8451-11AN-1 Adcuff+ Reusable BP Cuff Instructions

: October 30, 2023
: ADC

Table of Contents

8451-11AN-1 Adcuff+ Reusable BP Cuff
Product Information
Product Usage Instructions
Intended Use
Symbol Definitions
Size Chart
Usage Instructions
Maintenance
Warranty
Contacts
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

8451-11AN-1 Adcuff+ Reusable BP Cuff

Product Information

The One-piece Reusable BP Cuff by American Diagnostic Corporation is a cuff used for measuring blood pressure. It is contraindicated for neonate use and should not be used with neonatal cuffs or neonate patients. The cuff is not made with natural rubber latex and is phthalate-free. It meets the general safety and performance requirements of Regulation (EU) 2017/745 of the European Union. The cuff has a manufacturer, authorized representative in the European Community/European Union, date of manufacture, circumference size, catalog number, batch code, humidity limitation, medical device compliant with Regulation (EU) 2017/745, unique device identifier, and non-sterile. The cuff comes in different sizes for infants, children, small adults, adults, large adults, and thighs. The cuff also has a Size GuideTM Marking System to assure the use of the correct cuff size and proper cuff alignment.

Product Usage Instructions

Review the size chart for proper age and limb range usage.
Choose the appropriate cuff size based on the limb range measurement.
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 inflation pocket around arm snugly and smoothly and engage adhesive strips.
To verify a correct fit, check that the INDEX line falls between the two RANGE lines.
Cleaning and disinfection procedures must be conducted by persons trained in medical device cleaning and disinfection. If using a germicidal or other cleaning agent, consult the manufacturer’s instructions for proper use and efficacy.
Use only the cleaning or germicidal cleaner agent types listed in the manual to avoid damage to the cuff. Do not aggressively scrub cuff as damage to cuff markings and/or cuff closure integrity may occur.

Intended Use

ADC® blood pressure cuffs are noninvasive blood pressure cuffs that are intended for use with manual and automated noninvasive blood pressure measurement devices.

Contraindications

Aneroid sphygmomanometers are contraindicated for neonate use. Do not use with neonatal cuffs or neonate patients.

Symbol Definitions

The following symbols are associated with your ADC Adcuff+ reusable cuff:

Size Chart

Review the size chart for proper age and limb range usage.

Cuff Size /Color /Limb Range (cm)

Infant	Orange	9-14.8
Child	Green	13-19.5
Sm Adult	Royal Blue	19-27
Adult	Navy	23-40
---	---	---
Lg Adult	Burgundy	34-50
Thigh	Brown	40-66

Usage Instructions

Adcuff+ Size GuideTM Marking System

ADC’s Size Guide™ Marking System assures use of correct cuff size and proper cuff alignment (Figure 1).
Printed Index and Range markings and applicable limb range (in cm) allow easy identification of the correct cuff size. A printed artery mark indicates the bladder midpoint for correct cuff positioning. A convenient nylon coated TPU hang tag (on most sizes) permit sflexible use with pocket aneroid gauges.
The cuffs can also be used with palm and clock aneroids, as well as NIBP monitors. Hook-and-loop adhesive surface provides a snug, infinitely variable fit and is designed to withstand a minimum of 30,000 open/close cycles.

Applying the Cuff

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 inflation pocket around arm snugly and smoothly and engage adhesive strips. To verify a correct fit, check that the INDEX line falls between the two RANGE lines. (Figure 2)

Maintenance

Cleaning and disinfection procedures must be conducted by persons trained in medical device cleaning and disinfection. If using a germicidal or other cleaning agent, consult the manufacturer’s instructions for proper use and efficacy.

CAUTION

Use only the cleaning or germicidal cleaner agent types listed below or damage to cuff may occur.
Repeated reprocessing may cause degradation of device; follow inspection procedures to assure integrity of device.
Do not aggressively scrub cuff as damage to cuff markings and/or cuff closure integrity may occur.

Materials

When cleaning or disinfecting, use sterile cloths, soft brush, soaking tray, and potable rinse water (softened preferred). For low-level disinfection, use one of the following:

Bleach-based germicidal cleaner suitable for use on healthcare equipment and capable of low-level disinfection; for example, a 1:10 dilution of bleach (6500 ppm sodium hypochlorite) and detergent.
Commercial wipes with 0.5% bleach and water solution or 70% isopropyl alcohol.

Reference EPA-registered disinfectants at: https://www.epa.gov/pesticide- registration/list-antimicrobial-products-registered-epa-sterilizers.

Basic Cleaning

_ Note: _Do not allow liquid to enter tubing while cleaning.

Use a soft brush to remove visible contamination.
Thoroughly rinse with water.
Damp dry with a clean cloth and allow to air dry further if needed.

Low-Level Disinfecting

_ Note: _Do not allow liquid to enter tubing while disinfecting.

Use a soft brush to remove visible contamination.
Rinse with water.
Thoroughly saturate (spray or immerse) all surfaces of the cuff and accessories with a selected cleaning agent.
Soft brush all surfaces. Allow a 5-minute wet contact time, or longer, if directed by the germicidal cleaner manufacturer.
- Do not exceed 10 minutes of wet contact time.
Thoroughly rinse with water.
Damp dry with a clean cloth and allow to air dry further if needed.
- After cleaning or disinfecting, inspect cuff for deterioration and adequate closure integrity, and inflate to assess for leaks.
- Do not use the cuff if any abnormalities are found.

Environmental Conditions

Storage temperature: -4°F to 149°F (-20°C to 65°C)| Operating temperature: 32°F to 122°F (0°C to 50°C)
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Storage relative humidity: 15% to 95% non-condensing| Operating relative humidity: 15% to 90% non-condensing

Warranty

ADC warranty service extends to the original retail purchaser only and commences from the date of delivery. ADC warrants its products against defects in materials and workmanship under normal use and service.
Adcuff inflation system components (cuff, tubing, bulb, valves, and connectors) are warranted for three years.

What Is Covered: Replacement of parts, and labor.

What Is Not Covered: Transportation charges to ADC®. 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.

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.

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.

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 Consumers

On request, send to ADC by e-mail (info@adctoday.com), we can send to you this manual on 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 fulfills the requirements of personal data protection, according to Directive 95/46/EC and GDPR on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Any serious incident that has occurred in relation to 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.