Welch Allyn Spot Vital Signs SYS kPa (mmHg) DIA kPa (mmHg) SpO2 % / min Spot Vital Signs Directions for Use REF 420 Series
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
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.
Directions for Use iii 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.
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v Contents Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii 1 - Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Related Publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
vi Contents Welch Allyn Spot Vital Signs Normal Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Monitor Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 7 - Pulse Oximetry (Sp02). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 8 - Error Indications and Interpretation . . . . . . . . . . . . . . . . . . . . . . . . 37 Error Codes. . . . . . . . . . . . . . .
1 1 Introduction 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., SpO2, temperature, mobile stand, and wall mount). The applicability of some sections of this manual depends on the configuration of your particular unit. Read this manual thoroughly before attempting to use the device. Table 1.
2 Welch Allyn Spot Vital Signs Related Publications Masimo Directions for Use - for models 42M0B and 42MTB Nelcor Directions for Use - for models 42N0B and 42NTB Indications/Contraindications for Use The Welch Allyn Spot Vital Signs measures blood pressure, pulse rate, temperature, and SpO2 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.
Directions for Use 3 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 Transport Temperature Storage Humidity + Pb Internally Powered, Lead Acid Battery.
4 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.
Directions for Use 5 WARNING There are no user-serviceable 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.
6 Welch Allyn Spot Vital Signs SpO2 Warnings WARNING Only use Spot Vital Signs with Masimo or Nellcor SpO2 option with Masimo or Nellcor brand sensors and accessories, respectively. Using the wrong or unapproved sensors or cables may cause improper performance. WARNING The SpO2 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.
Directions for Use 7 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. 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.
8 Welch Allyn Spot Vital Signs Blood Pressure Cautions Caution Extremity and blood pressure cuff motion should be minimized during blood pressure determinations. Caution If 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.
Directions for Use 9 Avertissements et précautions de sécurité Tout le personnel l’utilisant doit être familiarisé avec les informations globales de sécurité contenues dans ce résumé. Ce manuel comprend également des avertissements et précautions spécifiques. Il est possible que ces avertissements et précautions spécifiques ne soient pas indiqués dans ce résumé.
10 Welch Allyn Spot Vital Signs AVERTISSEMENT Tous les trois mois, vérifier que la sonde de température, le câble SpO2 et les accessoires ne s’effilochent pas et qu’ils ne sont endommagés de quelque façon. Remplacer si nécessaire. AVERTISSEMENT Hormis la batterie, aucune pièce de l’appareil n’est remplaçable par l’utilisateur. Retourner le Spot Vital Signs au centre d’entretien autorisé.
Directions for Use 11 Avertissements relatifs à SpO2 AVERTISSEMENT N’utiliser Spot Vital Signs avec l’option Masimo ou Nellcor SpO2 qu’avec les accessoires et capteurs de la marque Masimo ou Nellcor, respectivement. L’utilisation de capteurs ou de câbles erronés ou non-approuvés peut entraîner des performances incorrectes. AVERTISSEMENT Les rallonges et capteurs SpO2 sont conçus pour être utilisés uniquement avec les mesures d’oxymétrie pulsée.
12 Welch Allyn Spot Vital Signs 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. AVERTISSEMENT N’utiliser que des sondes orales (bleues) pour le relevé de températures orales et axillaires.
Directions for Use 13 Précautions relatives à la pression artérielle Attention Veiller à minimiser le mouvement de l’extrémité et du brassard de pression artérielle en cours de détermination de la pression artérielle. Attention Si le brassard de tensiomètre n’est pas au niveau du coeur, la différence de valeur due à l’effet hydrostatique doit être notée. La valeur de 1,80 mmHg doit être ajoutée à la valeur affichée pour chaque pouce (2,5 cm) au-dessus du niveau du coeur.
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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.
16 Welch Allyn Spot Vital Signs Front Panel Functions Thermometer Eject Button: push to remove used temperature probe cover. SYS kPa (mmHg) DIA kPa (mmHg) SpO2 % Next Patient/Clear/Cancel Button: • active display: clears the display. • in Standby Mode: recalls the last patient information. Pressing a second time clears the screen. • cancels an active blood pressure measurement and deflates the cuff.
Directions for Use 17 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, SpO2, MAP (mmHg or kPa), and battery charge level. . Option no longer available. SYS mmHg DIA mmHg Date/Time: indicates that the user must set/re-set the current date and time.
18 Welch Allyn Spot Vital Signs Top, Side, and Rear Panel Connections Probe Cover Storage Compartment: storage space for one box of probe covers. SpO2 Cable Connection Port (for units with SpO2 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.
19 3 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: 1. Turn the Spot Vital Signs off. 2. Press and hold the Power and Blood Pressure Start/Stop buttons. The device enters the Internal Configuration Mode and displays the software version. 3.
20 Internal Configuration Welch Allyn Spot Vital Signs
21 4 Setup 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 completely inserted over the connector and that the fit is snug. 2.
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.
23 5 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.
24 Welch Allyn Spot Vital Signs Durable One-Piece Cuff (Single Unit) Disposable One-Piece Cuffs (5 pack) Cuff Size Minimum (cm) Maximum (cm) Minimum (inches) Maximum (inches) 5082-203-3 5082-93-3 Small Child 12.4 16.8 4.9 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 7.9 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.
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. 2. Push the Pressure Preset button. The blood pressure cuff inflation pressure decreases in 20 mmHg increments beginning at 160 mmHg (160 -> 140, 120, 200, 180, 160).
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 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.
Directions for Use 27 • 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. 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.
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29 6 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.
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.
Directions for Use 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 completely surrounds the probe tip and place the arm snugly at the patient’s side. 6.
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).
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.
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35 7 Pulse Oximetry (Sp02) Factors that may degrade the performance of the pulse oximeter: • Excessive ambient light • Sensor not at heart level • Excessive motion • Anemia or low hemoglobin concentrations • Fingernail polish (if finger sensor • Arterial catheters, blood pressure, is used) and infusion lines, etc.
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37 8 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.
38 Welch Allyn Spot Vital Signs Table 3. Temperature 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. SpO2 Code Description Corrective Action E7 Internal SpO2 error. 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. • Use reference markings on blood pressure cuff. • 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).
40 Welch Allyn Spot Vital Signs Table 7. No Blood Pressure Cuff Inflation Possible Cause Explanation and Corrective Action Connections between device and blood pressure cuff loose Check all connections (do not overtighten). 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.
Directions for Use 41 Table 12. Blood Pressure Cuff Pops Off Possible Cause Explanation and Corrective Action Inappropriate blood pressure cuff size Determine blood pressure cuff size with the blood pressure cuff markings or see “Chart for Determining Blood Pressure Cuff Size” 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.
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43 9 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.
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. SpO2 accuracy from 70% to 100%. Pulse rate accuracy from 25 to 240 bpm.
Directions for Use 45 Nellcor® Sensor Accuracy Guide Accuracy specifications are based on controlled hypoxia studies with healthy, non-smoking adult volunteers over the specified saturation SpO2 range. Pulse oximeter SpO2 readings were compared to SaO2 values of drawn blood samples measured by hemoximetry. All accuracies are expressed as + “X” digits. This variation equals plus one standard deviation (+ 1 SD), which encompasses 68% of the population.
46 Welch Allyn Spot Vital Signs Mechanical Dimensions Weight Mounting Portability Height: 9.7 inches (24.6 cm) Length: 5.7 inches (14.5 cm) Depth: 4.7 inches (12.0 cm) Approximately 4.6 pounds (2.2 kg) Self-supporting on rubber feet Custom Mobile Stand Custom Wall Mount Custom IV Pole Mount May be hand-carried when held by the rear handle. Electrical Power Requirements Battery Patient-rated isolation transformer is connected to AC mains: North American Version:120VAC, 60Hz. 0.13A Input, 7.2VDC, 1.
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.
48 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. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic discharge (ESD) ± 6 kV contact ± 6 kV contact ± 8 kV air ± 8 kV air Floors should be wood, concrete, or ceramic tile.
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.
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.
Directions for Use 51 Patents D392,043 and other patents pending. Agency Approvals CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1 CONFORMS TO: IEC 60601, UL STD 60601-1 Welch Allyn PTY, Ltd - Australia Metro Centre 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 to and conforms with the provisions noted within the 93/42/ EEC Medical Device Directive.
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53 10 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. Caution Do not sterilize or autoclave the Spot Vital Signs.
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. SpO2 Sensor WARNING Do not immerse the sensor in water, solvents, or cleaning solutions (the sensors and connections are not waterproof).
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 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.
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.
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.
58 Welch Allyn Spot Vital Signs Pulse Oximetry Accessories and Supplies Masimo Table 5.
Directions for Use 59 Nellcor Table 8. OxiMax Adhesive Sensors: Single-patient use Catalog # Description Weight Range Quantity MAX-AI Adult sensor >30 kg 24 MAX-PI Pediatric sensor 10 - 50 kg 24 MAX-II Infant sensor 3-20 kg 24 MAX-RI Adult nasal sensor >50 kg 24 Weight Range Quantity SRC-MAX Portable oximetry tester Table 9.
60 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) 01802-110 Model 9600 Plus Calibration Tester Mounting Table 13.
Directions for Use 61 Miscellaneous Table 15.
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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 authorized distributors or agents. The battery is covered by a one-year warranty against original defects in material or workmanship.
64 Warranty Welch Allyn Spot Vital Signs
Reorder No. 4200-87E Material No. 706272 Ver.
