ADC 9350N-00 Reusable BP Cuff Instruction Manual

: June 5, 2024
: ADC

ADC 9350N-00 Reusable BP Cuff

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Inflate the cuff

Close the Adflow 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 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 chest piece 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 clearest detection of the lowpitched 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 1 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 female 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 a measurement is completed, open the valve fully to release any remaining air in the cuff. Remove cuff.

Care and Maintenance

Pocket Gauge: After measurement, fully exhaust the cuff then wrap the cuff around the gauge and bulb and store in a zippered carrying case.
Palm Gauge: After measurement, fully exhaust cuff and store in a zippered carrying case. If the unit will not be used for an extended period of time, leave the trigger valve in the full exhaust position.
Clock Gauge: After measurement, fully exhaust cuff then wrap the cuff around bulb and store in the storage compartment.

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 safely be stored at temperatures ranging from -4°F to 131°F (-20°C to 55°C) with a relative humidity of 15% to 85%.

Manometer: Your Diagnostix brand pocket aneroid gauge (#800 or #802), palm aneroid (#804N) or clock aneroid (#805) 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 5), 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. In the event that the gauge is ever in need of calibration, simply return to ADC.mDamaged or broken parts will be replaced as needed at a minimum charge. Refer to the warranty for specific details of warranty coverage. The manufacturer recommends a calibration check every 2 years.

NOTE: Store gauge with valve in full exhaust position. (Figure 5)

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 manufacturer’s instructions. Rinse.
Wipe with .5% bleach and water solution. Rinse
Wipe with 70% isopropyl alcohol.
Launder with a mild detergent in warm water, normal wash cycle. Remove bladder first. 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 cuff with 10% bleach solution until saturated, agitate with a sterile brush over 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.
Do not heat or steam sterilize the cuff.

ADC-9350N-00-Reusable-BP-Cuff-fig-2 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 6).mThe lot number is located on the outside label of the manometer packaging (Figure 7).

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 in accordance with all regional and national environmental regulations. Devices that have become contaminated should be disposed of in accordance with all local ordinances and regulations.

ADC Aneroid Sphygmomanometer

(manometer, cuff, bladder, bulb, and valve)

Thank you for choosing an ADC Diagnostix Aneroid Sphygmomanometer. Your new aneroid is designed to provide unrivaled durability and unparalleled comfort. Every component has been carefully designed to maximize performance. This Instructions for Use guide refers to ADC model series 700, 703, 705, 720, 728, 731, 732, 740, 750, 752, 778, and 788.

Device Description and Intended Use

ADC aneroid sphygmomanometers are 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 neonatal cuffs or neonate patients. Review the size chart for proper age and limb range usage (right).

Symbol Definitions

The following symbols are associated with your ADC Diagnostix Aneroid.

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General Warnings

A warning statement in this manual identifies a condition or practice that, 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.
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.
Safety and effectiveness with neonate cuff size 1 through 5 are not established.
If this equipment is modified, appropriate inspection and testing must be conducted to ensure its continued safe use.
Do not apply the cuff to delicate or damaged skin. Check cuff site frequently for irritation.
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.
Allow space between patient and cuff. Two fingers should fit in this space if the cuff is correctly positioned.
Do not apply the cuff to limbs used for IV infusion.
The patient should remain still during measurement to avoid erroneous readings.
When using with an infant or child cuff, extra care must be taken to prevent over-inflation. With smaller cuffs (infant or child) the cuff can inflate to, over 300mmHg 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).
Extreme altitudes may affect blood pressure readings. Your device has been designed for normal environmental conditions.

Operation of Diagnostix Pocket Aneroids

This booklet contains operating and maintenance information for the Diagnostix 700, 720, 728, and 778 Series pocket aneroid sphygmomanometers. Please read and retain. Your Diagnostix brand pocket aneroid sphygmomanometer consists of an aneroid manometer (gauge), a complete inflation system (Adcuff calibrated nylon cuff, latex-free inflation bladder, squeeze bulb, and Adflow 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.

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Operation of Diagnostix Palm Aneroids

This booklet contains operating and maintenance information for the Diagnostix 703 and 788 Series, the Pediatric and General Practice multi cuff kits, and the 731, 732, and System 5 portable multi cuff kits. Please read and retain. Your Diagnostix palm-style aneroid includes a manometer with integral bulb and trigger air release valve (#804N), Adcuff calibrated cuff with Size Guide™ marking system, bladder, bayonet-style connector (attached to bladder tubing), zippered carrying case, and instruction booklet. ADC’s Multicuff Systems (731, 732, System 5, GPK, and PMK) contain the #804N manometer and a variety of cuffs with single tube bladders, each equipped with a bayonet-style connector, and a compartmentalized case.

Connecting Palm Style Model: 804N

Legacy Connector: Assemble the supplied Luer slip connector into the connector port on top of the palm gauge, rubber gasket side down. Make sure the connector is fully seated in the connector port. Slide cuff tubing over the barbed end of the connector. The connector will friction fit onto the tubing of most commercially available ONE-tube cuff and bladder systems (Figure 1). New 804N Connector: Insert the metal bayonet connector into the metal receiver until it clicks (Figure 2).
To Release: Slide receiver collar downward toward gauge until connector releases.

WARNING

Do NOT remove the metal receiver from the gauge.
The palm-style manometer is designed for use with ONE-tube systems.
To avoid damage to the instrument, do not force a connector into port.

Using the Trigger Valve

Deflation: Gently squeeze the bottom of the trigger to deflate the cuff. Altering the pressure affects the deflation rate.
Rapid Exhaust: To exhaust the remaining air after the measurement is completed, squeeze the trigger until it clicks and locks in place.

CAUTION: Never force trigger.

Operation of Diagnostix Clock Aneroids

This booklet contains operating and maintenance information for the Diagnostix 750W series (wall mount), 752M series (mobile), and 750D series (desktop) aneroid sphygmomanometers. Please read and retain. Your Diagnostix 750/752 consists of a large “clockface” aneroid with an easy-to-read 6” dial, an integral swivel bracket/cuff storage compartment (wall series only), a complete inflation system (which includes the Adcuff nylon cuff with Size Guide marking system, latex-free inflation bladder, bulb, and Adflow valve), 8-foot length coiled tubing, Luer connectors, mounting hardware, and operating instructions. The Diagnostix 752M is mounted on a height-adjustable, Spider- Leg™ 5-leg mobile stand. The Diagnostix 750D is mounted on a desktop stand. To assemble the inflation system, connect coiled tubing to the air inlet nipple at bottom of the gauge. Insert male Luer adapter on bladder tubing into a female receptacle at free end of coiled tubing.Store folded inflation system in swivel bracket behind gauge on 750W and 750D or in an integral basket on 752M.

Acuff Intended Use

ADC blood pressure cuffs are noninvasive and are intended for use with manual and automated noninvasive blood pressure measurement devices. ADC’s Size Guide marking system assures use of correct cuff size and proper cuff alignment. Printed Index and Range markings and applicable limb range (in cm)\ allow easy identification of the correct cuff size. An artery mark printed on both sides indicates bladder midpoint for correct cuff positioning. A convenient nylon gauge hang tab permits flexible use with either pocket aneroids or mercury manometers. Hook-and-loop adhesive surface provides a snug, infinitely variable fit and is designed to withstand a minimum of 30,000 open/close cycles.

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. Prior to measurement the patient should relax 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

Acuff 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 3). To verify a correct fit, check that the Index Line falls between the two Range Lines (Figure 4).

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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.
Your Diagnostix™ manometer is warranted for life. The manometer is warranted to remain accurate to ±3mmHg (or the prevailing standard) over its full range when compared to a reference standard for life.
Inflation system components (cuff, bladder, 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 are 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 mvary 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 Customers

On request, send to ADC by e-mail (info@adctoday.com), we can send to 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 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.

To register your product visit us at: www.adctoday.com/support/warranty- registration