This document describes the DeVilbiss SleepCube Model DV57 Series AutoBilevel CPAP, a positive airway pressure device designed for treating Obstructive Sleep Apnea (OSA) in spontaneously breathing patients weighing 30 kg (66 lbs) or more. It is intended for use in both home and clinical environments.
Function Description:
The SleepCube delivers positive air pressure to maintain an open airway, preventing the collapse of the upper airway that characterizes OSA. It features AutoBilevel operation, which is typically used for OSA patients requiring higher prescribed pressures. This mode adjusts inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP) to support breathing.
An optional heated humidifier system (DV5HH) can be integrated to alleviate symptoms of dry throat, nasal passages, and mouth, common with positive airway pressure therapy, especially in dry or cold climates. The humidifier's heater setting can be adjusted from 1 (minimum) to 10 (maximum), with corresponding plate temperatures ranging from approximately 29°C (84°F) to 65°C (149°F).
The device incorporates a SmartFlex pressure relief feature, which lowers pressure slightly during exhalation to make breathing out easier. Pressure returns to the prescribed level during inhalation. SmartFlex offers three relief settings (1-3, with 3 being the most relief) and can be set to operate "Full-Time" or "Delay Only" (during the comfort delay period). Pressure waveform smoothing for both inhalation (SmartFlex-i) and exhalation (SmartFlex-e) can be adjusted from 0 to 5.
A Comfort Delay feature allows the airflow to start at a lower pressure and gradually ramp up to the prescribed setting over a specified delay time (0 to 45 minutes in 5-minute increments), aiding in falling asleep.
The SleepCube includes Auto-ON/OFF functionality, which automatically starts airflow upon breathing into the mask and stops it when the mask is removed. This feature can be enabled or disabled. A Mask Fit Check feature continuously measures airflow to detect significant leaks, notifying the user if leakage exceeds 95 liters/minute for more than 10% of the usage time.
Important Technical Specifications:
- CPAP Device Dimensions (HxWxD): 10.7 cm (4.2”) x 16.5 cm (6.5”) x 17.5 cm (6.9”)
- CPAP Device Weight: 1.22 kg (2.7 lbs.)
- Electrical Requirements AC: 100-240V~, 50/60 Hz
- Electrical Requirements DC: 10.4 - 15 VDC, 5 Amps
- Maximum Power Consumption: 65 watts max (flow generator only)
- Bilevel Pressure Range: 3-25 cmH2O
- Operating Temperature Range: 5°C to 40°C (41°F to 104°F)
- Operating Humidity Range: 0% to 95% RH non-condensing
- Operating Atmospheric Conditions: Sea level to 8,500 feet (2600 m)
- Sound Pressure Level: 26 dBA (tested per ISO 17510)
- Sound Power Level: 38 dBA
- Humidifier Output: ≥10 mgH2O/l air (in operating flow range)
- Humidifier Dimensions (HxWxD): 6.6 cm (2.6”) x 16.0 cm (6.3”) x 21.3 cm (8.4”)
- Humidifier Weight: 0.794 kg (1.75 lbs.)
- Humidifier Power Consumption: 85 Watts
- Heater Plate Temperature: Approx. 29°C (84°F) to Approx. 65°C (149°F)
- Filter Specifications: Standard Filter > 3.0 micron particles, Optional Fine Particle Filter > 0.3 micron particles
- Expected Service Life: CPAP and humidifier cradle = 5 years, Humidifier water chamber = 1 year, Tubing and gross particle intake filter = 180 days.
Usage Features:
The SleepCube is designed for ease of use with a simple keypad and LCD display.
- ON/OFF Button: Starts and stops airflow.
- HEATER Buttons (Up/Down Arrows): Adjust humidifier heater settings (1-10) for desired humidity.
- DELAY Button: Activates the comfort delay feature if enabled.
- Navigation Arrows (Left/Right): Access menus for specific settings and compliance information.
- Patient Messages: The device displays reminders (e.g., "Clean Filter") and notifications (e.g., "Mask Leak," "Delay Running xx Minutes Left") to guide the user.
- SmartCode Technology: Records therapy data for compliance reporting, accessible via the keypad. Data includes days used, AHI, high leak percentage, and daily usage, viewable for 1, 7, 30, and 90-day periods.
- International Power: Universal power supply (100-240V~, 50/60Hz) automatically adapts to different line voltages.
- Altitude Compensation: Automatically compensates for altitude changes between sea level and 8500 ft (2600 m).
- DC Operation: Can be powered by a 12V DC source (e.g., car, marine battery) with appropriate cables and inverters. The heated humidifier does not operate directly from 12V DC.
- Supplemental Oxygen: Oxygen can be added via an optional adapter or a mask with an oxygen port, under physician supervision.
Maintenance Features:
Regular maintenance is crucial for optimal device performance and longevity.
- Device Cabinet: Wipe with a clean, damp cloth every few days to keep dust-free. Allow to dry completely before plugging in.
- Air-Inlet Filter (Standard): Check every 10 days, clean if dirty, replace every 6 months or sooner if damaged. Wash with warm water and dishwashing detergent, rinse, and air dry completely.
- Fine Particle Filter (Optional): Check every 10 days, replace if dirty or damaged (do not wash), replace every 30 days. Install behind the standard filter.
- Humidifier Water Chamber: Clean daily. Disassemble, hand wash with warm water and mild dishwashing detergent, rinse, and air dry. Can be washed weekly in a dishwasher (delicate/glassware cycle, top shelf only).
- Humidifier Cradle: Clean as needed with a soft, damp cloth. Allow to cool for 10 minutes after use before detaching the flow generator.
- Tubing: Clean daily with mild detergent and water, rinse, and air dry.
- Mask and Headgear: Clean according to the manufacturer’s instructions.
Product Disposal:
The device contains electrical and/or electronic equipment that must be recycled according to EU Directive 2012/19/EU (WEEE). It should not be disposed of with regular household waste. Components like the internal motor, PC board, power supply board, and wiring should be removed and recycled as electronic waste. Remaining plastic components should be recycled as plastics.
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