Spot Vital Signs Monitor Series 420 Directions for Use Ver C

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. Welch Allyn®, Spot Vital Signs®, and SureTemp® are registered trademarks of Welch Allyn. LNCS™, SET®, LNOP®, and Masimo® are registered trademarks of, Masimo Corporation. Possession or purchase of a Masimo SpO2-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 rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors. For information about any Welch Allyn product, call Welch Allyn Technical Support: USA +1 800 535 6663 + 1 315 685 4560

Australia +61 2 9638 3000 +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 3 3219 0071

Latin America +1 305 669 9003

Netherlands +31 157 505 000

Singapore +65 6419 8100

South Africa +27 11 777 7555

United Kingdom +44 207 365 6780

Reorder No. 4200-87E Manual Material No. 706272 Ver. C Welch Allyn 4341 State Street Road Skaneateles Falls, NY 13153 USA Printed in USA

Sweden +46 85 853 6551

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.

SYS

(mmHg)

DIA

(mmHg)

/ min

v

Contents Configuration... iii

1 - Introduction... 1 Product Overview... 1 Related Publications... 2 Indications/Contraindications for Use... 2 Symbols and Descriptions... 3 Safety Warnings and Cautions... 4 Avertissements et précautions de sécurité... 9 Précautions générales... 12

2 - Controls, Indicators, and Connections... 15 Unpacking Checklist... 15 Possible Attachments... 15 Front Panel Functions... 16 LCD (Liquid Crystal Display)... 17 Top, Side, and Rear Panel Connections... 18

3 - Internal Configuration... 19 4 - Setup... 21 Blood Pressure Hose and Cuff Connections... 21 Temperature Probe Connection... 21 SpO2 Sensor Connection... 21 Quick Reference/Error Code Card... 22 AC Power Connection... 22 Charging the Battery... 22 Standby Mode... 22

5 - Blood Pressure... 23 Selecting the Blood Pressure Cuff... 23 Reviewing Information from the Last Cycle... 25 Checking the Blood Pressure Calibration... 26

6 - Temperature... 29 Selecting Temperature Operation Mode... 29 Temperature Measurement Range Indicators... 29

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... 37 Causes and Corrective Action... 39

9 - Specifications... 43 Patient Population... 43 Blood Pressure... 43 Temperature... 43 Pulse Oximetry... 44 Mechanical... 46 Electrical... 46 Environmental... 46 Guidance and Manufacturer’s Declaration... 47 Patents... 51 Agency Approvals... 51

10 - Maintenance... 53 Cleaning... 53 Battery Removal and Replacement... 54 Masimo SpO2 Calibration Check... 55 Nellcor SpO2 Functional Check... 55 SpO2 Accessory Disposal... 55 Temperature Calibration Check... 55 Service Manual/Spare Parts... 56 Service Loaners... 56 Service Policy... 56 Technical Assistance... 56

11 - Supplies and Accessories... 57 Latex-Free Blood Pressure... 57 Pulse Oximetry Accessories and Supplies... 58 Temperature... 60 Mounting... 60 Extended Warranty... 60 Miscellaneous... 61

Warranty... 63 Spot... 63 Accessories... 63

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. 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 SpO2

42NOB

Spot Vital Signs with blood pressure and Nellcor SpO2

42MTB

Spot Vital Signs with blood pressure, SureTemp thermometer, and Masimo SpO2

42NTB

Spot Vital Signs with blood pressure, SureTemp thermometer, and Nellcor SpO2

Product Overview The Welch Allyn Spot Vital Signs non-invasively and automatically measures systolic and diastolic blood pressure, pulse rate, and oxygen saturation (SpO2) 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 SpO2 values are viewed on a large, easy-toread display. The 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 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. 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. 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

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.

Class II Equipment

IPXØ

Not protected against the ingress of water.

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 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.

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. 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 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, SpO2 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, SpO2 cord, and accessories for fraying or other damage. Replace as necessary.

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. 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 WARNING 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. 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.

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. 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 SpO2 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 SpO2 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 SpO2 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 SpO2 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 SpO2 in the Welch Allyn Spot Vital signs is not intended for use as an apnea monitor. WARNING Consider the SpO2 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

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. 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 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 this manual identifies a condition or practice, which if not corrected or discontinued immediately, could lead to equipment failure, equipment damage, or data loss. Caution If 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.

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. 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.

SpO2 Cautions Caution The pulse oximeter is calibrated to determine the percentage of arterial oxygen saturation of functional hemoglobin. Significant levels of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin may affect the accuracy of the measurement. Caution 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 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.

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 Vital 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 (SpO2). The finger clip SpO2 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

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.

/ min

Pressure Preset Button: pressing this button allows the user to change the factory inflation default for one reading.

Mode Button: • holding for 2 seconds while the display is active turns off/on the backlight. • in Standby Mode, recalls the last patient information. • with the temperature probe removed from the probe holder, switches the temperature from Oral to Axillary Mode.

Blood Pressure Start/Stop Button: initiates a new blood pressure cycle. Pressing again cancels an active blood pressure measurement and deflates the cuff.

Pressure Hose Connector: port for blood pressure hose. Spot Vital Signs

Power Button: controls power to the device.

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. SpO2 %

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.

SpO2 Display: shows the percent saturation of arterial hemoglobin (for devices with SpO2 only). Pulse Display: shows the pulse rate.

Measurement Indicator: displays the blood pressure, SpO2, or temperature icon as Spot Vital Signs is taking the respective measurement.

/ min

M P

Temperature 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).

Thermometer Mode icon: shows temperature mode (for devices with SureTemp only).

Icon not used.

Temperature Probe Problem: indicates a temperature probe problem (for devices with SureTemp only).

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 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. Battery Door AC Power Connection Port

Threaded Insert: to mount the Spot Vital Signs to a mobile stand.

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. Press the Mode button to cycle through the Internal Configuration menu until you see the menu option displayed on the screen. 4. Use the Next Patient/Clear/Cancel or Blood Pressure Start/Stop buttons to change the default setting. 5. 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 Displays “Cal”

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.

Inflation Pressure Preset Level 120, 140, 160, 180, 200, 240, 280 mmHg. Factory default is 160 mmHg. Displays “PrP” Pressure Preset Level Displays “PrP“

On or off. Disables or enables the front panel Pressure Preset button.

Backlight Displays “BLT”

On or off.

Mean Arterial Pressure Displays “MAP”

On or off.

Date/Time

Changes or updates the actual date and time.

Temperature Scale Displays “TMP MOD”

Fahrenheit (°F) or Celsius (°C) Normal Mode / Fahrenheit (°F) or Celsius (°C) Monitor Mode

Blood Pressure Units Displays “BP”

mmHg or kPa.

Battery Readings Displays “BAT”

Displays the total battery voltage.

Battery Life Displays “LFE”

Total number unit measurements. Displayed information only; operator cannot change.