8451-11AN-1 Adcuff TM One Reusable BP Cuff Instruction Manual

: June 12, 2024
: ADC

Table of Contents

8451-11AN-1 Adcuff TM One Reusable BP Cuff
Specifications
Instructions for Use
Symbol Definitions
Maintenance
Warranty
Frequently Asked Questions
References
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8451-11AN-1 Adcuff TM One Reusable BP Cuff

Specifications

Manufacturer: American Diagnostic Corporation
Material: Phthalate-free, not made with natural rubber Vlatex
Compliance: Meets the general safety and performance requirements of Regulation (EU) 2017/745
Cuff Sizes and Limb Ranges:
- Infant – Orange – 9-14.8 cm
- Child – Green – 13-19.5 cm
- Small Adult – Royal Blue – 19-27 cm
- Adult – Navy – 23-40 cm
- Large Adult Thigh – Burgundy – 34-50 cm

Instructions for Use

Intended Use:
ADC® blood pressure cuffs are noninvasive blood pressure cuffs intended for use with both non-automated and automated sphygmomanometers to measure blood pressure.

Contraindications:
Aneroid sphygmomanometers are contraindicated for neonate use.

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.

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 TM
nylon coated TPU hang tag (on most sizes) permits flexible use with pocket Reusable BP Cuff 11 23-40 cm 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, Index Line 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 the cuff may occur.
CAUTION: Repeated reprocessing may cause degradation of the device; follow inspection procedures to assure the integrity of the device.
CAUTION: Do not aggressively scrub the cuff as damage to cuff markings and/or cuff closure integrity may occur.
Materials:
When cleaning or disinfecting, use sterile cloths, a soft brush, a 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 the 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 the 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 the 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)
Storage relative humidity: 15% to 95% non-condensing
Operating temperature: 32°F to 122°F (0°C to 50°C)
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: A printed copy of this manual can be sent to you at no charge within seven calendar days. To request a copy, e-mail us at info@adctoday.com. 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.

Inspected & Packaged in the U.S.A.

Printed in the U.S.A.

ADC
55 Commerce Drive
Hauppauge, NY 11788 U.S.A.
SC Cattus SRL
Str. Baneasa Nr. 10 C
Târgu-Mures, Jud. Mures România, EU
Vera Global Ltd
86-90 Paul St., 3rd Fl.
EC2A 4NE, London United Kingdom
MedLife S.A.
Chemin du Pont-du-Centenaire 109
1228 Plan-les-Ouates Suisse

Frequently Asked Questions

Q: Can aneroid sphygmomanometers be used for neonates?
- A: No, aneroid sphygmomanometers are contraindicated for neonate use.
Q: How can I verify the correct fit of the cuff?
- A: Check that the INDEX line falls between the two RANGE lines after applying the cuff.
Q: What should I do if the cuff package is damaged?
- A: Do not use a damaged package; consult the manufacturer or distributor for a replacement.