Instruction for Use Wireless dynamic multi-parameter holter Shenzhen Viatom Technology Co., Ltd.
Content 1. Introduction......................................................................... 1 2. Product introduction............................................................ 6 3. Preparation before use......................................................... 9 4. How to use.........................................................................10 5. Care and maintenance....................................................... 23 6. Attachment list.....................................................
1. Introduction Thank you for purchasing a wireless dynamic multi-parameter holter (hereinafter referred to as: holter). This manual describes the purpose, function and safe use of the equipment. Before using this equipment, please read carefully and fully understand the contents of this manual to ensure the correct use of this equipment and the safety of patients and operators.
immediately. If you have a pacemaker in your body, we do not recommend that you use this device. Follow your doctor’s advice if necessary. This equipment cannot be used simultaneously with defibrillators and electrosurgical equipment. This equipment cannot be used during CT or MRI. When using this equipment, please stay away from equipment that generates strong electric and magnetic fields.
The user should try to avoid sweating, as sweat will affect the contact between the ECG electrodes and the skin and affect the quality of the measurement. Do not participate in strenuous or extensive physical activities in order to conduct proper monitoring. In order to measure pulse oximetry and pulse rate more accurately, the device should be used in a quiet and comfortable environment. The measurement results of this equipment cannot distinguish all diseases.
saturation of functional hemoglobin. The following factors may reduce performance or affect the accuracy of pulse oximetry measurements: -The surrounding environment is too light -The sensor type is incorrect -Excessive movement -Moisture in the sensor -High frequency electrosurgical interference -Improper use of sensors -Blood flow restrictor -Weak pulse or poor signal Waste (including the scrapped equipment itself) shall be treated in accordance with relevant laws and regulations.
Indicates the item is a medical device Follow Instructions for Use. Type CF applied part IP22 Dustproof and waterproof grade Non-Ionizing Radiation Indicate separate collection for electrical and electronic device (WEEE).
Authorized representative in the European Community 2. Product introduction 2.1 Product name and model Product name：Wireless dynamic multi-parameter holter Product model ： M5, M12, Lepod, Lepod Pro, LMT-5 and LMT-12.
Softwa re release version Shell color V1 V1 V1 V1 V1 V1 Black Black White White Blue Blue Note 1: ● indicates that this function is available, × indicates that this function is not available, and △ indicates optional function. Note 2: The model you purchased may not have all the above functions, please refer to the actual model purchased. 2.
2.3 About holter Figure 1 1. On/Off button: Used to turn on and turn off the device. You can switch the ECG lead channel. 2.ECG interface/charging interfacev: Used to connect the ECG cable, and used to connect the charging cable. 3. Display: Used to display information such as time, battery and ECG waveform. 4. Lanyard hole: Used to install the lanyard. 5. Body temperature/blood oxygen interface: When measuring body temperature, it is used to connect body temperature cable.
6. Electrode buckle: When wearing measurement, the device can be fixed. 2.4 Product structure and composition It consists of a host, corresponding accessories (cardiog cable, charging data cable), multi-parameter data management software and optional accessories (blood oxygen probe, body temperature probe, chest strap). 3. Preparation before use 3.1 Unpacking inspection Before unpacking, please check the packing box carefully.
disposal system and place the packaging materials out of the reach of children. The equipment may be contaminated by microorganisms during storage, transportation and use. Please confirm whether the packaging is intact before use, especially the disposable accessories. If any damage is found, please do not use it. The production date and expiration date of the product are shown on the label. 3.2 Turn on and turn off The button screen lights up and the device turns on.
Use only the cables and other accessories specified in this manual. Ensure the integrity of the packaging of the purchased disposable ECG electrodes. If the packaging is damaged, please discard it directly. Non-grounded equipment next to the patient and interference from electrosurgery can cause waveform instability. If the ECG electrodes are dirty, please clean them with a soft cloth or cotton swab moistened with alcohol. 4.2 ECG lead wire, temperature probe and blood oxygen probe placement A.
the blood oxygen probe must be in direct contact with the finger skin, and the temperature probe In close contact with the underarm skin. Caution： It is recommended to use it under the guidance of professional medical staff. It is recommended that a person with professional medical training place the ECG lead, chest strap, temperature probe and blood oxygen probe. The correct pretreatment of the patient’s skin is essential to obtain a good ECG record.
Front reference image for twelvelead placement Side reference image for twelve -lead placement Six-lead placement reference diagram 13 Five-lead placement refere nce diagram
Three-lead placement reference diagram Table 1 Lead Color Body surface position (common name) 12-lead electrode cable RA White Intersection point between the midline of the right clavicle and the second rib (right arm) LA Black The intersection of the left midline of the clavicle and the second rib (left arm) RL Green Right lower abdomen (right leg) LL Red Left lower abdomen (left leg) V1 Red Thoracic lead V1: the fourth 14
intercostal space at the right edge of the sternum V2 Yellow Thoracic lead V2: the fourth intercostal space at the left edge of the sternum V3 Green Chest lead V3: midway between V2 and V4 V4 Blue Thoracic lead V4: midclavicular line at the fifth intercostal space V5 Orange Chest lead V5: at the front axillary line, at the same level as V4 V6 Purple Chest lead V6: at the mid-axillary line, at the same level as V4 and V5 6 lead electrode cable RA White Intersection point between the midline
V1 Red Thoracic lead V1: the fourth intercostal space at the right edge of the sternum V5 Orange Chest lead V5: at the front axillary line, at the same level as V4 5 lead electrode cable RA White Intersection point between the midline of the right clavicle and the second rib (right arm) LA Black The intersection of the left midline of the clavicle and the second rib (left arm) RL Green Right lower abdomen (right leg) LL Red Left lower abdomen (left leg) V1 Red Thoracic lead V1: the fourt
LA Black The intersection of the left midline of the clavicle and the second rib (left arm) LL Red Left lower abdomen (left leg) The user can use the chest strap to fix the holter to record ECG, respiration rate and body temperature. C.Spo2 probe placement The pulse oximetry probe is a precision measurement component, and its use must be measured in accordance with the regular methods and procedures. If your operation method is wrong, the probe may be damaged.
The temperature probe provided is a body surface probe. When using it, please stick the metal patch part of the body surface probe on the patient's body surface, such as the armpit. If you need to detect the patient's temperature, please attach the temperature probe to the corresponding measurement site of the patient, and connect the other end to the temperature/blood oxygen interface.
ECG holter, paste the electrodes according to Table 1, after the lead is successful, start the measurement and save the ECG data; 2）Body temperature measurement: When measuring the ECG, the body temperature can be measured; after connecting the body temperature cable, the holter will automatically save the body temperature data.
the power button to switch the ECG waveform of different lead types. Note: a. The ECG electrode pads must be adhered closely to the skin. b. If the skin where the electrode pads are applied is dry or hairy, please wipe the skin with a damp cloth or clean the hair before the measurement. c. When measuring, try not to make large movements, which may affect the ECG signal acquisition. 4.3.
After the measurement is over, the data measured in the holter can be transmitted to the PC or mobile device software for viewing via USB data cable or Bluetooth.
charging cable. The specific steps of charging are as follows: 1. Connect the host through the charging cable. As shown below. 2. Connect the charging cable to the USB interface with 5V output voltage for charging. After entering the charging state, the screen displays the charging icon. Figure 2 Caution: The laptop should meet the requirements of IEC60950 and IEC60601 standards. A separate charging cable cannot constitute a medical device. For your safety, please follow the steps to charge.
5. Care and maintenance 5.1 Repair Caution This equipment must be repaired by a designated after-sales service center, otherwise the warranty rights will not be enjoyed. Under the premise of proper maintenance, the expected service life of this equipment is 5 years. 5.2 Warranty During the warranty period, equipment use problems caused by product material defects can provide free warranty. The warranty is only for end users.
Do not expose the host to high temperature environments, such as ovens, water heaters and microwave ovens. The battery may explode if overheated. Do not contaminate or modify the battery. Otherwise, it may cause battery leakage, overheating, fire or explosion. If the battery leaks, please keep your skin and eyes free from the leakage of the liquid. If your skin or eyes come into contact with the leaked liquid, please rinse your skin or eyes immediately and go to the hospital for treatment.
Medical alcohol (75% concentration) Caution The power must be turned off before cleaning the holter. When cleaning the monitor, only wipe the outer periphery of the connector, not the inside. Never use abrasive materials. Do not let any liquid enter the case, and never immerse any part of the holter in the liquid. Do not leave any cleaning fluid on any part of the surface of the holter. Do not autoclave the accessories. Do not use a damaged holter.
5.6 Question answer Question The device cannot perform normal collection The ECG waveform is disordered and the clutter is large Cause Solution 1. Low battery 1. Please charge the device 2. Equipment 2. Please contact your local damage agent 1. Incorrect wearing 1. Please re-wear according style to the instructions 2. Expired ECG 2.
2. Excessive finger 2. Keep the measuring part movement still 1.Incorrect Pulse rate value is not displayed placement of fingers 2. Fingers or hands are moving 6. 1. Re-insert the finger 2. Try to keep calm and re-measure Attachment list No.
8 Chest strap (optional) 1 * If the user purchases disposable ECG electrode pads, he must purchase a product that meets the long-term Holter use and has a medical device registration certificate. * The above attachments are for reference only, please refer to the actual attachments. Caution Only use the accessories specified in this manual, using other accessories may damage the device. Check whether the single-use ECG electrodes are expired before use.
Appendix A Specifications Classification Protection against electric Internal power supply shock Application part protection against electric CF type shock Environment Transport Work temperature and storage 5 ~ 40°C -25 ~ 55°C 10% ~ 95% 10% ~ 95% Relative humidity (non-condensing ) Atmospheric 700 pressure hPa ~ 29 1060 700 ~ 1060 hPa
Waterproof and dustproof IP22 Power supply Battery Type Rechargeable lithium polymer battery Battery 3.8Vdc, 400mAh specifications Battery runtime 72 hours (under full state) Charging 4.5 ~ 5.5V DC voltage input voltage range Charging time 2 hours (to over 90% battery) ECG Lead 3 leads, 5 leads, 6 leads, 12 leads input resistance ≥50MΩ，10Hz Input signal range Common mode rejection ratio 10mV（p-v） ≥120dB Bandwidth 0.
Heart rate Measuring range Measurement error Resolution 30 ~ 250 bpm ±2bpm ， ±2%，Whichever is larger 1 bpm Body temperature Mode Direct mode Measurement site REFERENCE BODY SITE Display range Axilla Resolution 0.1℃ Maximum allowable error Axilla 25.0℃ ~ 45.0℃ ±0.
Measuring range 0rpm～150rpm measurement ±2rpm or ±2% of the measured accuracy value, whichever is greater. Blood oxygen Blood oxygen range 70%～100% Blood oxygen Within the range of 70%～100%, accuracy the accuracy should be ±2%. Pulse rate range 30bpm～250bpm Pulse rate accuracy Wavelength ±2bpm or ±2%, whichever is greater Red light: 600nm, infrared light: 940nm Maximum optical output 0.8mW/1.
Modulation type GFSK modulation Effective -20dBm-+8dBm radiated power Dimensions 48.2mm×48.2mm×15.
Appendix B Electromagnetic compatibility The device meets the requirements of IEC 60601-1-2. Warnings and Cautions • This device should not be used in the vicinity or on the top of other electronic equipment such as cell phone, transceiver or radio control products. If you have to do so, the device should be observed to verify normal operation.
Recommended separation distances between portable and mobile RF communications equipment and the A&D unit The model Wireless dynamic multi-parameter holter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Recommended separation distances between RF wireless communications equipment The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between RF wireless communications equipment and the device as recommended below, according to the maximum output power of the communications equipment.
2450 2 0.3 28 28 0.2 0.3 9 9 5240 5500 should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: 5785 Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Portable and mobile RF communications equipment should be used no closer to any The Conducted RF IEC61000-46 Radiated RF IEC61000-43 3Vrms 150kHz to 80MHz 10V/m 80MHz to 2.7GHz model recorder, N/A than part Dynamic including of ECG cables, the recommended separation distance calculated from the equation applicable to the 10V/m frequency of the transmitter. Recommended separation distance 80MHz to 800MHz 800MHz to 2.
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than compliance level in each frequency range b a the Interference may occur in the vicinity of equipment marked with following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 a MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
Electrical fast transient/ burst IEC 61000-4-4 Surge IEC61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 ± 2 kV for power supply lines ± 1 kV for input/ output lines ± 1 kV line to line ±2 kV line to earth 0% UT 0,5cycle At 0°,45°,90°,135°,18 0°,225°,270°and 315°, n.a. n.a. n.a. n.a. n.a. n.a.
Wireless dynamic multi-parameter holter Shenzhen Viatom Technology Co., Ltd 501, Building B, Ganghongji High-tech Intelligent Industrial Park, No.1008 Songbai Road, Xili Street, Nanshan District, Shenzhen, 518055, Guangdong, P.R. China www.viatomtech.com MedNet GmbH Borkstrasse 10 , 48163 Muenster,Germany TEL: +49 251 32266-0 FAX: +49 251 32266-22 Version: A Contents of this manual are subject to changes without prior notice. ©Copyright 2018 Shenzhen Viatom Technology Co., Ltd. All rights reserved.
FCC Warnning: FCC ID:2ADXK-8100 Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: This device may not cause harmful interference, and this device must accept any interference received, including interference that may cause undesired operation.
