Prosphyg 760 Aneroids Pocket Sphygmomanometer User Guide

Prosphyg 760 Aneroids Pocket Sphygmomanometer

Thank you for choosing an ADC® ProsphygTM Aneroid sphygmomanometer.

Device Description and Intended Use

An ADC® aneroid sphygmomanometer is used by professional healthcare providers and individuals trained in the auscultatory blood pressure technique to determine systolic and diastolic blood pressure in humans.

Contraindications
Aneroid sphygmomanometers are contraindicated for neonate use. Do not use it with neonatal cuffs or neonate patients. Review the size chart (below) for proper limb range

780-790 Series Size Chart

Adcuff Series Size Chart

Symbol Definitions
The following symbols are associated with your ADC sphygmomanometer.

General 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: Do not allow a blood pressure cuff to remain on the patient for more than 10 minutes when inflated above 10 mmHg. This may cause patient distress, disturb blood circulation, and contribute to the injury of peripheral nerves.
WARNING: If luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to intra- vascular fluid systems, allowing air to be pumped into a blood vessel. Immediately consult a physician if this occurs.
WARNING: Safety and effectiveness with neonate cuff sizes 1 through 5 are not established.
WARNING: If this equipment is modified, appropriate inspection and testing must be conducted to ensure its continued safe use.
WARNING: Do not apply cuff to delicate or damaged skin. Check cuff site frequently for irritation.
WARNING: Only use the cuff when the range markings indicated on the cuff show that the proper cuff size is selected, otherwise erroneous readings may result.
WARNING: Allow space between patient and cuff. Two fingers should fit in this space if the cuff is correctly positioned.
WARNING: Do not apply cuff to limbs used for IV infusion.
WARNING: The patient should remain still during measurement to avoid erroneous readings.
WARNING: When using an infant or child cuff, extra care must be taken to prevent over-inflation. With smaller cuffs (infant or child) the cuff can inflate over 300 mmHg with just two full compressions of the bulb. To prevent discomfort or injury to the patient and damage to the instrument, the bulb should only be partially squeezed, so that each “stroke” inflates the cuff in 40mmHg to 60mmHg increments until inflated to the desired level.
CAUTION: To obtain the greatest accuracy from your blood pressure instrument, it is recommended that the instrument be used within a temperature range of 50°F to 104°F (10°C to 40°C), with a relative humidity range of 15%-85% (non-condensing).
CAUTION: Extreme altitudes may affect blood pressure readings. Your device has been designed for normal environmental conditions.

Operation of Pocket Aneroids

This booklet contains operating and maintenance information for pocket aneroid sphygmomanometers. Please read and retain.

Your pocket aneroid
the sphygmomanometer consists of an aneroid manometer (gauge), a complete inflation system, (latex-free inflation bladder, squeeze bulb, and valve), a zippered carrying case, and operating instructions. Most models are preassembled and ready for use. In units requiring assembly, the bulb and valve should connect to the tube closest to the Index Line. The gauge connects to the remaining tube. Apply a small amount of alcohol or soapy water to the tubing if needed.

Measurement Procedure

Patient Position
The patient should sit or lie comfortably. The arm should be fully supported on a flat surface at heart level. (If the arm’s position varies, or is not level with the heart, measurement values obtained will not be consistent with the patient’s true blood pressure.) When seated, the patient should have their back and arm supported, and their legs should not be crossed. The patient should relax before measurement comfortably for five minutes and should refrain from talking or moving during measurement. The observer should view the manometer in a direct line to avoid “parallax error.”

Apply the Cuff
Nylon cuffs are specially designed to promote the precisely accurate determination of blood pressure. Index and range markings ensure the use of the correct cuff size. The artery mark indicates proper cuff positioning. Place the cuff over the bare upper arm with the artery mark positioned directly over the brachial artery. The bottom edge of the cuff should be positioned approximately one inch (2-3cm) above the antecubital fold. Wrap the end of the cuff not containing the bladder around the arm snugly and smoothly and engage adhesive strips (Figure 1).

NOTE: If the unit is equipped with a calibrated nylon cuff, featuring Index and Range markings, a correct fit may be verified by checking that the Index Line falls between the two Range Lines. (Figure 2).

Inflate the Cuff
Close the valve by turning the thumbscrew clockwise. Palpate the radial artery while inflating the cuff. Be sure to inflate the cuff quickly by squeezing the bulb rapidly. Inflate the cuff 20-30 mmHg above the point at which the radial pulse disappears.
NOTE: Cuff pressure range is 0 mmHg to 300 mmHg.

Position the Stethoscope
Position the chestpiece in the antecubital space below the cuff, distal to the brachium. Do not place the chest piece underneath the cuff, as this impedes accurate measurement.  Use the bell side of a combination stethoscope for the clearest detection of the low-pitched Korotkoff (pulse) sounds.

Deflate the Cuff
Open the valve to deflate the cuff gradually at a rate of 2-3 mmHg per second.

Measurement
Record the onset of Korotkoff sounds as the systolic pressure and the disappearance of these sounds as diastolic pressure. (Some healthcare professionals recommend recording diastolic 1 and diastolic 2. Diastolic one occurs at phase 4.)
NOTE: It is recommended that K4 be used in children aged 3 to 12, and K5 should be used for pregnant patients unless sounds are audible with the cuff deflated, in which case K4 should be used. K5 should be used for all other adult patients. After the measurement is completed, open the valve fully to release any remaining air in the cuff. Remove cuff.

Care and Maintenance

Storage
Pocket Gauge: After measurement, fully exhaust the cuff then wrap the cuff around the gauge and bulb and store in a zippered carrying case.
NOTE: This product will maintain the safety and performance characteristics specified at temperatures ranging from 50°F to 104°F (10°C to 40°C) at a relative humidity level of 15% to 85%. This device can be safely stored at temperatures ranging from -4°F to 131°F (-20°C to 55°C) with a relative humidity of 85% or below.
Manometer: Your pocket aneroid gauge requires minimal care and maintenance. The manometer may be cleaned with a soft cloth but should not be dismantled under any circumstances.

Should the indicator needle of the manometer rest outside the oval calibration mark (Figure 3), then the manometer must be re-calibrated to within ±3 mmHg when compared to a reference device that has been certified to national or international measurement standards. A manometer whose indicator needle is resting outside of this mark is NOT acceptable for use. If the gauge is ever in need of calibration, simply return it for service. Damaged or broken parts will be replaced as needed at a minimal charge. Refer to the warranty for specific details of warranty coverage. The manufacturer recommends a calibration check every 2 years.

Cuff Cleaning and Disinfecting

Use one or more of the following methods and allow to air dry:

• Wipe with mild detergent and water solution (1:9 solution). Rinse.
• Wipe with Enzol per the manufacturer’s instructions. Rinse.
• Wipe with .5% bleach and water solution. Rinse.
• Wipe with 70% isopropyl alcohol.
• Launder with mild detergent in warm water, normal wash cycle.
• Remove the bladder first. The cuff is compatible with 5 wash cycles.

Low-Level Disinfection
Prepare Enzol enzymatic detergent according to the manufacturer’s instructions. Spray the detergent solution liberally onto the cuff and use a sterile brush to agitate the detergent solution over the entire cuff surface for five minutes. Rinse continuously with distilled water for five minutes. To disinfect, first follow the cleaning steps above, then spray the cuff with 10% bleach solution until saturated, and agitate with a sterile brush over the entire cuff surface for five minutes. Rinse continuously with distilled water for five minutes. Wipe off excess water with a sterile cloth and allow the cuff to air dry.
CAUTION: Do not iron the cuff.
CAUTION: Do not heat or steam sterilize the cuff.

Manometer Quality Control
A serial number and lot number are automatically assigned to every aneroid during manufacturing, ensuring every item is “controlled.” The serial number can be located on the faceplate of each aneroid (Figure 4). The lot number is located on the box end label (Figure 5).

Standards
ANSI/AAMI/ISO 81060-1:2007
EN/ISO 81060-1:2012

Disposal
When your sphygmomanometer or any of its parts have reached their end of life, please be sure to dispose of them by all regional and national environmental regulations. Devices that have become contaminated should be disposed of by all local ordinances and regulations.

Warranty

ADC® warrants its products against defects in materials and workmanship under normal use and service as follows:

• Warranty service extends to the original retail purchaser only and commences with the date of delivery.
• See end panel label for package contents and to determine warranty duration.
• The warranty duration is as follows:

What Is Covered: Replacement of parts and labour.
What Is Not Covered: Transportation charges. Damages caused by abuse, misuse, accident, or negligence. Incidental, special, or consequential damages. Some states do not allow the exclusion or limitation of incidental, special, or consequential damages, so this limitation may not apply to you.
Implied Warranty: Any implied warranty shall be limited in duration to the terms of this warranty and in no case beyond the original selling price (except where prohibited by law).  This warranty gives you specific legal rights and you may have other rights which vary from state to state.
To Obtain Warranty Service: Send item(s) postage paid to ADC, Attn: Repair Dept., 55 Commerce Dr., Hauppauge, NY 11788. Please include your name and address, phone no., proof of purchase, and a brief note explaining the problem.

For Australian Consumers
Our goods come with guarantees that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or refund for a major failure and compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure.

For our European Customers
On request, send to ADC by e-mail (info@adctoday.com), we can send you this manual on the paper form within 7 calendar days at no additional cost to the user. Our website, https://www.adctoday.com, where these instructions for use are available fulfils the requirements of personal data protection, according to Directive 95/46/EC and GDPR on the protection of individuals about the processing of personal data and on the free movement of such data. Any serious incident that has occurred with this medical device should be reported to ADC and the competent authority of the Member State in which the user and/or patient is established.
To register your product, visit us at www.adctoday.com/support/warranty- registration

FOR QUESTIONS, COMMENTS, OR SUGGESTIONS CALL TOLL-FREE
1-800-ADC-2670 or visit www.adctoday.com/feedback

Inspected, assembled and packaged in the U.S.A.
tel: 631-273-9600
1-800-232-2670
fax: 631-273-9659
www.adctoday.com
email: info@adctoday.com

References

• American Diagnostic Corporation - Core Medical Device Manufacturer. Stethoscopes, Blood Pressure, Thermometry, and EENT
• Customer Feedback Form | American Diagnostic Corporation
• Support | American Diagnostic Corporation
• American Diagnostic Corporation - Core Medical Device Manufacturer. Stethoscopes, Blood Pressure, Thermometry, and EENT

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