Gima PM10 Palm ECG Monitor

Chapter 1: Notice

1.1 Indication for Use

The PM10 is a handheld, personal electrocardiograph for measuring heart electrical activities. It allows manual recording of transient cardiac events, suitable for home health care. It can detect, display, and store ECG signals, providing average heart rate. It is intended for adult users monitoring their heart condition or those with cardiovascular diseases. It serves as a healthcare tool to provide data references for doctors, not a conventional diagnostic tool.

1.2 Generic Notice

• Do not use in high temperature or humidity locations (operate between 5-40°C and 25-80% RH).
• Do not wash the device with water.
• Allow up to 30 minutes for temperature acclimatization.
• Avoid use or storage near fires, open flames, strong vibration, or strong electromagnetic fields.
• Do not disinfect in an autoclave or gas sterilizer.
• Do not use if you have skin allergies or skin damage.
• The device has a service life of 3 years. Dispose of according to local laws.
• Responsible organizations must contact local authorities for biohazardous part disposal.
• Do not connect multiple wireless devices simultaneously.
• The device has no contraindications.
• ECG parameters must be interpreted by a professional physician.
• Do not use on infants weighing less than 10 kg.

1.3 Measurement Notice

• If skin is dry, use disinfectant alcohol or electric salve to improve conductivity.
• Sit comfortably, relax, and begin measurement when heart rate is stable.
• Ensure finger and chest electrodes have firm, round, and good contact with the skin.

1.4 Safety Notice

• No ECG data sampling occurs during battery charging. A charging symbol will appear, and the device cannot be operated while charging.
• Store the device in a cool, shady environment when not in use for extended periods, and charge it every three months.
• Do not use the device in environments with flammable objects like anesthetics.
• Connected equipment must meet national safety standards.
• Conductive parts of electrodes and connectors (Type BF applied parts) should not contact other conductive parts, including earth.

1.5 EMC Notice

• Be aware of Electromagnetic Compatibility (EMC) effects from portable or mobile RF devices.
• Installation and service must follow accompanying documents.
• Keep portable and mobile RF communication equipment at a recommended distance 'd' from the device, calculated based on IEC 60601-1-2:2014 standards.

1.6 RF Instruction

This device complies with FCC Part 15. Operation is subject to two conditions: (A) it must not cause harmful interference, and (B) it must accept any interference received. Unauthorized modifications void the user's authority. Use the equipment at least 20 cm away from other electronic devices to avoid interference. The device is designed to comply with FCC limits for radio frequency (RF) energy exposure. It has been tested and found to comply with Class B digital device limits, providing reasonable protection against harmful interference in residential installations. If interference occurs, try reorienting the antenna, increasing separation, connecting to a different circuit, or consulting a technician.

A minimum separation distance of 0.2 m must be maintained between the equipment and persons for RF exposure compliance.

1.7 Quality of Service and Security

The device ensures timely, reliable, accurate, and secure data and wireless information transfer through its design. Correct communication instructions are required for wireless connection, preventing unauthorized access to ECG data.

1.8 Intended Operator

A layperson is intended to operate this device, provided they can read and understand the manual and distinguish anatomical sites (chest, palm, upper/lower extremity).

Chapter 2: Introduction

The portable ECG monitor is designed for family and individual users to help prevent cardiovascular disease. It records and displays ECG waveforms and heart rate easily and conveniently anytime, anywhere.

2.1 Characteristic

• Handsome shape, handy operation, and convenient portability.
• Records real-time heart rate anytime, anywhere.
• Built-in rechargeable lithium battery provides over 200 ECG waveforms on a single charge.
• Measures QRS intervals and VEB (Ventricular Extrasystole).

2.2 Application

• Occasion: Family, medical clinics, and hospitals. Not for general clinical examination.
• Object: Individuals under high pressure, those with heart disease, middle-aged and elderly people, and those concerned about sub-health.
• Purpose: Primarily for heart rate recording with simple operation and minimal personnel requirements.

Chapter 3: Primary Technical Orders

3.1 Normal Work Environment

• Operation: Temperature +5°C to +40°C, Relative humidity 25% to 80%, Atmospheric pressure 70 kPa to 106 kPa, Power supply 3.7 V rechargeable lithium battery.
• Transportation/Storage: Temperature -40°C to +55°C, Relative humidity ≤95%, Atmospheric pressure 50 kPa to 106 kPa.

3.2 Basic Parameters

• Leads: Standard 3 leads (I, II, III).
• Calibration Voltage: 1 mV ±5%.
• Standard Sensitivity: 10 mm/mV ±5%.
• Amplitude Frequency Characteristic: 1 Hz to 20 Hz (+0.4 dB, -3 dB).
• Noise Level: ≤30 μV.
• Input Impedance: ≥50 MΩ.
• CMRR: ≥60 dB.
• Scanning Speed: 25 mm/s ±5%.
• Sampling Rate: 250 dots/s.
• HR Measurement Range: 30 bpm to 300 bpm (error ±1 bpm or 1%).
• Battery Voltage: DC 3.7 V.
• Protection Against Electric Shock: Internal power device, Type BF applied part.
• Waterproof Degree: IP22.
• Display: 1.77” color TFT-LCD.
• Size: 100 mm (L) x 45 mm (W) x 15 mm (H).
• Weight: Approx. 60 g.
• Bluetooth Specifications: V4.0 (Classic and Low Energy), 2.4 GHz ISM band, GFSK modulation, Transmitting power <10 dBm (Class 1), Sensitivity -92 dBm, Transfer rate 1.5 Mbps, Safety features (Authentication, encryption), Support Services (SPP/IAP/HID/OBEX), Operating Range 2400 MHz – 2485 MHz.
• FCC ID: 2AB0GPM10.

Chapter 4: Operation Directions

4.1 The Sketch Map and Components Name

Refer to the manual's diagrams for component identification.

4.2 How to Use

Ensure electrodes have full skin contact. Measurement methods are illustrated in the manual.

4.3 Menu Operations

1. Start-up: Long press the ON/OFF key for 3 seconds. A beep sound and screen illumination indicate power on. The device remains idle when not measuring.
2. Start Measurement: After start-up, the device enters the pre-sample interface. Use the guided measurement method. The ECG waveform and heart rate will be displayed. The heart rate calculation formula is HR = 60000 / (Sum of R-R intervals / N). Once the waveform stabilizes, formal sampling begins, indicated by a countdown timer turning red. After sampling, the case review interface shows the start time and heart rate. The device stores up to 100 cases, overwriting the oldest first. Holding electrodes again will return to the sampling interface.
3. Battery Operation Notes: The device operates for over 2 hours on a full charge, with a battery cycle life of up to 200 times. Charging can be done via Micro USB cable connected to a computer or a 5V/500mA power adapter, taking about 2 hours. A charging symbol indicates charging status; the device cannot record ECG during charging. Battery display icons show power levels: full, 3/4, 1/2, 1/4, and low power (recommended recharge, auto shutdown).
4. Auto Power Off: The device shuts down automatically after 1 minute of inactivity.

4.4 PC Sync Software Operation and Communication

1. Intended Use: PC Management software allows parameter setting (language, acquisition types), downloading ECG data, and data management.
2. PC Software Download: Available from www.contecmed.com under DOWNLOAD Software.
3. Software Installation: Follow on-screen prompts (OK, Next, Browse for path, Install, Finish). Default installation path is "C:\PM10".
4. Data Communication: Connect the device via USB, turn it on, and click "New search" in the software to find the device. Device information (case ID, time length, check time, heart rate) is displayed in a list. Help is available via the "?" button.
5. Operation:
   • Download Case: Select one or multiple cases and click "Download selected" or "Download all".
   • Delete Case: Select cases and click "Delete selected" or "Delete all". Confirmation is required.
   • Firmware Upgrade: Click "Upgrade", select the firmware file (.bin). Follow prompts for standard or forced upgrades. Maintain connection during the process.
   • Set Device Parameters: Language and sample time can be set via the interface.
6. System Requirements: The software supports WIN8/WIN10. Minimum hardware requirements for PC are detailed for both operating systems, including processor, screen resolution, memory, and hard disk space. For Windows 8 tablets, specific hardware configurations are also listed.

Mobile Application Operation and Communication

1. Intended Use: The mobile application downloads and displays case data from the PM10; it does not control the device or alter settings.
2. Mobile Application Download: Available from www.contecmed.com under DOWNLOAD Software (PM10SyncSoftwareLite_xxx.apk).
3. Software Installation: Install on Android phones. Not suitable for Apple systems.
4. Functions: Connect with PM10 via Bluetooth, download case data (date, time, duration, average heart rate), and display/store/review case data.
5. Data Communication: Start the software, turn on the device, and click "PM10" to search. Click "ALL" to display device information in a list.

Chapter 5: Trouble Shooting and Solution

Chapter 6: Maintenance & Transportation & Storage

6.1 Cleaning and Disinfecting

Turn off the device before cleaning. Use medical alcohol for disinfection and air dry, or wipe with a dry, clean cloth. Do not allow liquids to enter the device.

6.2 Maintenance

• Do not open the instrument case unless authorized by the company.
• All maintenance and upgrades must be performed by trained and authorized professionals.
• Prevent liquids from seeping into the device.
• Avoid violent shaking or impact.
• Do not place objects on the device to prevent screen damage.
• If storing for a long period, charge the battery fully every 3 months to prevent permanent damage.
• Do not maintain the device while it is in use.

6.3 Transportation and Storage

Transport the device using general means, avoiding shock, vibration, and moisture. Store in a well-ventilated room at temperatures between -40°C to +55°C, with relative humidity no more than 95%, and atmospheric pressure between 500 hPa to 1060 hPa, away from corrosive gases.

Chapter 7: The Explanation of Symbols

The device uses various symbols to convey information:

• [Instructions]: Follow instructions for use.
• [Type BF]: Type BF applied part.
• Pulse rate (bpm): Indicates heart rate measurement.
• [Bluetooth]: Bluetooth connectivity.
• [USB]: USB connection port.
• IP22: Protection rating against ingress of solid objects and water.
• [WEEE]: Waste Electrical and Electronic Equipment disposal symbol.
• % [Humidity]: Humidity limitation.
• [Atmospheric Pressure]: Atmospheric pressure limitation.
• CE: Conforms to European Union directives.
• 0123: Notified Body identification.
• [Serial Number]: Device serial number.
• [Date of Manufacture]: Manufacturing date.
• [Caution]: Read instructions (warnings) carefully.
• [Sunlight]: Keep away from sunlight.
• [Cool/Dry]: Store in a cool, dry place.
• [No MRI]: Do not use this equipment in MRI scan rooms.
• [Product Code]: Device product code.
• [This side up]: Indicates the correct orientation for handling.
• [Fragile]: Handle with care.

Chapter 8: Packing List

The package typically includes:

• 1 x Host (PM10 ECG Monitor)
• 1 x USB cable
• 1 x User Manual

Chapter 9: Electromagnetic Compatibility and Interference

The PM10 is designed to operate within specific electromagnetic environments. It complies with standards for electromagnetic emissions and immunity.

Electromagnetic Emissions

The PM10 uses RF energy internally, resulting in very low emissions unlikely to cause interference. It is suitable for use in all establishments, including domestic ones connected to a low-voltage power supply network.

Electromagnetic Immunity

The device is designed to be immune to electrostatic discharge (ESD) and power frequency magnetic fields within specified limits. Floors should be wood, concrete, or ceramic tile, with relative humidity at least 30% if synthetic materials are used. Mains power quality should be typical of commercial or hospital environments.

Radiated RF Immunity and Separation Distances

Portable and mobile RF communications equipment should be used at a recommended separation distance from the PM10 to prevent interference. These distances are calculated based on the transmitter's maximum output power and frequency, as per IEC 60601-1-2. For example, for a transmitter with 1W output power, the recommended distance is 1.17m for 80-800 MHz and 2.33m for 800-2.7 GHz. If the device exhibits abnormal performance, measures like reorienting or relocating it may be necessary.

Disposal

The product must not be disposed of with domestic waste. Users must bring it to a specific recycling point for electric and electronic equipment.

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.

Manufacturer: CONTEC MEDICAL SYSTEMS CO., LTD, No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE'S REPUBLIC OF CHINA.

Imported by: Gima S.p.A., Via Marconi, 1 - 20060 Gessate (MI) Italy. Contact: gima@gimaitaly.com, export@gimaitaly.com, www.gimaitaly.com.