Welch Allyn Aneroid Sphygmomanometer - User Manual - Manual

Aneroid
Sphygmomanometer
Blood pressure measurements determined with this device are equivalent
to those obtained by a trained observer using the auscultatory method, within
the limits prescribed by:
• American National Standard ANSI/AAMI SP9, 1994, Non-automated
sphygmomanometers.
• American National Standard ANSI/AAMI SP10, 2002, Manual, electronic,
or automated sphygmomanometers (FlexiPort cuff only).
Introduction
Intended Use
Aneroid sphygmomanometers are used by professional healthcare providers
and individuals trained in auscultatory blood pressure technique to determine
systolic and diastolic blood pressure in humans and animals.
Contraindications
Aneroid sphygmomanometers are contraindicated for neonate use. Do not
use with neonatal cuffs or neonate patients.
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: U.S. Federal law restricts this device to sale by or on the order of a
physician.
WARNING: If luer lock connectors are used in the construction of tubing, there
is a possibility that they might be inadvertently connected to intravascular fluid
systems, allowing air to be pumped into a blood vessel. Immediately consult a
physician if this occurs.
WARNING: Do not allow a blood pressure cuff to remain on patient for more
than 10 minutes when inflated above 10 mm Hg. This may cause patient
distress, disturb blood circulation, and contribute to the injury of peripheral
nerves.
WARNING: Safety and effectiveness with neonate cuffs (sizes from neo 1 to
neo 5) is not established.
WARNING: Use o
nly Welch Allyn manuf actured blood pressure cuffs and
accessories; substitution might result in measurement error.
WARNING: Only use the cuff when visible artery index marker falls within the
range markings indicated on the cuff, otherwise erroneous readings may
result.
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 readings.
WARNING: Ensure an airtight seal at all connection points prior to use.
WARNING: Intravenous Systems (IV) - Do not connect cuffs with luer lock
connectors to intravenous fluid systems or air may enter patient.
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 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: Intravenous Systems (IV) - Do not connect cuffs with luer lock
connectors to intravenous fluid systems or fluid may enter the cuff.
CAUTION: Do not inflate the cuff unless the hook and loop is closed.
Directions for Use
Connections
PSS-44
1. Attach the inflation bulb to the tube (if needed).
Use alcohol to facilitate this.
2. Align and press the Durashock gauge with the FlexiPort
adapter onto the cuff port.
3. Verify an airtight seal is achieved at all connection points.
PSS-45
1. Push the gauge stem into the adapter port until you feel
it engage.
2. Connect the short cuff tube to the barb on the adapter.
3. Connect the barb on the inflation bulb valve to the long cuff tube.
4. Make certain an airtight seal is achieved at all connection points.
Operation
Blood pressure measurements can be affected by the position of the patient
and their physiologic condition. Before beginning a measurement, ensure that
the patient rests for at least five minutes, has support of their back and feet,
and does not cross their legs. Passively support the patient’s lower arm and
keep the upper arm at heart level. The procedure needs to take place in a
quiet environment with no talking. Failure to follow these recommendations
can result in inaccurate blood pressure measurements.
1. Select cuff size appropriate for the patient’s arm circumference.
The applicable range, in centimeters, is printed on each cuff.
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 the
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.
2. Wrap the cuff around the arm with the artery index marker located over the
brachial artery and with the lower edge of the cuff 2.5 cm above the bend
in the elbow.
3. Inflate cuff rapidly to a level 30 mm Hg above estimated (or palpatory)
systolic pressure.
4. Partially open the valve to allow deflation at a rate of 2 to 3 mm Hg per
second. As the pressure falls, note systolic pressure and diastolic pressure
detected with your stethoscope.
5. Rapidly release the remaining pressure and record measurements
immediately. After a minimum of 30 seconds, repeat the above steps for a
second reading.
Specifications
The aneroid sphygmomanometer is accurate to +/-3 mm Hg.
This product will maintain the safety and performance characteristics specified
at temperatures ranging from 0° C to 46° C at a relative humidity level not to
exceed 85%.
Standards
• American National Standard ANSI/AAMI, SP9: 1994, Non-automated
sphygmomanometers.
• American National Standard ANSI/AAMI SP10, 2002, Manual,
electronic, or automated sphygmomanometers (except for section
4.2.2a for size 13 disposable cuffs)(FlexiPort cuff only).
• European Standard EN 1060-1: 1995, Non-invasive sphygmomanometers
- Part 1: General Requirements (except for section 9.3a for sizes 6, 7, 8, 9
disposable and reusable cuffs).
• European Standard EN 1060-2: 1996, Non-invasive sphygmomanometers
- Part 2: Supplementary requirements for mechanical sphygmomanometers.
• European Standard EN 1060-3: 1997, Non-invasive sphygmomanometers
- Part 3: Supplementary requirements for electro-mechanical blood pressure
measuring systems (FlexiPort cuff only).
PSS World Medical, Inc.
4345 Southpoint Blvd.
Jacksonville, FL 32216
PMS Colors
Wave
Logo
Text
Select Medical Products
Artwork Template
Doc. # T-GS-003
Rev. 1
Effective Date: 10-08-2007
Author: Meghan Little
Artwork Approvals
Drawn By
Checked By
Information
Label
Description
Scale; Dimensions
Revisions
Rev.
Description
Date K
N/A Meghan Little Multiple Sku’s
BP Cuffs
1:1 Proportion, 8.5 x 11”
Draft 3
Working Draft
05-30-08
PMS 281 C Blue, 356 C Green