Hillrom Welch Allyn FlexiPort Blood Pressure Cuffs Instructions For Use

®
Welch Allyn
Blood Pressure Cuffs
Soft, Vinyl, and Reusable versions
Instructions for use
749414 DIR 80025281 Ver. A, Revised 2019-09
CAUTION: U.S. federal law restricts this device to sale by or on
the order of a physician or licensed healthcare practitioner. This
device should be used by trained personnel.
Standards
This device is designed to function within the limits prescribed by:
• AAMI/ANSI/EN/ISO 81060-1:2007 specification for non-invasive
sphygmomanometers - Part 1: Requirements and test methods for
non-automated measurement type.
Cuff connections and symbols
Port Fitting
FlexiPort Cap
Regulatory Affairs Representative, Welch Allyn Limited, Navan Business
Park, Dublin Road, Navan, County Meath, Republic of Ireland
Welch Allyn, Inc.
4341 State Street Road, Skaneateles Falls, NY 13153 USA
Tel: 800-535-6663 (USA only) or 315-685-4560
Fax: 315-685-3361 hillrom.com
Welch Allyn, Inc. is a subsidiary of Hill-Rom Holdings, Inc.
PATENTS / PATENT hillrom.com/patents
May be covered by one or more patents. See above Internet address.
The Hill-Rom companies are the proprietors of European, US, and other patents
and pending patent applications.
For information about any Hillrom product, contact Hillrom Technical Support:
hillrom.com/en-us/about-us/locations/.
© 2019 Welch Allyn, Inc. All rights reserved. No one is permitted to reproduce
or duplicate, in any form, this directions for use or any part thereof without per-
mission from Welch Allyn. Welch Allyn® and FlexiPort® are trademarks of Welch
Allyn, Inc. Hillrom™ is a trademark of Hill-Rom Services, Inc.
®
FlexiPort
Global Trade Item Number
Reorder number
Lot number
Product identifier
Consult directions for use
Limb circumference (min/max)
Not made with natural latex
Range
RANGE
Artery symbol
Index edge

Introduction

Intended use

Flexiport pediatric through adult blood pressure cuffs are noninvasive
blood pressure cuffs intended for use in conjunction with non-auto-
mated and automated sphygmomanometers to determine blood
pressure in pediatric through adult patients.

Contraindications

Flexiport pediatric through adult blood pressure cuffs are contraindi-
cated for neonate use.

Warnings

A warning statement in this manual identifies a condition or practice
which, if not corrected or discontinued immediately could lead to
injury, illness, or death.
WARNING Possible measurement error. Use only approved blood
pressure cuffs and accessories; substitution might result in measure-
ment error.
WARNING Inaccurate measurement risk. Only use the cuff when the
artery index marker falls within the printed range indicated on the
cuff, otherwise erroneous readings may result.
WARNING Patient injury risk. Never install luer lock connectors on
Hillrom blood pressure tubing. Using these connectors on blood pres-
sure cuff tubing creates the risk of mistakenly connecting this tubing
to a patients intravenous line and introducing air into the patients cir-
culatory system.
WARNING Do not apply cuff to areas on patient where skin is delicate
or damaged. Check cuff site frequently for irritation.
WARNING Allow space for 1 to 2 fingers between patient and cuff.
WARNING Do not apply cuff to limbs used for IV infusion.
WARNING Minimize cuff movement and limb motion during read-
ings.
WARNING Ensure an airtight seal at all connection points prior to use.

Cautions

A caution statement in this manual identifies information within the
manual to avoid equipment failure.
CAUTION Do not press cuff with a hot iron.
CAUTION Do not inflate cuff unless the hook and loop is closed.
CAUTION Do not allow foreign debris to ingress into tubes or port on
cuff.
CAUTION Do not use steam or heat to sterilize the cuff, or tubing.
CAUTION Do not exceed 250 mmHg with thigh size disposable cuffs
at or above 30 °C/86 °F.
CAUTION Intravenous Systems (IV) - Do not connect cuffs with luer
lock connectors to intravenous fluid systems or fluid may enter the
cuff.

Operation

Use the Flexiport blood pressure cuff the same as a traditional blood
pressure cuff. The blood pressure cuff works with manual and auto-
mated sphygmomanometers.
Select cuff size appropriate for the patient's arm circumference. The
applicable range, in centimeters, is printed on each cuff.
Operational Pressure Range: 0 to 300 mmHg
NOTE The "Artery Index Marker" on the cuff should fall within the
"Range" indicated on the cuff. If the artery index marker falls short of
range, use a larger cuff to ensure accurate results. If the artery index
marker is past the range, use a smaller cuff to ensure accurate results.