American Diagnostic Corporation - Core Medical Device Manufacturer. Stethoscopes, Blood Pressure, Thermometry, and EENTAmerican Diagnostic Corporation - Core Medical Device Manufacturer. Stethoscopes, Blood Pressure, Thermometry, and EENT
Instruction Manual for ADC models including: 8451-11AN-1 Adcuff TM One Reusable BP Cuff, Adcuff TM One Reusable BP Cuff, One Reusable BP Cuff, Reusable BP Cuff
American Diagnostic Corporation - Core Medical Device Manufacturer. Stethoscopes, Blood Pressure, Thermometry, and EENT
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.
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DocumentDocument93-adcuffplus-00 rev 4.qxp_Layout 1 5/24/24 10:30 AM Page 1 ADC® Adcuff +TM One-piece Reusable BP Cuff Instructions for Use AMERICAN DIAGNOSTIC CORPORATION 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: Symbol Definition Important Warning/Caution Not made with natural rubber latex Phthalate free Meets the general safety and performance requirements of Regulation (EU) 2017/745 of the European Union Authorized representative in the European Community/European Union Authorized representative in the United Kingdom Authorized representative in Switzerland Manufacturer Date of Manufacture Circumference Size 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 Symbol Definition Catalog Number Batch Code °F Temperature Limit Humidity Limitation Medical Device compliant with Regulation (EU) 2017/745 Unique Device Identifier Non-Sterile Do not use if package is damaged Importer Distributor Consult Instructions for Use Cuff Size Adult Lg Adult Thigh Color Navy Burgundy Brown Limb Range (cm) 23-40 34-50 40-66 Adcuff+ Size GuideTM Marking System: ADC's Size GuideTM Marking System assures use of correct cuff size and proper cuff alignment (Figure 1). Printed Index and Range markings and applicable limb Size Icons Range Lines 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) permits flexible use with pocket aneroid gauges. The cuffs can also be used with palm and clock aneroids, Index Line use smaller cuff +TM Reusable BP Cuff 11 23-40 cm 13 12 11 10 9 7 T X A SA C I Adult - 11 23-40 cm MODEL REF GTIN 1 Tube 8451-11AN-1 00634782095963 2 Tube 8451-11AN-2 00634782095970 as well as NIBP monitors. Hook-and-loop adhesive surface provides a snug, Index Line (Figure 1) infinitely variable fit and is designed to withstand a minimum of 30,000 open/close cycles. Gauge Hang Tab Hook & Loop Closure Adhesive use larger cuff Tube Ports Artery Mark 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) Left Arm Tube (Figure 2) 93-adcuffplus-00 rev 4.qxp_Layout 1 5/24/24 10:30 AM Page 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. CAUTION: Repeated reprocessing may cause degradation of device; follow inspection procedures to assure integrity of device. CAUTION: 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-registeredepa-sterilizers. Basic Cleaning: Note: Do not allow liquid to enter tubing while cleaning. 1. Use a soft brush to remove visible contamination. 2. Thoroughly rinse with water. 3. 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. 1. Use a soft brush to remove visible contamination. 2. Rinse with water. 3. Thoroughly saturate (spray or immerse) all surfaces of the cuff and accessories with selected cleaning agent. 4. 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. 5. Thoroughly rinse with water. 6. 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) 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: 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 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. ADC 55 Commerce Drive Hauppauge, NY 11788 U.S.A. Vera Global Ltd 86-90 Paul St., 3rd Fl. EC2A 4NE, London United Kingdom SC Cattus SRL Str. Baneasa Nr. 10 C Târgu-Mures, Jud. Mures România, EU MedLife S.A. Chemin du Pont-du-Centenaire 109 1228 Plan-les-Ouates Suisse IB p/n 93-adcuffplus-00 rev 4 (05/15/2024) Inspected & Packaged in the U.S.A. tel: 631-273-9600 toll free: 1-800-232-2670 fax: 631-273-9659 www.adctoday.com info@adctoday.com Printed in the U.S.A.