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Welch Allyn Medical Diagnostic Equipment REF 420 Thermometer User Manual

1. Date Time indicates that the user must set re set the current date and time m SpO 991 Measurement Indicator Y min pressure SpO2 or temperature icon as Spot Vital Signs is taking the respective measurement displays the blood i ic v A o Na TY WE GB Thermomet r Mode icon shows temperature mode for devices with SureTemp only Temperature Probe Problem indicates a temperature probe problem for devices with SureTemp only 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 SpO0 Display shows the percent saturation of arterial hemoglobin for devices with SpO only Pulse Display shows the pulse rate d rai Display and Indicator shows the temperature in Fahrenheit or Celsius for devices with SureTemp only Monitor Mode Temperature indicates the thermometer is in Monitor Mode for devices with SureTemp only Out of range indicator shows the patient s temperature reading above or below the measurement range limits for devices with SureTemp only Icon not used Battery Level indicator displays the battery charge level Battery Charging indicates the device is powered through the AC power transformer 18 Welch Allyn Spot Vital Signs Top Side and Rear Panel Connections Probe Cover Storage Compartment storage spa
2. AVERTISSEMENT Welch Allyn n est pas responsable de l int grit de toute installation de montage Welch Allyn recommande au client de contacter son service d ing nierie biom dicale ou d entretien afin de s assurer de la fiabilit la s curit et l installation professionnelle de tout accessoire de montage Avertissements relatifs la pression art rielle AVERTISSEMENT Afin d assurer la pr cision et la s curit de la pression art rielle chez l enfant le brassard Welch Allyn pour enfant 5200 03 le brassard longue dur e mono pi ce Welch Allyn pour enfant en bas ge 5082 203 3 et le brassard mono pi ce jetable Welch Allyn pour enfant en bas ge 5082 93 3 sont les plus petits brassards autoris s pour utilisation sur de jeunes enfants et des nourrissons La circonf rence du bras de l enfant doit se situer dans la plage indiqu e sur le brassard AVERTISSEMENT Les valeurs de pression art rielle peuvent tre impr cises si des brassards et ou flexibles de pression art rielle autres que ceux fournis par Welch Allyn pour le Spot Vital Signs sont utilis s AVERTISSEMENT Les patients souffrant d arythmies mod r es aigu s peuvent d livrer des mesures de pression art rielle impr cises AVERTISSEMENT Lorsque plusieurs valeurs de pression art rielle sont relev es sur le m me patient il est recommand de contr ler r guli rement l extr mit et le site du brassard de pression art rielle afin de d tecter
3. Corrective Action Retake reading C6 SpO pulse rate out of range Check patient condition C8 Faulty SpO sensor Replace sensor C9 SpO time limit exceeded Remove sensor from patient Reapply sensor and retake reading Directions for Use 39 Causes and Corrective Action Table 5 Inaccurate Blood Pressure Readings Possible Cause Explanation and Corrective Action Incorrect blood pressure cuff size Use Welch Allyn approved blood pressure cuffs only Determine correct blood pressure cuff size e Use reference markings on blood pressure cuff e Measure patient s arm circumference midway between elbow and shoulder see Chart for Determining Blood Pressure Cuff Size on page 23 to select correct blood pressure 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 e 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 Incorrect reference Use the correct Korotkoff sound to determine diastolic blood pressure e Many listeners incorrectly equate diastolic blood pressure with the isappearance of sound onl
4. SYS mmHg Welch Allyn Spot Vital Signs Contents CONQUE Osos PC PT P BAP ad yu te eB Y RF NE RORY ey iii TS gts Mo os ea ar REC Ree I HU e ou Re IO pas ROR ce peces 1 Product O VE VIE Wicca ale DeL nep eti AAG eid bud 1 Related Publications s e rrt RR ea lia 2 Indications Contraindications for Use 2 Symbols and Descriptiornis J i eee o bite EDO ER NL Dr TOR 3 Safety Warnings and Cautions 4 Avertissements et pr cautions de s curit 9 Precautions generales osx pe oh e NU E TORIS RC ORE ea P But Qut des 12 2 Controls Indicators and Connections 15 UNPACKING Checklist rhe PRI NI GW Ont 15 Possible Attachment3a sen ud GY GG Od ADD dy 15 FrontPane FUNCIONS s uro A WU ee TRE dw CGG rs 16 LCD Liquid Crystal Display 17 Top Side and Rear Panel Connections 18 3 Internal Configuration eii a a 19 Ae SOU A O en ean eRe wa a eae ee 21 Blood Pressure Hose and Cuff Connections 21 Temperature Probe Connection 21 SpO Sensor Connection 21 Quick Reference Error Code Card 22 AC Power CONNECTION se ae deb Y at Gee uns MES RES 22 Charging the Battery 4 cct ep ET NG WW O NV datant
5. dur e d utilisation incorrecte d un capteur SpO Inspecter le site du capteur comme indiqu dans le mode d emploi du capteur AVERTISSEMENT Ne pas utiliser les capteurs en cours d examen d imagerie par r sonnance magn tique IRM Le courant produit peut potentiellement provoquer des br lures L oxym tre de pouls MS board peut affecter l image de l IRM et l appareil d IRM peut affecter la pr cision des mesures de l oxym tre de pouls AVERTISSEMENT Certaines conditions environnementales ambiantes erreurs d application de capteur et certaines conditions de patients peuvent affecter les valeurs de SpO et le signal de pouls AVERTISSEMENT Ne pas immerger les c bles patient ou capteur dans de l eau des solvants ou des solutions de nettoyage les capteurs et les connexions ne sont pas tanches Ne pas utiliser de rayonnement de vapeur ou d oxyde d thyl ne pour la st rilisation AVERTISSEMENT Ne pas utiliser le c ble SpO ou le c ble d alimentation pour soulever l unit En effet ces deux c bles sont susceptibles de se d connecter de l appareil entrainant la chute de l appareil sur le patient AVERTISSEMENT Le SpO du Welch Allyn Spot Vital signs n est pas concu pour une utilisation comme moniteur d apn e AVERTISSEMENT Consid rer le SpO comme un dispositif d avertissement pr coce Si une tendance la d soxyg nation du patient est indiqu e utiliser des instruments de laboratoire pour analyser des pr l veme
6. on page 23 If blood pressure cuff continues to pop off notify biomedical department or Welch Allyn Technical Support Blood pressure cuff applied inside out Re apply blood pressure cuff Make sure Welch Allyn label is facing away from arm Table 13 Blood Pressure Cuff Deflating Too Slowly Possible Cause Explanation and Corrective Action Normal operation Typical time to take a reading is 20 to 45 seconds 165 seconds is the maximum Pressure preset too high Check default pressure preset setting in internal configuration mode Patient movement Have patient sit still Do not have arm tight against chest wall as respiration may affect speed and accuracy of blood pressure measurement Small leak in pneumatic system Check blood pressure cuff tubing and pressure hose for leaks 42 Welch Allyn Spot Vital Signs E Specifications Patient Population The Welch Allyn Spot Vital Signs is designed for use with adult and pediatric patients Welch Allyn defines a pediatric patient as 29 days or more of age THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED FOR USE ON NEONATES Welch Allyn defines neonates as children 28 days or less of age born at term 37 weeks gestation or more otherwise up to 44 gestational weeks Blood Pressure Cuff Pressure Range Cuff Inflation Factory Default Systolic Range Diastolic Range Accuracy Determination Time Pulse Rate Range Pulse Rate Acc
7. use gas sterilization 54 Welch Allyn Spot Vital Signs Cables and Pressure Hose Wipe the cabling and pressure hose with a damp cloth moistened in a mild detergent solution Do not immerse Temperature Probe Periodically wipe the temperature probe clean with an alcohol dampened cloth warm water or properly diluted non staining disinfectant Do not immerse the probe SpO Sensor 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 and allow to air dry Do not immerse the sensor or cable Every 3 months inspect the temperature probe SpO cord and accessories for fraying or other damage Replace as necessary Battery Removal and Replacement Caution Only use the Welch Allyn 4200 84 lead acid battery Using the incorrect battery will cause damage to the Spot Vital Signs and void the warranty As necessary replace the internal battery after heavy use or the battery no longer charges Use a battery with the same part number 1 Turn the Spot Vital signs off and disconnect the AC power transformer cord 2 Remove the 4 screws holding the battery door using a phillips head screwdriver Remove the battery door to expose the battery 3 Tip the Spot Vital Signs to slide the battery out Disconnect and discard the o
8. 50 wraps D YS Dura Y9 oxygen transducer gt 1 kg 1 sensor 40 wraps D YSE Ear clip use with Dura Y sensor gt 30 kg 1 D YSPD PediCheck pediatric spot check sensor use with 3 40 kg 1 Dura Y sensor Table 11 OxiMax Sensor Cables Catalog Description Quantity DEC 4 Sp0 extension cable 4 ft 1 DEC 8 Sp0 extension cable 8 ft 1 The Welch Allyn Spot Vital Signs is not intended for use on neonatal patients 60 Temperature Table 12 Accessories and Supplies Welch Allyn Spot Vital Signs Catalog Description Catalog Description 02678 100 Oral axillary probe 9ft 2 7M 05031 110 Disposable probe covers 10 000 covers 25 box 02679 100 Rectal probe 9ft 2 7M 06137 000 Temperature Calibration Key 05031 101 Disposable probe covers 1 000 covers 25 box 01802 110 Model 9600 Plus Calibration Tester Mounting Table 13 Accessories and Supplies Catalog Description Catalog Description 4200 60 Mobile Stand 4200 64 IV Pole Mount 4200 62 Wall Mount 4200 70 Anti Theft Kit Extended Warranty Table 14 One year extended warranty Catalog Description Catalog Description 4200 00B Model 4200B 4200 M0B Model 42M0B 4200 0TB Model 420TB 4200 NTB Model 42NTB 4200 NOB Model 42N0B 4200 MTB Model 42MTB Directions for Use Miscellaneous Table 15 Accessories and Supplies 61 Catalog Description Catalog Description 4200 84 Lead A
9. 5082 206 3 One piece cuff adult one tube 5082 96 3 One piece cuff adult one tube box of 5 5082 207 3 One piece cuff large adult one tube 5082 97 3 One piece cuff large adult one tube box of 5 5082 208 3 One piece cuff thigh adult one tube 5082 98 3 One piece cuff thigh one tube box of 5 Table 3 Replacement Cuffs and Bladders Catalog Description Catalog Description 5200 04 Adult Bladder one tube 5082 01 Adult cuff sleeve 5200 05 Large Adult Bladder one tube 5082 16 Large adult cuff sleeve 5200 06 Child Bladder one tube 5082 18 Child cuff sleeve 5200 11 Thigh Bladder one tube 5082 64 Thigh cuff sleeve Table 4 Miscellaneous Blood Pressure Accessories Catalog Description Catalog Description 5200 12 Straight Pressure Hose 8ft 2 4M 5200 08 Calibration T Connector 5200 19 Straight Pressure Hose 5ft 1 5M 58 Pulse Oximetry Accessories and Supplies Masimo Table 5 Adhesive Sensors Single Patient Use Welch Allyn Spot Vital Signs Catalog Description Weight Range LNCS ADTX Adhesive Finger Sensor Adult 20 per case gt 30 kg LNCS PDTX Adhesive Finger Sensor Pediatric 20 per case 10 to 50 kg LNCS INF L Adhesive Finger Sensor Infant 20 per case 3 to 20 kg LNOP ADT Adhesive Adult sensor 20 per case gt 66 Ibs 30 kg LNOP PDT Adhesive Pediatric sensor 20 per case 22 to 110 Ibs 10 to 50 kg LNOPINF L X Adhesive Infant sensor 20 pe
10. Cal ion Pressure Preset Level ays PrP Pressure Preset Level Disp ays PrP Backlight Disp Mea Disp Date ays BLT n Arterial Pressure ays MAP Time Temperature Scale Disp ays TMP MOD Blood Pressure Units Disp ays BP Battery Readings Disp ays BAT Battery Life Disp ays LFE Prepares the Spot Vital Signs for calibration Only qualified personnel should verify the Spot Vital Signs blood pressure calibration For more details see Checking the Blood Pressure Calibration on page 26 120 140 160 180 200 240 280 mmHg Factory default is 160 mmHg On or off Disables or enables the front panel Pressure Preset button On or off On or off Changes or updates the actual date and time Fahrenheit F or Celsius C Normal Mode Fahrenheit F or Celsius C Monitor Mode mmHg or kPa Displays the total battery voltage Total number unit measurements Displayed information only operator cannot change 20 Internal Configuration Welch Allyn Spot Vital Signs 21 Ee Blood Pressure Hose and Cuff Connections Have available the Spot Vital Signs blood pressure cuff and blood pressure hose 1 Inspect the pressure hose note that one end has a connector fitting and the other end does not Attach the end without the connector fitting to the pressure hose connector see page 16 Verify that the pressure hose is complete
11. Carefully check for leaks in the blood pressure cuff tubing and pressure hose attached to the device Arm movement during cycle Keep arm still during blood pressure cycle Movement may cause inaccuracies from artifact Blood pressure cuff tubing or pressure hose movement artifact Do not contact blood pressure cuff tubing or pressure hose during blood pressure cycle Movement may cause inaccuracies from artifact 40 Welch Allyn Spot Vital Signs Table 7 No Blood Pressure Cuff Inflation Possible Cause Explanation and Corrective Action Connections between device and blood Check all connections do not overtighten pressure cuff loose Table 8 Temperature Malfunction Possible Cause Explanation Corrective Action Error code displayed Broken probe Replace probe Consult Service Manual Notify biomedical department or Welch Allyn Technical Support Low temperature Improper probe Place probe in most posterior sublingual pocket when in readings placement Oral Mode Verify patient has had nothing to eat or drink for 20 minutes No temperature displayed Probe not replaced Replace probe in holder prior to taking another temperature Table 9 Sp0 Malfunction Possible Cause Sensor in place but no Sp0 on Corrective Action Insert the patient s finger completely into sensor display Verify blood pressure and SpO measurements are not taken on the same extremity Verify the
12. RF emissions are very low and are not likely to cause any interference in nearby CISPR 11 electronic equipment RF emissions Class B The 420 Series Spot Vital Signs is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage CISPR 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 48 The 420 Series Spot Vital Signs is intended for use in Spot Vital Signs should assure that it is used in such Immunity Test IEC 60601 Test Level Welch Allyn Spot Vital Signs Electromagnetic Immunity the electromagnetic environment specified below The customer or user of the 420 Series an environment Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should 8 kV air 8 kV air be at least 30 IEC 61000 4 2 Electrical fast transient 2 KV for power supply 2 kV for power supply Mains power quality should be that of a typical commercial or burst lines lines hospital environment IEC 61000 4 4 1 kV for input output 1 kV for input output lines lines Surge 1 kV differential mode 1 kV differential mode Mains
13. 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 V1 3Vrms d 1 17 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m El 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 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 d is 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
14. is not defibrillator proof WARNING The Welch Allyn Spot Vital Signs is not intended for continuous monitoring Do not leave the device unattended while taking measurements on a patient WARNING To ensure patient safety use only accessories and supplies i e blood pressure cuffs hoses temperature probes SpO sensors etc recommended for or supplied with Spot Vital Signs Using unapproved accessories with Spot Vital Signs can affect patient and or operator safety 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 Avoid compression of the blood pressure cuff tubing or pressure hose of the Welch Allyn Spot Vital Signs Compression of the cuff tubing or pressure hose may cause system errors to occur in the device WARNING Care should be taken to prevent water or other fluid from entering any connectors on the device Should this occur the connectors should be dried with warm air All operating functions should then be checked for proper operation WARNING Any Spot Vital Signs which has been dropped or damaged should be checked by qualified service personnel to ensure proper operation prior to use Do not use the Welch Allyn Spot Vital Signs if you notice any signs of damage Contact the Welch Allyn Customer Service Department for assistance WARNING Every three months inspect the temperature probe SpO cord and accesso
15. 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 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 Some sensors may not be appropriate for a particular patient If at least 15 seconds of perfusion pulses cannot be observed for a given sensor change sensor location or sensor type for perfusion to resume 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 duration of monitoring Temperature Cautions A Caution The Welch Allyn Spot Vital Signs is FDA cleared to measure the axillary temperature in Normal Mode for children under the age of 4 Normal Mode axillary temperatures may not be accurate on older children or adults THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED TO BE USED ON NEONATAL PATIENTS Directions for Use Avertissements et precautions de s curit Tout le personnel l utilisant doit tre familiaris avec les informations gl
16. secondes d impulsions de perfusion pour un capteur donn modifier l emplacement du capteur ou le type de capteur pour la perfusion afin de reprendre l op ration Attention Lors du choix d un capteur prendre en consid ration le poids du patient et son niveau d activit l ad quation de la perfusion les sites de capteurs disponibles le besoin de st rilit et la dur e pr vue du monitorage Pr cautions relatives la temp rature A Attention Le Welch Allyn Spot Vital Signs est approuv par la FDA pour mesurer la temp rature axillaire en mode normal pour les enfants de moins de 4 ans Les temp ratures axillaires du mode normal peuvent ne pas tre pr cises sur des enfants plus g s ou des adultes LE WELCH ALLYN SPOT VITAL SIGNS N EST PAS CON U POUR UNE UTILISATION SUR DES NOUVEAU N S 14 Welch Allyn Spot Vital Signs 15 2 Controls Indicators and Connections In this section all drawing and text are representative of the Spot Vital Signs with all available options Your device may not include all functions depending on the options purchased Unpacking Checklist Unpack the Welch Allyn Spot Vital Signs and applicable accessories identify each item with the following checklist and 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 All Spot Vital Signs include the following components Spot V
17. standards traceable to NIST National Institute of Standards and Technology Welch Allyn recommends that blood pressure calibration for the Spot Vital Signs is checked on an annual basis using the following procedure Put the Spot Vital Signs into its blood pressure calibration check mode In this mode the device continuously displays the measured pressure and closes the pressure release valve 1 Enter the internal configuration mode see Internal Configuration on page 19 2 Press the Blood Pressure Start Stop button to close the device s internal valve to apply an external pressure 3 Connect the Spot Vital Signs as shown to a calibrated pressure meter verify certificate is traceable to the National Institute of Standards and Technology The pressure meter testing the Spot Vital Signs must have an accuracy of better than 3 mmHg Use a fixed volume or a blood pressure cuff wrapped around a cylinder for the stabilization volume Spot Vital Signs Stabilization Calibrated Pressure 1 Volume Meter traceable to 4 Pressurize the Spot Vital Signs to slightly 150 500cc NIST above 250 mmHg Bleed the pressure to approximately 250 mmHg Clamp and C Pressure Source record the pressure reading and the measurement standard Repeat this step for 150 and 50 mmHg approximate 5 Calculate the difference between the readings Subtract the rated accuracy of the pressure measurement standard from the 8 mmHg ra
18. to obtain accurate oral or axillary temperatures Normal Mode axillary temperatures are FDA cleared for children under the age of four THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED FOR USE ON NEONATAL PATIENTS 1 Verify that the correct probe blue cap is installed 2 Hold the probe handle with your thumb and two fingers on the sides of the probe handle and withdraw the probe 3 Verify the desired temperature mode is in the temperature display area and the desired temperature mode icon is flashing If the desired mode is not selected press the Mode button until the LCD displays Orl or Aly 4 Insert 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 close his her lips SUBLINGUAL POCKET SUBLINGUAL POCKET N Directions for Use 6 8 31 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
19. tre soit la taille et l emplacement ad quats pour assurer la pr cision de la d termination de la pression art rielle Voir Tableau de d termination de la taille de brassard de tensiom tre on page 17 pour obtenir des informations sur la taille du brassard de pression art rielle Attention Lors de la mesure de la pression art rielle sur des enfants de moins de 3 ans il est recommand de d finir le r glage de la pression pression de gonflage initiale sur une valeur inf rieure ou gale a 160 mmHg Pr cautions relatives Sp0 Attention l oxymetre de pouls est talonn pour d terminer le pourcentage de saturation en oxyg ne du sang art riel de l h moglobine fonctionnelle Des niveaux importants d h moglobine dysfonctionnelle comme la carboxyh moglobine ou m th moglobine peuvent affecter la pr cision de la mesure Attention Certaines conditions physiologiques interventions m dicales ou substances externes sont susceptibles d interf rer avec les fonctions de d tection et de mesure de l oxym tre de pouls par exemple les h moglobines dysfonctionnelles les colorants art riels les conditions de faible perfusion et les pigments fonc s ainsi que les agents de coloration appliqu s par voie externe tels que le vernis ongle les teintures ou les cr mes pigment es Attention Certains capteurs peuvent s av rer inad quats pour un patient en particulier S il n est pas possible d observer au moins 15
20. year warranty against original defects in material and workmanship Probe covers are intended for single use only 64 Warranty Welch Allyn Spot Vital Signs WelchAllyn Advancing Frontline Care Reorder No 4200 87E Material No 706272 Ver C
21. NG The SpO sensors and extension cables are intended for use only for pulse oximetry measurements Do not attempt to connect these cables to a PC or any similar device WARNING Before use carefully read the sensor s directions for use including all warnings cautions and instructions WARNING Do not use a damaged sensor or SpO cable Do not use a sensor with exposed optical components WARNING Tissue damage can be caused by incorrect application or duration of use of an SpO sensor Inspect the sensor site as directed in the sensor s Directions for Use WARNING Do not use the sensors during magnetic resonance imaging MRI scanning Induced current could potentially cause burns The pulse oximeter may affect the MRI image and the MRI unit may affect the accuracy of the pulse oximetry measurements 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 Do not use the SpO cable or power cord to lift the unit because the cable or cord could disconnect from the unit causing the unit to drop on the patient WARNING The SpO in the Welch Allyn Spot Vital signs is not intended for use as an apnea monitor WARNING Consider
22. Welch Allyn Spot Vital Signs Directions for Use REF 420 Series WelchAllyn Advancing Frontline Care CAUTION United States Federal Law restricts this device to sale by or on the order of a health care practitioner Welch Allyn Spot Vital Signs Directions for Use Welch Allyn Advancing Frontline Care ii Welch Allyn Spot Vital Signs Copyright 2007 Welch Allyn All rights are reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Welch Allyn Welch Allyn assumes no responsibility for any injury to anyone or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or statement of intended use published in this manual Welch Allyn Spot Vital Signs and SureTempQ are registered trademarks of Welch Allyn LNCSTM SET LNOP and Masimo6 are registered trademarks of Masimo Corporation Possession or purchase of a Masimo SpO gt equipped device does not convey any express or implied license to use the device with unauthorized sensors or cables which would alone 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 2007 Welch Allyn or its vendors All r
23. as con u pour un monitorage continu Ne pas laisser l appareil sans surveillance lors du relev de mesures sur un patient AVERTISSEMENT Afin d assurer la s curit du patient utiliser uniquement des accessoires et fournitures savoir des brassards des flexibles des sondes de temp rature des capteurs de SpO etc recommand s ou fournis avec le Spot Vital Signs L utilisation d accessoires non approuv s avec le Spot Vital Signs peut affecter la s curit du patient et ou de l op rateur AVERTISSEMENT Cet appareil n est pas concu pour une utilisation en pr sence d un m lange anesth sique inflammable avec l air l oxyg ne ou le protoxyde d azote Une explosion pourrait se produire AVERTISSEMENT viter de comprimer les tubes du brassard ou le tuyau de tensiom tre de tension art rielle du Welch Allyn Spot Vital Signs La compression des tubes du brassard ou du tuyau de tensiom tre peut entrainer des erreurs du Syst me au niveau du dispositif AVERTISSEMENT convient de proc der avec soin afin d emp cher l eau ou tout autre fluide de p n trer dans les connecteurs du dispositif Si cela se produit les connecteurs doivent tre s ch s l air chaud Toutes les fonctions d utilisation doivent ensuite tre contr l es AVERTISSEMENT Tout Spot Vital Signs ayant subi une chute ou un dommage doit tre v rifi par un technicien qualifi qui s assurera de son bon fonctionnement avant utilisation Ne pas utiliser le We
24. ce for one box of probe covers Sp0 Cable Connection Port for units with SpO only Temperature Probe Holder storage space for the temperature probe when not in use for devices with SureTemp only Suretemp Thermometer Connection Port for devices with SureTemp only IR Data Interface Port for communicating with an external device Battery Door AC Power Connection Port Threaded Insert to mount the Spot Vital Signs to a mobile stand 19 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 25 Turn the Spot Vital Signs off Press and hold the Power and Blood Pressure Start Stop buttons The device enters the Internal Configuration Mode and displays the software version Press the Mode button to cycle through the Internal Configuration menu until you see the menu option displayed on the screen Use the Next Patient Clear Cancel or Blood Pressure Start Stop buttons to change the default setting Press the Mode button once to save the change and press the Power button to exit the Internal Configuration Mode Table 2 Configuration Menu Options Setting Description Blood Pressure Calibration Disp Infla Disp ays
25. cid Battery 5200 101A AC Power Transformer US Canada Japan 120V 60Hz 4200 87X Directions for Use 5200 103A AC Power Transformer Europe UK 240V 50Hz 4200 88X Quick Reference Error Code Card 5200 1037 AC Power Transformer Australia 240V 50Hz 4200 155 Inservice CD English only 76400 Line Cord US Canada Japan 4200 89E Service Manual English only 76402 Line Cord Europe 4200 100 Carrying Case 76404 Line Cord UK 4200 170 Connectivity Accessory Kit 76406 Line Cord Australia 53600 Printer paper 24 rolls 4200 250 Pediatric accessory kit small child child small adult cuffs and Nellcor SpO5 sensor 53600B Printer paper 4 rolls 4200 350 Pediatric accessory kit small child child small adult cuffs and Masimo SpO sensor Replace the X with the following letter abbreviation to order the appropriate language manual Table 16 Printed Material Language List Language Language Language Language Language Language Abbreviation Abbreviation Abbreviation E English G Deutsch PO Polish C Chinese Italiano P Portugu s DK Dansk N Norsk S Espa ol F Francais NL Nederlands SW Svensk Fl Suomi 62 Welch Allyn Spot Vital Signs 63 Warranty Spot Welch Allyn warrants Spot Vital Signs when new to be free of defects in material and workmanship and to perform in accordance with manufacturer s specifications for a period of two years from the date of purchase from Welch Allyn or its aut
26. completely surrounds the probe tip and place the arm snugly at the patient s side 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 Spot Vital Signs beeps once after reaching the final temperature The temperature display area displays the patient temperature Spot Vital Signs displays the current temperature for two minutes after the probe is placed back in the holder The display then goes blank unless another measurement is active If Spot Vital Signs displays a probe position icon during the temperature determination the temperature display alternates between the final predicted temperature and the letter P To switch to Monitor Mode leave the probe in place after obtaining a reading and press the Mode button once The temperature display shows an M to indicate Monitor Mode Once in Monitor Mode proceed to Step 5 on page 33 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 Return the probe to Spot Vital Signs 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 Caution To obtain accurate rectal temp
27. cor SpOs sensors and accessories with the Spot Vital Signs with Masimo or Nellcor configurations respectively 22 Welch Allyn Spot Vital Signs Quick Reference Error Code Card The Quick Reference Error Code Card should be attached either to the Spot Vital Signs handle the Mobile Stand or the Wall Mount AC Power Connection Use the Spot Vital Signs with AC or battery power after charging the battery 1 Insert the round transformer connector into the AC power connection port on the left of the Spot Vital Signs see page 18 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 Charging the Battery CHARGE THE BATTERY FOR SIXTEEN 16 HOURS PRIOR TO INITIAL USE Attach the AC power transformer to the Spot Vital Signs then plug the transformer into the AC main power source While charging the charger icon remains on and the battery icon segments continuously sequence When the battery is fully charged all battery icon segments display As the battery voltage level drops the segments turn off from left to right If the Spot Vital Signs is not plugged in to charge when the second last segment is turned off the Spot Vital Signs issues a warning beep As the voltage level drops to compromise measurements an error beep is heard and all other display fields turn off Spot Vital Signs beeps at increasingly frequent intervals u
28. dance with facility local and goverment regulations Temperature Calibration Check Use the 9600 Plus Calibration Tester to check the SureTemp thermometer accuracy If the thermometer is out of calibration contact Technical Service 56 Welch Allyn Spot Vital Signs Service Manual Spare Parts A Service Manual is available upon request to qualified electronic personnel The Service Manual is a comprehensive guide to troubleshooting service and repair of the Spot Vital Signs Also included with the Service Manual is a complete spare parts list Order spare parts from your local Welch Allyn Service Center listed on page ii Service Loaners Service loaners are provided on request when a Welch Allyn Service Center provides service Loaners for products repaired while under the original warranty or while under extended warranty or service contract are provided free of charge and are shipped within 48 hours of notification of need Welch Allyn pays the shipment charges For service repairs outside of warranty or contract loaners are available for a nominal daily charge and shipment This is subject to availability Loaners are shipped pre paid however this charge is added to the service charges Service Policy A Welch Allyn Service Center must approve and perform all repairs on products under warranty Unauthorized repairs will void the warranty Qualified electronics personnel or a Welch Allyn service center should repair produc
29. e Start Stop or the Next Patient Clear Cancel button at any time during a blood pressure determination cancels the measurement and rapidly deflates the blood pressure cuff When the measurement cycle is complete the Spot Vital Signs beeps once and displays the systolic diastolic and pulse rate measurements for two minutes unless another measurement is active If the MAP is turned on then the Spot Vital Signs toggles between the blood pressure reading and the MAP value If Spot Vital Signs cannot take a successful blood pressure measurement it beeps twice and displays a C error code unless the measurement was purposely stopped Pulse rate as determined from the blood pressure measurement method is displayed with the blood pressure reading only if the SpO option is not in use If the SpO function is in use all pulse rate determinations are a result of the SpO measurement method Reviewing Information from the Last Cycle The Spot Vital Signs holds the last patient measurement cycle in memory The informa tion is held in memory until the unit is turned off or you initiate the next patient s measure ment If the display is blank press the Mode button to review data from the last measurement cycle 26 Welch Allyn Spot Vital Signs Checking the Blood Pressure Calibration The Welch Allyn Spot Vital Signs is manufactured to the highest industry standards for quality and accuracy The device is manufactured using calibrated pressure
30. e rechargeable lead acid battery and variety of mounting accessories make the Welch Allyn Spot Vital Signs convenient for many locations You may choose any combination of simultaneous measurement modalities The Welch Allyn Spot Vital Signs can be used in a wide variety of health care settings This includes hospital departments as well as alternate care settings such as physicians offices clinics and long term care facilities The Welch Allyn Spot Vital Signs is not intended for continuous monitoring of patients nor for use during the transport of a patient The Welch Allyn Spot Vital Signs is not intended for use in environments that are not supervised by a health care practitioner 2 Welch Allyn Spot Vital Signs Related Publications Masimo Directions for Use for models 42MOB and 42MTB Nelcor Directions for Use for models 42NOB and 42NTB Indications Contraindications for Use The Welch Allyn Spot Vital Signs measures blood pressure pulse rate temperature and SpO of adult and pediatric patients The device is not designed sold nor intended for use other than previously stated THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED FOR USE ON NEONATAL PATIENTS To ensure pediatric blood pressure accuracy and safety the Welch Allyn Child Print Cuff 5200 03 the Welch Allyn Small Child Durable One Piece Cuff 5082 203 3 and the Welch Allyn Small Child Disposable One Piece Cuff 5082 93 3 are the smallest cuffs allowed for use
31. ect dg e ete td are Rt o YW AF FWA 46 Guidance and Manufacturer s Declaration 47 Patents c ep XE nement a Penn Sedan D rs 51 Agency Approvals odd data a A Mel bu mynyd ditch olde 51 TO Maintenance ee ares med Pa ER A a 53 CIEARING ss Mare a tae e o ta Pr UV A ur RAT ATE E OA 53 Battery Removal and Replacement 54 Masimo SpOs Calibration Check 1 55 Nellcor SpO Functional Check 55 SpO Accessory Disposal 55 Temperature Calibration Check lors ha ee PET RE oi 55 Service Manual Spare Parts 0 0 ene 56 DOIVICE LOANGIS rd Aas d A reda eure Ed Bald dod da 56 SENCE ROC See ata wie od Aah ort Mn Y A NEN tet e bots Y EF 56 TechnicaltAssistance ua ne e toca ooh SM UR UAE Se TR 56 11 Supplies and Accessories 57 LatexFree Blood Pressure 57 Pulse Oximetry Accessories and Supplies 58 Temperature ess wei be eee Se poe ee REG BG OPT GY BOS YA GOING GAD dT 60 MOULE O 60 Extended Warranty 2 60 MiscellaneotuS we emot bet Bele ante e Uo S 61 Warranty soc Las den chard isa ete enti he E NUS ptus ite ie ae 63 SDOt yui cone e mee A ed C ur ns AE EN 63 ACCESSOMO Sens ent dep Ui tnt ho bos Mn OE Bs ott okt el Aoc 63 Introductio
32. ent Range Indicators The following display appears when temperatures are outside of the measurement range of the device Condition Temperature Display Audible Notification Temperature is outside of high measurement range of Fahrenheit 109 4 f No the device Celsius 43 Temperature is outside of low measurement range of Fahrenheit g6 U No the device Celsius 30 U 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 30 Welch Allyn Spot Vital Signs 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 inaccurate axillary temperature readings 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 To take a temperature in oral or axillary mode A A Note WARNING Do not take an axillary temperature over the patient s clothing Direct contact between the patient s skin and the probe is required Caution Use the temperature probe with the blue cap
33. eratures use the temperature probe with the red ejection button Verify that the rectal probe red cap is installed Spot Vital Signs only operates in Rectal Mode if the red rectal probe is installed Hold the probe handle with your thumb and two fingers on the sides of the probe handle and withdraw the probe from Spot Vital Signs Verify the Spot Vital Signs temperature display shows rEC to indicate a rectal probe is in use 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 32 Welch Allyn Spot Vital Signs Spot Vital Signs beeps once after reaching the final temperature The temperature display area displays the patient temperature Spot Vital Signs displays the current temperature for two minutes after the probe is placed back in the holder The display then goes blank unless another measurement is active If Spot Vital Signs displays a probe position icon during the temperature determina
34. es 68 of the population Pulse Rate Range Pulse Rate Accuracy Table 15 OxiMax Sensor Models Single Patient Use 25 to 240 bpm 3 bpm 3 bpm low perfusion Sensor Models Sp0 Range 70 to 100 MAX Al 2 MAX PI 2 MAX II 2 MAX RI 35 The accuracy specification has been determined between saturations of 80 to 100 Table 16 OxiCliq Sensor Models Single Patient Use Sensor Models Sp0 Range 70 to 100 OXICLIO PI 25 Table 17 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 YSPD 35 DS 100A 3 OXI A N Adult Adult 3 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 46 Welch Allyn Spot Vital Signs Mechanical Dimensions Height 9 7 inches 24 6 cm Length 5 7 inches 14 5 cm Depth 4 7 inches 12 0 cm Weight Approximately 4 6 pounds 2 2 kg Mounting Self supporting on rubber feet Custom Mobile Stand Custom Wall Mount Custom IV Pole Mount Portability May be hand carried when held by the rear handle Electrical Power Requirements Patient rated isolation transformer is connected to AC mains North American Version 120VAC 60Hz 0 13A Inpu
35. fy that the correct probe oral axillary blue cap or rectal red cap is installed Hold the probe handle with your thumb and two fingers on the sides of the probe handle and withdraw the probe from Spot Vital Signs Insert the probe into a probe cover and press the probe handle down firmly The probe handle moves slightly to engage the probe cover Take the patient s temperature using the Normal Mode as previously described Leave the probe in place after Spot Vital Signs beeps once and displays the temperature Press the Mode button once An M appears on the display to indicate Monitor Mode 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 Record the temperature before removing the probe from the site the monitored temperature does not remain on the display once the probe is removed from the site and is not stored in memory for recall Remove the probe from the patient and firmly press the ejection button on the top of the probe to release the probe cover Return the probe to the Spot Vital Signs to reset the thermometer to Normal Mode 34 Welch Allyn Spot Vital Signs 35 Pulse Oximetry Sp0 Factors that may degrade the performance of the pulse oximeter e Excessive ambient light e Sensor not at heart level Excessive motion e Anemia or low hemoglobin e Fingernail polish if fin
36. ger sensor Arterial catheters blood pressure concentrations is used and infusion lines etc Moisture in the sensor e Cardiovascular dyes e Improperly attached sensor e Incorrect sensor for patient e Electrosurgical interference e Poor patient perfusion e Venous pulsations WARNING Tissue damage can be caused by incorrect application or duration of use of an SpO sensor Inspect the sensor site as directed in the sensor Directions for Use WARNING Do not use a damaged sensor or pulse oximetry cable or a sensor with exposed optical components To take an SpO measurement If blood pressure measurement is occurring simultaneously place the finger 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 finger clip sensor The pulse signal bar graph illuminates indicating the patient s pulse at the sensor site The sensor takes approximately 10 seconds to determine the initial SpO value and pulse rate When the initial values are determined they are shown in the SpOs display and the pulse rate display respectively If the accuracy of any measurement does not seem reasonable first use an alternate means to check the patient s vital signs and then check the Spot Vital Signs for proper functioning Spot Vital Signs measures a patient s SpO for up to 10 minutes After 10 minutes Spot Vital Signs di
37. horized distributors or agents The battery is covered by a one year warranty against original defects in material or workmanship Welch Allyn will either repair or replace any components found to be defective or at variance from manufacturer s specifications within this time at no cost to the customer It shall be the purchaser s responsibility to return Spot Vital Signs to Welch Allyn or an authorized distributor agent or service representative This warranty does not include breakage or failure due to tampering misuse neglect accidents modification or shipping This warranty is also void if the instrument is not used in accordance with manufacturer s recommendations or if repaired by other than Welch Allyn or an authorized agent Purchase date determines warranty requirements No other express warranty is given Remember to submit the instrument registration warranty card for warranty validation Complete the information and mail the pre addressed card to Welch Allyn Accessories The Masimo finger sensor and cable are covered by a sixmonth warranty against original defects in material or workmanship The Nellcor DS 100A is covered by a one year warranty and the Nellcor DEC 4 cable is covered by a three month warranty against original defects in material or workmanship The Reusable Two Piece Blood Pressure Cuff is covered by a two year warranty against original defects in material or workmanship The SureTemp probe is covered by a one
38. ights 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 1 800 535 6663 Australia 61 2 9638 3000 1315 685 4560 800 074 793 Canada 1 800 561 8797 China 86 21 6327 9631 European Call Center 353 46 90 67790 France 33 1 55 69 58 49 Germany 49 7477 9271 70 Japan 81 33219 0071 Latin America 1 305 669 9003 Netherlands 31 157 505 000 Singapore 65 6419 8100 South Africa 27 11777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Reorder No 4200 87E Manual Material No 706272 Ver C Welch Allyn 4341 State Street Road Skaneateles Falls NY 13153 USA Printed in USA CE os MOON Advancing Frontline Care Directions for Use Configuration After recharging a dead battery or after disconnecting the battery for a few minutes you must program the date and time screen See page 19 for more details
39. ital Signs Device This device automatically measures and displays blood pressure and pulse rate Options include thermometry and pulse oximetry Directions for Use Manual Read this manual thoroughly before using Spot Vital Signs Save this manual for reference Warranty Card This card validates the Spot Vital Signs warranty Fill out the warranty card and mail it today Blood Pressure Cuff Latex free blood pressure 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 Vital Signs AC Power Transformer and Cord Assembly Provides power to the Spot Vital Signs and charges the internal battery Quick Reference Error Code Card Attach this quick operating and error code guide to the device handle mobile stand or wall mount Possible Attachments Spot Vital Signs may include the following items based on the model and accessories purchased SureTemp Temperature Probe and Covers One oral temperature probe blue cap and one box of 25 single use disposable probe covers Pulse Oximetry SpO The finger clip SpO sensor and extension cable are for use with adult and pediatric patients Other sensors are available separately Note Report any signs of shipping damage to the carrier If an item is missing or damaged contact the Welch Allyn Service Center near you 16 Welch Allyn Spot Vital Signs Fro
40. lch Allyn Spot Vital Signs en cas de signes d endommagement Contacter le Service client le de Welch Allyn pour obtenir de l aide 10 Welch Allyn Spot Vital Signs AVERTISSEMENT Tous les trois mois v rifier que la sonde de temp rature le c ble SpO et les accessoires ne s effilochent pas et qu ils ne sont endommag s de quelque facon Remplacer si n cessaire AVERTISSEMENT Hormis la batterie aucune pi ce de l appareil n est remplacable par l utilisateur Retourner le Spot Vital Signs au centre d entretien autoris AVERTISSEMENT Le Spot Vital Signs ne doit pas tre utilis sur des patients reli s des machines cardiaques pulmonaires AVERTISSEMENT Le Spot Vital Signs ne fonctionne pas efficacement sur des patients souffrant de convulsions ou de tremblements AVERTISSEMENT Ce dispositif se conforme aux normes courantes exigibles en mati re de brouillage lectromagn tique et ne devrait ni provoquer d interf rences ni en recevoir de la part d autres quipements Par mesure de pr caution viter d installer l appareil proximit d autres quipements AVERTISSEMENT Ce dispositif n est pas con u pour une utilisation manuelle en cours de fonctionnement AVERTISSEMENT Welch Allyn recommande de laisser la batterie dans l appareil m me si ce dernier n est pas utilis pendant de longues p riodes En effet laisser la batterie dans l appareil ne pr sente aucun danger AVERTISSEMENT Ne pas st riliser en autoclave
41. ld Disposable One Piece Cuff 5082 93 3 are the smallest cuffs allowed for use with young children and infants The circumference of the child s arm must fit within the range markings on the blood pressure cuff To position the blood pressure cuff 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 WARNING Do not place the blood pressure cuff on any extremity that is used for intravenous infusions or any area Where circulation is compromised 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 Note Blood pressure cuff inflation during an SoO measurement may cause inaccurate SpO results when used on the same extremity Wrap the blood pressure cuff snugly with room between the blood pressure cuff and the arm for no more than two fingers Excessive tightness may cause venous congestion and discoloration of the limb Possible error may occur if the blood pressure cuff is wrapped too loosely preventing proper inflation Place the blood pressure cuff on a bare arm clo
42. ld battery per local regulations Reconnect the new battery as shown as quickly as possible to prevent loss of power to the unit and subsequent loss of clock time Battery Directions for Use 55 4 Slide the new battery completely into the compartment Lay the connector on the battery The relief pocket in the battery door purposely provides sufficient clearance for the battery connector Relief Pocket ig Battery Battery Connector 5 Replace the battery door and tighten each of the 4 screws 6 Connect the AC power transformer to the Spot Vital Signs and charge the new battery for 16 hours It is possible to use the Spot Vital Signs during this charging period The battery is a lead acid battery In the USA call 1 800 SAV LEAD for instructions on how to recycle For users outside the US please contact your local authorities on recycling Masimo SpO Calibration Check Use a Masimo approved SpO simulator Fluke Biotek Index 2 or Clinical Dynamics SmartSat to check the SpO accuracy There is no way to change the calibration of the SpO module If the SpOs is out of calibration contact Technical Service Nellcor SpO5 Functional Check Use a Nellcor SpO simulator SRC MAX to check the SpO functionality There is no way to change the functionality of the SpO5 module If the SpO is not functioning properly contact Technical Service Sp0 Accessory Disposal Dispose of all finger sensors and cables in accor
43. ly inserted over the connector and that the fit is snug 2 Join the other end of the pressure hose to the blood pressure cuff pneumatic tubing Twist the connectors together until fingertight DO NOT OVERTIGHTEN Temperature Probe Connection The Welch Allyn Spot Vital Signs is available with two probes one for oral axillary temperatures blue cap and one for rectal temperatures red cap The rectal probe is an accessory item that is ordered separately Press down on the tab on top of the connector and insert the connector into the temperature probe connector port on the back of the Spot Vital Signs The probe connector only fits into Spot Vital Signs one way Verify the connector clicks into place Insert the temperature probe into the probe holder on the top of the Spot Vital Signs To remove the temperature probe press down on the connector tab and lift out Sp0 Sensor Connection Spot Vital Signs is available with a wide variety of SpO sensors and ships with a reusable finger sensor and extension cable All other sensors are accessory items that are sold separately 1 Align the shape and pin configuration of the extension cable connector to the SpO cable connection port on the top side of the Spot Vital Signs device 2 Push the connector firmly into the SpO cable connection port 3 Align the opposite end of the extension cable to the sensor cable connector and firmly push them together Note Use only Masimo or Nell
44. n This manual is designed to help you understand the capabilities and operation of your Welch Allyn Spot Vital Signs The information in this manual includes all options available with the Spot Vital Signs e g SpO temperature mobile stand and wall mount The applicability of some sections of this manual depends on the configuration of your particu lar unit Read this manual thoroughly before attempting to use the device Table 1 Available Versions of Spot Vital Signs REF Description 4200B Spot Vital Signs with blood pressure only 420TB Spot Vital Signs with blood pressure and SureTemp thermometer 42MOB Spot Vital Signs with blood pressure and Masimo Sp0 42NOB Spot Vital Signs with blood pressure and Nellcor SpO 42MTB Spot Vital Signs with blood pressure SureTemp thermometer and Masimo SpO 42NTB Spot Vital Signs with blood pressure SureTemp thermometer and Nellcor SpO5 Product Overview The Welch Allyn Spot Vital Signs non invasively and automatically measures systolic and diastolic blood pressure pulse rate and oxygen saturation SpO for adult and pediatric patients Further the Welch Allyn Spot Vital Signs measures temperature invasively in natural body orifices i e mouth and rectum THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED FOR USE ON NEONATAL PATIENTS All blood pressure pulse temperature and SpO values are viewed on a large easy to read display Th
45. nded separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Directions for Use 51 Patents D392 043 and other patents pending Agency Approvals CERTIFIED TO CAN CSA STD C22 2 NO 601 1 S CONFORMS TO IEC 60601 UL STD 60601 1 166292 G Welch Allyn PTY Ltd Australia Metro Centre N 34 Unit 5 38 South Street Rydalmere NSW 2116 Australia EMC Framework of Australia The CE mark on this product indicates that it has been tested C 0297 to and conforms with the provisions noted within the 93 42 EEC Medical Device Directive Authorized European Representative Address EC REP European Regulatory Manager Welch Allyn Ltd Navan Business Park Dublin Road Navan County Meath Republic of Ireland Tel 353 46 90 67700 e Fax 353 46 90 67756 52 Welch Allyn Spot Vital Signs 53 Maintenance Welch Allyn will make available upon request circuit diagrams and other information which will assist appropriately qualified technical personnel in repair
46. ne Piece Cuff 5082 203 3 and the Welch Allyn Small Child Disposable One Piece Cuff 5082 93 3 are the smallest cuffs allowed for use with young children and infants The circumference of the child s arm must fit within the range markings on the cuff WARNING You may experience inaccurate blood pressure measurements if blood pressure cuffs and or hoses other than those provided by Welch Allyn for the Spot Vital Signs are used WARNING Patients who are experiencing moderate to severe arrhythmias may give inaccurate blood pressure measurements WARNING When several blood pressure measurements are taken on the same patient it is recommended that the blood pressure cuff site and extremity are checked regularly for possible ischemia purpura and or neuropathy 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 Sp0 Warnings Welch Allyn Spot Vital Signs WARNING Only use Spot Vital Signs 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 WARNI
47. nt Panel Functions Thermometer Eject Button push to remove used temperature probe cover Next Patient Clear Cancel Button e active display clears the display in Standby Mode recalls the last patient information Pressing a second time clears the screen e cancels an active blood pressure measurement and deflates the cuff ic DIA kPa mmHg gt J SpO 991 Y min 997 Ade aa Pressure Preset Button pressing this button allows the user to change the factory inflation default for one reading Blood Pressure Start Stop Button initiates a new blood pressure cycle Pressing again cancels an active blood pressure measurement and deflates the cuff Mode Button e holding for 2 seconds while the display is active turns off on the backlight e in Standby Mode recalls the last patient information e with the temperature probe removed from the probe holder switches the temperature from Oral to Axillary Mode Pressure Hose Connector port for blood pressure hose Power Button controls power to the device Directions for Use LCD Liquid Crystal Display 17 The LCD may indicate any of the following systolic blood pressure mmHg or kPa diastolic blood pressure mmHg or kPa temperature F or C thermometer mode pulse rate pulse signal level SpO MAP mmHg or kPa and battery charge level Option no longer available SYS mmHg amp ap IC y 1
48. ntil it finally powers itself off If not used for extended periods of time then recharge the battery standby Mode When the device is powered up but has not been used for 2 minutes it goes into Standby Mode Z Z Z appears across the top of the display with no backlight Standby Mode conserves battery power To bring the Spot Vital Signs out of Standby Mode press the Mode or Pressure Preset button or begin a patient measurement 23 s Blood Pressure Caution When measuring blood pressure on children younger than age 3 it is recommended that the Pressure Preset initial inflation pressure be set at 160 mmHg or lower Selecting the Blood Pressure Cuff Note A durable blood pressure cuff is included with your Spot Vital Signs A full range of blood pressure cuff sizes are available as accessory items Careful sizing of the blood pressure cuff is important to the accuracy of blood pressure readings If the blood pressure cuff is too small you may have false high readings If the blood pressure cuff is too large you may have false low readings Please refer to the range markings on the blood pressure cuff for correct blood pressure cuff sizing When there is an area of overlap whereby you could use a smaller or larger blood pressure cuff it is strongly recommended that you use the larger size blood pressure cuff Determining Blood Pressure Cuff Size with the Markings Wrap the blood pressure cuff around the patient s up
49. nts sanguins afin de comprendre compl tement l tat du patient 12 Welch Allyn Spot Vital Signs Avertissements relatifs la temp rature A AVERTISSEMENT Les embouts de sonde jetables a usage unique disponibles aupr s de Welch Allyn limitent les contaminations entre patients ll est sp cialement d conseill d utiliser tout autre embout de sonde ou de ne pas utiliser d embout En effet cela peut g n rer des erreurs de temp rature AVERTISSEMENT N utiliser que des sondes orales bleues pour le relev de temp ratures orales et axillaires N utiliser que des sondes rectales rouges pour le relev de temp ratures rectales l utilisation de la mauvaise sonde peut produire des erreurs de temp rature AVERTISSEMENT Ne pas laisser l extr mit de la sonde de temp rature entrer en contact avec une source de chaleur par ex les mains ou les doigts avant de proc der un relev de temp rature Si cela se produit jeter l embout de la sonde et reprendre la d termination de la temp rature AVERTISSEMENT Un monitorage continu longue dur e de trois cinq minutes n est pas recommand quel que soit le mode Avertissements relatifs au port de communication infrarouge AVERTISSEMENT Le Welch Allyn Spot Vital Signs contient un port de communication infrarouge pour les communications isol es avec des p riph riques externes Ce port se trouve sur le c t de l appareil pour emp cher tout contact visuel direct c
50. obales de s curit contenues dans ce r sum Ce manuel comprend galement des avertissements et pr cautions sp cifiques ll est possible que ces avertissements et pr cautions sp cifiques ne soient pas indiqu s dans ce r sum 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 blessures des maladies ou le d c s du patient A AVERTISSEMENT Le Welch Allyn Spot Vital Signs est concu pour tre utilis par des m decins Si ce manuel pr sente des techniques de v rification m dicale ponctuelle seul un clinicien form sachant comment relever et interpr ter les signes vitaux d un patient doit utiliser ce systeme AVERTISSEMENT Les informations contenues dans ce manuel sont un guide d taill du fonctionnement du Welch Allyn Spot Vital Signs Pour obtenir des r sultats satisfaisants merci de lire ce manuel attentivement avant d essayer d utiliser l appareil AVERTISSEMENT Spot Vital Signs n est pas con u pour relever des donn es sur des patients nouveau n s Selon la norme AAMI SP10 1992 un nouveau n est un enfant de moins de 28 jours s il est n terme 37 semaines de gestation ou plus Sinon jusqu 44 semaines de gestation AVERTISSEMENT Le Welch Allyn Spot Vital Signs n est pas prot g en cas de d fibrillation AVERTISSEMENT Le Welch Allyn Spot Vital Signs n est p
51. oduct is contaminated this directive does not apply 2 For more specific disposal information see www welchallyn com weee or contact Welch Allyn Customer Service at 44 207 365 6780 Welch Allyn Spot Vital Signs Safety Warnings and Cautions All operating personnel should be familiarized with the general safety information in this summary Specific warnings and cautions are also found throughout this manual Such specific warnings and cautions may not appear here in this summary General Warnings A warning statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to patient injury illness or death A WARNING The Welch Allyn Spot Vital Signs is designed for use by medical clinicians Although this manual may illustrate medical spot check techniques only a trained clinician who knows how to take and interpret a patient s vital signs should use this system WARNING The information in this manual is a comprehensive guide to the operation of the Welch Allyn Spot Vital Signs To achieve satisfactory results you should read the manual thoroughly before attempting to use the device WARNING Spot Vital Signs is not intended to take measurements on neonatal patients The AAMI SP10 1992 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 The Welch Allyn Spot Vital Signs
52. of this device Please reference 4200 89E on page 61 Cleaning Spot Vital Signs Caution Do not use ethyl alcohol to clean the Spot Vital Signs device Caution Do not sterilize or autoclave the Spot Vital Signs Occasionally wipe the Spot Vital Signs as necessary with a cloth slightly dampened with appropriately diluted non staining disinfectant solution Use either 70 isopropyl alcohol 10 chlorine bleach solution or mild detergent in warm water Never immerse the Spot Vital Signs in any type of fluid Note Prevent water or other fluids from entering any connectors Should this occur dry the connectors with warm air Check all measurement functions for proper operation Blood Pressure Cuff Caution Do not press with a hot iron Clean the blood pressure cuff with a damp cloth or wash in water with soap or detergent Before washing the blood pressure cuff remove the tube fitting s close off tubes with plugs available as accessory 5082 163 and place the hook and loop fasteners in the closed position After washing allow the blood pressure cuff to air dry Re assemble the tube fitting s Disinfection You may use glutaraldehyde type liquid disinfectants on the durable blood pressure cuff Prolonged use of these disinfectants at full strength may cause discoloration of the white blood pressure cuff markings Sterilization Do not use steam or heat to sterilize the blood pressure cuff or pressure hose If necessary
53. ontinu lors de la consultation de l affichage A titre de pr caution ne pas regarder directement le port infrarouge en cours de fonctionnement Pr cautions g n rales Dans ce manuel Attention identifie les conditions ou pratiques qui si elles ne sont pas corrig es ou arr t es imm diatement risquent de provoquer des pertes de donn es un endommagement o une d faillance du mat riel A Attention Si la pr cision de toute mesure est mise en question v rifier le s signe s vital vitaux du patient en employant une autre m thode puis s assurer que l appareil fonctionne correctement Attention S assurer que l appareil est situ sur une surface s re ou utiliser un des accessoires de montage optionnels Attention Ne pas placer de fluides sur l appareil Directions for Use 13 Pr cautions relatives a la pression art rielle A Attention Veiller minimiser le mouvement de l extr mit et du brassard de pression art rielle en cours de d termination de la pression art rielle Attention Si le brassard de tensiom tre n est pas au niveau du coeur la diff rence de valeur due a l effet hydrostatique doit tre not e La valeur de 1 80 mmHg doit tre ajout e a la valeur affich e pour chaque pouce 2 5 cm au dessus du niveau du coeur La valeur de 1 80 mmHg doit tre retir e a la valeur affich e pour chaque pouce 2 5 cm en dessous du niveau du coeur Attention est essentiel que le brassard de tensiom
54. per arm and visually check it The blood pressure cuff is marked with a distinct white edge and two divisions that indicate range When the blood pressure cuff is properly fit the edge meets the blood pressure cuff at some point within the range Chart for Determining Blood Pressure Cuff Size You can also determine blood pressure cuff size by measuring the patient s arm circumfer ence midway between the elbow and shoulder then use the chart below to select the correct blood pressure cuff Cuff Size Reusable Two Piece Cuff Maximum Range Maximum Range 1 per pack cm in Child 5200 03 20 8 8 2 Adult 5200 01 31 5 124 Large Adult 5200 02 38 4 15 1 Thigh 5200 10 47 4 18 7 24 Welch Allyn Spot Vital Signs Durable Disposable Cuff Size Minimum Maximum Minimum Maximum One Piece Cuff One Piece Cuffs cm cm inches inches Single Unit 5 pack 5082 203 3 5082 93 3 Small Child 12 4 16 8 49 6 6 5082 204 3 5082 94 3 Child 15 8 21 3 6 2 8 4 5082 205 3 5082 95 3 Small Adult 20 0 27 0 79 10 6 5082 206 3 5082 96 3 Adult 25 3 34 3 10 0 13 5 5082 207 3 5082 97 3 Large Adult 32 1 43 4 12 6 17 1 5082 208 3 5082 98 3 Thigh 40 7 55 0 16 0 21 7 THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED FOR USE ON NEONATAL PATIENTS To ensure pediatric blood pressure accuracy and safety the Welch Allyn Child Print Cuff 5200 03 the Welch Allyn Small Child Durable One Piece Cuff 5082 203 3 and the Welch Allyn Small Chi
55. perature module malfunction Internal communications error Contact Technical Service Disconnect the battery and wait 5 minutes Reconnect the battery and then set the date and time see Blood Pressure Hose and Cuff Connections on page 21 E20 E50 General internal malfunction Contact Technical Service Table 2 Blood Pressure Code Description Corrective Action C02 Auto zero failure Check for air obstruction limit patient movement C03 Inflation too rapid Check for kinked blood pressure cuff tubing pressure hose or other air obstruction C04 Excessive inflation time Check for air leaks C05 Excessive noise Check patient condition blood pressure cuff placement limit patient movement C06 Measurement was outside of device s measurement range Check patient condition E10 Blood pressure cuff overpressure condition Check patient condition 38 Table 3 Temperature Welch Allyn Spot Vital Signs Code Description Corrective Action C20 Broken missing probe Replace probe P Loss of tissue contact Ensure proper probe positioning E0 2 E0 3 Ambient temperature out of range Adjust ambient temperature or device location C22 10 minute diagnostic time exceeded Remove probe discard probe cover retake temperature Table 4 SpO Code E7 Description Internal SpO error
56. power quality should be that of a typical commercial or hospital environment IEC 61000 4 5 2 kV common mode 2 kV common mode Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60Hz magnetic field IEC 61000 4 8 gt 95 dip in 0 5 cycle 6096 dip in 5 cycles 3096 dip for 25 cycles gt 95 dip in 5 seconds 3 A m gt 95 dip in 0 5 cycle 6096 dip in 5 cycles 3096 dip for 25 cycles gt 95 dip in 5 seconds 3 A m Mains power quality should be that of a typical commercial or hospital environment If the user of the 420 Series Spot Vital Signs requires continued operation during power mains interruptions it is recommended that the 420 Series Spot Vital Signs be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Directions for Use 49 Electromagnetic Immunity The 420 Series Spot Vital Signs is intended for use in the electromagnetic environment specified below The customer or user of the 420 Series Spot Vital Signs 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 420 Series Spot Vital Signs
57. r case 3 to 20 kg Table 6 Reusable Sensor Catalog Description Weight Range Quantity LNCS DCI Finger sensor adult gt 66 Ibs 30 kg 1 LNCS DCIP Finger sensor pediatric 10 to 50 kg 1 LNOP DCI Finger sensor adult gt 66 Ibs 30 kg 1 LNOP DCIP Finger sensor pediatric 10 to 50 kg 1 Table 7 Sensor Cables Catalog Description Weight Range Quantity 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 WA 4 foot cable with DB 9 connector for LNOP NA 1 PC 08 WA 8 foot cable with DB 9 connector for LNOP NA 1 Directions for Use Nellcor Table 8 OxiMax Adhesive Sensors Single patient use 59 Catalog Description Weight Range Quantity MAX Al Adult sensor gt 30 kg 24 MAX PI Pediatric sensor 10 50 kg 24 MAX I Infant sensor 3 20 kg 24 MAX RI Adult nasal sensor gt 50 kg 24 SRC MAX Portable oximetry tester Table 9 OxiMax OxiCliq Sensors Reusable cable Catalog Description Weight Range Quantity OC 3 OxiClig sensor cable 3 ft 1 OXICLIO PI Pediatric oxygen transducer user with OC 3 cable 10 50 kg Case of 24 Table 10 OxiMax Reusable Sensors Catalog Description Weight Range Quantity DS 100A Durasensor adult oxygen transducer gt 40 kg 1 OXI A N Oxiband OXI A N adult neonatal transducer lt 3kgor gt 40kg 1 sensor 50 wraps OXI P I Oxiband OXI P l pediatric infant transducer 3 40 kg 1 sensor
58. rement standards is acceptable provided they have an accuracy of better than 3 mmHg are traceable to NIST and have a current calibration Note Do not take more than 3 minutes to take the readings as the Spot Vital Signs will open its pressure relief valve as a safety feature If this occurs turn the device off and start over The Spot Vital Signs has the option to measure pressure in kPa units If the device is set to kPa instead of mmHg temporarily set the device to mmHg units or convert all pressures to kPa units 28 Welch Allyn Spot Vital Signs 29 Temperature WARNING Long term continuous monitoring beyond three to five minutes is not recommended in any mode Selecting Temperature Operation Mode When configured with the temperature option the Welch Allyn Spot Vital Signs takes a temperature in either Normal or Monitor Mode In the Normal Mode the thermometer predicts body temperature in approximately 4 seconds for oral temperatures 10 seconds for axillary temperatures and 15 seconds for rectal temperatures Monitor Mode is normally used when difficult situations prevent taking an accurate temperature in the Normal Mode In Monitor Mode maintain probe contact with the tissue for at least 3 minutes for accurate oral rectal temperature measurement and 5 minutes for accurate axillary temperature measurement The default setting for the Spot Vital Signs thermometer is Normal Mode Temperature Measurem
59. ries for fraying or other damage Replace as necessary Directions for Use A WARNING There are no userserviceable parts inside the device other than battery replacement Refer Spot Vital Signs to the Authorized Service Center WARNING The Spot Vital Signs should not be used on patients who are linked to heart lung machines WARNING The Spot Vital Signs does not operate effectively on patients who are experiencing convulsions or tremors WARNING This device complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices As a precaution avoid using this device in close proximity to other equipment WARNING This device is not intended for hand held use during operation WARNING Welch Allyn recommends leaving the battery in the device regardless if the device is not used for long periods of time since there is no hazard of leaving the battery in the device WARNING Do not autoclave 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 Blood Pressure Warnings A WARNING To ensure pediatric blood pressure accuracy and safety the Welch Allyn Child Print Cuff 5200 03 the Welch Allyn Small Child Durable O
60. s manual identifies a condition or practice which if not corrected or discontinued immediately could lead to equipment failure equipment damage or data loss A Caution f the accuracy of any measurement is in question check the patient s vital sign s by an alternate method then check to make sure the device is functioning properly Caution Ensure the device is placed on a secure surface or use one of the optional mounting accessories Caution Do not place fluids on the device Welch Allyn Spot Vital Signs Blood Pressure Cautions A Sp0 Cautions A Caution Extremity and blood pressure cuff motion should be minimized during blood pressure determinations Caution f the blood pressure cuff is not at heart level the difference in reading due to the hydrostatic effect should be noted The value of 1 80 mmHg must be added to the displayed reading for every inch 2 5 cm above heart level The value of 1 80 mmHg must be subtracted 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 Chart for Determining Blood Pressure Cuff Size on page 23 for blood pressure cuff sizing information Caution When measuring blood pressure on children younger than 3 years of age It is recommended that the Pressure Preset initial inflation pressure be set at 160 mmHg or lower Caution The pulse
61. sensor cable is correctly plugged into device Verify you are using the correct sensor Use only Masimo or Nellcor SpO sensors and accessories with the Welch Allyn Spot Vital Signs with Masimo or Nellcor configurations respectively Table 10 Device Does Not Turn On Possible Cause Explanation and Corrective Action Low battery Check connections between device and transformer and transformer and wall receptacle Device not powering up Unplug unit from wall receptacle and check for breaks in cord If connections are secure check electrical outlet Charging indicator is on if connections are good and the device is plugged into a working outlet Notify biomedical department or Welch Allyn Technical Support Table 11 Blood Pressure Cuff Too Tight Over Inflation Possible Cause Explanation and Corrective Action Pressure preset too high Check default Pressure Preset setting in internal configuration mode Unless patient has underlying systolic hypertension set pressure preset at 160 mmHg If systolic blood pressure greater than pressure preset the device automatically increases an additional 40 mmHg Directions for Use 41 Table 12 Blood Pressure Cuff Pops Off Possible Cause Inappropriate blood pressure cuff size Explanation and Corrective Action Determine blood pressure cuff size with the blood pressure cuff markings or see Chart for Determining Blood Pressure Cuff Size
62. splays a C9 error code and beeps twice This error code means that the use has exceeded the 10 minute time limit To clear the error code disconnect the sensor from Spot Vital Signs and then re attach it or press the Next Patient Clear Cancel button 2 Check sensor sites periodically to assess circulation sensor positioning and skin sensitivity 3 Remove the sensor from the patient The device continues to display the last SpO reading 36 Welch Allyn Spot Vital Signs 37 Error Indications and Interpretation The following table of conditions and error codes provides a quick reference of the descriptions and probable causes of error codes To clear the error code Power the Spot Vital Signs off wait five seconds and power on If the error code reappears then power the Spot Vital Signs off and disconnect the battery for five minutes Reconnect the battery and power on If the error code continues to reappear call Welch Allyn for a Service Notification Number see Technical Assistance on page 56 Press the Blood Pressure Start Stop button to reset flashing patient alarm conditions Error Codes Table 1 General Code Description Corrective Action E11 Internal safety violation Check patient contact Technical Service C12 Ambient temperature out of range Adjust ambient temperature or device location C13 Battery failure Use wall transformer E0 0 E9 9 E42 Tem
63. t 7 2VDC 1 0A Output International Version 240VAC 50Hz 0 065A Input 7 2VDC 1 0A Output Australian Version 240VAC 50Hz 13VA Input 7 2VDC 1 0A Output Battery Lead acid with external charger A fully charged battery supports 130 typical blood pressure determinations taken at 7 minute intervals The battery is 90 100 charged after 12 hours of charging The battery automatically charges when the Spot Vital Signs is powered through the AC power transformer The battery charges faster when the instrument is not in operation Environmental Operating Temperature 10 to 40 C Thermometer operating temperature 16 to 40 C 50 to 104 F Thermometer operating temperature 61 to 104 F Storage Temperature 20 to 50 C 4 to 122 F Transport Temperature 20 to 49 C 4 to 122 F Relative Humidity 15 to 90 non condensing Operating Altitude 170 to 4877 m 557 to 16 000 ft Directions for Use 47 Guidance and Manufacturer s Declaration Emissions and Immunity Information Electromagnetic Emissions The 420 Series Spot Vital Signs is intended for use in the electromagnetic environment specified below The customer or user of the 420 Series Spot Vital Signs should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The 420 Series Spot Vital Signs uses RF energy only for its internal function Therefore its
64. te 25 to 240 bpm No Motion Adults and Pediatrics 3 digits Motion Adults and Pediatrics 5 digits Low Perfusion Adults and Pediatrics 3 digi a Table 14 Masimo Sensor Accuracy Guide Saturation Accuracy Pulse Rate Accuracy Sensor Weight Range No Motion Motion No Motion Motion LNCS DCI gt 30 kg 2 3 3 bpm 5 bpm LNCS DCIP 10 to 50 kg 2 3 3 bpm 5 bpm LNCS ADTX gt 30 kg 2 3 3 bpm 5 bpm LNCS PDTX 10 to 50 kg 2 3 3 bpm x 5 bpm LNCS INF L 3 to 20 kg 2 3 3 bpm x 5 bpm LNOP DCI 30 kg 2 3 3 bpm x 5 bpm LNOP DCIP 10 to 50 kg 2 3 3 bpm x 5 bpm LNOP ADT 30 kg 2 3 3 bpm x 5 bpm LNOP PDT 10 to 50 kg 2 3 3 bpm x 5 bpm LNOP INF L 3 to 20 kg 2 3 3 bpm x 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 Directions for Use Nellcor Sensor Accuracy Guide 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 45 hemoximetry All accuracies are expressed as X digits This variation equals plus one standard deviation 1 SD which encompass
65. ted accuracy of Spot Vital Signs This is the pass fail criteria to determine if the device is within calibration or not If the differences between Spot Vital Signs and the pressure measurement standard are within the pass fail criteria at all specified pressures then the device is within calibration If the Spot Vital Signs needs re calibration the procedures are included in the Spot Vital Signs Service Manual Alternatively send the device back to Welch Allyn for calibration by contacting Technical Service Note The pass fail criteria for the blood pressure calibration check depends upon the accuracy of the pressure measurement standard used For example e fthe pressure measurement standard used is rated with an accuracy of 0 1 mmHg the pass fail criteria is 2 9 mmHg in order to guarantee that the instrument under test is within x3 mmHg of NIST e fthe pressure measurement standard used is rated with an accuracy of 1 0 mmHg the pass fail criteria is 2 0 mmHg in order to guarantee that the instrument under test is within x3 mmHg of NIST Welch Allyn recommends using a pressure meter that is as accurate as possible when performing calibration checks Welch Allyn offers two different pressure measurement standards for use Directions for Use 27 e Setra Pressure Meter calibrated accuracy of 0 1 mmHg part no 2270 01 e Netech Pressure Meter calibrated accuracy of 21 0 mmHg part no 200 2000IN Use of other pressure measu
66. the 420 Series Spot Vital Signs is used exceeds the applicable RF compliance level above the 420 Series Spot Vital Signs should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the 420 Series Spot Vital Signs Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 50 Welch Allyn Spot Vital Signs Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the 420 Series Spot Vital Signs The 420 Series Spot Vital Signs is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the 420 Series Spot Vital Signs can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the 420 Series Spot Vital Signs as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency 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 11667 0 11667 0 23333 0 1 0 36894 0 36894 0 73785 1 1 1667 1 1667 2 3333 10 3 6894 3 6894 7 3785 100 11 667 11 667 23 333 For transmitters rated at a maximum output power not listed above the recomme
67. 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 Temperature Warnings A WARNING Single use disposable probe covers available from Welch Allyn limit patient cross contamination The use of any other probe cover or the failure to use a probe cover may produce temperature errors and is specifically not recommended WARNING Use only oral probes blue cap for taking oral and axillary temperatures Use only rectal probes red cap for taking rectal temperatures The use of the wrong probe may produce temperature errors WARNING Do not allow the tip of the temperature probe to come into contact with any heat source e g hands or fingers prior to taking a temperature measurement If this occurs discard the probe cover and start the temperature determination again WARNING Long term continuous monitoring beyond three to five minutes is not recommended in any mode IR Communications Port Warnings A WARNING The Welch Allyn Spot Vital Signs contains an infrared communications port for isolated communications with external devices The port is located on the side of the device to preclude direct eye contact on a continual basis when viewing the display As a precaution do not look directly into the infrared port during operation General Cautions A caution statement in thi
68. thing interferes with measurement accuracy Verify that the cuff artery marker is placed over the brachial artery Ensure that the hose is not twisted kinked or compressed as this may cause measurement errors Directions for Use 25 To set the pressure preset level one time only 1 Press and hold the Pressure Preset button for half a second Spot Vital Signs displays PrP pressure preset in the SYS and the inflation pressure in the DIA displays respectively Push the Pressure Preset button The blood pressure cuff inflation pressure decreases in 20 mmHg increments beginning at 160 mmHg 160 gt 140 120 200 180 160 To return to the normal operating mode push the Next Patient Clear Cancel button or wait 3 seconds The inflation pressure resets to the default pressure setting after completing one blood pressure cycle The factory default is 160 mmHg There is a disable feature in the Internal Configuration Mode that allows the facility to disable this button see page 19 To initiate a blood pressure measurement 1 Ensure that the blood pressure cuff is properly sized and wrapped around the patient s upper arm or alternate site as necessary With the device powered on press the Blood Pressure Start Stop A button The Spot Vital Signs inflates the blood pressure cuff to the if appropriate pressure and displays the pressure as the blood pressure measurement is in process Pressing the Blood Pressur
69. tion the temperature display alternates between the final predicted temperature and the letter P To switch to Monitor Mode after obtaining a reading leave the probe in place after obtaining a reading and press the Mode button once The temperature display shows an M to indicate Monitor Mode Once in Monitor Mode proceed to Step 5 on page 33 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 Spot Vital Signs and wash your hands Directions for Use 33 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 equilibrium 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 To switch to Monitor Mode without taking a predictive temperature remove the probe from the holder attach a new probe cover and wait one minute Do not place the probe in the patient s mouth underarm or rectum After one minute the thermometer switches to Monitor Mode and an M shows in the temperature display Continue to take the patient s temperature To take a temperature in Monitor Mode 1 2 Veri
70. ts out of warranty Technical Assistance If you have an equipment problem that you cannot resolve call the Welch Allyn Service Center nearest you during normal business days at the phone numbers listed on page ii 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 Our service personel will give you a Service Notification number Note this number on the outside of your shipping box Service centers will not accept returns without a Service Notification number for delivery 57 11 Supplies and Accessories Latex Free Blood Pressure Table 1 Cuff and Bag Combination Catalog Description Catalog Description 5200 01 Cuff and bladder adult one tube 5200 10 Cuff and bladder thigh one tube 5200 02 Cuff and bladder large adult one tube 5200 03 Cuff and bladder child one tube Table 2 One Piece Cuff Durable Cuff Disposable Cuff Catalog Description Catalog Description 5082 203 3 One piece cuff small child one tube 5082 93 3 One piece cuff small child one tube box of 5 5082 204 3 One piece cuff child one tube 5082 94 3 One piece cuff child one tube box of 5 5082 205 3 One piece cuff small adult one tube 5082 95 3 One piece cuff small adult one tube box of 5
71. un 22 Standby Mode c a eb gl es Det ur egeo ton de a dosi a Acted eel A 22 5 Blood Pressure cuta Cet ES Va ROSE EY dc oer AER KE eR SL 23 Selecting the Blood Pressure Cuff 23 Reviewing Information from the Last Cycle 25 Checking the Blood Pressure Calibration 26 6 Temper atis tt Witte a quat e ale ee eee vit 29 Selecting Temperature Operation Mode 29 Temperature Measurement Range Indicators 29 vi Contents Welch Allyn Spot Vital Signs Normal Mode fx sacs con a aa aKa ke ace e ada S E ct e Af E Te Ge ANN 29 Monitors Modes x bt dte dee rt TER De AU coe ee em T UP UR Eu eeu mae 33 7 Pulse Oximetry Sp0 4 vies sup pe E ah eT RO des 35 8 Error Indications and Interpretation 37 EMORCOdES Su site st od a fueras Tenens rd ten ds LA ad card Ap An od had MA a 37 Causes and Corrective Action 39 9 Specifications cartas e dia RR Ae eee 43 Patient Population 25 44 246 ne ee a SAS ad eS 43 Blood Pr SSUr esce uA EE T IS RAI EE Ies 43 Jemperatun amp oeste ert mete Y Y eere EMT dee p Me PER IN 43 METRO by a stern deb geo tei AN dics uat Pap recur etia ahs oc al nee A ai d 44 Mechanical x Be ce fede An any tese E pee rede ved 46 ElSCUICA LORE AR o A eee ra EA aE UE Y tte le GA e ad 46 Environmental ese verat e ut ee E S
72. une isch mie un purpura et ou une neuropathie ventuels AVERTISSEMENT Ne pas changer le s connecteur s sur le tuyau du tensiom tre de cet appareil pour un type luer Les connecteurs de type luer sont couramment utilis s dans des syst mes de perfusion par intraveineuse L utilisation de connecteurs luer sur un tuyau de brassard de pression art rielle cr e le risque que le tuyau de pression art rielle soit connect par erreur une intraveineuse du patient entrainant l introduction d air dans l appareil circulatoire du patient Directions for Use 11 Avertissements relatifs SpO AVERTISSEMENT N utiliser Spot Vital Signs avec l option Masimo ou Nellcor SpO qu avec les accessoires et capteurs de la marque Masimo ou Nellcor respectivement L utilisation de capteurs ou de c bles erron s ou non approuv s peut entrainer des performances incorrectes AVERTISSEMENT Les rallonges et capteurs SpO sont con us pour tre utilis s uniquement avec les mesures d oxym trie puls e Ne pas essayer de connecter ces c bles un PC ou tout autre appareil similaire AVERTISSEMENT Avant utilisation lire soigneusement le mode d emploi du capteur y compris tous les avertissements les pr cautions et instructions AVERTISSEMENT Ne pas utiliser un c ble SpO ou de capteur endommag Ne pas utiliser un capteur dont les composants optiques sont expos s AVERTISSEMENT Un tissu peut tre endommag par une application ou une
73. uracy Overpressure Cutoff Temperature Accuracy Range Determination Time 0 mmHg to 300 mmHg 160 mmHg 60 mmHg to 250 mmHg 30 mmHg to 160 mmHg Blood pressure accuracy meets or exceeds SP10 1992 AAMI standards for non invasive blood pressure accuracy AAMI standard 5 mmHg mean error 8 mmHg standard deviation Blood pressure accuracy is validated for pressure measurement using the upper arm only Typical 20 to 45 seconds Maximum 165 seconds 40 bpm to 200 bpm 5 0 305 mmHg 0 15 mmHg Calibration accuracy 0 2 F 0 1 C Maximum 109 4 F 43 0 C Minimum 86 0 F 30 0 C Oral approximately 4 seconds Axillary approximately 10 seconds Rectal approximately 15 seconds 44 Welch Allyn Spot Vital Signs Pulse Oximetry Masimo Sensor Accuracy Guide Accuracy specified when used with Masimo SET pulse oximetry monitors or with licensed Masimo SET pulse oximetry modules using Masimo 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 SpO5 70 to 100 Pulse Rate 25 240 beats per minute BPM Perfusion 0 02 to 20 Sp0 Accuracy Saturation 70 to 100 No Motion Adults Pediatrics 2 digits Motion Adults Pediatrics 3 digits Low Perfusion Adults Pediatrics 2 digits Pulse Rate Accuracy Pulse Ra
74. with young children and infants The circumference of the child s arm must fit within the range markings on the cuff The Welch Allyn Spot Vital Signs is FDA cleared to measure the axillary temperature in normal mode for children under the age of 4 The Welch Allyn Spot Vital Signs is not intended for continuous monitoring and is therefore not defibrillator proof Do not leave the device unattended while taking measurements on a patient The Welch Allyn Spot Vital Signs should not be used on patients who are linked to heart lung machines Directions for Use Symbols and Descriptions Familiarize all operating personnel with the general safety information in this summary Operators will also find specific warnings and cautions throughout the Directions for Use Such specific warnings and cautions may not appear here in this summary Caution Consult manual for additional information Type BF Equipment Handle with Care o5 50 C Transport Temperature Storage Humidity ES aj Pb Internally Powered Lead Acid Battery Class Il Equipment Not protected against the ingress of water IPXO i i j Mode of Operation Continuous 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 pr
75. y phase 5 The Welch Allyn Spot Vital Signs was eveloped 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 phase 4 is to be used Deflate blood pressure cuff no faster than 3 mmHg per second e One of the major sources of error in auscultatory blood pressure measurement is deflating the blood pressure 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 take inaccurate blood pressure measurements EL Change in blood pressure between auscultatory reading and Welch Allyn Spot Vital Signs reading Check blood pressure immediately prior to Welch Allyn Spot Vital Signs reading Poor auscultatory sound recognition by observer Use higher quality stethoscope Have a different observer check patient s blood pressure Note Differences of up to 10 mmHg are considered normal and occur for a number of reasons including intra patient blood pressure variability observer hearing differences and auscultatory deflation rate Table 6 Cuff Inflation and Deflation with No Blood Pressure Reading Displayed or Error Code in Display Possible Cause Explanation and Corrective Action Leak in pneumatic system Ensure all blood pressure cuff attachments are tight

Welch Allyn Medical Diagnostic Equipment REF 420 Thermometer User Manual

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