ProBP™ 2000 Digital Blood Pressure Device with Power Supply CLEARANCE

Welch Allyn

Diagnostic equipment

Digital blood pressure monitor (non-invasive sphygmomanometer)

Meets AAMI standards for non Invasive blood pressure measurement accuracy (as stated by the manufacturer).
Class II medical electrical equipment with Type BF applied part classification.
Designed and tested for electromagnetic compatibility per IEC 60601 1 2 (EMC compliance details in user manual).
Includes safety and EMC testing documentation and SGS safety mark as noted in the instructions for use.
Intended for prescription Only professional use (Rx only in the United States and similar regulatory classifications in other regions).

Meets AAMI standards for non Invasive blood pressure measurement accuracy (as stated by the manufacturer).
Class II medical electrical equipment with Type BF applied part classification.
Designed and tested for electromagnetic compatibility per IEC 60601 1 2 (EMC compliance details in user manual).
Includes safety and EMC testing documentation and SGS safety mark as noted in the instructions for use.
Intended for prescription Only professional use (Rx only in the United States and similar regulatory classifications in other regions).

Digital blood pressure monitor (non-invasive sphygmomanometer)

Description

The Welch Allyn ProBP™ 2000 is a professional, automated digital blood pressure device designed for clinical use. It uses the SureBP algorithm to capture oscillometric blood pressure and pulse rate readings during cuff inflation, typically in about 20 seconds, improving patient comfort and workflow efficiency. The device is compatible with Welch Allyn FlexiPort reusable blood pressure cuffs (arm circumference 15–55 cm) and is powered by four AA batteries or an AC power supply. This clearance listing is for a unit with slightly damaged outer packaging; the device itself and included accessories remain fully functional.

Bnefits

Captures blood pressure readings in approximately 20 seconds during cuff inflation for faster measurements.
Uses the SureBP algorithm to provide clinically accurate, oscillometric blood pressure and pulse readings.
Improved patient comfort by measuring while the cuff inflates, reducing inflation time.
Compatible with Welch Allyn FlexiPort reusable blood pressure cuffs from child size 9 to thigh size 13 (15–55 cm).
Meets AAMI standards for non-invasive blood pressure accuracy when used as directed.
Compact, lightweight design (about 283 g without batteries) for easy handling and portability.
Can operate on 4 AA alkaline batteries or via an AC power adapter for flexible power options.
Large digital LCD that clearly displays systolic, diastolic and pulse rate values.
Professional clinical device intended for use by trained healthcare staff in medical environments.
Box contents include device, adult size FlexiPort cuff, power supply (where applicable), batteries and startup guide.

Indications

Non-invasive measurement of systolic and diastolic blood pressure and pulse rate.
Use in patients aged 3 years and older with upper arm circumferences between 15 cm and 55 cm.
Professional use by clinicians and medically qualified personnel in clinical environments (e.g. hospitals, clinics, physician offices).
Intermittent spot-check blood pressure measurements rather than continuous monitoring.

Composition

Electronic medical device; not a pharmaceutical product.
Contains a digital pressure transducer, microprocessor, LCD display and pneumatic system for cuff inflation and deflation.
Used with compatible Welch Allyn FlexiPort reusable blood pressure cuffs (polyester or synthetic cuff materials with internal bladder).

Formulation

Not applicable – diagnostic electronic device (no medicinal formulation).

Packaging

Retail carton containing: ProBP 2000 Digital Blood Pressure Device.
One Welch Allyn FlexiPort reusable blood pressure cuff, adult size 11 (approx. 25–34 cm arm circumference).
4 x AA alkaline batteries (for battery-powered operation).
AC power supply / plug adapter (where supplied by configuration).
Startup or quick reference guide and user instructions.
This specific clearance listing notes minor damage to the external packaging.

Usage

Install 4 AA alkaline batteries or connect the approved AC power adapter before use.
Connect the compatible Welch Allyn FlexiPort cuff firmly to the device’s cuff port.
Select an appropriate cuff size so the bladder range marking covers the patient’s arm circumference (15–55 cm).
Apply the cuff on a bare upper arm, positioning the artery marker over the brachial artery.
Wrap the cuff snugly, leaving room for no more than two fingers under the cuff edge.
Seat the patient comfortably with back supported, feet flat on the floor, legs uncrossed and arm supported at heart level.
Allow the patient to rest quietly for about 5 minutes before measurement; avoid talking during the reading.
Press the power button to switch on the device and start a single blood pressure measurement cycle.
Keep the patient’s arm still during inflation and measurement until the device completes the reading and displays values.
Record or transfer the systolic, diastolic and pulse rate values according to your clinical workflow.
Follow the user manual for any repeat measurements, troubleshooting, cleaning and regular performance checks.
Do not use the device near MRI equipment or in strong electromagnetic environments; observe all warnings in the instructions for use.

Contraindications

Not intended for use on neonates, infants or children under 3 years of age.
Not evaluated for use in pregnant or pre-eclamptic patients; use in these patients is at clinician discretion.
Do not use on limbs with compromised circulation, intravenous infusions, or on the same side as a mastectomy unless clinically justified.
Not intended for continuous blood pressure monitoring during medical emergencies or surgical procedures.
Not intended for use in home healthcare environments; designed for professional clinical settings.
Do not use in or near MRI scanner rooms (device is unsafe in MRI environments).

Adverse Effects

Possible transient discomfort or pain in the arm during cuff inflation.
Risk of bruising or skin discoloration if the cuff remains inflated at high pressure for an extended period.
Potential skin irritation or reactions in patients sensitive or allergic to polyester or synthetic cuff materials.
Potential circulatory disruption or numbness in the limb if measurements are taken too frequently or if the cuff is applied incorrectly.
Inaccurate readings if used on limbs with poor circulation, with simultaneous IV infusions, or alongside other monitoring devices on the same limb.

Storage Conditions

Store and transport the device in a clean, dry environment within the temperature, humidity and pressure limits specified in the instructions for use.
Avoid excessive heat, cold, moisture, dust and direct sunlight.
Remove the batteries if the device will not be used for an extended period to prevent leakage.
Keep the device and accessories away from strong electromagnetic fields and corrosive or flammable substances.
Protect the device from mechanical shock, drops and impact during storage and transport.