiliser exclusivement une alimentation Welch Allyn 4500 101 A pour charger le Spot LXi Ne pas utiliser le chargeur de la balance fournie par le fabricant lorsque celle ci est reli e au Spot LXi Lors du chargement du Spot LXi il convient de charger son imprimante l aide de l alimentation 713703 ou BC1300M Avertissement D branchez toujours le transformateur d alimentation C A de la prise avant de placer le pied mobile dans un nouvel endroit Avertissement La capacit du panier est limit e 1 32 kg ll est donc important de ne pas d passer cette limite Avertissement Utilisez exclusivement une batterie de 9 V avec la balance Healthometer Retirez et jetez le dispositif d alimentation mural Avertissement La balance Healthometer REF 349KLX ne se vend pas avec un c ble de type RS 232 pour connecter la balance au Spot LXi Pour pouvoir r aliser cette op ration vous devez acheter un c ble standard de type RS 232 Avertissement Pour utiliser la balance He
75. phase 4 is to be used Deflate cuff no faster than 3 mmHg per second e One of the major sources of error in auscultatory blood pressure measurement is deflating the cuff too quickly The American Heart Association recommends deflation no faster than 3 mmHg per second Only use a sphygmomanometer that is calibrated e An uncalibrated sphygmomanometer may result in inaccurate blood pressure measurements Poor auscultatory sound recognition by observer Use high quality stethoscope Have a different observer check patient s blood pressure Table 17 Cuff Inflation and Deflation with No Blood Pressure Reading Displayed or Error Code in Display Possible Cause Leak in pneumatic system Corrective Action and Explanation Ensure all cuff attachments are tight Carefully check for leaks in the blood pressure cuff tubing and pressure hose attached to Spot LXi Arm movement during cycle Keep arm still during blood pressure cycle Movement may cause inaccuracies from artifact long cycle times and error message Cuff tubing or pressure hose movement artifact Do not contact cuff tubing or pressure hose during blood pressure cycle Movement may cause inaccuracies from artifact 52 Troubleshooting Table 18 No Cuff Inflation Welch Allyn Spot Vital Signs LXi Possible Cause Corrective Action Connections between device and cuff loose Check all connections
76. pot Vital Signs LXi also calculates Body Mass Index BMI following height and weight entry The device is intended to be used by clinicians and medically gualified personnel It is available for sale only upon the order of a physician or licensed health care provider 2 Introduction Welch Allyn Spot Vital Signs LXi Symbols The following symbols are associated with the Spot Vital Signs LXi Safety Symbols Identifies information within the Identifies information within the manual to avoid injury A manual to avoid equipment failure Caution consult accompanying Internally Powered Lead Acid documents Pb Battery Handle with Care Transport Temperature Storage Humidity gw Recycle Class II Equipment IPXO a against Type BF Equipment D On Off Non ionizing radiation RF Recycle the product separate from e transmitter other disposables see Product Disposal on page 68 M blo OOF gt Mode of Operation Continuous DC Power In Button Symbols Navigation Buttons Select Power On Off O80 o Blood Pressure Memory A MEM Connection Symbols 2 USB Connection 10101 Serial Port Connection Directions for Use Introduction Agency Symbols CONFORMS TO UL STD 60601 1 IEC 60601 1 C The CE mark on this product indicates that it has been tested to and conforms with the provisions noted within the 93 42 EEC Medical Device Directive 0297 Ml Am Navan Business Park Dublin Road Nav
77. pulsations Significant levels of dysfunctional hemoglobins e g carboxyhemoglobin or methemoglobin Patient has hypotension severe vasoconstriction severe anemia or hypothermia Exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilrubin lamps fluorescent lights infrared heating lamps or direct sunlight exposure to excessive illumination can be corrected by covering the sensor with a dark or opague material WARNING Tissue damage can be caused by incorrect application or duration of use of a Nellcor OxiMax sensor Inspect the sensor site as directed in the sensor WARNING _Do not use a damaged sensor or pulse oximetry cable or a sensor with exposed optical components If blood pressure measurement is occurring simultaneously place the finger clip sensor on the limb opposite the one with the blood pressure cuff 1 Insert the patient s finger completely into the sensor the thumb is specifically not recommended for use with the Nellcor finger clip sensor The pulse signal bar graph illuminates indicating the relative strength and guality of the patient s pulses at the sensor site The sensor takes approximately 10 seconds to determine the initial SpO596 value and pulse rate When the initial values are determined they are shown in the SpO display and the pulse rate display respectively If the accuracy of any measurement does not seem reasonable first use an alternat
78. pulse oximeter may affect the MRI image and the MRI unit may affect the accuracy of the oximetry measurements WARNING Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation WARNING Failure to cover the Nellcor OxiMax sensor site with opaque material in high ambient light conditions may result in inaccurate measurements WARNING Do not use the pulse oximeter as a replacement or substitute for ECG based arrhythmia analysis General Cautions A caution statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to equipment failure equipment damage or data loss These cautions pertain to the entire Spot Vital Signs LXi device A Caution f the accuracy of any measurement is in question check the patient s vital sign s with an alternate method and then check to verify the device is functioning properly Caution Place the device on a secure surface or use one of the optional mounting accessories Caution Do not place fluids on or near the device Caution ltis recommended that the device is used within stated operating temperature ranges see Environmental on page 59 The device will not meet its performance specifications if used outside these temperatures ranges Caution For proper patient electrical isolation use only a Welch Allyn power supply 4500 101A to charge Spot LXi Do not use the weight scale manufa
79. que lorsque le puits de sonde est en place Avertissement N utilisez pas de piles alcalines dans le Braun ThermoScan PRO 4000 Avertissement Mordre la pointe de la sonde risque d endommager la sonde 18 Introduction Welch Allyn Spot Vital Signs LXi Avertissements relatifs au SpD Ces avertissements ont trait la fonction Spot LXi SpO Avertissement L oxym tre de pouls est calibr de fa on d terminer le pourcentage de A la saturation art rielle en oxyg ne de l h moglobine fonctionnelle Des teneurs importantes en h moglobine dysfonctionnelle comme la carboxyh moglobine et la m th moglobine peuvent alt rer l exactitude de la mesure Avertissement Certains capteurs peuvent s av rer inappropri s pour un patient donn Si vous ne parvenez pas observer un minimum de 10 secondes de pulsations de perfusion sur un capteur donn changez l emplacement du capteur ou le type du capteur jusqu ce que cette observation soit faite Avertissement Les conditions physiologiques les proc dures m dicales ou les agents externes pouvant interf rer avec la capacit de l oxim tre du pouls de d tecter et d afficher les mesures incluent l h moglobine dysfonctionnelle les colorants art riels les perfusions faibles les pigments fonc s et les agents colorants application externe tels que les vernis ongle les teintures ou les cr mes pigment es Avertissement Lorsque vous s lectionnez un capteur consid rez le poids et
80. r tremors WARNING Use only Welch Allyn blood pressure cuffs and or hoses Using other manufacturers blood pressure cuffs and or hoses may produce inaccurate blood pressure readings WARNING When several blood pressure measurements are taken on the same patient regularly check the cuff site and extremity for possible ischemia purpura and or neuropathy WARNING Do not allow a blood pressure cuff to remain on the patient more than 10 minutes when inflated above 10 mmHg This may cause patient distress disturb blood circulation and contribute to injury of peripheral nerves WARNING Do not place the cuff on any extremity that is used for intravenous infusions or any area where circulation is compromised WARNING _Excessive cuff tightness may cause venous congestion and discoloration of the limb WARNING Wrapping the cuff too loosely preventing proper inflation may result in errors WARNING Do not change the connector s on the blood pressure cuff tubing of this device to luer type Luer type connectors are commonly used in intravenous infusion systems Using the luer connectors on blood pressure cuff tubing creates the risk that the blood pressure tubing could be mistakenly connected to a patient s intravenous line resulting in the introduction of air into the patient s circulatory system Directions for Use Introduction 7 Temperature Warnings These warnings pertain to the Spot LXi temperature feature SureTemp Plus
81. r un technicien d entretien qualifi qui s assurera de son bon fonctionnement N utilisez pas le Spot LXi en cas de signe d endommagement Contactez le service client le Welch Allyn pour assistance MISE EN GARDE N utilisez pas simultan ment un capteur de doigt SpO et un brassard sur le m me membre Ceci risquerait d entra ner des lectures inexactes de la fr quence du pouls et de la perfusion MISE EN GARDE Le port USB est strictement r serv aux op rations d entretien Ne I utilisez pas pour le raccordement d quipements externes MISE EN GARDE Tous les connecteurs d entr e et de sortie du signal I O sont con us pour le branchement uniquement d appareils conformes aux normes CEI 60601 1 ou autres normes CEI par exemple CEI 60950 selon ce qui est adapt l appareil Le branchement d autres appareils au Spot LXi peut augmenter le courant de fuite Pour assurer la s curit de l op rateur et du patient il est n cessaire de prendre en compte les exigences de la norme CEI 60601 1 1 MISE EN GARDE Pour une isolation lectrique appropri e du patient utiliser exclusivement une alimentation Welch Allyn 4500 101 A pour charger le Spot Vital Signs LXi Ne pas utiliser pas le chargeur fourni par le fabricant pour charger la balance lorsque celle ci est reli e au Spot LXi REMARQUE lors du chargement du Spot LXi il convient de charger son imprimante l aide de l alimentation 713703 ou BC1300M Directions for Use I
82. rate axillary temperature readings 38 Temperature Operation Welch Allyn Spot Vital Signs LXi To take a temperature in oral or axillary mode WARNING Do not take an axillary temperature through the patient s clothing Direct contact between the patient s skin and the probe is reguired Caution Use the temperature probe with the blue ejection button and blue probe well to obtain accurate oral or axillary temperatures 1 Verify that the oral probe blue ejection button and matching probe well are installed see SureTemp Plus on page 27 2 Hold the probe handle with your thumb and two fingers on the indentations of the probe handle and withdraw the probe from the probe well 3 Verify the desired temperature mode in the temperature display area and the desired temperature mode icon is flashing Figure 8 Temperature Mode Icons Oral Adult Axillary e Pediatric Axillary If the desired mode is not selected press the Navigation button up or down until the desired mode is highlighted in the Navigation Window and the correct icon is flashing in the temperature display area Then press the Select button 4 lnsert the probe into a probe cover and press the probe handle down firmly The probe handle moves slightly to engage the probe cover 5 Quickly put the probe in place a For oral temperatures place the probe tip under the patient s tongue on either side of the mouth to reach the sublingual pocket and ask the patient to cl
83. re initial use Environmental WARNING This device is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide An explosion may result Operating Temperature 50 to 104 F 10 to 40 C Storage Transport Temperature Device with SureTemp Plus 13 to 1319F 259 to 55 C Device with Braun ThermoScan PRO 4000 4 to 1229F 20 to 50 C Relative Humidity 15 to 95 non condensing Operating Altitude 557 to 16 000 ft 170 to 4877 m Patents The Spot LXi is covered under the following patents 6 827488 6 971 790 and other patents pending 60 Specifications Welch Allyn Spot Vital Signs LXi Guidance and Manufacturer s Declaration Emissions and Immunity Information Electromagnetic Emissions The Spot Vital Signs LXi is intended for use in the electromagnetic environment specified below The customer or user of the Spot Vital Signs LXi should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The Spot Vital Signs LXi 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 CISPR 11 eguipment RF emissions Class B The Spot Vital Signs LXi is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage CISPR
84. s Code Description Corrective Action C22 Temperature time limit exceeded Remove probe from patient E0 1 Probe heater error Retake reading If problem persists replace probe E0 2 Thermometer probe or device malfunction Replace probe If problem persists contact Technical Service E0 4 Probe is over temperature If problem persists contact Technical Service E0 5 Unable to determine temperature Retake reading If problem persists replace probe E0 6 Probe data error Retake reading If problem persists replace probe E0 7 Broken thermometer probe Replace probe E0 8 Cannot read the probe s configuration Contact Technical Service information E0 8 Temperature module data error Contact Technical Service to return the device E0 8 Cannot read the device s Error Log This problem will correct itself If it persists contact Technical Service E0 9 Broken thermometer probe Replace probe E4 0 Internal temperature malfunction Retake temperature If problem persists contact Technical Service E4 1 Internal temperature malfunction Retake temperature If problem persists contact Technical Service E4 2 Internal temperature malfunction If problem persists contact Technical Service E4 3 Internal temperature malfunction If problem persists contact Technical Service E4 4 Temperature ma
85. se the Navigation buttons to scroll to the appropriate reading and press the Select button Use the Navigation buttons to scroll to Print and then press the Select button A Caution Only use a 9V battery with the weight scale Do not use the weight scale s external power supply Caution When using the Healthometer scale remove the two hex nuts on the RS 232 cable as supplied before screwing the cable into the scale base The Healthometer scale is not sold with an RS 232 cable to connect the scale to the Spot Vital Signs LXi The customer must purchase a standard RS 232 cable If the weight scale is enabled in the Internal Configuration Mode you cannot manually enter the patient s weight The Spot LXi supports the Healthometer http www healthometer com Tanita http www tanita com weight scales 1 2 Follow the weight scale s instructions to zero out the weight scale Instruct the patient to step on the scale and to remain relatively still until the weight levels out The Spot LXi display shows the weight The patient may step off the scale the weight will remain on the display Barcode Scanner The Internal Configuration Mode allows you to enable the scanning of patients and or clinicians barcodes for identification purposes The barcode scanner supports most linear barcodes 1 2 Remove the barcode scanner from its holder Hold the scanner approximately 6 inches 15 4 cm from the barcode and sgueeze
86. sont pas tanches N immergez pas ces l ments et ne faites pas tomber de gouttes dessus Si cela se produisait s chez les connecteurs et la sonde avec de l air chaud V rifiez ensuite que toutes les fonctions sont bien op rationnelles et fournissent des r sultats exacts MISE EN GARDE Ne prenez pas la temp rature axillaire au dessus des v tements du patient La sonde doit toucher directement la peau MISE EN GARDE Ne pas passer l autoclave MISE EN GARDE Utilisez des protections de sonde usage unique et jetables afin de limiter la contamination crois e entre patients MISE EN GARDE l insertion incorrecte de la sonde risque de provoquer la perforation des selles MISE EN GARDE Se laver les mains r duit consid rablement le risque de contamination crois e entre les patients et le risque d infection hospitali re MISE EN GARDE Pour vous assurer d obtenir une exactitude optimale assurez vous toujours que le mode appropri est s lectionn Directions for Use Introduction 15 Braun Thermoscan PRO 4000 Ces mises en garde sont sp cifiques l option du thermom tre Braun ThermoScan PRO 4000 MISE EN GARDE Maintenez tout moment la fen tre de la sonde propre s che et sans dommages pour vous assurer de l exactitude des mesures Pour prot ger la fen tre de la sonde gardez toujours le thermom tre dans sa protection de rangement lorsque vous ne le transportez pas ou ne l utilisez pas MISE EN GARDE
87. ter only PULSE v min OZ gt Weight Pain range limits For devices with Height Clear SureTemp Plus thermometer only Respiratip Send Next Reading Out of range indicator shows the patient s temperature reading above or below the measurement Enter Pulse display shows the pulse rate Pulse Signal Bar Graph shows the strength of the pulses detected Clinician ID icons The figure icon signifies that Spot Vital Signs LXi reguires the clinician to enter the Clinician ID The check mark signifies Spot Vital Signs LXi has recorded the Clinician ID For devices with a bar code scanner only Directions for Use Controls Display Window and Connections 25 Connections Use the following instructions to connect the blood pressure hose thermometer probe and optional attachments to the Spot Vital Signs LXi Figure 5 Spot LXi Side and Rear Panel Connections SpO cable SureTemp Plus thermometer connection connection port for units port for with SureTemp Plus only units with SpO only Blood pressure hose connection port Port I for external device connection DC power connection port USB connection for PC behind plug Port ll for external device connection Battery door Mobile stand or wall mount screw connection 26 Controls Display Window and Connections Welch Allyn Spot Vital Signs LXi Braun ThermoScan PRO 4000 Lock Press the lock tab toward the Braun ThermoScan PRO 4000
88. ternal Configuration Mode you can use plain or label paper If you use label paper you must clean the printer heads after every 10 rolls A head cleaner kit is provided with each package of label paper available from Welch Allyn To connect the printer to the Spot LXi 1 Connect the the large end of the cable 405210 to the Spot LXi 2 Connect the small end of the cable 405210 to the Spot LXi printer Connect to Connect to Spot LXi Spot LXi printer To charge the Spot LXi printer 1 Remove the guard on the power supply body 713703 or BC1300M and attach the appropriate power supply plug adapter 2 Connect the Spot LXi printer power supply to the Spot LXi printer 3 Charge the Spot LXi printer for at least 6 hours before initial use To enable the Spot LXi printer 1 Connect the Spot LXi printer to the Spot LXi 2 Enable the printer in the Internal Configuration Mode of the Spot LXi see Internal Configuration on page 31 and then see Table 7 on page 34 To print the most recent reading 1 Press the Memory button to recall the last reading Directions for Use 2 Manual Entries and External Device Operation 47 Use the Navigation buttons to scroll to Print and then press the Select button To print a previous reading 1 2 3 Weight Scale Press the Memory button the most recent reading is displayed Use the Navigation buttons to move to Scroll and then press the Select button U
89. the button so that the light from the scanner appears on the barcode The scanner provides an audible tone with each successful barcode reading If the scanner has difficulty reading the barcode slowly adjust the distance and the angle between the scanner and the barcode while sgueezing the scanner button If it continues to have difficulty verify that the barcode is as flat as possible The patient identification number displays in the Navigation Window on the Spot LXi display However if both Patient ID and Clinician ID are enabled in the Internal Configuration Mode Spot LXi asks if the scanned ID is for the patient or the clinician If Patient ID is enabled and the Clinician ID is disabled in the Internal Configuration Mode Spot Vital Signs LXi interprets the scanned bar code as the Patient ID 48 Manual Entries and External Device Operation Welch Allyn Spot Vital Signs LXi Follow the instructions on the display Clinician ID numbers do not appear on the Spot LXi display however they are retained in memory for recall printing or to send electronically to patient records Troubleshooting 49 Error Codes The following tables of error codes provide a quick reference of the descriptions and probable causes of error codes For service level troubleshooting refer to the Service Manual part number 704432 Table 12 General Error Codes C
90. the battery into the compartment as far as it will go Push the connector down into the case next to the battery 5 Replace the battery door and tighten each of the four screws 6 Connect the AC power transformer to the Spot LXi and allow the new battery to charge for approximately 6 hours The rechargeable batteries in the Braun ThermoScan PRO 4000 thermometer requires an additional 1 hour to charge You can use the Spot LXi during this charging period via the AC power cord If Spot LXi displays the E38 error code after power up set the date see Date Time Menu Options on page 32 ay The battery is a non spillable lead acid battery and must be recycled or e disposed of properly according to national or local regulations Braun ThermoScan PRO 4000 Caution Do not use alkaline batteries in the Braun ThermoScan PRO 4000 NM thermometer 66 Maintenance and Service Welch Allyn Spot Vital Signs LXi Welch Allyn supplies a rechargeable battery pack with the Braun ThermoScan PRO 4000 thermometer 1 Open the battery compartment 2 Remove the battery pack and replace with a new battery pack verify the poles are in the right direction 3 Slide the battery door back in until it snaps into place If the battery is completely discharged the LEDs will not illuminate Allow the unit to charge at least 15 minutes before proceeding ay The battery is a rechargeable battery and must be recycled or disposed of properly according to na
91. tion Key 01802 11 S S Sure Temp Plus Oral Well S S 9 600 Plus Calibration Tester 05031 10 Disposable SureTemp Plus Probe Covers 1 000 covers packaged 25 box Table 34 Braun ThermoScan PRO 4000 REF Description 04000 20 A Braun ThermoScan PRO 4000 Thermometer for North America South America and Asia Pacific 04000 60 05075 80 A B Braun ThermoScan PRO 4000 Disposable Probe Covers Case of 800 covers for North America South America and Asia Pacific aun ThermoScan PRO 4000 Thermometer for Europe Middle East and Africa 04000 80 A Braun ThermoScan PRO 4000 Disposable Probe Covers Case of 800 covers for Europe Middle East and Africa 01802 11 9600 Plus Calibration Tester 53020 00 Braun ThermoScan PRO 4000 Rechargeable Battery Pack 4500 53 Braun Locking Key Directions for Use Pulse Oximetry Masimo Accessories Table 35 Adhesive Sensors Single Patient Use Supplies and Accessories 73 Catalog Description Weight Range Ouantity LNCS ADTX Adhesive Finger Sensor Adult 20 per case gt 30 kg LNCS ADTX LNCS PDTX Adhesive Finger Sensor Pediatric 20 per case 10 to 50 kg LNCS PDTX LNCS INF L Adhesive Finger Sensor Infant 20 per case 3 to 20 kg LNCS INF L LNOP ADT Adult sensor gt 66 Ibs 30 kg 20 LNOP PDT Pediatric sensor
92. tional or local regulations Printer A Caution Do not use alkaline batteries in the printer 1 2 Open the battery compartment Remove the battery pack and replace with a new battery pack verify the poles are in the right direction Slide the battery door back in until it snaps into place Allow the printer to charge at least 6 hours before initial use ay The battery is a rechargeable battery and must be recycled or disposed of properly according to national or local regulations Directions for Use Maintenance and Service 67 Calibration Blood Pressure Calibration Check The calibration check is a simple yet valuable test to determine that the unit is sensing pressure accurately Verify the pressure measurement accuracy of the Welch Allyn Spot LXi with an accurate calibrated pressure meter or sphygmomanometer To perform the calibration check Have the following eguipment available e Accurate calibrated pressure meter or e 4 tubing with an inside diameter of sphygmomanometer approximately 250 quantity 3 each e__ T connector e Bulb and valve 5088 01 e Female fittings 12P524 1 quantity 2 each 1 Disconnect the blood pressure cuff from the blood pressure tubing 2 Attach two pieces of the 4 tubing to the T connector Verify that the tubing is positioned perpendicular to each other 3 Attach the pressure meter or sohygmomanometer to one of the tubes and the bulb and value assembly to the se
93. urer l int grit des donn es enregistrez les mesures et effacez l affichage du Spot LXi entre les patients MISE EN GARDE Le Spot LXi n est pas con u pour r sister aux d fibrillateurs MISE EN GARDE Le Spot LXi n est pas destin tre utilis pendant le transport des patients MISE EN GARDE Ce dispositif n est pas adapt aux utilisations en pr sence d un m lange anesth sique inflammable contenant de l air de l oxyg ne ou de l oxyde nitreux Une explosion pourrait se produire MISE EN GARDE Pour garantir la s curit du patient utilisez seulement les accessoires et fournitures par ex brassards sondes de temp rature d tecteurs de SpO capteurs etc recommand s pour ou fournis avec le Spot LXi L utilisation d accessoires non approuv s pour le Spot LXi est nuisible la s curit du patient et ou de l op rateur MISE EN GARDE Veillez viter que de l eau ou d autres fluides p n tre nt dans l un des connecteurs du dispositif Si cela se produisait s chez les connecteurs avec de l air chaud V rifiez l exactitude de toutes les fonctions op rationnelles MISE EN GARDE Tous les trois mois inspectez le brassard le c ble du SpO et les autres accessoires pour v rifier qu ils ne sont pas effiloch s ni autrement endommag s Remplacez les si n cessaire MISE EN GARDE N utilisez pas le Spot LXi sur des patients raccord s des appareils cardiaques respiratoires AVERTISSEMENT Risque d lectrocutio
94. vigation Window returns to its previous state with the accepted parameter value appearing next to the parameter heading in the list If a parameter is entered incorrectly repeat these steps to correct the value Body Mass Index Body Mass Index BMI is calculated with weight and height entry After you save the reading press the Memory button to view the BMI calculation as part of the entire reading Memory Recall The Memory button allows you to scroll through print or erase readings 1 Press the Memory button Spot Vital Signs LXi displays the previous MEM reading The Navigation Window displays the scroll print erase and erase all options Scroll Allows the user to move up and down through the saved readings with the Navigation button Print Sends the current reading to the printer see Printer on page 46 Erase Removes the displayed record from memory Yes or no Erase All Removes all records from memory Yes or no 46 Manual Entries and External Device Operation Welch Allyn Spot Vital Signs LXi 2 Press the Navigation buttons to select the desired function and press the Select button Follow instructions on the display External Devices Printer You must enable each external device in the Internal Configuration Mode before using it see Table 7 on page 34 Verify that each device is attached on the back of Spot LXi as instructed in the Internal Configuration Mode Once the printer is enabled in the In
95. wo fingers on the indentations of the probe handle and withdraw the probe from the probe well 8 Insert the probe into a probe cover and press the probe handle down firmly The probe handle moves slightly to engage the probe cover 4 Take the patient s temperature using the Normal Mode as previously described Leave the probe in place after Spot LXi beeps and the temperature is displayed 5 Hold the probe in place for approximately 30 seconds after the temperature is displayed until the temperature display shows the Monitor Mode indicator MONITOR 6 Hold the thermometer in place for a total of three minutes for oral and rectal mode or five minutes for axillary mode The thermometer will not beep to indicate a final temperature 7 Record the temperature before removing the probe from the site the monitored temperature is not stored in memory for recall 8 Remove the probe from the patient and firmly press the ejection button on the top of the probe to release the probe cover 9 Return the probe to the probe well to reset the thermometer to Normal Mode Temperature Measurement Range Indicators When Spot LXi detects a temperature out of the SureTemp Plus measurement range it beeps twice and displays the exceeded temperature limit A small arrow flashes to indicate whether the out of range temperature measurement is too high up arrow or too low down arrow Directions for Use Temperature Operation 41 Ear Temperatures Sp
96. workmanship The barcode scanner is covered by a five year warranty against original defects in material or workmanship WelchAllyn Advancing Frontline Care Material No 705310 Rev F
97. y Manager Welch Allyn Ltd Navan Business Park Dublin Road Navan County Meath Republic of Ireland Tel 353 46 90 67700 Fax 353 46 90 67755 WelchAllyn Advancing Frontline Care C 0297 Directions for Use Initial Configuration Before using Spot LXi for the first time you must program an initial configuration screen See page 23 for more details Change Local Defaults Menu Model No 45NTO Serial No 2005040004 Language BP Units Temperature Units Height Units Weight Units Date Format Date Time Format Time Select Welch Allyn Spot Vital Signs LXi Contents Initial zContiguratiOn aeh ab Rak dau a do AREA ad ne ee he MA RD dd dB ill OILS INES teh ys es Oo de RC wa is MW Ae natin v VALE A UCA A ai 1 intended Us dd sd WY DY ak 1 SUMBOIS AN Eee Mn a cta E al DD e dede rd A TN gs nlc Bary A A an 2 Sale ly SYEODO S 8 4 a a a ds od Fa A 2 PUO OOO E gt gt dl ER in GAE GT 2 Connection SYDS sec iu oi mi aW on E A 2 Agenecy oymbol8 A YF Y ol aah yd 3 Related Publications sa uy uyg date mes APSR EYE DE DRAG pe wo RA Y 3 Warnings and Cautions 3415404082 GE dl e dt dol gydd hah omy doch NA 4 General Nangis piste SUR WN data a De O E 4 Blood Pressure Warnings seuraa vee at be In WAE 6 Temperature Warnings 7 SDO gt VVamimngSa ee et de ge ee gad nk ES RENE aaa ee A 8 G n ral Cautions er duU wo GR sca Ter Om Gos tes 9 Blo
98. y button option recalls up to 50 most recent measurements Blood Pressure Start Stop button initiates a new blood pressure cycle Pressing again aborts an active blood pressure measurement Directions for Use Controls Display Window and Connections 23 Display Window Before using Spot LXi for the first time you must program an initial configuration screen 1 Press the Power button The display window shows the initial configuration screen Figure 3 Initial Configuration Screen Change Local Defaults Menu Model No 45NTO Serial No 2005040004 Language BP Units Temperature Units Height Units Weight Units Date Format Date Time Format Time 2 Use the Select button to access the options and accept the entries and use the Navigation buttons to move through the menu 3 The word Exit appears at the bottom of the list after you have programmed all items in the menu You must program all items before you can start to use the device 4 Scroll to Exit and press the Select button to save the entries 24 Controls Display Window and Connections Welch Allyn Spot Vital Signs LXi The liguid crystal display LCD may indicate any of the following systolic blood pressure mmHg or kPa diastolic blood pressure mmHg or kPa MAP mmHg or kPa temperature F or C temperature mode pulse rate pulse signal level SpO percent department location date time record number height in or
99. zing of the cuff is important for accurate blood pressure readings If the cuff is too small or too large you may have false high or low readings respectively When there is an area of overlap for using a smaller or larger cuff use the larger size cuff The device uses oscillometric technology therefore if the cuff extends to the antecubital fossa bend in the elbow this does NOT result in an inaccurate blood pressure reading Measure the arm circumference midway between the elbow and shoulder for the correct Reusable Two Piece Cuff size Table 10 or Durable One Piece Cuff size Table 11 Wrap the cuff around the patient s upper arm and verify that the artery index marker falls within the two divisions that identify the range on the cuff to indicate a proper fit Table 10 Reusable Two Piece Cuff Measurements Cuff Size Reusable Maximum Maximum Two Piece Cuff Range Range 1 per pack cm in Child 4500 01 20 8 8 2 Adult 4500 02 31 5 12 4 Large Adult 4500 03 38 4 15 1 Thigh 4500 04 47 4 18 7 Table 11 One Piece Cuff Measurements Cuff Size Reusable One Piece Cuff Disposable One Piece Range Range 1 per pack Cuff 20 per pack cm in Infant REUSE 07 2M0 S0FT 07 2MO 9 0 to 13 0 3 5t0 5 1 Small Child REUSE 08 2M0 SOFT 08 2MQ 12 0 to 16 0 4 7 to 6 3 Child REUSE 09 2M0 SOFT 09 2M0 15 0 to 21 0 5 9 to 8 3 Small Adult REUSE 10 2M0 S0FT 10 2MO 20 0 to 26 0 79t010 2 Adult REUSE 11 2MO SOFT 11 2MQ 25 0 to 34 0 9 8

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