This product is not cleared or available for use in the U.S. A 510(k) submission is pending

Accu-Chek Spirit Combo 360Accu-Chek Aviva Combo 360

System Features and Benefits

• Bluetooth technology provides 2-way wireless communication to let you control your pump with your meter
• Lets you quickly view many insulin pump screens on the meter
• Bolus advisor lets you quickly and easily calculate and administer a bolus from the meter
• Personalized bolus advice is based on insulin already in your system, your current blood sugar level, carb intake and other important factors, including how long it can take for insulin to begin lowering your blood sugar
• Lets you or your healthcare team customize settings to match your individual needs
• Boluses are completely delivered even if you set the meter down and walk out of the 6-foot wireless communication range (or if you’re a parent who operates the pump for a child who wanders out of range)

Pump Features and Benefits

Place the ACCU-CHEK Spirit Combo insulin pump in a discreet location, and you might not touch it again until bedtime.

• Minimum basal rate of 0.05 units helps meet the needs of those who require a very low amount of basal insulin
• Lets you or your healthcare team set hourly basal rates in increments as precise as 0.01 units of insulin
• Can always be operated independently in case the meter is misplaced or accidentally damaged
• Temporary basal rate function lets you quickly adjust basal rate delivery to match changing conditions (illlness, exercise, stress, etc.)
• Makes it easy for you to precisely set hourly basal rates using 3 different increments (0.01, 0.05 or 0.1 units), depending on amount of basal insulin required

Meter Features and Benefits

• Full-color display - with a color display, graph clarity is enhanced and key items are highlighted.
• Discretion and convenience when delivering an insulin dosing command - wirelessly send your bolus 6.5 feet (2 meters) from the pump via Bluetooth® wireless technology
• Scroll menu with 3 user menu levels and menu-driven user interface - Easy-to-use and intuitively designed functionality lets you grow in the features you use as you get more comfortable with pump therapy
• Bolus Advice function on smart meter - straightforward and “intuitive” bolus calculation process from blood glucose to insulin delivery.
• Customizable reminders - for changing infusion sets, making doctor and lab visits, retesting following meals and/or out-of-range blood glucose incidents
  • Confidence—You don’t have to keep track of everything in your head—you can program reminders into the system.
  • Discretion—You don’t have to get the pump out to see and act on reminders
• View insulin pump screens via meter

This product is not cleared or available for use in the U.S. A 510(k) submission is pending

Your ACCU-CHEK Combo system provides automatic safety features to help make sure you get the right amount of insulin at the right time.  

Some of these features include:

• A Bolus Advice function that accounts for the amount of insulin that's already active in the body and calculates a bolus based on a variety of factors, including:
  • Your current blood sugar level
  • Your carb intake
  • And, when applicable, variables such as:
    • Exercise level
    • Stress
    • Illness
    • Premenstrual
• Automatic occlusion detection that alerts you to a blockage in the infusion set so action can be taken to avoid high blood sugars
• An on-screen Status Bar that immediately shows if blood sugar is in/out of range so you can respond quickly.
• Warnings and error alerts* to prompt you to take action when necessary, including:
  • High/low and hyper/hypo blood sugar warnings
  • Insulin cartridge low error
  • Meter/pump battery low warning
• Programmable reminders*, including those to:
  • Test after a meal
  • Test after high/low result
  • Change infusion set
• A key lock feature that temporarily disables all keys on your meter and/or pump to prevent accidental activation of functions.

This product is not cleared or available for use in the U.S. A 510(k) submission is pending

ACCU-CHEK Spirit Combo Insulin Pump

• Maximum Dimensions: (without Adapter) Approx. 3.2 x 2.2 x 0.8 inches (82.5 x 56 x 21 mm)
• Weight:
  • Empty insulin pump: approx. 2.8 ounces (80 grams)
• Insulin pump with battery, full plastic cartridge and infusion set: approx. 3.9 ounces (110 grams)
• Pump Casing:
  • Shock- and scratch-resistant plastic
  • Resistant to pharmaceuticals
  • All edges rounded
• Temperature Ranges:
  • During operation: 41°F–104°F (5°C–40°C)
  • Storage in shipping case: 41°F–113°F (5°C–45°C)
  • During transport: –4°F–122°F (–20°C–50°C)
• Air Humidity (Relative Humidity):
  • During operation: 20%–90%
  • Storage in shipping case: 5%–85%
  • During transport: 5%–95%
• Barometric Pressure:
  • During operation or storage in its shipping case: 70–106 kPA (700–1060 mbar) (do not exceed 3000 meters [10,000 feet] above sea level)
  • During transport: 50–106 kPA (500 to 1060 mbar)
• Basal Rate: Min. = 0.05 U/h, Max. = 50 U/h. There are 24 hourly basal rates, adjustable in unit increments of 0.01 (up to 1.00 U/h), 0.05 (up to 10.0 U/h) and 0.1 (up to 50.0 U/h).
• Bolus:
  • Max.: 50 insulin units
  • Quick Bolus: adjustable in unit increments of 0.1, 0.2, 0.5, 1.0 and 2.0
  • Standard Bolus, Extended Bolus and Multiwave Bolus: adjustable in fixed increments of 0.1 units
  • Duration of Extended Bolus and Multiwave Bolus: adjustable in intervals of 15 minutes (from 15 minutes up to 12 hours)
• Temporary Basal Rate Adjustable in 10% increments, 0%–90% (decreases), 110%–500% (increases). The duration is adjustable in 15-minute intervals, up to a maximum of 12 hours. The last programmed duration is given by default for the next Temporary Basal Rate change programmed.
• Maximum Pressure 400 kPa (4.0 bar), for plastic and Aventis Insuman® Infusat glass cartridges*** and infusion sets
• Flow (Delivery Rate) During infusion-set priming and bolus: 0.2 U/sec.
• Maximum Quantity Delivered at a Single-Fault Condition ≤ 1.0 U
• Data Transfer Infrared interface
• Water Tightness IPX 8—Protected against the effects of temporary immersion in water under standardized conditions (≤ 60 minutes and ≤ 2.5 meters [8 feet])
• Power Supply One 1.5-volt AA Alkaline (LR6) or lithium (FR6) battery or One 1.2-volt rechargeable NiMH AA (HR6) battery. Batteries should have a minimum capacity of 2500 mAh. Use only a battery charger officially recommended by the battery manufacturer.
• Lifetime of Battery If used in a typical usage pattern (50 U/day using U100 insulin; operating temperature 73°F ±4°F [23°C ±2°C]) the battery life is approximately: 
  • Alkaline 15 days 30 days
  • Lithium 25 days 50 days
  • NiMH 10 days 20 days
• Data Storage Time The time and date are safely stored in the memory for about 1 hour after the battery has been removed. Other insulin pump settings (the hourly basal rates, remaining cartridge content, bolus increments and active user menu) and the event memory (bolus history, history of daily insulin totals, Temporary Basal Rate history, alarm history) are saved, regardless of battery voltage and the time your insulin pump has been without a battery.
• Cartridges ACCU-CHEK® Spirit 3.15 mL cartridge system and ACCU-CHEK® 3.15 mL plastic cartridge with a luer-lock connection.
• Infusion Sets ACCU-CHEK® infusion sets with a luer-lock connector. (ACCU-CHEK® infusion sets are PVC and latex free.)
• Safety Systems Alert system, beeps, information on the display, vibrations, dual microprocessors. Your insulin pump is controlled by two microprocessors. The safety concept is based on one processor (supervisor processor) supervising the other (main processor). Whenever a defect or fault occurs in the main processor, it is identified by the supervisor processor. The motor is immediately switched off and an “Error E7: ELECTRONIC ERROR” occurs. Conversely, the main processor can also determine at any time whether the supervisor is working correctly. The motor also constitutes an important safety component, as the combination of the main and supervisor processor and brushless motor provides the best possible reliability and accuracy in insulin delivery.

ACCU-CHEK Aviva Combo Blood Glucose Monitor

• Display Color dot matrix
• Automatic Power
  • Auto-on with correct strip insertion
  • Auto-off after removing strip (2 minutes)
  • Auto-off after 2 minutes if meter not used
• Power Supply 3 AAA alkaline batteries
• Battery Life Battery life depends on specific use (number of connections to the pump, data downloads, blood glucose tests, etc.)
• System Operating Conditions See ACCU-CHEK® Aviva/Performa test strip package insert
• Meter Storage Conditions –10°C to 50°C with batteries inserted
• Relative Humidity Operating Range 10%–90%
• Memory Capacity 1000 diary records
• Dimensions 94 x 55 x 25 mm (3.7 x 2.1 x 1 in)
• Weight Approx. 3.6 oz (103 grams) with batteries
• Construction Handheld
• Data Port Infrared (IR) window to download to information management solutions
• Test Principle Electrochemical
• Coding Code key
• Test Averages • 7, 14, 30, 60, 90 days
• Data Management
  • Logbook
  • Trend graph
  • Target Report
  • Standard Week
  • Standard Day
• New Features
  • Remote control: Control ACCU-CHEK® Spirit Combo insulin pump via Bluetooth®wireless technology (RF)
  • Bolus advice:
    • Bolus calculator
    • Up to 5 Timeblocks that are associated with bolus advice
  • Reminders
    • Event-based reminders (after low blood glucose, after high blood glucose and after meal)
    • Alarm clock (up to 8 times—e.g., use to remind for blood glucose test)
    • Date reminders (e.g., doctor visit, lab visit, infusion change)
  • Entry for health events (e.g., exercise, stress, illness, etc.)
  • Customizable parameters
    • Vibrate and beep feature (one must be on at all times)
    • 12-hr vs. 24-hr clock
    • Keylock
    • Select carbohydrate units (g, KE, BE, CC)
    • Select language from a list loaded to the meter (holds up to 4)
    • Hyper and hypo warning limits (beep and/or vibrate)
    • Backlight—low, med, high
• Blood Sample Volume 0.6 μL
• Measuring Range 10–600 mg/dL (0.6–33.3 mmol/L)
• Sample Types Capillary, venous, arterial, neonatal
• Sample Dosing Capillary-fill function; suitable for AST
• Storage Conditions 35°F–84°F (2°C–30°C)
• Hematocrit Range 20%–70%
• Quality Control 2 levels of ACCU-CHEK® Aviva control solution
• Stability 18 months at room temperature