Welch Allyn Spot Vital Signs 420 Series User manual

WelchAllyn
Spot Vital Signs
420 Series
11988
Ade - A DE
Operator's Manual

Table of Contents
AbouttheOperator'sManual .......................... 0 ο κ εν ο ων 1
Ргодис* Омегмем/ ........... ener neee 1
Symbols and Descriptions .............................................. 2
Safety Warnings and Cautions .......................................... 3
General Warnings に に に ーー 3
Blood Pressure Warnings ...............................,.....,..... 4
SpO, Wamings ....oooocoo 와 요요 에 에 이 이이 이 이 이 이 이 5
Temperature Warnidgs ....... 84 5
IR Communications Port Warnings ................................... 5
GeneralCautions ......................... 40000 eae 5
BloodPressureClautions ........................................... 6
SpO,Cautions ............................ aaa 6
Temperature Cautions ............... ees 6
Avertissements et précautions de sécurité ................................ 7
Avertissements göndraux ων νε ενω ων ων νε νε κ κ κ εν ο τον 7
Avertissements relatifs à la pression artérielle .......................... 8
Avertissements relatifs à SpO> μμ ἑἐἑ. 9
Avertissements relatifs à la température ............................... 9
Avertissements relatifs au port de communication Infrarouge .............. 9
Précautions générales 2... eee 10
Précautions relatives à la pression artérielle ........................... 10
Précautions relatives à SPO, 0000 00000 의 10
Pr&cautlonsrelativesâlatempedrature................................ 11
Indications/Contraindications for Use ................................... 11
Special Features ..................................................... 11
Choice of Measurement Modalities ............................,...... 11
Non-Invasive Oscillometric Blood Pressure ............................ 11
Operator Friendly Results .................,.........,...,....,..... 11
AC or Self-ContainedBatteyPower ................................. 12
Blood Pressure .................................................. 12
Temperature . eneret 12
A 13
Pulse Rate ーー 14

Performance Specifications ............................................ 15
Patient Population .........................,..,........,........1 15
Cuff Pressure Range .......................,.......,,,,....,,,... 15
Initial Cuff Inflation し し し eens 15
Systolic Range eee es 15
Diastolic Range ...........................,..,........,........ 15
Blood Pressure Accuracy .......................................... 15
Blood PressureDeterminationTime ................................ 15
Pulse Rate Range (using SpO, determination) ......................... 15
Pulse Rate Range (using Blood Pressure determination) .................. 15
Pulse Rate Accuracy (using SpO2 determination) ....................... 15
Pulse Rate Accuracy (using Blood Pressure determination) ............... 15
OverpressureCutoff ........................ aaa 16
Temperature Ranges . eee eneret 16
Temperature Accuracy ee eee 16
Temperature Determination Time ....................,....,........ 16
Oxygen SaturationRange(SpO5ho) .................................. 16
SpO; Accuracy .................................................. 16
Sensor Accuracy Guide ーーー 17
Mechanical Specifications ............................................, 18
Dimensions .................................................... 18
Weight ........................... aaa 18
Mounting .......................... ， 18
Portabilty ........................... aaa aaa κος 18
Electrical Specifications ............................................... 18
Power Requirements .....................,....................... 18
Battey ........................ aaa 18
Environmental Specifications ........................................., 18
Operating Temperature ene 18
Storage Temperature し し. し し し し ュー ュー し に に に に ーー に に に に に に に に し に し レー に に ーーーーーー・ーーー・ 18
Transport Temperature ーー 19
Relative Humidity .. een ennen eee eve eee erne 19
Operating Aitud6 1 --υ-ἷ-ἷ-ἷῃυῃυυ-.. 이, 19
Guidance and Manufacturer's Declaration ..........,................... 19
Agency Approvals .................................................... 22
UnpackingChecklist............................. een 23
Controls, Indicators, and Connections ...............................,.... 24
Front Panel Functions ............................................ 24
LCD (Liquid Crystal Display) ........................................ 25
Top, Side, and Rear PanelConnections ............................. 26
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Setup Procedure ............................................,........ 27
AC Power Connection ........................................... 27
Charging the Battery ........................,..,,....,,,.,,.,...2. 27
Setting the Date and Time ,,,,, ο ων ων ων ων εν ο εκ εκ εν ερ ο εν εννοω ο ον 27
Blood Pressure HoseandCuffConnections ........................... 28
Temperature Probe Connection... nen 28
SpO。 Sensor Connection .................. 11.44 28
Quick Reference/Error Code Card .......................,,.......... 28
Power On/Off and System Check Procedure .............................. 29
Standby Mode .................................,.......,.,...... 29
Temperature Measurement Range Indicators .......................... 29
Measuring Blood Pressure ............................................. 31
Blood Pressure Cuff Selection ...................................... 31
Positioning the Cuff o... ene eee ere veere 32
Manual Blood Pressure Measurement ............................... 33
Reviewing Information from the Last Cycle し し νε νε εν κ ων ων 33
Setting the Default Inflation Pressure Preset Level ων ων 33
Setting Change Between mmHg and kPa ee eee 34
Mean Arterial Pressure (MAP) Mode .....................,.,...,,.... 34
Blood PressureCalibratonCheck ................................... 35
Measuring Temperature .........................................,,.... 36
Selecting the Temperature Scale . κ ων ν εν ων εν ων εν ων 36
Selecting Temperature Operation Mode ....................,,.,...... 37
Taking an Oral Temperature ............................,,.......... 37
Takingan Axillarylemperature ................................. 0... 39
TakingaRectallemperature ....................................... 40
Measuring 5002 coco τε τετ νε ετεκ ντττ εντ τλτ εκ ττττ κ τετ τετ 42
Automatic Calibration .................................,........,.. 43
OxiMaxTechnology ...................... aaa 43
Using the Finger Clip Sensor ....................................... 43
Other SensorS 1 44
Taking an SpO; Measurement ...................................... 44
Troubleshooting ..................................................... 44
Error Indications and Interpretation .................................. 44
General Guide to Problems and Corrective Actions ...................... 47
Maintenance ...................,................,................... 51
Cleaning に に ου ἀ---. 51
Battery Removal and Replacement .................................. 52

Supplies And Accessories ............................................. 53
Latex-Free Blood Pressure Accessories and Supplies .................... 53
Temperature Accessories and Supplies .......................,....... 53
Nellcor Pulse Oximetry Accessories and Supplies ....................... 54
Mounting Accessories and Supplies .........................,....... 55
Miscellaneous Supplies . . ere rrree 55
Warranty and Service ..................................,.............. 56
Warranty........................ ee 56
Service PolcVy し aaa 56
Technical Assistance ...................................... 1 56
Welch AliynServiceCenters ....................................... 57
Service Manual/Spare Parts .................................,,..... 57
Service Loaners .........................,.........,........,.... 57
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About the Operator's Manual
This Operator's 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 Operator's Manual depends on the configuration of your particular unit.
This manual is a comprehensive guide to the operation of the Spot Vital Signs. To achieve
satisfactory results, you should read this manual thoroughly before attempting to use the device. A
Ouick Reference Card is provided with certain models of the device as a convenient reference for
experienced operators.
Product Overview
The Welch Allyn Spot Vital Signs non-invasively and automatically measures systolic and diastolic
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
and can be printed via the IR port to an external device as desired.
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.
Spot
Vital
Signs
1

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 Operator’s Manual. Such specific warn-
ings and cautions may not appear here in this summary.
Caution: Consult Operator's Manual for additional information.
Type BF Equipment
Handle with Care
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Transport Temperature
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Storage Humidity
+ Pb} Internally Powered, Lead Acid Battery. For disposal see page 52.
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Class Il Equipment
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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 Parlia-
ment and the Council of the European Union on Waste Electronic and Electrical Equip-
ment (WEEE). If this product is contaminated, this directive does not apply.
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For more specific disposal information, see www.welchallyn.com/weee, or contact
Welch Allyn Customer Service at [phone].
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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 Operator's Manual. Such specific
warnings and cautions may not appear here in this summary.
General Warnings
THE WELCH ALLYN SPOT VITAL SIGNS IS NOT INTENDED TO BE USED ON NEONA-
TAL PATIENTS. Welch Allyn 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. This definition
comes from the AAMI SP10-1992 standard.
To ensure pediatric blood pressure accuracy and safety, the Welch Allyn Child Print Cuff
A (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 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.
The information in this Operator's 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.
Λ The 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.
A To ensure patient safety, use only accessories and supplies (i.e., cuffs, hoses, temperature
probes, SpO, sensors, etc.) recommended or supplied by Welch Allyn for the Welch Allyn
Spot Vital Signs. See “Supplies And Accessories” on page 53.
Do not operate the Welch Allyn Spot Vital Signs in the presence of flammable anesthetics or
other explosive atmosphere. An explosion may result.
Avoid compression of the 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.
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.
Any Spot Vital Signs which has been dropped or damaged should be checked by qualified
service personnel to ensure proper operation prior to use.
Every three months, inspect the temperature probe, SpO, cord, and accessories for fraying or
A other damage. Replace as necessary.
Spot
Vital
Signs
3

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PEPEE
BP
BBB
There are no userserviceable parts inside the device other than battery replacement. Refer to
unit to the Authorized Service Center listed on page 57.
The Spot Vital Signs should not be used on patients who are linked to heart/lung machines.
The Spot Vital Signs does not operate effectively on patients who are experiencing
convulsions or tremors.
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.
This device is not intended for hand-held use during operation.
Welch Allyn recommends that the battery is left 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.
Connection of accessories not approved by Welch Allyn with the Spot Vital Signs can affect
patient and/or operator safety.
Do not autoclave.
Welch Allyn is NOT responsible for the integrity of any wall or IV pole mounting interface.
Welch Allyn recommends that the customer contact their Biomedical Engineering
departmen »r maintenance service to ensure professional installation, safety, and reliability
of any Mounting accessory.
A Blood Pressure Warnings
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.
You may experience inaccurate blood pressure measurements if cuffs and/or hoses other than
those provided by Welch Allyn for the Spot Vital Signs are used.
Patients that are experiencing moderate to severe arrhythmias may give inaccurate blood
pressure measurements.
When several blood pressure measurements are taken on the same patient, it is recommended
that the cuff site and extremity are checked regularly for possible ischemia, purpura, and/or
neuropathy.
Welch Allyn

/N SpO, Warnings
The operation of the SpO; sensor in MRI environments is specifically not recommended.
Use only SpO, sensors and accessories that are compatible with the SpO, configuration
purchased. The Welch Allyn Spot Vital Signs with Nellcor® pulse oximetry option may only be
used with Nellcor brand sensors and accessories. Other sensors or cables may cause improper
performance.
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.
Before use, carefully read the sensor's directions for use, including all warnings, cautions, and
instructions.
Do not use a damaged sensor or pulse oximetry cable. Do not use a sensor with exposed optical
components.
Tissue damage is caused by incorrect application or duration of use of an SpO2 sensor. Inspect
the sensor site periodically as directed in the sensor's direction for use.
Pulse oximetry readings and pulse signal is affected by certain ambient environmental
conditions, sensor application errors, and certain patient conditions.
Do not immerse or wet the sensor.
Do not use the pulse oximetry 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.
A Temperature Warnings
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.
Use only oral probes (blue) for taking oral and axillary temperatures. Use only rectal probes (red)
for taking rectal temperatures. The use of the wrong probe may produce temperature errors.
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.
A IR Communications Port Warnings
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.
A General Cautions
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.
Ensure the device is placed on a secure surface or use one of the optional mounting accessories.
Do not place fluids on the device.
Spot
Vital
Signs
5

А Blood Pressure Cautions |
e Extremity and cuff motion should be minimized during blood pressure determinations. |
ο lf 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.
e Proper blood pressure cuff size and placement is essential to the accuracy of the blood pressure
determination. See “Chart for Determining Cuff Size” on page 31 for cuff sizing information. |
e 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. |
A SpO, Cautions |
e The pulse oximeter is calibrated to determine the percentage of arterial oxygen saturation of
functional hemoglobin. Significant levels of dysfunctional hemoglobin such as carboyhemoglobin |
or methmoglobin may affect the accuracy of the measurement. |
e Some intravascular dyes, depending on the concentration, may affect the accuracy of the SpO;
measurement.
|
e Some sensors may not be appropriate for a particular patient. If at least 10 seconds of perfusion |
pulses cannot be observed for a given sensor, change sensor location or sensor type for
perfusion to resume. |
ο The sensor disconnect message indicates that the sensor is either disconnected or the wiring is |
faulty. The user should check the sensor connection and, if necessary, replace the sensor, pulse
oximetry cable, or both. |
NOTE: 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.
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.
A Temperature Cautions |
e 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.
6 Welch Allyn

/N Précautions relatives à la température
e Le Welch Allyn Spot Vital Signs est approuvé par la FDA pour mesurer la température axillaire en
mode normal pour les enfants de moins de 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 CONCU POUR UNE UTILISATION SUR DES
NOUVEAU-NES.
Indications/Contraindications for Use
The Welch Allyn Spot Vita! Signs measures blood pressure, pulse rate, temperature, and oxygen sat-
uration (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 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.
Special Features
The following special features enhance the use of the Welch Allyn Spot Vital Signs:
Choice of Measurement Modalities
The Welch Allyn Spot Vital Signs takes non-invasive blood pressure, temperature, and SpO,
measurements independently or simultaneously.
Non-Invasive Oscillometric Blood Pressure
Eliminates the risk associated with invasive monitoring, with no need for microphones or
external transducers.
Operator Friendly Results
Large, easy-to-read Liquid Crystal Display (LCD).
Spot Vital Signs 11

AC or Self-Contained Battery Power
The Welch Allyn Spot Vital Signs can be made available in many convenient locations, for a
variety of spot-check needs.
Blood Pressure
A single blood pressure determination is made when the Blood Pressure Start/ je
Stop button is pushed. (A, i
To cancel a measurement cycle at any time, press the Blood Pressure Start/Stop
button again. This action immediately initiates a rapid cuff deflation.
The blood pressure measurement data appears on the display immediately following the
measurement and remains displayed for 2 minutes. After 2 minutes, the display goes blank and the
device goes into Standby Mode. To recall the most recent blood pressure measurement, press the
Print, Mode, Next Patient/Clear/Cancel, or Blood Pressure Start/Stop button.
Maximum and Minimum Blood Pressure Ranges
The maximum and minimum blood pressure ranges are as follows:
Measurement Maximum Minimum
Systolic Pressure 250 mmHg 60 mmHg
Diastolic Pressure 160 mmHg 30 mmHg
Mean Arterial Pressure (MAP)
The MAP ranges are 40 to 190 mmbg, calculated from systolic and diastolic data (not measured
directly).
Temperature
Thermometry measurements are made with Welch Allyn SureTemp® technology. Oral and rectal
probes utilize single-use disposable probe covers that limit cross-contamination. Oral, axillary, or rec-
tal temperatures are taken using Normal or Monitor operating modes. Oral and axillary temperatures
are taken using the blue oral probe. Rectal temperatures are taken using the red rectal probe.
in Normal Mode, the thermometer's microprocessor predicts body temperature in approximately 4
seconds for oral temperatures, 10 seconds for axillary temperatures, and 15 seconds for rectal
temperatures. When using Monitor Mode, allow the temperature readout to stabilize for 3 minutes
for oral and rectal temperatures, and 5 minutes for axillary temperatures. The Monitor Mode
continues to display an updated temperature as long as the probe remains in place. Settings for
Fahrenheit or Celsius scales are available for the temperature readings display.
12 Welch Allyn

Normal Temperature Mode
Normal oral mode is the default operating mode for temperature determinations.
In Normal Mode, the Spot Vital Signs measures temperature at discrete intervals, then calculates
the rate of change according to a proven algorithm. This allows the thermometer to predict the
end point the thermistor would reach if it were left in the mouth until it reached mouth
temperature. This predictive feature allows the thermometer to arrive at an accurate oral
temperature reading in approximately 4 seconds.
Operatorselectable patient alarm limits are not available in Normal Mode. However,
temperatures that are outside the operating range of the device are noted on the temperature
display (see “Temperature Measurement Range Indicators” on page 29 for further details).
Monitor Temperature Mode
Continuous Monitor Mode operation is normally used when difficult situations prevent taking
accurate temperatures in the Normal Mode, or in clinical situations in which the clinician is inter-
ested in trending the patient's temperature (see “Temperature Measurement Range Indicators”
on page 29 for further details). 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. Monitor Mode temperatures may not match identically to predicted “normal”
temperatures because of ambient temperature influence and other factors. The trend in temper-
ature is the important standard when in Monitor Mode.
Operatorselectable patient alarm limits are not available in Monitor Mode. However,
temperatures that are outside the operating range of the device are noted on the temperature
display (see “Temperature Measurement Range Indicators” on page 29 for further details).
SpO>
The Spot Vital Signs incorporates the Nelicor pulse oximetry system which determines arterial
oxyhemoglobin saturation (Sp05%) by measuring the absorption of red and infrared light passed
through the tissues. Changes in absorption caused by pulsation of blood in the vascular bed are
used to determine arterial saturation and pulse rate.
Oxygen saturation percent is calculated with each pulse detected, so the display is continually
updated. The pulse signal bar graph is an indicator of the strength and quality of the detected
pulses.
The Spot Vital Signs determines pulse rate as an adjunct to blood pressure measurement and
SpO, measurement.
The pulse rate, in beats per minute, is determined primarily from the SpO, measurement
methodology. In the case where SpO, is not available, or is disabled, the pulse rate display is
driven from data collected as part of the blood pressure measurement method.
Removal of the SpO, sensor from the patient initiates an audible beep, to alert you to the fact
that the sensor is no longer attached to the patient.
Spot
Vital
Signs
13

SpO, is generally measured via pulses detected using a finger sensor and performs most
accurately with the finger clip sensor. All fingers, except the thumb, can use the finger clip
sensor. For certain situations, measurement and alternate site measurements for SpO, can
include the earlobe, forehead, and toes. These situations require special sensors. The finger clip
sensor is recommended for spot checks or short-term evaluation (less than 60 minutes). Patient
supervision is required, since the Spot Vital Signs has no alarm capability.
Oxygen saturation and pulse rate are displayed on the LCD screen. On each detected pulse, the
pulse signal bar graph flashes. The intensity of this signal is a simple visual indicator of waveform
signal strength and can identify possible situations of inadequate pulsatile nature of tissue for an
accurate SpO, reading. The update interval bar of the bar graph should correspond to the
patient's pulse rate. This is an indication of the quality of the SpO, signal.
Pulse Rate
The Welch Allyn Spot Vital Signs determines pulse rate as an adjunct to blood pressure measure-
ment and SpO, measurement.
The pulse rate, in beats per minute, is determined primarily from the SpO5 measurement
methodology. In the case where SpO, is not available or is disabled, the pulse rate display is
derived by data from the blood pressure measurement method.
14 Welch Allyn

Performance 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 old or more.
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 gesta-
tion or more), otherwise up to 44 gestational weeks.
Cuff Pressure Range
0 mmHg to 300 mmHg
Initial Cuff Inflation
160 mmHg
Systolic Range
60 mmHg to 250 mmHg
Diastolic Range
30 mmHg to 160 mmHg
Blood Pressure Accuracy
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 !s validated for pressure measurement using the upper arm only.
Blood Pressure Determination Time
Typical: 20 to 45 seconds Maximum: 165 seconds
Pulse Rate Range (using SpO; determination)
20 bpm to 250 bpm
Pulse Rate Range (using Blood Pressure determination)
40 bpm to 200 bpm
Pulse Rate Accuracy (using SpO2 determination)
Typical: 20 to 250 bpm + 3 digits*
Low Perfusion: 20 to 250 bpm + 3 digits*
Pulse Rate Accuracy (using Blood Pressure determination)
+5.0%
* Specification applies to monitor performance and was validated with Biotek and Nellicor simulators.
Spot Vital Signs 15

Overpressure Cutoff
300 mmHg -0/+15 mmHg |
Temperature Ranges
Measurement Maximum Minimum |
Temperature 109.49 F 86.09 F
43.09 C 30.056 |
Temperature Accuracy
Calibration accuracy: + 0.2° F (+ 0.19 C). |
Temperature Determination Time |
Oral: 4 seconds typical, 15 seconds maximum |
Axillary: 10 seconds typical
Rectal: 15 seconds typical |
Oxygen Saturation Range (SpO,%) |
40 to 100% oxygen saturation |
SpO, Accuracy |
Typical: 70 to 100% + 2 digits*
Low Perfusion: 70 to 100% + 2 digits**
</0% unspecified by the OEM
Biocompatibility testing has been conducted on Nellcor sensors in compliance with |S010993-1,
Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. The sensors have
passed the recommended biocompatibility testing and are therefore in compliance with ISO
10993-1.
* Adult specifications are shown tor OxiMax MAX-Al sensors. Saturation accuracy will vary by
sensor type. Refer to the following Sensor Accuracy Grid.
** Applicability: OxiMax MAX-Al, MAX-ALI, MAX-PI, and MAX-II sensors.
16 Welch Allyn

Sensor Accuracy Guide
Sensor Models
SpO; Range
70% - 100%
OXIMAX Sensor Models Single Patient Use
MAX-AI,* MAX-ALI* +2
MAX-PI* +2
MAX-11* +2
MAX-RI** + 3.5
OxiCliq Sensor Models Single Patient Use
OXICLIO-A + 2.5
OXICLIQ-P +265
Reusable Sensor Models
D-YS (Infant to Adult) +3
D-YS & D-YSE + 3.5
DS-100A +3
OXI-A/N (Adult) +3
ΟΧΙ-Ρ/ +3
* The accuracy specification under motion conditions is + 3. For a definition of motion, contact
Nellcor Technical Services or your local Nellcor representative.
**The accuracy specification has been determined between saturations of 80% - 100%.
Accuracy Specifications: 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 Sa02 values of drawn blood samples measured by
hemoximetry. All accuracies are expressed as + “X” digits. This variation equals + one standard
deviation (4 1 SD), which encompasses 68% of the population.
Spot Vital Signs
17

Mechanical Specifications
Dimensions
Height: 9.70 inches (24.64 cm)
Length: 5.72 inches (14.53 cm)
Depth: 4.73 inches (12.01 cm)
Weight
Approximately 4.25 pounds (1.91 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 Specifications
Power Requirements
Patient-rated isolation transformer is connected to AC mains:
North American Version: 120VAC, 60Hz. 0.20A Input, 8VDC, 0.75A Output
International Version: 240VAC, 50Hz 0.10A Input, 8VDC, 0.75A Output
Australian Version: 240VAC, 50Hz, 13VA Input, 8VDC, 0.75A 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 Specifications
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
18 Welch Allyn

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.
Guidance and Manufacturer’s Declaration
issions and | nity Inform
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 electrocardiograph 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 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 À
IEC
61000-3-2
Voltage fluctuations/ Complies
flicker emissions
上 EC 61000-3-3
Spot Vital Signs
19