Welch Allyn 4200B Directions For Use Manual
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Welch Allyn 4200B Directions For Use Manual

Spot vital signs ref 420 series
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Welch Allyn Spot Vital Signs
Directions for Use
REF 420 Series
SYS
kPa
(mmHg)
DIA
kPa
(mmHg)
SpO
%
2
/ min
Spot Vital Signs

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Summary of Contents for Welch Allyn 4200B

  • Page 1 Welch Allyn Spot Vital Signs (mmHg) (mmHg) / min Spot Vital Signs Directions for Use REF 420 Series...
  • Page 2 CAUTION: United States Federal Law restricts this device to sale by or on the order of a health care practitioner.
  • Page 3 Welch Allyn Spot Vital Signs Directions for Use...
  • Page 4 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.

  • Page 5: Configuration

    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. (mmHg) (mmHg) / min...
  • Page 6 Welch Allyn Spot Vital Signs...

  • Page 7: Table Of Contents

    Contents Configuration ........... . iii 1 - Introduction .
  • Page 8 Contents Welch Allyn Spot Vital Signs Normal Mode ........... 29 Monitor Mode.

  • Page 9: Introduction

    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’...

  • Page 10: Related Publications

    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.

  • Page 11: Symbols And Descriptions

    96/EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. For more specific disposal information, see www.welchallyn.com/weee, or contact Welch Allyn Customer Service at +44 207 365 6780.

  • Page 12: Safety Warnings And Cautions

    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.
  • Page 13 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.
  • Page 14 WARNING The SpO in the Welch Allyn Spot Vital signs is not intended for use as an apnea monitor. WARNING Consider the SpO an early warning device. As a trend toward patient deoxygenation is indicated, use laboratory instruments to analyze blood samples to completely understand the patient’s condition.
  • Page 15 Directions for Use Temperature Warnings 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.
  • Page 16 Temperature Cautions 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.

  • Page 17: Avertissements Et Précautions De Sécurité

    28 jours, s’il est né à terme, (37 semaines de gestation ou plus). Sinon, jusqu’à 44 semaines de gestation. AVERTISSEMENT Le Welch Allyn Spot Vital Signs n’est pas protégé en cas de défibrillation. AVERTISSEMENT Le Welch Allyn Spot Vital Signs n’est pas conçu pour un monitorage continu.
  • Page 18 Avertissements relatifs à la pression artérielle AVERTISSEMENT Afin d’assurer la précision et la sécurité de la pression artérielle chez l’enfant, le brassard Welch Allyn pour enfant (5200-03), le brassard longue durée mono-pièce Welch Allyn pour enfant en bas-âge (5082-203-3) et le brassard mono-pièce jetable Welch Allyn pour enfant en bas-âge (5082-93-3) sont...
  • Page 19 En effet, ces deux câbles sont susceptibles de se déconnecter de l’appareil, entraînant la chute de l’appareil sur le patient. AVERTISSEMENT Le SpO du Welch Allyn Spot Vital signs n’est pas conçu pour une utilisation comme moniteur d’apnée. AVERTISSEMENT Considérer le SpO comme un dispositif d’avertissement...

  • Page 20: Précautions Générales

    Avertissements relatifs à la température AVERTISSEMENT Les embouts de sonde jetables à usage unique, disponibles auprès de Welch Allyn, limitent les contaminations entre patients. Il est spécialement déconseillé d’utiliser tout autre embout de sonde ou de ne pas utiliser d’embout. En effet, cela peut générer des erreurs de température.
  • Page 21 4 ans. Les températures axillaires du mode normal peuvent ne pas être précises sur des enfants plus âgés ou des adultes. LE WELCH ALLYN SPOT VITAL SIGNS N’EST PAS CONÇU POUR UNE UTILISATION SUR DES NOUVEAU-NÉS.
  • Page 22 Welch Allyn Spot Vital Signs...

  • Page 23: Controls, Indicators, And Connections

    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 Vital Signs Device.

  • Page 24: Front Panel Functions

    Welch Allyn Spot Vital Signs Front Panel Functions Thermometer Eject Button: push to remove used temperature probe cover. Next Patient/Clear/Cancel Button: • active display: clears the display. (mmHg) • in Standby Mode: recalls the last patient information. Pressing a second time clears the screen.

  • Page 25: Lcd (Liquid Crystal Display)

    Directions for Use LCD (Liquid Crystal Display) 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.

  • Page 26: Top, Side, And Rear Panel Connections

    Welch Allyn Spot Vital Signs Top, Side, and Rear Panel Connections Probe Cover Storage Compartment storage space for one box of probe covers. 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).

  • Page 27: Internal Configuration

    Internal Configuration You can change several device operating parameters in the Internal Configuration Mode. When changed, these settings become the default power-up settings. You will also see non-changeable device configurations for technical service purposes. To enter the Internal Configuration Mode: Turn the Spot Vital Signs off.
  • Page 28 Internal Configuration Welch Allyn Spot Vital Signs...

  • Page 29: Setup

    Twist the connectors together until finger-tight. 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.

  • Page 30: Quick Reference/Error Code Card

    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).

  • Page 31: Blood Pressure

    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 A durable blood pressure cuff is included with your Spot Vital Signs. A full range Note of blood pressure cuff sizes are available as accessory items.
  • Page 32 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 with young children and infants.

  • Page 33: Reviewing Information From The Last Cycle

    Directions for Use To set the pressure preset level (one time only): 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.

  • Page 34: Checking The Blood Pressure Calibration

    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 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.
  • Page 35 Directions for Use • Setra Pressure Meter, calibrated accuracy of ±0.1 mmHg (part no. 2270-01) • Netech Pressure Meter, calibrated accuracy of ±1.0 mmHg (part no. 200-2000IN) Use of other pressure measurement standards is acceptable, provided they have an accuracy of better than ±3 mmHg, are traceable to NIST, and have a current calibration. Do not take more than 3 minutes to take the readings, as the Spot Vital Signs will Note open its pressure relief valve as a safety feature.
  • Page 36 Welch Allyn Spot Vital Signs...

  • Page 37: Temperature

    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.
  • Page 38 Normal Mode axillary temperatures are FDA cleared for children under the age of Note four. THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED FOR USE ON NEONATAL PATIENTS. Verify that the correct probe (blue cap) is installed.
  • Page 39 Directions for Use 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.
  • Page 40 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).

  • Page 41: Monitor Mode

    Directions for Use 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.
  • Page 42 Welch Allyn Spot Vital Signs...

  • Page 43: Pulse Oximetry (Sp0 )

    Pulse Oximetry (Sp0 Factors that may degrade the performance of the pulse oximeter: • Excessive ambient light • Sensor not at heart level • Excessive motion • Anemia or low hemoglobin • Fingernail polish (if finger sensor • Arterial catheters, blood pressure, concentrations is used) and infusion lines, etc.
  • Page 44 Welch Allyn Spot Vital Signs...

  • Page 45: Error Indications And Interpretation

    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.
  • Page 46 Welch Allyn Spot Vital Signs Table 3. Temperature Code Description Corrective Action Broken/missing probe Replace probe. Loss of tissue contact Ensure proper probe positioning. E0.2, E0.3 Ambient temperature out of range Adjust ambient temperature or device location. 10-minute diagnostic time exceeded Remove probe, discard probe cover, retake temperature.

  • Page 47: Causes And Corrective Action

    Use the correct Korotkoff sound to determine diastolic blood pressure. • Many listeners incorrectly equate diastolic blood pressure with the disappearance of sound only (phase 5). The Welch Allyn Spot Vital Signs was developed using the American Heart Association recommendations, which state that phase 5 be used unless sound continues to 0 mmHg, in which case the change in the quality of sound (phase 4) is to be used.
  • Page 48 Verify the 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...
  • Page 49 Welch Allyn Technical Support. Blood pressure cuff applied Re-apply blood pressure cuff. Make sure Welch Allyn label is facing away from arm. inside out Table 13. Blood Pressure Cuff Deflating Too Slowly...
  • Page 50 Welch Allyn Spot Vital Signs...

  • Page 51: Specifications

    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.

  • Page 52: Pulse Oximetry

    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.
  • Page 53 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 readings were compared to SaO values of drawn blood samples measured by hemoximetry.

  • Page 54: Mechanical

    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.

  • Page 55: Guidance And Manufacturer's Declaration

    Directions for Use 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...
  • Page 56 Welch Allyn Spot Vital Signs 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.
  • Page 57 Directions for Use 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...
  • Page 58 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...

  • Page 59: Patents

    Agency Approvals CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1 CONFORMS TO: IEC 60601, UL STD 60601-1 EMC Framework of Australia Welch Allyn PTY, Ltd - Australia Metro Centre Unit 5/38 South Street Rydalmere NSW 2116, Australia The CE mark on this product indicates that it has been tested to and conforms with the provisions noted within the 93/42/ EEC Medical Device Directive.
  • Page 60 Welch Allyn Spot Vital Signs...

  • Page 61: Maintenance

    Maintenance Welch Allyn will make available,upon request, circuit diagrams and other information which will assist appropriately qualified technical personnel in repair 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.

  • Page 62: Battery Removal And Replacement

    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.

  • Page 63: Masimo Spo Calibration Check

    Directions for Use 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 Battery Battery Connector 5. Replace the battery door and tighten each of the 4 screws. 6.

  • Page 64: Service Manual/Spare Parts

    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.

  • Page 65: Supplies And Accessories

    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.

  • Page 66: Pulse Oximetry Accessories And Supplies

    Welch Allyn Spot Vital Signs Pulse Oximetry Accessories and Supplies Masimo Table 5. Adhesive Sensors: Single-Patient Use Catalog # Description Weight Range LNCS-ADTX Adhesive Finger Sensor - Adult (20 per case) >30 kg LNCS-PDTX Adhesive Finger Sensor - Pediatric (20 per case)
  • Page 67 3 - 40 kg Dura-Y sensor) Table 11. OxiMax Sensor Cables Catalog # Description Quantity DEC-4 extension cable, 4 ft. DEC-8 extension cable, 8 ft. * The Welch Allyn Spot Vital Signs is not intended for use on neonatal patients.

  • Page 68: Temperature

    Welch Allyn Spot Vital Signs Temperature Table 12. Accessories and Supplies 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)

  • Page 69: Miscellaneous

    Directions for Use Miscellaneous Table 15. Accessories and Supplies Catalog # Description Catalog # Description 4200-84 Lead Acid 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 5200-103Z AC Power Transformer (Australia) - 240V, 50Hz 4200-155...
  • Page 70 Welch Allyn Spot Vital Signs...

  • Page 71: Warranty

    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 authorized distributors or agents.
  • Page 72 Warranty Welch Allyn Spot Vital Signs...
  • Page 74 Reorder No. 4200-87E Material No. 706272 Ver. C...

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