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Background and Identification
The Getemed VitaGuard VG 3100 is a heart rate, apnea, and respiration monitor made by Getemed. Getemed Medizin is a producer of medical devices in the following categories: cardiac function diagnostics, ambulatory patient monitoring, and telemonitoring.
The VG 3100 features manual storage for physiological signals, which increases the application spectrum of the monitor. A high-resolution graphical LCD display shows various measured parameters, status messages, waveforms, and alarm settings. When measured parameters move above or below the preset limits, the monitor produces an audible and visual alarm. When an alarm occurs, the monitor stores the physiological parameters and waveforms. The VG 3100 uses Masimo Signal Extraction Technology to measure the patient’s pulse rate and oxygen saturation. This model does not detect obstructive apnea but does produce an alarm when no movement or respiration is detected for a set time.
The VG 3100 monitor can be powered by either four 1.5-Volt alkaline batteries or with an external 9-Volt power adapter. With fully charged batteries, the monitor can operate for up to 24 hours.
The name “VitaGuard VG 3100” is printed in blue font in the upper right-hand corner of the device’s front face. The manufacturer’s name, “Getemed'' is printed vertically in light blue lowercase font on the left-hand side of the device's front face. Four arrow buttons are located on the right-hand side of the device’s display.
Technical Specifications
General:
- Weight with power pack: Approx. 700 g
- Dimensions: 13.5 x 20.5 x 4.5 cm
- Casing material: ABS
- Power supply:
- Power pack (4.8 V, NiMH) or 4 x batteries (1.5 V, LR6, alkaline)
- 9 V power adapter NA 3000-2
- Power adapter: NA 3000-2 Input: 100 – 240 V, 50 – 60 Hz, 400 mA / Output: 9 V d.c., 1.5 A
- Power pack recharge time: < 6 h
- Operating time: > 8 hours with alkaline batteries or NiMH power pack
- Replace battery message: Message on LCD display
- Battery exhaustion message: Visual and acoustic warning
- Keys: 6 pushbuttons
- ECG / respiration connector: 8-pin miniature round connector, type CF input
- SpO2 connector: 14-pin mini-ribbon connector, type BF input
- USB connector: Mini USB to connect with a PC
- AUX connector features:
- RS232 interface for modem or online output
- External alarm unit output
- Nurse call unit output
- 2 analog inputs (AUX 1 & 2)
- Display elements: 5 LED’s and a graphical LCD display (320 x 240 dots) with backlight when powered by external or automobile power adapter
- Alarm warnings: Visual and acoustic as per DIN EN 60601-2-49 and IEC 601-1-8
Apnea Monitor:
- Method: Impedance pneumography
- Respiration range: 4 – 120 breaths /min, depending on age group selected
- Resolution: 1 /min
- Apnea pause settings: 8, 10, 12 ... 30, 32, 34 s
- End of alarm condition: 2 breaths within 6 s
- Minimum amplitude: Approx. 0.2 Ohm
- Signal recognition: Green LED and selectable beep tone
Heart Rate Monitor:
- Heart rate range: 25 – 270 /min
- Resolution: 1 /min
- Bradycardia alarm settings: 30, 35 ... 175, 180 /min
- Tachycardia alarm settings: 100, 105 ... 250, 255 /min
- Minimum amplitude: Approx. 0.2 mV
- Selectable ECG leads: Einthoven I, II, or III
- Signal recognition: Green LED and selectable beep tone
Pulse Rate Monitor:
- Method: Pulse oximetry
- Pulse rate range: 25 – 240 /min
- Resolution: 1 /min
- Accuracy:
- ± 3 digits without motion
- ± 5 digits during motion
- Alarm settings: Same as for heart rate monitor
SpO2 Monitor:
- SpO2 range: 1 – 100 %
- Resolution: 1 %
- Accuracy: ± 3 digits for SpO2 above 70 %
- Alarm settings: Selectable from 50 – 100 %
- Sensitivity: Minimum (APOD), Standard, Maximum (APOD = Adaptive Probe Off Detection)
Memory:
- Storage functions: Event, trend, full-disclosure and compliance memory
- Storage capacity:
- Approx. 200 events, depending on pre-alarm and post-alarm settings
- 72 h trend, 8 h full-disclosure
- Stored data: ECG, heart rate, respiration, basal impedance, SpO2, pulse rate, signal IQ, plethysmogram, perfusion index, status, 2 analog inputs
Classifications:
- Product classification: IIb as per MDD 93/42/EEC
- Electrical classification: Class II as per DIN EN 60601-1
- EMC classification: Group 1, class B as per DIN EN 60601-1-2
- Ingress protection: IP 21 as per DIN EN 60529
- German “Hilfsmittelnummer”: 21.24.02.5005 (applies to Germany only)
Environmental Conditions:
- Operating temperature range: 5 – 40 °C
- Operating humidity range: 5 – 95 %, non-condensing
- Altitude: -300 m to +5000 m
- Storage temperature range: -40 to +70 °C