ImpediMed SFB7 - User Manual

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Overview

Function Description
Important Technical Specifications
Usage Features
Maintenance Features

The ImpediMed SFB7 is a portable, battery-powered device designed for the assessment of body composition using bioelectrical impedance analysis (BIA). It offers a rapid, reliable, non-invasive, and cost-effective method for measuring body composition parameters such as fat-free mass, fat mass, and intra-/extracellular fluid. The device operates by measuring how easily electrical currents move through the body, as fat offers more resistance than lean tissue due which contains most of the body's water.

Function Description:

The ImpediMed SFB7 functions in two primary modes: Bioimpedance Spectroscopy (BIS) and Selected Frequencies Bioimpedance (SFBI).

BIS Mode: This mode measures bioimpedance parameters over a broad frequency range of 4-1000 kHz, utilizing 256 data points to provide a true bioimpedance spectroscopy. On-screen graphs display the measured data in the form of a Cole-Cole plot, which visually represents reactance versus resistance. This plot helps indicate a valid measurement, with the absence of scattered data points and a well-fit Cole-Cole plot signifying noise-free data. The BIS mode also determines the characteristic frequency for the subject and total cell membrane capacitance, which are then used in algorithms to estimate body water and fat-free mass. Additionally, resistance versus frequency and reactance versus frequency plots are provided as visual representations of the measured bioimpedance data.
SFBI Mode: This mode also measures bioimpedance parameters over a frequency range of 4-1000 kHz but uses selected frequencies. There are 8 selectable frequencies, including 5 fixed frequencies (5, 10, 50, 100, 500 kHz) and 3 user-definable frequencies within the available range. Users can also specify the number of measurements to be taken and the measurement interval. The SFBI function is designed to allow users to compute and present body composition estimates using published algorithms.

Important Technical Specifications:

Measurement Range: 4-1000 kHz (256 data points in BIS mode).
Fixed Frequencies (SFBI): 5, 10, 50, 100, 500 kHz.
User-Definable Frequencies (SFBI): 3 frequencies within the available range.
Power Source: Portable battery-powered device with an internally installed rechargeable Lithium-ion battery. Recharging is done via a power module and main power cable.
Calibration Check: The device includes a test cell for calibration checks, ensuring accuracy with specific Rzero (604 ± 7 ohms) and Rinf (403 ± 5 ohms) readings.
Data Storage: BIS and SFBI measurement data are stored on board. BIS measurement data is retrievable via Ethernet.
Connectivity: Data transfer to a PC for analysis requires an AMD-Tek or Swann USB-Ethernet adapter and a RED Ethernet crossover cable.
Display: Touch screen interface for operation, with a stylus pen provided for interaction.
Automatic Shutdown: The device automatically shuts off after a period of inactivity.

Usage Features:

User Interface: The device features a touch screen for navigation and input, with a stylus pen recommended for making selections. The main menu provides options for "Measure," "Setup," "Test," and "Files."
Battery Status Indicator: An LED indicator on the device displays the battery status, with different colors and flicking patterns indicating various states such as off, charging, operational, near flat, flat, battery charger fault, or battery voltage detection fault.
Measurement Settings: Users can select single or continuous measurements, or several measurements spaced at a selected interval. The number of measurements and interval can be adjusted via arrow buttons or a keypad.
Patient Data Entry: Participant ID and other patient details can be entered directly on the device via the touch screen.
Electrode Placement: Specific anatomical locations are provided for electrode placement (wrist next to the ulnar head, dorsal surface of the hand, dorsal surface of the foot, and ankle at the level of medial and lateral malleoli). Electrodes should be placed 5 cm apart, center to center, with tabs pointing away from the body.
Lead Connection: Color-coded leads (yellow, red, blue, black) connect to corresponding colors on the back of the device and to the electrodes. Alligator clips are used to attach leads to electrode tabs.
Data Retrieval and Export: Files can be viewed and sorted by name or date/time on the device. Data can be exported to a PC using the provided USB-Ethernet adapter and crossover cable, for analysis with Biolmp Body Composition Analysis software. Uploaded files are automatically deleted from the device after confirmation of receipt.
Contraindications: The device must not be used on participants with active implanted medical devices (e.g., cardiac pacemakers, defibrillators, electronic life support devices), those undergoing external defibrillation, or pregnant individuals (as it has not been clinically validated for this group). Participants should also avoid excessive exercise and alcohol consumption prior to measurement, and certain conditions like menstruation, diuretic use, renal or heart failure can affect body water concentration.

Maintenance Features:

Cleaning: The SFB7 device should be cleaned with a dry, clean cloth only. Leads can be cleaned with a damp cloth if required. The touch screen should be cleaned with a soft damp cloth, avoiding direct liquids.
Care of Leads: Leads should ideally remain connected to the device to prolong their life. They should not be wound tightly, crinkled, or twisted to prevent damage to internal wires. If leads appear damaged, contact ImpediMed or a licensed distributor for replacements.
Electrode Care: Electrodes are single-use and should be discarded after use. Unused electrodes should be resealed in their pouch and stored in a cool, dry place to prevent gel dehydration. They should be used by their expiry date, and electrodes with dry or non-pliable/sticky conductive adhesive should not be used.
Storage: When not in use, the SFB7 should be kept in its carry case. It should be protected from water, impact, excessive heat, and direct sunlight.
Power Adapter: Only the supplied Amtex 9940 power adapter should be used for recharging to avoid electrocution risks.
Pre-measurement Check: The device should be unplugged from the recharging unit before use to avoid noise contamination.
Troubleshooting: A troubleshooting guide is provided to address common issues such as no display, "Out of Range Check Leads and Electrodes" messages, device unresponsiveness, or power light indicators, offering solutions ranging from checking connections and battery status to performing calibration checks or contacting ImpediMed for internal software faults.
No User-Adjustable Parts: The device does not contain user-adjustable parts and should not be disassembled.

ImpediMed SFB7 Specifications

General

Brand	ImpediMed
Model	SFB7
Category	Medical Equipment
Language	English