Welch Allyn SureTemp Plus User manual

SureTemp

REF 690 and 692

Plus

Directions for use

ii Welch Allyn SureTemp

© 2016 Welch Allyn, Inc. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn.

Welch Allyn assumes no responsibility for any injury, 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 indications for use published in this manual.

Welch Allyn is a registered trademark of Welch Allyn, Inc.

Patent information

For patent information, please visit www.welchallyn.com/patents.

Welch Allyn Technical Support:

http://www.welchallyn.com/about/company/locations.htm

106701 (CD)

Material No. 411744,

80018382 Ver. A

Revision date: 2016-07

Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 U.S.A.

www.welchallyn.com

Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road, Navan County Meath, Republic of Ireland

Directions for use iii

TABLE OF CONTENTS

Conforms With ........................................1

Symbols and Descriptions ................................1

Safety and Warnings ....................................2

Introduction ...........................................4

SureTemp Plus Model Comparison Chart ....................5

Indications/Contraindications..............................5

Latex Statement .......................................6

Parts and Features......................................6

Button Functions .......................................7

Set-Up ...............................................7

Display Indicators ......................................9

Oral Temperature Measurement ..........................11

Axillary Temperature Measurement .......................12

Rectal Temperature Measurement ........................13

Monitor Mode Temperature Measurement .................15

Instrument Security ....................................17

Maintenance .........................................17

Cleaning and Disinfection ...............................18

Disposal .............................................18

Performance and Technical Specifications ..................19

Guidence and Manufacturer’s Declaration ..................20

EMC compliance ...................................20

Emissions and Immunity Information ...................20

Replacement Parts and Accessories.......................23

Accessories List ......................................24

Service..............................................24

Welch Allyn Service Policy ............................24

Contacting Welch Allyn ..............................24

Limited Warranty ......................................25

Service Centers .......................................25

iv Welch Allyn SureTemp Plus

Directions for use 1

Conforms With

IEC/UL/CSA/EN 60601-1

Australian Communications and Media Authority (ACMA) Radio Compliance Mark (RCM)

Symbols and Descriptions

Consult directions for use (DFU). A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days.

Type BF Applied Part

-25°C

95%

15%

IPXØ

Fragile

+55°C

Temperature Limit

Humidity Limitation

Internally Powered Alkaline Battery - AA 1.5V

Not protected against the ingress of water.

Does not contain natural rubber latex.

Keep Dry

Do not re-use, Single use device

Recyclable

Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.

Product Identifier.

Reorder Number

2 Welch Allyn SureTemp Plus

Safety and Warnings

WARNING No modification of this equipment allowed.

WARNING Patient injury risk. Prior to taking a temperature, instruct the patient

not to bite down on the probe as patient injury and damage to the probe may result.

WARNING Patient injury risk. Use only Welch Allyn single-use disposable probe covers. A new probe cover needs to be used with each new temperature taken. Never take a temperature measurement without a single-use probe cover securely attached. Failure to use a probe cover can cause patient discomfort from a heated probe, patient cross-contamination, and inaccurate temperature readings.

WARNING Patient injury risk. Inaccurate measurement risk. Oral/axillary probes (blue ejection button at top of probe) and blue removable probe wells are used for taking oral and axillary temperatures only. Rectal probes (red ejection button) and red removable probe wells are used for taking rectal temperatures only. Use of the incorrect removable probe well could result in patient cross-contamination. Use of the probe at the wrong site will result in temperature errors.

WARNING Patient injury risk. When taking rectal temperatures, insert the probe tip only 5/8 inch (approximately 1.5 cm) inside the rectum of adults and only 3//8 inch (approximately 1 cm) inside the rectum of children to avoid the risk of bowel perforation.

WARNING Inaccurate measurement risk. Never take an axillary temperature through the patient’s clothing. Carefully place the probe in the axilla, avoiding contact with other objects or material.

WARNING Patient injury risk. Continuous measurement durations of 3 minutes at the oral and rectal sites and 5 minutes at the axillary site are recommended for accurate measurement. Do not continuously measure beyond 10 minutes in any mode.

WARNING To ensure patient safety and temperature measurement accuracy, use only accessories and supplies recommended or supplied by Welch Allyn.

WARNING Never use a damaged temperature probe. The thermometer consists of high-quality precision parts and should be protected from severe impact or shock. Do not use the thermometer if you notice any signs of damage to the probe or instrument. If the thermometer probe is dropped or damaged, remove it from use and have it inspected by qualified service personnel.

WARNING Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

WARNING Inaccurate measurement risk. For rectal measurements, apply a thin layer of lubricant to probe cover, if necessary, for patient comfort. Use of excessive lubricant may affect reading accuracy.

WARNING Inaccurate measurement risk. To ensure optimal accuracy, always confirm that the correct mode and site are selected.

Directions for use 3

Caution Liquids can damage electronics inside the thermometer. Prevent liquids from spilling on the thermometer. If liquids are spilled on the thermometer, dry off the thermometer with a clean cloth. Check for proper operation and accuracy. If liquids possibly entered the thermometer, remove the thermometer from use until it has been properly dried, inspected, and tested by qualified service personnel.

Caution Welch Allyn recommends that batteries are removed for long term storage since alkaline batteries can deteriorate and leak over extended periods of time, and possibly cause damage to the thermometer.

Caution Do not autoclaveany component of this product. Please note the cleaning procedures described on page 18 of this manual.

Caution Do not use this instrument for any purpose other than that specified in this booklet. Doing so will invalidate the instrument’s warranty.

Caution This thermometer complies with current required standards for electromagnetic interference and should not present a problem to other equipment nor is it effected by other devices. As a precaution, avoid using this device in close proximity to other equipment.

Caution Inaccurate measurement risk. Patient activites such as strenuous exercise, ingesting hot or cold liquids, eating, chewing gum or mints, brushing teeth, or smoking may effect oral temperature measurements for up to 20 minutes.

Caution Probe covers are disposable, nonsterilized, and single-use. Probes are also nonsterilized. Do not autoclave probes and probe covers. Ensure that probe covers are disposed of according to facility requirements or local regulations.

4 Welch Allyn SureTemp Plus

Introduction

Please follow the operating and maintenance instructions provided in this manual to ensure years of accurate and reliable service. Please read these instructions thoroughly before using the instrument, and then store these instructions in a safe place for future reference.

The Welch Allyn SureTemp Plus is a portable thermistor thermometer used for accurately measuring body temperatures at oral, axillary, or rectal sites. The device measures temperature by default in predictive (Normal) mode, during which it uses a predictive algorithm to calculate patient temperature. If you cannot correctly measure the patient’s temperature in Normal Mode, the unit will automatically enter Monitor (Direct) Mode.

Normal body temperature is a range, which varies from person to person and is influenced by factors such as time of day and an individual’s level of activity, ingested medications, age, and gender. A person’s normal temperature tends to decrease with age.

The following table shows that ranges of normal also vary by site. Do not directly compare measurements from different sites.

This booklet provides informative tips and instructions for using the SureTemp Plus model 690 and model 692 thermometers. The chart on the following page provides details about the differences between these SureTemp Plus instruments.

Directions for use 5

SureTemp Plus Model Comparison Chart

This manual describes features found in SureTemp Plus model 690 and 692 thermometers. Certain features are not available to users of the model 690 thermometer.

Probe Cover Storage

F/C Conversion

Last Temperature Recall

Monitor Mode

Detachable Probe

Oral / Axillary / Rectal Modes on Each Thermometer

Color-Coded Removable Probe Well

Wall-Holder Standard

Pulse Timer

Backlight

Security (Electronic)

Configurable On-Screen Labeling for Identification of Instrument

SureTemp Plus Model

690

SureTemp Plus Model

692

Sold in U.S./Canada

Sold Internationally

Instrument Warranty

Removable Probe Well

Probe Warranty

Indications/Contraindications

The Welch Allyn SureTemp Plus thermometer measures patient’s temperature in the oral, axillary, and rectal body sites of adult, pediatric, and newborn patients. The device is not designed, sold, or intended for use except as indicated.

2 years 3 years

90 days 90 days

1 year 1 year

6 Welch Allyn SureTemp Plus

Latex Statement

The components of the SureTemp Plus device that could contact the user or patient were not made with natural rubber latex. This includes all items that could be contacted during normal operation, and all other functions, such as user maintenance and cleaning, as are defined in the Directions for use.

No internal components are known to be made with natural rubber latex.

Parts and Features

You can find the serial number of your device on a label affixed to the rear housing inside the unit’s probe cover storage compartment. Please note the parts of your Welch Allyn SureTemp Plus thermometer as shown below:

Ejection Button (blue or red)

Thermometer

LCD Display

C/F (Celsius/

Fahrenheit) Button

Pulse Timer Button

(692 Only)

Recall Button

Mode Selection

Button

Probe

Box of Probe Covers

Removable Probe Well (blue or red)

Latching Probe Connector

Battery Door/Probe Cover Storage Compartment

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