LAB24 – Ambulatory Blood Pressure Monitor
- CE: MDD CE 0413 / Valid until 12.Feb.2025
- Model: Oscar 2, M250 D (Bravo Mini)
- Manufactured by SunTech Medical, Inc.
- GMDN: 36888
- UMDNS: 18364
Get accurate and timely blood pressure readings from your patients with the LAB24
Bionet’s LAB24 is an advanced, motion-tolerant ambulatory blood pressure monitor supporting the care and diagnosis of hyper and hypotensive patients. The LAB24 provides 24 hours of blood pressure data within 48 hours, allowing breaks for daily activity and rest.
Product Highlights
- Motion tolerant algorithm for 24 hrs up to 48 hrs monitoring
- Clinically validated (AAMI, ESH, BIHS, AAMI-SP10, ISO 81060-2)
- Patented cuffs with inner pocket
- Easy wearing & reassuring of BP accuracy
- Intuitive, user-friendly Windows-based software
- Easy to use & one-button design
Comfort, Accuracy, Dependability. Experience the LAB24 Ambulatory Blood Pressure Monitoring System from Bionet.
When blood pressures need to be retried or confirmed due to:
- “White coat” hypertension
- Masked hypertension
- Titrating medication
- Active child-induced artifact
- Identifying pre-hyper/hypotension, High normal BP
Identifying NON-Dippers
- 24hr hypertension exposed
- Potential LVH (Left Ventricle Hypertrophy)
- Congestive heart failure
- Potential MI
- Target organ damage
- Stroke & Renal failure
Easy, traceable patient data & capacity
- Clinically approved by meeting or exceeding the latest BHS, ESH, AAMI: SP10 standards.
- Motion Tolerant algorithm applied.
- Patented inner pocket, unique, self-fitting, comfortable cuff. Durable for all ABPM applications.
- BMS Mini software for intelligent programming, analysis tools, and reports
Situations when BP accuracy matters the most
- “White Coat” hypertension: The patient shows hypertension at the doctor’s office but not in other settings, such as at home.
- Masked hypertension: The patient shows normal BP at the doctor’s office but exhibits hypertension at home or during daily life.
- Titrating medication for antihypertensive medication
- Self-BP reading with accuracy is the key to titrating hypertensive medication.
- Other hypertensive symptoms needing ABPM
- Resistant hypertension
- Childhood hypertension
- Nocturnal hypertension
- Episodic hypertension and/or anxiety disorders
- Hypotensive symptoms
- Changes in diet and daily routine designed to reduce hypertension
Non-dippers with 24-hour hypertension exposed to high potential LVH (left ventricular hypertrophy)
- Non-dippers are a particular group of patients with potential target organ damage or LVH whose nocturnal systolic and diastolic blood pressure do not average clinically expected lower readings.
- One of the significant factors of LVH is continuous exposure to 24-hour hypertension, even during the night.
- LVH gradually changes the structure of the heart by thickening the left ventricle chamber wall, and complications can include:
- Arrhythmia
- Stroke
- Cardiac Arrest
- As a prevention, regular BP monitoring, with accurate 24-hour monitoring, is critical, as are moderate physical activities, dietary control, and quitting smoking.
Why LAB24 ABPM ?
- Motion tolerant algorithm for 24 hrs up to 48 hrs monitoring
- The most advanced BP algorithm for day/night monitoring even under circumstances of motion artifact.
- Clinically validated by standards of AAMI, ESH, BIHS, AAMI-SP10, ISO 81060-2
- Patented cuffs with inner pockets for easy wearing & reassuring BP accuracy
- Equipped with an inner pocket design, it will hold cuff position for BP monitoring, ensuring accurate, consistent readings.
- BMS Mini ABPM software is an intuitive, user-friendly Windows-based program that includes:
- Interpretive summary report
- Time-slice periods with statistical analysis
- Custom report options with a single page with ABP graph
- PDF report format with EMR compatibility with built-in direct email menu
- Easy to use & one-button design
- Simple operation with a one-button design
- 250 memory readings
- 2 AA batteries required
Includes:
Lab24 ABP Monitor, USB Cable, ABP Monitor Belt, ABP Monitor Shoulder Strap, Pouch, ABPM Cuff – Size 2 (26cm-34cm), ABPM Cuff – Size 3 (32cm-44cm), NIBP Hose Female to Female Extension, Multilingual Quick Guide & Instruction for use (USB Drive), BMS-Mini Software (USB Drive)
Method of Measurement | Oscillometric with step deflation |
---|---|
Blood Pressure Range | Systolic: 40-260mmHg Diastolic: 25-200 mmHg |
Heart Rate Range | 40-200 bpm |
Maximum Inflate Pressure | 280 mmHg |
Accuracy | Heart Rate accurate within +/-2% or +/-3 bpm, whichever is greater. Blood Pressure results meet or exceed ANSI/AAMI/ISO 81060-2:2013 standards for noninvasive accuracy: ±5 mmHg mean error & 8 mmHg standard deviation. |
Validations | Clinically validated to ANSI/AAMI/ISO 81060-2:2013, BHS (A/A), and ESH International Protocol. |
Operating Conditions | 10°C (50°F) to 50°C (122°F) 20-95% RH non-condensing |
Shipping/Storage Conditions | -20°C (-4°F) to 70°C (158°F) 15-95% RH non-condensing |
Classification | Continuous operation Power: Two (2) AA batteries, alkaline |
Data Memory | Flash memory stores up to 250 readings |
Calibration Check Recommendation | Minimally, once every two years |
Safety Systems | Maximum inflation pressure limited to 300 mmHg; Auto safety release valve for power failure; Maximum measurement time limited to less than 140 seconds |
Sampling Periods | 24 independently programmable periods (Time interval options: none, 5, 10, 15, 20, 30, 45, 60, 90, and 120 minutes) |
Parameter | Standard | EU Norm |
---|---|---|
Safety | AAMI/ANSI ES60601-1:2005/(R) 2012 +A1:2012 | EN 60601-1 :2006/A1:2013/ IEC 60601-1: 2005/A1:2012 |
Blood Pressure | IEC 80601-2-30 :2009 + A1:2013 | N/A |
Usability | IEC 60601-1-6 :2013 Ed. 3.1 IEC 62366:2015 Ed. 1.0 |
EN 60601-1-6 :2010 EN 62366:2008 |
EMC/EMI/ESD | IEC60601-1-2:2014 | EN 60601-1-2:2015 |
Home Use | IEC 60601-1-11:2015 Ed. 2.0 | EN IEC 60601-1-11:2010 |
Biocompatibility | ISO 10993-1:2009/(R)2013 ISO 10993-5:2009 ISO 10993-10:2010 |
EN ISO 10993-1:2009/AC:2010 EN ISO 10993-5:2009 N/A |
Software | IEC 62304:2015 | EN IEC 62304:2006/AC:2008 |
Symbols | ISO 15223-1:2016 | EN ISO 15223-1:2016 |
Sphygmomanometers | ANSI/AAMI/ISO 81060-2:2013 | EN ISO 81060-1:2012 |
Quality | ISO 13485:2016 | EN ISO 13485:2016 |
Risk Management | ISO 14971:2007 (Ed. 2) | EN ISO 14971:2012 |
Size | Approximately 100 x 70 x 30 mm | |
Weight | Approximately 233 g, including batteries | |
Storage Conditions | -20° C to +70° C, 15%-95% RH non-condensing | |
Data | USB 3.0 (USB-C) |
* Specifications can be changed without prior notification.
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