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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Not
protected
against
the
ingress
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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 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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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