SYREBO SY-HRC11 User Manual

Soft rehabilitation glove

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Soft Rehabilitation Glove

SY-HRC11 User Manual

Version: V1.0

Issuance Date: 17/3/2021

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Summary of Contents for SYREBO SY-HRC11

Page 1 Soft Rehabilitation Glove SY-HRC11 User Manual Version: V1.0 Issuance Date: 17/3/2021...
Page 2 Contact Information Manufacturer: Shanghai SiYi Intelligent Technology Co.,Ltd. Address: East Area Of Floor 5,No.26,Lane 3399,Kangxin Road,Pudong New Area,Shanghai, China,201321 Tel: 008617317983724 Country of Origin: China Website: http://siyizn.com E-mail: info@siyizn.com Name: MedPath GmbH Add: Mies-van-der-Rohe-Strasse 8, 80807 Munich, Germany Tel: +49(0)89 189174474 Fax: +49(0)89 5485 8884 E-mail: info@medpath.pro...
Page 3: Important
Important Descriptions on the Environment of Use This product is a common device that can run continuously (enclosed device without the ability to prevent liquid from entering), and it cannot be used in the presence of a mixture of flammable anesthetic gas and air or a mixture of flammable anesthetic gas and oxygen or nitrous oxide.
Page 4: Contact Information
Notification Before using the Soft Rehabilitation Glove, please read this manual carefully to have a clear understanding of its functions and operations. Keep this manual handy so that it can be referred to whenever needed. Follow the operating procedures and usage described in this guide. Do not modify the device, replace any parts, use non-specified parts, or remove protection devices, as these actions could result in a hazardous situation.
Page 5 General Cautions Do not use the device if users are distracted or not paying attention to the operation of the glove. This product is contraindicated in the following people: 1) Patients with severe disturbance of blood circulation; 2) Patients with comminuted fracture or bone cancer; 3) Patients with burn injury, bleeding condition, suppuration or uncontrollable infectious diseases;...
Page 6 2) Do not expose it to direct sunlight or high temperature; 3) Do not expose it to high humidity; 4) Do not store it in a place with intense vibration; 5) Do not store it in a place where children or pets can reach. Working environment: Temperature, +5℃~+40℃;...
Page 7: Table Of Contents
Content Contact Information..........................2 Important............................. 1 Disclaimer............................1 Notification............................2 1. Introduction............................. 7 1.1 About this User Manual......................7 1.2 Glossary and Abbreviations....................7 2. System Description......................... 8 2.1 Intended Use..........................8 2.2 Applicable Locations......................8 2.3 Indications..........................8 2.4 Contraindications........................8 3. Symbols used in this User Manual....................10 4.
Page 8 13. Warranty............................25 12.1 Service Support......................... 25 14. Packing List..........................25 Appendix A............................26 SY-UM-01...
Page 9: Introduction
Introduction 1.1 About this User Manual This User Manual provides the information necessary to operate the Soft Rehabilitation Glove. PLEASE READ THIS USER MANUAL BEFORE OPERATING the glove. If any part of this User Manual is not clear, contact Customer Support for assistance. 1.2 Glossary and Abbreviations Table 1.1 Glossary and Abbreviations The current method to operate the Soft Rehabilitation Glove system,...
Page 10: System Description
System Description 2.1 Intended Use The soft rehabilitation glove is suitable for rehabilitation training of patients with finger joint dysfunction. 2.2 Applicable Locations The device can be used in institutions engaged in rehabilitation, including hospitals, rehabilitation centers or clinics, community-based rehabilitation centers and elderly-care institutions, Patients can also use it at home.
Page 11 • A patient during menstruation or pregnancy; • A patient with heart diseases and implanted with pacemaker and other medical electronic devices. Note: In case of abnormal hand muscle tension or severe hand swelling, pain and other discomfort during training, please contact the attending doctor or rehabilitation physician in time, and stop using the soft rehabilitation glove immediately if necessary.
Page 12: Symbols Used In This User Manual
Symbols used in this User Manual Table 3.1 Symbols Description Symbol Warning! Please refer to the document attached! General warning symbol Do not discard with household waste Information about the manufacturer of the device Follow the user manual Shutdown button Caution! Please read the operating instructions carefully! Frangible Upward...
Page 13 Protected from rain Protected from direct sunlight Protected from radiation Serial number Authorized representative in the E.U use by Type B applied part date of manufacture Medical device CE Marking SY-UM-01...
Page 14 Electrical safety classⅡ SY-UM-01...
Page 15: System Components
System Components This section describes various components of the Soft Rehabilitation Glove system. (See Fig. 4.1~Fig. 4.7 ). 4.1 Host Components of host: (1) display space; (2) buttons area; (3) data interface; (4) Power interface; (5) Charge interface 4.2 Rehabilitation gloves Components of power-assisted rehabilitation gloves: (1) Non-indentation fabric;...
Page 16: Dg01 Data Gloves
4.3 DG01 Data Gloves Components of data gloves: (1) Sensor; (2) Hyper-elastic lycra fabric; (3) Collection plate 4.4 Charger and Data Line Components of adapter: (1) DC plug; (2) Power plug SY-UM-01...
Page 17: System Features
System Features This section explains the features of the Soft Rehabilitation Glove system. 5.1 Working Mechanism The working mechanism of the soft rehabilitation glove is described as below. The control module of the glove issues a control instruction according to the parameters set by the operator in advance, to realize the bending and stretching movements of the power-assisting rehabilitation glove through the positive and negative pressure switching of the pneumatic driving technology, thus to drive the joints for rehabilitation training.
Page 18: Instructions On Use And Installation
Instructions on Use and Installation 6.1 Preparation before Use （1） Take out all parts from the box, confirm the absence of any abnormal conditions such as breakage or missing, and place them on a horizontal and vibration-free desktop; （2） Connect the air supply plug of Rehabilitation gloves with Rehabilitation interface on the side of the host;...
Page 19: Glove Size
6.3 Glove Size Hand Length Hand Width Size Height (cm) (mm) (mm) >178 190~210 85~89 156~178 162~190 78~85 140~156 135~162 60~78 <140 90~135 50~60 Other sizes are available through customization SY-UM-01...
Page 20: Descriptions On Product Training Functions
7. Descriptions on Product Training Functions The functions and operation steps in this Manual are described according to full functions, some of which are not universally applicable to all types of products. For detailed information on model configurations and functions, please refer to the descriptions specific to the product model or seek advices from Shanghai SiYi Intelligent Technology Co., Ltd.
Page 21 Rest: The rest icon lights up when the patient train too much. To avoid overtraining, the patient can train again after the countdown is over. Passive training: lights up the icon in the passive training. Mirror training: lights up the icon in the mirror training. Active training: lights up the icon in the active training.
Page 22: Passive Training
7.2 Passive training Long press the power button “ ”on the host for 2s. After the host is turned on, the five fingers of the pneumatic rehabilitation gloves will be stretched out. Then the patient puts on the rehab glove and click the passive training button“ ”.
Page 23: Active Training
”on the host lights on. Open the Syrebo app on the mobile phone and follow the prompts to connect to the host (Bluetooth needs to be turned on, and some mobile phones need to turn on GPS at the same time), and perform active training on the affected hand according to the prompts in the app.
Page 24: Trouble-Shooting
Trouble-Shooting This section includes a guide to troubleshooting various operational incidents, describes the symptoms and gives an explanation of how to fix them if these occur. 8.1 The movement range of power-assisted rehabilitation gloves is obviously reduced or there is no movement at all: Check whether the joint between glove and host is damaged;...
Page 25: Cleaning And Maintenance
Cleaning and Maintenance 9.1 Cleaning and Maintenance （1） Host: After the host is powered off, wipe its external surface with a fine fiber cloth moistened with water and wrung out, pay attention to avoid water entering the host, and prohibit the use of corrosive liquid to clean the product; （2）...
Page 26: Repair Policy
Repair Policy Shanghai Siyi Intelligent Technology Co., Ltd. is the only organization that can determine and confirm whether the products are within the warranty scope. The host is guaranteed or could be replaced free of charge within one year from the date of purchase if it has been found with any manufacturing or assembly defect;...
Page 27 13.Warranty 12.1 Service Support If the device needs repair, contact Shanghai SiYi Intelligent Technology Co.,Ltd. or the local distributor for Warranty details. If the device needs to be shipped, pack the device and its accessories carefully to prevent shipping damage. Always transport the device in the original shipping container. 14.Packing List Detail HR-C11...
Page 28 Appendix A roduct Cable Information Max. cable length, Cable Number Cable classification Shielded/unshielded AC Power Line 1.8m shielded 1 Set AC Power Important information regarding Electro Magnetic Compatibility (EMC) This electrical medical equipment needs special precautions regarding EMC and put into service according to the EMC information provided in the user manual;...
Page 29 b) WARNING: This equipment has been tested for radiated RF immunity only at selected frequencies, and use nearby of emitters at other frequencies could result in improper operation”; and c) Following frequencies and modulations are used to test the immunity of the equipment. Selected Frequency Emitter Frequency Range...
Page 30 EMI Compliance Table (Table 1) Table 1 - Emission Phenomenon Compliance Electromagnetic environment CISPR 11 Professional healthcare facility environment and RF emissions Group 1, Class A Home healthcare environment IEC 61000-3-2 Harmonic distortion Professional healthcare facility environment Class A Voltage fluctuations IEC 61000-3-3 Professional healthcare facility environment and flicker...
Page 31 Table 3 – Proximity fields from RF wireless communications equipment Immunity test levels Test frequency Band (MHz) (MHz) Professional healthcare facility environment 380-390 Pulse modulation 18Hz, 27V/m 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m 704-787 Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m 1720 1845...
Page 32 0% U ; 0.5 cycle At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º 0% U ; 1 cycle Voltage dips IEC 61000-4-11 70% U ; 25/30 cycles Single phase: at 0º Voltage interruptions IEC 61000-4-11 0% U 250/300 cycles Table 5 –...