- Lead Holter User manual Model : VSH101 Please read the instruction manual carefully and follow the instructions before use.
E01-0002-T01 VS-WI-001-016 V1.0 Important safety instructions ◼ Warning 01. The record and interpretation of this product is only for clinical evaluation and reference, and cannot be directly used as the diagnosis result. Please consult a doctor for advice. 02. Before using this product, please confirm that the equipment indicator lights in the environment can be clearly identified and operated. 03. When using this product, please use the special "ECG patch" of this product.
5 E01-0002-T01 VS-WI-001-016 V1.0 ◼ Matters needing attention 01. Please read the manual carefully before using this product. 02. During the period of using this product, users can carry out general daily life activities, but do not use it during high-intensity exercise (such as marathons, etc.). A lot of sweat on the surface of the skin may cause the ECG patch of this product to deteriorate or fall off, which will affect the accuracy of signal measurement. 03.
E01-0002-T01 VS-WI-001-016 V1.0 Table of Contents Product Introduction ........................................................................................................................2 Product description ...................................................................................................2 Scope of product application ....................................................................................2 Intended use of the product .....................................................
2 E01-0002-T01 VS-WI-001-016 V1.0 Product Introduction ◼ Product description The ECG signal is collected by the sensor, the device processes and calculates the signal, and the analysis can obtain the ECG data. Finally, the data is wirelessly transmitted to each functional module of the mobile phone APP for display through Bluetooth. This 1-lead Holter monitor complies with the international standard IEC-60601-2-47.
3 E01-0002-T01 VS-WI-001-016 V1.0 Product content ◼ Product appearance * The illustrations used in this manual may be slightly different from the appearance of the actual product. ◼ The main contents of the package Equipment Description 1-Lead Holter 【Host】 Applicable ECG patch Remark : The ECG patch is a consumable, repeated use may cause skin irritation or affect the accuracy of signal measurement. VitalSigns Technology Co.
4 E01-0002-T01 VS-WI-001-016 V1.0 Equipment Description Micro-USB Cable * The illustrations used in this manual may be slightly different from the appearance of the actual product ◼ Host charging method 1. 2. Please combine the MICRO-USB cable with the charging terminal of the 1-lead Holter recorder. Please plug the other end into the USB charger interface。 3. When the indicator light is off, it means charging is complete（100%）. Reminder: The device is not allowed to be used while charging.
5 E01-0002-T01 VS-WI-001-016 V1.0 ◼ VSH101 How to turn on and turn off the host Instruction Long press the host Boot up Close up 1-lead Holter Remark “power button” 3 second Indicator light Indicates that the device has been turned Flashing green on successfully Long press the host “power button”3 second Indicator light Turn off the off state Indicates that the device has been shut down successfully VitalSigns Technology Co.
6 E01-0002-T01 VS-WI-001-016 V1.0 Instructions ◼ Preparations before use Please perform the following steps before using this product： 1. 2. 3. ◼ Please charge the 1-lead Holter recorder to 100% at first. Please install the exclusive application app on smart devices (such as smart phones and tablets). Please follow the instructions on the app to complete the registration and related initial settings.
7 E01-0002-T01 VS-WI-001-016 V1.0 2. Host and APP connection I. When the host is turned on, the Bluetooth function of the host will be turned on automatically. II. After the user opens the APP on the smart device, please make sure that the Bluetooth of the device is turned on, and set the connection to the host on the APP. III. Wait for the indicator light of the host to be steady blue, indicating that the connection is successful. VSH101 Boot up Connect 3.
8 E01-0002-T01 VS-WI-001-016 V1.0 Please keep the distance between the host and the smart device within 10 meters. Too far or too much shielding may affect the Bluetooth transmission function. II. The recording time of each piece of data takes 5 minutes. If the host is removed within 5 minutes of starting the measurement, the piece of data has no reference significance. III. After the host is close up, the APP on the smart device will automatically disconnect from the host. I.
9 E01-0002-T01 VS-WI-001-016 V1.0 Project Specification and description ⚫ ⚫ LED display ⚫ Boot up : Press and hold the main unit " power button " for 3 seconds, the indicator light flashes green, indicating that the device has been successfully powered on. Connection : Please start the APP, turn on the Bluetooth function on the smart device and set up the connection with the host. The indicator light is steady blue, indicating that the device has been successfully connected.
10 E01-0002-T01 VS-WI-001-016 V1.
11 E01-0002-T01 VS-WI-001-016 V1.0 Troubleshooting Problem The host cannot be turned on Host cannot connect The pairing between the smart device and the host is abnormal ECG data disappeared Reason The battery voltage is too low, causing the machine to fail to turn on. The connection fails continuously, the transmission distance between the host and the smart device has exceeded the upper limit, or there is a shielding that causes the connection to be abnormal.
12 E01-0002-T01 VS-WI-001-016 V1.0 Problem Reason Solution ⚫ The recorded waveform has a lot of noise ⚫ It means that there is interference to the signal during the measurement. The interference may come from poor contact of the ECG patch, ⚫ excessive body movement, and strong electromagnetic interference in the environment... etc. ⚫ VitalSigns Technology Co., Ltd Make sure to use a new ECG patch and the correct electrode sticker installation method.
13 E01-0002-T01 VS-WI-001-016 V1.0 ◼ ◼ 1-lead Holter cleaning method Item Cleaning method 1-lead Holter Wipe with dry cloth ECG patch The ECG patch is a consumable, if it needs to be replaced, the user can purchase it by himself Micro-USB Cable Wipe with dry cloth ECG patch Users can contact Vital Signs Technology Co., Ltd. or go to medical equipment stores to purchase ECG patches approved by the Ministry Of Health And Welfare. The specifications of the ECG patch are as follows, 1.
14 E01-0002-T01 VS-WI-001-016 V1.0 ◼ Chassis label illustration VSH101 Reference Description National Communications Commission Inspection certificate number : CCAN21LP0310T2 ISO 7010-M002 Please refer to instruction manual / booklet IEC 60417-5333 BF type body parts This product has passed IEC 60601-111 certification. 4: Isolate most wires from extending in and small sharp-pointed tools, or ants, etc. from crawling in.
