This document describes the Biocare iM 8 Patient Monitor, a portable or line-powered medical device designed for monitoring physiological signals in clinical settings such as intensive care units, cardiac care units, operation rooms, and emergency departments. It provides medical and nursing staff with additional information about a patient's physiological condition.
Function Description:
The iM 8 Patient Monitor acquires and processes physiological signals, examines data for alarm conditions, and displays the data. It supports monitoring of Electrocardiograph (ECG), Respiration (RESP), Non-Invasive Blood Pressure (NIBP), Pulse Oximetry (SPO2), and End-Tidal CO2 (EtCO2). The monitor is not a therapeutic instrument and should only be operated under the direction of professional medical staff. All monitoring parameters are for reference and should not be used for clinical diagnosis.
Important Technical Specifications:
- Power Supply: 100~240VAC (±10%), 50/60Hz (±3Hz), 2A, 40VA Max.
- Internal Battery Input: 6.4V~8.4V, 2200mAh, Rechargeable Lithium battery (optional 4400mAh).
- External DC Input: 9V~15V, Vehicle or DC power supply.
- Display: LED + 3.2" TFT LCD (320x240).
- Input Interface: ECG, RESP, NIBP, SPO2, TEMP, and EtCO2.
- Output Interface: Printer port, Network port.
- Data Storage: Supports SD card, capable of saving up to 3500 groups of alarm data.
- Operating Temperature: 5 ~ 40°C (41°F ~ 104°F).
- Relative Humidity: ≤95% (non-condensing).
- Air Pressure: 70kPa ~ 106kPa.
- Dimensions: 180mm × 250mm × 180mm.
- Weight: 2.0 kg (with battery).
- Safety: Class I, with internal power supply; Anti-defibrillation: CF type; Ordinary equipment (sealed equipment without liquid proof); Not suitable for use in the presence of flammable anesthetic mixtures with air, oxygen or nitrous oxide.
- EMC: Complies with EN 60601-1-2:2007.
Physiological Parameters Specifications:
- ECG: 3/5 leads selectable; Heart Rate (HR) range: Adult 20~300bpm, Neonate/Pediatric 20~350bpm; Sweep speed 12.5/25/50 mm/s; Trace gain 5mm/mv, 10mm/mv; S-T detecting range -2.00~2.00mv.
- NIBP (Biocare/SunTech): Oscillometric method; SYS/DIA/MAP; Measuring range: Adult (SYS 40~260mmHg, DIA 20~200mmHg, MAP 26~220mmHg), Pediatric (SYS 40~160mmHg, DIA 20~120mmHg, MAP 26~133mmHg), Neonate (SYS 40~130mmHg, DIA 20~100mmHg, MAP 26~110mmHg); Pulse Rate Range 30-220 BPM.
- SPO2 (Biocare/Nellcor/Masimo): Dual wavelength infrared wave; Measuring range 0~100%; Pulse rate measuring range 25~240bpm.
- RESP: Thorax impedance method (used with ECG leads); Measuring range 15 ~ 120rpm.
- TEMP (Thermal Probe/Infrared Probe): Measuring range 0~50°C (32~122°F) for thermal probe, 34°c~42.2°c (93.2°F ~108°F) for infrared probe.
- EtCO2 (IRMA/ISA Phasein): Mainstream/Sidestream method; CO2 measuring range 0~15%; Respiration rate 0~150 bpm.
Usage Features:
- Portable Structure: Designed for easy transport, suitable for first aid medical services.
- Display: High resolution, no distortion, high brightness, great view angle LCD with LED display for main physiological parameters.
- Modularized Design: Facilitates easy maintenance.
- Simultaneous Monitoring: Monitors multiple parameters simultaneously, with alarm signals raised when a parameter exceeds its limit.
- Alarm System: Features Technical Alarms (TA) for instrument malfunctions and Physiological Alarms (PA) for abnormal patient parameters. Alarms are visual (red indicator, glittering parameters) and auditory (adjustable volume). Mute and Pause/Disable functions are available.
- Data Storage: Waveforms can be frozen and saved, and an SD card can be used for data storage. All alarm records can be reviewed.
- Patient Login: Allows for new patient entry, continuation of previous patient data, or demo mode. Patient information (ID, name, sex, age, bed ID, hospital, department) can be edited and saved.
- Function Buttons: Includes on-off, printing, NIBP measurement, waveform freeze, audio control, and a multi-function key. A control knob navigates menus.
- Quick Reference Table: Provides quick access to system, alarm, NIBP, ECG, and other parameter setups.
- Trend Review: Allows reviewing NIBP tables, trend tables, and trend graphs (PR, SPO2, TEMP, NIBP) with selectable intervals (1min, 5min, 10min, 15min, 30min).
- Printing: Optional PRT 60 thermal recorder supports real-time, timing, and alarm record printing. Print content can be data only or data + wave.
Maintenance Features:
- Cleaning and Sterilization: Exterior surfaces can be cleaned with diluted ammonia, Cidex, diluted sodium hypochlorite bleach, or mild soap. Display screens can be cleaned with a soft, clean cloth dampened with glass cleaner. Cables and leadwires can be cleaned with warm, damp cloth and mild soap, or isopropyl alcohol wipes. SPO2 probes and cables can be surface-cleaned with 70% isopropyl alcohol or 1:10 bleach solution. Reusable NIBP cuffs can be sterilized by autoclaving, gas, or radiation, or machine/hand-washed. Reusable TEMP probes should not be heated above 100°C. EtCO2 probes can be cleaned with 70% ethanol or isopropyl alcohol.
- Battery Management: Internal Li-ion battery charges automatically when connected to AC power. Charging time is 4-8 hours for full capacity. Batteries should be charged at least once every six months to maintain performance. Scrap batteries must be disposed of according to local environmental regulations.
- Periodic Check: The instrument has a designed lifecycle of 5 years. It should be checked once a year, and accessories every six months.
- Service: Malfunctions should be reported to the dealer or service department. Unauthorized repairs void the warranty. The manufacturer provides circuit diagrams and component lists for a fee.
- Transportation and Storage: Store in environmental temperatures of -40°C ~ 55°C, relative humidity ≤95% (non-condensing), and air pressure 16.5kPa ~ 106kPa, in a well-ventilated area without caustic gas. The original packaging should be used for return shipments.
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