GIMA Palm Ecg Monitor User Guide

: June 7, 2024
: GIMA

GIMA

GIMA Palm Ecg Monitor

product

Thank you very much for purchasing the PM10 Portable ECG Monitor.
This user manual introduces detail product information about its character, requirement, structure, performance, specification, appropriate methods of transportation, installation, usage, operation, repair, maintenance and storage, and safety measures of how to protect the operator and product. Please read details in the following chapters.
Please read the user manual carefully before using the product and strictly follow its regulations to operate. The user manual indicates the operations that users need to pay much attention to, that may lead to abnormality, or may danger to the device or human body during using. Our company will not response the security, reliability and performance for any abnormality or device and human body damage caused by not following this user manual to use, maintain and store, nor provide free service for any situations above.

Warning:

The reliability depends on whether users are following the operation and maintenance in the user manual or not.
Our company’s website: http://www.contecmed.com is the unique route for downloading APP software and PC software, also the updates of firmware, if user download software and firmware updates from other unauthorized channels , it will cause the risks associated with cyber security, our company will not take responsibility for the consequence it may cause.
All servicing and future upgrade to the device must be carried out by personnel trained and authorized by our company, and using the original fittings for maintenance. The schematic diagram and component list can only be provided to the service station or maintenance personnel designated by our company. No modification of this equipment is allowed.
User should be aware of life-circle of battery, discard the battery in accordance with local laws when the life-circle of battery expire.
MR-unsafe!
Do not expose the device to a magnetic resonance (MR) environment.
- The device may present a risk of projectile injury due to the presence of ferromagnetic materials that can be attracted by the MR magnet core.
- Thermal injury and burns may occur due to the metal components of the device that can heat during MR scanning.
- The device may generate artifacts in the MR image. The device may not function properly due to the strong magnetic and radiofrequency fields generated by the MR scanner.

This user manual contains proprietary information, which is protected by copyright. All rights reserved. Reproduction, adaption or translation, for any part of the manual without prior written permission, is prohibited.
Our company takes the responsibilities as follows:

To provide qualified products according to enterprise standard for users.
To provide services of installation, debugging and training according to the contract.
To provide one year warranty and product maintenance after warranty period according to the contract.
To respond user’s requests in time.

Chapter 1 Notice

Indication for Use

The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users, who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.
The product is not a conventional diagnostic tool.

Generic Notice

Do not use the device in locations subject to high temperatures or humidity. Use in the temperature within 5~40˚C and humidity within 25%~80% RH.
Do not wash the device with water.
Pre-set up time is within 30mins, at condition of:
• Warm from the minimum storage temperature until it is ready to use at ambient temperature of 20°C.
• Cool from the maximum storage temperature until it is ready to use at temperature of 20°C.
Do not use or store the device in the following ambient conditions:
• Near fires or open flames.
• Locations exposed to strong vibration.
• Locations exposed to strong electromagnetic fields.
Do not disinfect the device in autoclave or gas sterilizer.
Such as skin allergies or skin damage, do not use this device.
The device service lift is 3 years. Do not throw away the device and accessories when they can’t work. If the device needs to dispose, it should meet the local laws and regulations requirement.
lay responsible organization must contact its local authorities to Determine the proper method of disposal of potentially bio hazardous parts and accessories.
Please don’t use multiple wireless devices connected to the product at the same time.
This device is no contraindication.
The parameters displayed by ECG should be interpreted by professional physician.
Please don’t use the device for infants weighing less than 10 kg.

Measurement Notice

If your skin is dry, wipe them with disinfectant alcohol or electric salve to strengthen the electric capability.
You are better to comfortably sit, draw yourself up, begin to measure when the heart rate level off.
When measuring, the finger and chest electrodes should touch your skin exactly, roundly and well.

Safety Notice

No sampling in the battery-charging. (sampling means acquiring ECG data of patient in the designated anatomical areas.) When the battery is charging, the device will not record ECG. The following symbol will present on the use interface to remind the charging state, device cannot be operated in battery charging state.
Lay the device in shady and cool environment when you are not going to use it for a long period of time, and electrify per three months.
Do not use the device in the environment placed inflammables objects, such as anesthetic.
Other equipment connected with it must meet national safety standards.
That conductive parts of ELECTRODES and associated connectors for TYPE BF APPLIED PARTS including the NEUTRAL ELECTRODE, should not contact other conductive parts including earth;

EMC Notice

Please note the effect from EMC when using the device, because it can be influenced by portable or movable high electromagnetic compatibility RF devices.
This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS.
Wireless communications equipment can affect ME EQUIPMENT and should be kept at least a distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 800 MHz to 2,5 GHz column of Table 5 or Table 6 of IEC 60601-1-2:2014.

RF Instruction

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

A. This device may not cause harmful interference;
B. This device must accept any interference received, including interference that may cause undesired operation.

Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
Some electronic devices are susceptible to electromagnetic interference sent by this equipment if inadequately shielded. Please use this equipment at least 20 cm or as far as you can from TV set, radio and other automated office equipment so as to avoid interference.

This device is a radio transmitter and receiver. It is designed and manufactured not to exceed limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission (FCC) of the U.S. Government. These limits are part of comprehensive guidelines and establish permitted levels of RF energy for the general population. The guidelines are based on standards that were developed by independent scientific organizations through periodic and thorough evaluation of scientific studies. The standards include a substantial safety margin designed to assure the safety of all persons, regardless of age or health.

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

A. Reorient or relocate the receiving antenna.
B. Increase the separation between the equipment and receiver.
C. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
D. Consult the dealer or an experienced radio/ TV technician for help. A minimum separation distance of at least 0.2 m between this equipment and all persons shall be guaranteed to satisfy the RF exposure compliance.

Quality of Service and Security

The device assures timely, reliable, accurate, and secure data and wireless information transfer by the following design.
When you want to establish wireless connection with the portable ECG monitor, you must input correct communication instruction. Therefore, unauthorized access to the ECG data is prevent.

Intended Operator

Lay Person, with the following requirements:

Be able to read and understand the content in the user manual;
Be able to distinguish the following anatomic sites: chest, left /right palm, upper extremity and low extremity.

Introduction

The portable ECG monitor is designed for family and individual users. It is a good helper for family members to prevent from cardiovascular disease. The device can record and display user’s ECG waveform and heart rate anytime at anyplace with easy operation.

Characteristic

Handsome shape, handy operation, convenient tote.
Record real-time heart rate anytime and anywhere.
Built-in large capability rechargeable lithium battery, continuously sample 200 ECG waveform after charged once.
QRS intervals and VEB measurement

Application

Occasion: family, medical clinic and hospital. The device can’t be used as a general electrocardiogram for clinical examination.
Object: people under high pressure and workload for long time, heart disease patients, middle aged and aged people, sub-health people
Purpose: The device is only used for heart rate record. Operation method is simple and less requirement for the operating personnel.

Primary Technical Orders

Normal Work Environment

Operation environment
- Temperature: +5°C~+40°C
- Relative humidity: 25%~80%
- Atmospheric pressure: 70 kPa~106 kPa
- Power supply: built-in rechargeable lithium battery, voltage: 3.7 V
Transportation and storage environment
- Temperature: -40°C~+55°C
- Relative humidity: ≤95%
- Atmospheric pressure: 50 kPa~106 kPa

Basic Parameters

Lead: Standard 3 leads, I II III
Calibration voltage: 1 mV±5%
Standard sensitivity: 10 mm/mV±5%
Amplitude frequency characteristic: standard: 10 Hz; 1 Hz~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~300 bpm, error: ±1 bpm or 1%
Battery Voltage: DC 3.7 V
Type of protection against electric shock: Internal power device
Degree of protection against electric shock: Type BF applied part
Degree of waterproof: IP22
Display: 1.77” color TFT-LCD
Size: 100 mm (L)45 mm (W)15 mm (H)
Weight: about 60 g
Bluetooth specifications:
• Bluetooth protocol: Bluetooth V4.0,Classic and Low Energy
• Operating frequency: 2.4 GHz ISM band
• Modulation: GFSK (Gaussian Frequency Shift Keying)
• Transmitting power: <10 dBm, Class 1
• Sensitivity: -92 dBm at BER <.001 with DH5
• Transfer rate: 1.5 Mbps data throughput
• Safety features: Authentication and encryption
• Support Services: Bluetooth SPP/IAP/HID/OBEX
• Effective RF Radiated Power Output: <10 dB
• Operating Range: 2400 MHz – 2485 MHz
• Bandwidth of Receiving Section: 85 M
FCC ID: 2AB0GPM10

Operation Directions

The Sketch Map and Components Name

Operations

How to Use

There are several measurement methods as shown in the following pictures Use

Caution: You shall ensure that the electrode fully contact the skin.

Start-up
Long press the on/off key for 3 seconds, you will hear a beep sound and see the screen lighting. The device will keep level off when not measuring.

Start measurement
After start-up, the device will enter into pre-sample interface. Please use the correct measurement method as guided, the ECG waveform and heart rate will displayed on the screen, as shown in Figure 4.1.The calculation method of heart rate: number of heart beats without interference in ECG fragment is set as N, then the calculation formula of heart rate is as follows:
HR=60000/(Sum of R-R intervals during numbers(N) of heart beats/N )

When the waveform becomes stable, the device will start formal sampling automatically, sample time countdown on the bottom right corner begins until finished one time sample and the color of sample time turns to red. See Figure 4.2:

The device will enter into case review interface after completed sampling. Case review interface displays the sampling start time and heart rate. See Figure 4.3.

When the device enters into case review interface, it will display the latest sampled case. Click the button to review other cases information. The device can store 100 pieces of cases at most. If reaches to the limit, new stored case will cover the original case, the one that stored at the earliest, piece by piece.
The device will automatically turn to sampling interface to continue if the user holding the electrode at both ends again when the device is under the case review interface.

Battery Operation Notes
The device can continuously work for more than 2 hours when battery is completely charged. The cycle life of the battery up to 200 times.
Two method for charging:

Connect the device with a computer by using Micro USB cable, charging completed after about 2 hours.
Use a Micro USB to connect the device with a power adapter (output current >500 mA, 5 V), charging completed after about 2 hours.
when the battery is charging, the device will not record ECG. The following symbol will present on the use interface to remind the charging state, device can not be operated in battery charging state.

Auto power off:
The device will automatically shut down after no operations within 1 minutes.

PC Sync Software Operation and Communication

The intended use of PC software:
PC Management software is intended to be used as supportive software for portable ECG device, Functions include setting of device parameters (language setting and acquisition types setting, etc), downloading ECG data from portable ECG device, data management.
PC software Download:
Website: http://www.contecmed.com DOWNLOAD Software Users can operate in the PC synchronous software according to necessary, which including sample mode and time setting, upload case, case review, measurement, etc.
Software Installation
Run the setup software, and you can see a window as follows, Click the button “OK”.

Click the button “Next”, and the dialog box in Fig.4.6 shows up, then if you click “Browse…”, you can set the installation path, otherwise the default installation path is “C:\ PM10”. Click the button “Next” again, and the dialog box showed in Fig.4.7 shows up. Click “Browse…”, you can reset the apellation in Startup Menu folder, the default folder will be “PM10”.

Click the button “install”, and the software will be installed at the appointed position. When the installation finished, the dialog box showed in Fig.4.9 shows up.

Click “Finish” to end installation.

Data Communication
Start the software under the circumstance of no device connected, it will enter to the following interface shown as Figure 4.12.Turn on the device, insert to USB port, click “New search”, then the software starts to search the device, shown as Figure 4.13.

After searching, device information will be displayed in “List” form, including: cases ID, time length, check time, heart rate, shown as Figure 4.14. Click the button “?”, you can get help from the operation.

Operation

Download case: double-click a case selected to download, or select multi-case, then click “Download selected” to download these cases, or click “Download all” to download all cases.
Delete case: select a case or multi-case, then click “Delete selected” to delete the case selected, or click “Delete all” to delete all cases. To prevent mistake, before deleting, the system will prompt user, the system will delete the records after selecting “Yes”..
Firmware upgrade: click “Upgrade”, select a firmware (naming rules: file name_version.bin, for example: xxx_USB_Vxxx.bin). If the firmware needs to upgrade from low to high version, then click “OK”. Otherwise “Force Upgrade” should be selected firstly, then click “OK”. During upgrading, please keep connection state between the computer and the device.
Set device parameters: Languages and sample time can be set by user. The interface for setting success is shown as

PC management software can be operated in WIN8/WIN 10 operation system, hereafter list the requirements of hardware of PC to run WIN10/WIN 8 operation system

Hardware Specifications for the WIN 10 operation system

Processor: 1.0 GHz or faster
Screen: above 800×600 resolution
Firmware: UEFI 2.3.1, support safety start
Start memory: 2 GB(64 bit), 1 GB(32 bit)
Hard disk space: no less than 16 GB(32 bit), no less than 20 GB(64 bit)
Graphic card: support Direct X9 tablet
Hardware specification for WIN 8 operation system: Windows 8 PC (32 bit ,64 bit) 2 bit (×86)

The Explanation of Symbols

table

Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and electronic equipment.

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