The Dopplex Ability is an automatic Ankle-Brachial Pressure Index (ABPI) or Ankle-Brachial Index (ABI) monitor, also capable of Pulse Volume Recording (PVR) / volume plethysmography. It is designed for rapid measurement in adults at risk of, or developing, peripheral arterial disease (PAD). The device is suitable for wound care assessment, assessing symptomatic PAD, and as a screening tool for PAD. It can also be used on patients with venous or arterial ulcers prior to compression therapy application and on patients with unilateral lower limb amputation.
Function Description:
The Dopplex Ability measures ABPI/ABI and PVR waveforms. It uses four dual-chamber cuffs, color-coded for easy placement on the right arm (red), left arm (yellow), right ankle (black), and left ankle (green). The device features a display for showing results and system settings, and function buttons below the display for navigation. It includes an integral printer (on model DA100PB) for immediate printouts of results and PVR waveforms. The unit can operate from mains power or an internal rechargeable battery.
Important Technical Specifications:
- Model Variants: DA100 (Dopplex Ability), DA100PB (Dopplex Ability with integral printer and battery).
- Power Supply: 100 to 240V ~ 50-60Hz.
- Fuse Type: T1AH 250V.
- Power Input: 3-80 VA.
- USB Port: Mini Type: 1, full speed, 12 Mbps, fully isolated. Used for software upgrades, not normal operation.
- Printer (DA100PB): Integral 58 mm, thermal.
- Paper (DA100PB): Roll width: 58 mm nominal, Roll diameter: 40mm. Standard (Plain) paper yields approximately 55 printouts; Label paper yields approximately 35 printouts.
- Dimensions: Height 160mm, Depth 240mm, Width 260mm.
- Weight: 3Kg.
- Service Life: 7 years.
- Operating Environment: Temperature 10°C to 35°C, Relative Humidity 10% to 90% (non-condensing), Atmospheric Pressure 860mb to 1060mb.
- Storage Environment: Temperature -20°C to 50°C, Relative Humidity 10% to 90% (non-condensing), Atmospheric Pressure 860mb to 1060mb.
- Battery (DA100PB): Internal rechargeable NiMH 12V battery (SP-771332) provides approximately ten ABI measurements when fully charged (charging time approx. 2 hours). Real-time clock backup battery is Lithium Manganese Dioxide 3V (SP-771514).
- Equipment Classification: Class II, internally powered, Type BF applied parts (cuffs). Continuous mode of operation. IP30 degree of protection against harmful ingress of particles and/or water. Not suitable for use in the presence of flammable anesthetics.
- Systolic Pressure Range: Arms: 80 - 220 mmHg, Ankles: 55 - 205 mmHg.
- ABI Performance: Provides valid ABI results for at least 80% of patients tested. Agreement with Doppler method to ± 0.28 for 95% limits of agreement for compressible vessels.
- PVR Performance: Provides filtered PVR waveforms from ankles with -3dB cut-off frequencies at 0.35 Hz and 10 Hz.
- Maximum Cuff Pressure: 230 mmHg.
- Standards Compliance: IEC60601-1: 2005, EN60601-1-2: 2014, EN10993-1:2009 & AC: 2018, EN62366:2015, IEC 62304: 2006, IEC 15223-1: 2012.
Usage Features:
- Initial Setup: Requires battery re-connection (for DA100PB) and language selection upon first use. Battery conditioning is mandatory before first use for reliable battery operation and can take up to 10 hours.
- User Interface: Intuitive display and function buttons for navigating system settings (contrast, time/date, paper type, audio volume, ABI classification thresholds, PVR waveforms, language, battery conditioner, demo mode, cuff leak test, service menu) and patient measurement menus.
- Patient Preparation: Emphasizes the use of infection control barrier sleeves for medium/high risk situations or non-intact skin. Cuffs should not be applied directly to non-intact skin; suitable wound dressing and barrier sleeve are required. Remove trapped air before tightening cuffs.
- Cuff Placement: Color-coded cuffs (Red: Right Arm, Yellow: Left Arm, Black: Right Ankle, Green: Left Ankle) with specific placement instructions to ensure accuracy. Cuffs can be fitted over thin clothing but not jumpers or trousers. Patient's heel must rest on the couch, and legs should not rest on cuffs. Tubing must not be kinked or obstructed.
- Measurement Process: Patient briefing is crucial to explain the procedure (cuff inflation, deflation) and ensure stillness and silence during the 3-minute test. The test can be stopped at any time by pressing the center key.
- Results Display: Results are displayed within 3 minutes, including ABI values and PVR waveforms (if enabled). ABI Classification thresholds are adjustable by a qualified clinician.
- Printing: Allows printing of results and PVR waveforms (for DA100PB). Paper low indication is provided.
- Power Save: When on battery, display backlight switches off after 3 minutes of inactivity; unit switches off after 10 minutes of inactivity.
- Troubleshooting: Includes guidance for common issues like cuff not connected, air leak, inflation problems, excess pressure, internal fault, systolic pressure out of measurable range, and inability to calculate systolic pressure. A cuff leak test is integrated.
- Accessories: Available accessories include a carry bag (ACC-VAS-015), roll stand (ACC-VAS-013) with a required mounting plate (ACC-VAS-012), wall mount (ACC-VSM-154) with utility hook (ACC-VSM-187) and mounting plate, and various adult cuff sets. Infection control barrier sleeves (ACC-VAS-016) and printer paper (ACC-VAS-017, ACC-VAS-019) are also available.
Maintenance Features:
- General Care: Keep external surfaces clean and free of dirt/fluids with a clean dry cloth. Use a soft cloth dampened with mild detergent solution for cleaning. Avoid electrical contacts and apertures.
- Disinfection: Wipe with a cloth dampened in 70% Isopropyl Alcohol. For contaminated products, use a more concentrated chlorine agent (10,000 ppm available chlorine). Avoid phenolic detergents, cationic surfactants, ammonia-based compounds, perfumes, and antiseptic solutions. Do not immerse the unit or allow fluids to enter.
- Cuff Cleaning/Disinfection: For low-risk situations, clean with soft cloth and mild, neutral detergent @ 40°C, then disinfect with 70% isopropyl alcohol wipe or chlorine releasing agent @ 1000ppm. Rinse with clean water and dry. For medium/high risk, infection control barrier sleeves are recommended as effective cleaning/disinfection is impractical. Do not iron, dry clean, tumble dry, or machine wash cuffs. Do not immerse tubeset in water.
- Cuff Inspection: Regularly inspect cuffs for damage (splitting, fraying) and legible labeling. Check tubing and connections. Replace cuffs every two years or if damaged.
- Annual Inspection: The Ability unit and accessories should be inspected and tested annually. Service manual available from Huntleigh Healthcare Service Department.
- Battery Replacement: Replace the internal battery every two years.
- Service Returns: Products must be cleaned, packed suitably, and include a decontamination certificate.
- End of Life Disposal: Dispose of responsibly according to WEEE regulations.
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