Hand Rehabilitation Robot System SY-HR03E/SY-HR03G User Manual VER.O1SUB LTo Please Paste the ID Label Here SY-UMOt 1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. ‘This product may break down due tothe interference of electromagnetic waves from portable TV, radio transceiver, and electric toys, ete, Please keep it away from these products. Electromagnetic compatibility. This product should be kept away from the objects that can generate strong electromagnetic waves or noise, such as nuclear magnetic resonance equipment, microwave generator, and radiation equipment (e.g. X-ray machine, CT machine, etc.) ‘This product should be kept away from high-frequency surgical instruments, such as high-frequency electrotome, and mobile phone, ete. Intellectual Property ‘The intellectual property rights of this Manual and its coresponding products are owned by ‘Shanghai SiYi Intelligent Technology Co., Ltd. ‘This User Manual may not be copied, modified, translated or distributed by any person or ‘organization in any form without the written consent of Shanghai SiYi Intelligent Technology Co., Lid. PUTS ET Cog All contents in this manual are written in strict accordance with relevant national laws and regulations and the technical specifications of Shanghai SiYi Intelligent Technology Co., Lid., and have been strictly checked and ensured to be correct. Shanghai SiYi Intelligent Technology Co., Ltd, is not liable for any consequences caused by improper use. ‘Shanghai Si¥i Intelligent Technology Co., Ltd. has the right to change the contents and version number of this User Manual according to the changes of product specification and the software upgrades without prior notice, Issuance Date of the User Manual: November, 2020 Version of the User Manual: V3.0 Notification PLEASE READ THIS USER MANUAL BEFORE. OPERATING THE SYSTEM‘Training is mandatory. Use this document as a guide during training and as a reference after training. ‘This manual is not a substitute for taining. Plug and unplug the power supply with the normal procedure! Otherwise, it wil lead to serious injury or death! Do not plug and unplug the power supply with wet hands! Otherwise, it will lead to serious injury or death! Use the power supply as specified, otherwise it will cause fire or clectrie shock? The device must not be disassembled or repaired by non-professionals without permission, otherwise it will cause fire or electric shock! ‘The power must be disconnected before opening the casing of the host. When the casing is opened, the device cannot be used >| PPP PPP Pe ‘The power supply of the device is 100-220V, S0/60Hz, and the socket must be grounded. Before using the device, it is necessary to verify that the power supply voltage matches with the voltage value of the adapter, and the power supply needs to be grounded. Do not use the device if users are distracted or not paying attention to the operation of the system, E> |> ‘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 bum injury, bleeding condition, suppuration or uncontrollable Infectious diseases; 4) Patients with severe deformation or spasm of hands; 5) Patients with obvious hand trauma or allergy to composite cloth (SBR). > Attention should be paid to avoid static clectricity during use, which may cause damage to the device. SY-UMOtPlease remove the adapter and disconnect the power supply in time if the device is not used for a long time. Do not use unofficial accessories for the sake of safety. Attention should be paid to avoid static electricity during use, which may cause damage to the device. > > > Shut down the device and unplug the power supply immediately in any one of following conditions during operation: 1) Lightning strike; 2) Occurrence of abnormal sound, smoke or peculiar smell; 3) Excessive surface temperature of the host; 4) Entry of water into the host; 5) The user feels pain, swelling or other discomfort, It is suggested that the duration of single training should be about 20 minutes. E> | As gloves are often worn by patients, the following measures can be taken to ensure the safety and hygiene of gloves: 1) Patients nced to wear disposable gloves for isolation during training: 2) Gloves shall be regularly wiped with 75% medical alcohol for five times or disinfected with ultraviolet radiation for one hour; 3) Pneumatic rehabilitation gloves and data gloves are consumables, with a service life of 3 months and 6 months respectively under continuous use. Failure to replace ‘the gloves after their expiration may reduce rehabilitation effect and clinical experience. The following requirements on storage shall be observed! 1) Do not place weights on the device and its accessories; 2) Do not expose it o 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 teach, The host is equipped with a fuse of T3.15AH 250V, and the same type of fuse should bbe used for replacement E> | Working environment: Temperature, +5 atmospheric pressure: 860 hPa ~ 1060 hPa; Transportation and storage environment: Temperature: -40'C~+55°C; relative 40°C; relative humidity, <80%; humidity, <93%; atmospheric pressure: 860 hPa ~ 1060 hPa. SY-UM-01It could be transported by general means or transported in the manner specified in the contract. During transportation, it shall be protected from sunlight, rain, severe vibration and impact, and shall not be transported together with toxic, corrosive or explosive substances, The device should be maintained regularly, and the routine maintenance should be carried out once a week to clean the dirt and dust outside the host and check whether all interfaces on the host function properly. When using the training system in a wheelchair, it is necessary to ensure that there is, enough barrier-free space under the desktop to accommadate the wheelchair. The hand length of patients using this product must be in the range of 8 ~ 22 em. Wear disposable medical gloves before using grip strength meter and manual switeh. PIP PIP >) & The wearing parts need to be cleaned and disinfected regularly, and the power-assisted rehabilitation gloves are consumable and need to be replaced rogularly to ensure hygiene and effectiveness. SY-UM-01Content ID Label sn Important Disclaimer. N 1. Introduction. 1.1 About this User Manual 1.2 Glossary and Abbreviations 2, System Deseription 2.1 Intended Use ification. 2.2 Applicable Locations. 2.3 Indications. 2.4 Contraindications. 3, Symbols used in this User Manual. 4, System Components. 4.1 Host... os 4.2 PGO2 Power-assisted Rehabilitation Gloves. 4.3 DGOI Data Gloves. 4.4 Manual Switeh 4.5 Adapter. 5, System Features. 5.1 Working Mechanism. 5.2 Product Naming Rules and Product Model Variations. 5.2.1 Model Naming Rules. 5.2.3 Software Version 6, Instructions on Use and Installation, 6.1 Preparation before Use. 6.2 Wearing Gloves, 6.3 Glove Size. 7. Descriptions on Product Training Functions. 7.1 Group Flexion and Extension Mode. 7.1.1 Setting of Parameters. 7.1.2 Passive Training. 7.1.3 Two-hands Mirror. 7.1.4 Assistance Training, 7.1.5 Resistance Training, 7.2. Game. 7.3 System Settings. 7.4 Manual Mode. 17.5 Safety Protection. 7.5.1 Shutdown. 7.5.2 Overpressure Protection... 8, Trouble-Shooting... 8.1 Afer the host is normally connected to the power supply, the power indicator does not SY-UM-01 6light and the host cannot be tumed on: 2 8.2 After the hos is tumed on normally, the sereen displays normally, but the touch function hails 2 8.3 The movement range of power-assisted rehabilitation gloves is obviously reduced or there is no movement at al: 2 8.4‘The host displays blank screen or shut down automatically during operation: 9. Cleaning and Maintenance. 9.1 Cleaning and Maintenance. 9.2 Maintenance of Training Equipment. 10, Repair Policy 11, Disposal 12, Technical Specifications 13, Warranty. 13.1 Service Support, Appendix A SY-UM-01 71.1 About this User Manual ‘This User Manual provides the information necessary to operate the Hand Rehabilitation Robot System, PLEASE READ THIS USER MANUAL BEFORE OPERATING THE SYSTEM. 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 Hand Rehabilitation Robot System Mod eee istive Mode, etc system, such as Passive Mode,Active Mode, R A specially-trained m edical professional who is qualified to adjust the Therapist Hand Rehabilitation Robot System to the user, and provides the user with proper usage instructions. User ‘The person who uses the Hand Rehabilitation Robot System. ‘The Group Flexion and Extension Solution, in which five fingers are Group Flexion flexed and extended at the same time, is suitable for patients with weak and Extension hand muscle strength, and itis helpful for relieving joint edema and Solution ‘muscle stiffness, increasing hand joint mobility and preventing. joint contracture, SY-UMOt 82.1 Intended Use ‘The hand function rehabilitation training and evaluation system 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, 2.3 Indications ‘The hand function rehabilitation training and evaluation system is mainly used for finger joint rehabilitation training of patients with finger movement dysfunction caused by cerebral stroke and brain trauma, 2.4 Contraindications Absolute Contraindications: The device must not be used! + Patients with severe disturbance of blood circulation; + Patients with comminuted fracture or bone cancer; + Patients with bum injury, bleeding condition, suppuration or uncontrollable infectious diseases; + Patients with severe deformation or spasm of hands; + Patients with obvious hand trauma or allergy to composite cloth (SBR), Relative Contraindications: Each patient must be conscientiously assessed by the doctoritherapist in charge individually to determine if Hand Rehabilitation Robot System therapy is suitable for the patient in case of: + A patient after surgery; + A patient with twisted finger joints; + A patient with abnormal skin function; + A patient with various acute diseases; + A patient with disturbance of blood circulation; + A patient with fever above 38°C; + A patient undergoing treatment; SY-UMOt @+ A patient during menstruation or pregnancy; + A patient with heart diseases and implanted with pacemaker and other medical electronic devices. Note: discomfort during training, please contact the attending doctor or rehabilitation physician in time, and stop using the hand function rehabilitation training and evaluation system immediately if necessary. Before using the hand function rehabilitation training and evaluation system, itis necessary to consider the opinions of the attending doctor or rehabilitation physician to carry out the corresponding hand function rehabilitation treatment, SY-UM-01 10mobols used in this User Manual Table 3.1 Symbols Symbol | Desetiption ‘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 Fl ||| |) O (OE te > SY-UMOt 1Protected from rain Protected from direct sunlight Protected from radiation SY-UM-01 12Aron en ota ey section describes various components of the Hand Rehabilitation Robot System system. (See Fig. 4.1~Fig. 4.7). 4.1 Host @ 3 Components of host: (1) Power button; (2) Key; (3) Run/Stop key; (4) Touch sereen; (5) Host handle 4.2 PGO2 Power-assisted Rehabilitation Gloves Components of power-assisted rehabilitation gloves: (1) Non-indentation fabric; (2) Corrugated pipe; (3) Air manifold box; (4) Air outlet pipe 4.3 DGO1 Data Gloves Components of data gloves: (1) Sensor; (2) Hyper-elastic Iyera fabric; (3) Collection plate SY-UMOt 134.4 Manual Switch mae ea ‘Components of manual switch: (1) Holding rod; (2) Switch button; (3) Plug co ‘Components of adapter: (1) DC plug; (2) Power plug 4.5 Adapter SY-UMOt 4Soe rey This section explains the features of the Hand Rehabilitation Robot System system, 5.1 Working Mechanism ‘The working mechanism of the hand function rehabilitation training and evaluation system is, described as below, The control module of the system 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. Through repeated rehabilitation training, the system could stimulate joints, generate a virtuous circle of the physiological synovial fluid, reduce joint swelling, and prevent or treat joint motion amplitude reduction and joint stiffness caused by trauma or insufficient exercise 5.2 Product Naming Rules and Product Model Variations 5.2.1 Model Naming Rules sy = WR OK x L__+ Product model configurat L___, product series |__-+ Medical product type {______________+ product brand name 5.2.2 Descriptions on Product Model Variations Table 5.1 Model Variations Hand Function Rehabilitation Training and Evaluation ‘System (HR-03 Series) fodel SY-HROSE | SY-HR03G Group passive training v v Sroup mirror training 7 7Y [Assistance training v v SY-UMOt 18‘The software is used in this product in its full version of V1.2.2.0. The software is used in this product in its release version of V1 SY-UM-01 esistance training, v v Active group game training Vv Vv Information module v v jroup training setting V V Game setting v v [System setting v v Manual mode v x 3 Software Version 16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 PGO2 power-assisted rehabilitation gloves with PGO2 rehabilitation interface on the side ofthe host; (3) Insert the DC plug of the adapter into the DC socket on the rear panel of the host, and connect the adapter to the AC power supply of 220V S0Hz through the power cord; then the power indicator on the hast is on; (4) Press the switch button in the lower left comer of the front panel ofthe host to tum on the host; (5) Insert the gloveslaccessories into the corresponding interfaces on the side of the host, ress the buttons on PG02 power-assisted rehabilitation gloves to inserting/pulling out the gloves; (6) Wear gloves and prepare for training; (7) Irdata gloves are connected, it will be needed to calibrate the data gloves on the taining interface before the start of training me Man’ snc f Don Recies ia 7 Power indicator 6.2 Wearing Gloves G02 power-assisted rehabilitation gloves have halves for left hand and halves for right hand with various sizes. Patients should select suitable gloves to wear according to their own conditions. If the stiffness of joint or the muscle tension of hand is high, please massage the affected hand for 345 minutes first. ‘When wearing the glove, put fingers into the glove first, and properly pull the whole glove towards the wrist, so that the fingertips go as far as possible into the glove, then tighten the glove SY-UMOt 7with the hook & loop waist fastener on the inner side of the glove. around between the thumb and forefinger and stick it tightly, Finally, wrap the tying tape Step 1 Sepz [Bep3 Sepa 6.3 Glove Size Hand Len Hand Width Size | Height (em | Hat tenet (mm) (am) L D178 190-210 85-89 + M 156-178 162-190 78-85 ae 8 140-156 135-162 60-78 xs <140 90-135 50~60 Other sizes are available through customization SY-UMOt 18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 seck advices from Shanghai SiYi Intelligent Technology Co., Lid. or its authorized agent. 7.1 Group Flexion and Extension Mode 7.1.1 Setting of Parameters After entering the setting page, adjustments can be made to the parameters related to functions such as “Passive Training”, “Two-hands Mirror”, “Assistance Training” and “Resistance “Training”. In the “General Settings” page, adjustments ean be made to the “Training Duration”, “Flexion” time and “Extension” time by pressing the buttons “+” and made for relevant parameters by means of checking the checkbox. After setting is completed, click the button “Return” to return to the home sereen, and then click the icon “Training” on the home screen to enter the training selection page for the Group Mode, as shown in Figure 7.1. and selections can be Figure 7.1 Figure 7.2 7.1.2 Passive Training, Afler setting the required parameters, click the icon “Passive Training” in the training sclection page to enter the passive training page, as shown in Figure 7.2. After wearing PGO2 power-assisted rehabilitation gloves, click the button “Start” to initiate the training. ‘After the training is completed, the system will automatically return to the home screen. Or during the training, the user may elick the button “Return” to stop training and return to the home sereen. 7.1.3 Two-hands Mirror ‘After setting the required parameters and confirming the connection of PGO2 power-assisted rehabilitation gloves and DGO1 data gloves, click the icon ““Two-hands Mirror” in the training selection page to enter the mirror training page, as shown in Figure 7.3. After the affected hand ‘wears PGO2 rehabilitation glove and the healthy hand wears DGO1 date glove, click the button “Start” to initiate the training. fier the training is completed, the system will automatically retum to the home screen. Or during the training, the user may click the button “Return” to stop training and return to the home screen, If the mirror training mode is run for the first time, it will be needed to calibrate gloves through clicking the button “Data Glove Calibration” on the right side of the screen to enter the DGO1 data glove calibration program, as shown in Figure 7.4, After calibration is successful, the system will SY-UMOt 19automatically retumn to the mirror training page. Figure 73 Figure 7.4 TA As After setting the required parameters and confirming the connection of PGO2 power-assisted rehabilitation gloves, click the icon “Assistance Training” in the taining selection page to enter the assistance training page in several seconds, as shown in Figure 7.5. After the affected hand istance Training ‘wears PGO2 rehabilitation glove, click the button “Start” to initiate the training, ‘After the traning is completed, the system will automatically return to the home screen. Or during the training, the user may click the button “Retum’” to stop training and return to the home screen, Figure 7.5 Figure 7.6 7.1.5 Resistance Training fier setting the required parameters, click the icon “Resistance Training” in the training selection page to enter the resistance training page in several seconds, as shown in Figure 7.6. After the affected hand wears PGO2 rehabilitation glove, click the button “Start” to initiate the training. After the training is completed, the system will automatically retum to the home screen. Or during the training, the user may click the button “Return” to stop training and return to the home screen. 7.2 Game ‘After starting up, the home screen is displayed. Click the icon “Setting” to enter the setting page, and click the tab “Game”, as shown in Figure 7.7. Then click the button “Return” to return to the home sereen, ‘After connecting DGO1 data gloves, click the icon “Game” on the home sereen to enter the “Game” page. After the affected hand wears DGOI data glove and the calibration of data glove is completed, click the button “Start” to start the game, After the training is completed, the system will automatically return to the home screen. Or during the training, the user may click the button, “Return” to stop training and return to the home screen. SY-UMOt 20Figure 7.7 Figure 7.8 7.3 System Settings After starting up, the home screen is displayed. Click the icon “Settings” to enter the setting page, and click the tab “System Settings”, as shown in Figure 7.8, to set the “Voice Switch”, system volume and system brightness. Then click the button “Return” to return to the home sereen, 7.4 Manual Mode In the passive training setting page, set the taining duration, select the affected hand and training intensity by checking the checkboxes, set the switch mode (Automatic/Manual) to “Manual”, ‘complete the scene selection (Normal/Ball Catching), and adjust the flexion time and extension time, After setting is completed, connect the manual switch at the data interface and the power-assisted rehabilitation glove at the power-assisted interface. After the affected hand wears the power-assisted rehabilitation glove, and the healthy hand grips the switch, start the training (The flexion-extension interval is not applicable in manual mode.) SY-UMOt a7.5 Safety Protection 7.5.1 Shutdown 1) A mechanical runstop button is provided at the lower right of the front panel of the host, ‘which can be used to slart or pause the training operation during the training process. 2) The screen of the host is a touch screen, and the interactive interface of the software is provided with the buttons “Stan” and “Pause”, which have the same function as the ‘mechanical run/stop button. 7.5.2 Overpressure Protection 1) Overpressure protection with overflow valve: The rehabilitation training and evaluation system is equipped with an overflow valve. When the working pressure value exceeds 120kPa+10kPa, the overflow valve will function to realize protection through exhausting the air; 2) Overpressure protection with solenoid valve: The rehabilitation training and evaluation system is equipped with a solenoid valve, When the working pressure value exceeds 120kPa+10kPa, the solenoid valve will function to realize protection through exhausting the Overpressure protection with air pressure sensor: The rehabilitation training and evaluation system is equipped with an air pressure sensor, When the working air pressure value exceeds 120kPat10kPa, the air pressure sensor will function to realize protection through exhausting the air. SY-UMOt 1PT acl Ont This section includes a guide to troubleshooting various operational incidents, describes the symptoms and gives an explanation of how to fix them ifthese occur. 8.1 After the host is normally connected to the power supply, the power indicator does not light and the host cannot be turned on: © Check whether the adapter is normal; © Check whether the fuse wire in the fuse protector on the back panel of the host works normally, and replace it with the fuse of the same model (T3.15AH 250V) if necessary; 8.2 Afier the host is turned on normally, the screen displays normally, but the touch function fails: © Power offand restart the host; 8.3 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; © Check whether the glove hose is twisted and knotted or pressed by heavy objects; © Check whether the corrugated pipes on the gloves are damaged or missing; 8.4 The host displays blank screen or shut down automatically during operation: © Power off and restart the host; Note: If the problem is still not resolved after troubleshooting according to the above steps, please contact Shanghai SiYi Intelligent Technology Co., Ltd, which will arrange the professional technicians for maintenance as soon as possible, SY-UMOt 2Coenen tT 9.1 Cleaning and Maintenance (1) Host: After the host is powered off, wipe its extemal surface with a fine fiber cloth ‘moistened with water and wrung out, pay attention (o avoid water entering the host, and prohibit the use of corrosive liquid to clean the product; (2) Glove: Wipe it with 75% medical alcohol for five times or disinfect it with ultraviolet radiation for 1 hour before use. 9.2 Maintenance of Training Equipment (1) The routine maintenance i carried out regularly by the user, mainly including the cleaning of the external surface of the host and the regular cleaning and disinfection of the wearing parts. For specific descriptions on the operation, refer to the section “Cleaning and Maintenance” above, (2) Overhauling ofthe host: 1) Power supply-related components (c.g. power cord, adapter and power interface) get loose, invalid or damaged; 2) Connection, operation and display components (e.g. buttons, screens and interfaces on the host) fail or get damaged; 3) Confirmation of the running status and soflware version of each module ofthe operating software; ‘The above maintenance operations need to be performed by the professional technicians appointed by Shanghai SiYi Intelligent Technology Co., Ltd. (3) Update of software: Shanghai Si¥i Intelligent Technology Co., Ltd. will update the system software according to the stability and actual use ofthe device; (4) It is recommended to refer to the Section 8.1 “Simple Troubleshooting” of this Manual for troubleshooting SY-UMOt aUae Tg Shanghai Siyi Intelligent Technology Co. Lid isthe only organization that can determine and confirm whether the products are within the warranty scope The host is guaranteed or could be replaced ffee of charge within one year from the date of purchase if it has been found with any manufacturing ot assembly defect; and the glove is guaranteed or could be replaced fee of charge within three months from the date of purchase if it has been found with any manufacturing and assembly defect. Shanghai SiYi Intelligent Technology Co., Ltd, will be responsible for the safety, reliability and performance of the product only when the assembly, adjustment, maintenance and upgrade of the product are all carried out by Shanghai SiYi Intelligent Technology Co., Ltd. or its authorized party; the electrical equipment used together withthe product mects the special requirements of national standards and this Manual; and the operation ofthe product is caried out according to the methods and steps described inthis Manual Faults caused by improper use of the product or by use of the product beyond the conditions indicated in the Manual are all not covered by the warranty, Faults caused by wearing or negligence accidents, improper supervision or unauthorized disassembly and use change of the product are all not covered by warranty. Mechanical parts of this product cannot be discarded at will, otherwise they will pollute the environment. Please consult or contact a professional waste disposal company or the distributor to dispose the scrapped or waste produets or accessories in accordance with the requirements of relevant local laws and regulations. SY-UMOt 4SPAN rate iy aati No, tems Techical Panmctee Appi Tnning Modes Training | '™" ~~ Simin, adjustable |p s-nement mode duration | continuously by Imin, with an error | Group flexion and extension mode. ‘Trainin of 410%; ‘ (1) Guratio | plecion Passive training (refinement, 2 texon | 55~ 124, adjunible cominousty | group) extension | by Is, with an error of 10%: Resistance Training (group) ‘Assistance Tsing (up) 2) | Convotseings | Auomaticant Manu opionat | Paste ening Genome Refer mode 6) ‘Affected hand Left and Right optional Group flexion and extension mode Tanke taiing —(etnenont Tring int: Low and High | grup) “Taning inten nd | opal $id sino (gop) @ passive movement Resistance training (group) speed ‘Average passive moving speed: Passive training (refinement, 90-10% Bon) Cuan ofgnmes | At east one or tre games can be| SY-HROR: —_Acive —_wenng (3) | “Staticlfyor | slesed, ne th gume iia os | enemen group) ting | low ned and Svat: Gamer (6 | anispasiciy | nbledand Disled options! | Pasve wining (oun) scene selection rdinary and Ball Catching optional | Passive twining (group) a se Ordinary and Ball Catching optional Resistance Training (group) Toweraiad woke evion Extension, Exemfon. and Hexion (8) Assistance training | optional Assistance training (group) ower sn: High, Mss and Leona! Voice ‘On and Off optional Woies TY onand oF apo co) | Sem PERSE Yio ~100 aja cons 6 10 System 10~100, adjustable continuously by 10 brightness ae yey 10) | satire Chas Type an | sie ortos 500mm omm*275mm (L+W°H) 12) | waite -5kg- sks Gp | Nonitalvtase | 000-200 svete Rated per Sova (04) | batcofmanstactze | Sethe conte of product (15) } Service life ‘Siyears SY-UMOt13. Warrant 13.1 Service Support If the device needs repair, contact Shanghai SiVi 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 dlamage. Always transport the device in the original shipping container. SY-UMOt 6Appendix A Product Cable Information Max. cable length, Cable Number Shielded/unshielded ‘able classification AC Power Line 1.8m. shielded I Set AC Power Important information regarding Electro Magnetic Compatibili ‘This electrical medical equipment needs special precautions regarding EMC and put into service fing to the EMC information provided in the user manual; The equipment conforms to this TEC (60601-1-2:2014 standard for both immunity and emissions. Nevertheless, special precautions need to be observed: The equipment with no ESSENTIAL PERFORMANCE/Following ESSENTIAL, PERFORMANCE is intended used in Professional healthcare facility environment except for near active HE SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high, /Home healthcare environment ESSENTIAL PERFORMANCE: None ‘> WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation, If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally’ = The use of accessories, transducers and cables other than those specified or provided by the ‘manufacturer ofthis equipment could result in inereased electromagnetic emissions or decreased clectromagnetie immunity ofthis equipment and result in improper operation. ‘> WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 em (12 inches) to any part of the Model Name, including cables specified by the manufacturer, Otherwise, degradation of the performance of this ‘equipment could result.” ‘> STATEMENT: For the purpose of its operation, the equipment has wireless communication function, it includes RF transmitter and receiver, 2.4GHz, Pulse modulation, ‘= STATEMENT: The equipment isa large, permanently-installed system. According to chapter 8.6 of IEC 60601-1-2:2014, the test was only performed at some discrete frequencies. ) An exemption has been used and that the equipment has not been tested for radiated RF immunity over the entire frequency range 80 MElz to 6 000 MHz; SY-UM-01 7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 ©) Following fiequencies and modulations are used to test the immunity of the equipment Selected Frequency Emitter Frequency Range Modulation (thie, 103.7 Ratio Business radio band FM 4392 Remote controller TSM frequency ry 46 Walkie-takie walkie-talkie FM 915 Mobile phone ‘asM900 Pulse 2400 Wireless router WIFI Pulse 5000 Wireless router wir Pulse h high frequency surgical equipment; STATEMENT: The equipment is designed compatible wit the condition includes working or standby in close proximity to high frequency surgical equipment. ‘When the AC input voltage is interrupted, the equipment will shut down and if the power supply restored, it should be recovered by operator manually, this degradation could be accepted because it will not lead to unacceptable risks and it will not result in the loss of basic safety or essential performance. eal fast transients/burst could = Following degradation caused by Electrostatic Discharge or Elec be accepted because it will not lead to unacceptable risks and it will not result inthe loss of basic safety ‘or essential performance: Vertical bars appear on the sereen, it can recover to previous condition by operator manually by restart, the power switeh, Data transmission stopped, the transmission could be restarted by operator manually by restart the power switch or re-insert the data eable. SY-UM-01 8EMI Compliance Table (Table 1) ‘Table 1 - Emission Phenomenon Compliance Electromagnetic environment RF emissions CISPR I] Group 1, Class A Professional healtheare facility environment and Home healtheare environment and flicker Compliance TEC 61000-3-2 Harmonie distortion Professional healtheare facility environment Class A Voltage fluctuations IEC 61000. Professional healthcare facility environment NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 ck ss A), Ifit is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment, EMS Compliance Table (Table 2-5) Table 2 - Enclosure Port Basie EMC Immunity test levels Phenomenon lena standar Professional healtheare facility environment Electrostatic TEC 61000-4-2 | =8kV contact Discharge =2KV, £4KV, £80 3Vim TEC 61000-4-3, Radiated RF EM field 80MEI2-2.7GH2 80% AM at Ikitz Proximity fields from RF wireless TEC 61000-4-3, Refer to table 3 communications equipment Rated power frequene 30Aim . we TBC 61000-4-8 magnetic fields SOEKz or 60H SY-UM-01Table 3 — Proximity fields from RF wireless communications equipment Test frequency Band Immunity test levels tt) (tt) Professional healtheare facility environment 385 380-390 Pulse modulation 18H2, 27Vim 450 430-470 FM, 25kH deviation, 1k sine, 28V/m 70) 743 704-787 Pulse modulation 21742, 9V/m 780 810) 370 800-960 Pulse modulation 18H, 28V/m 930 1720 18a3 1700-1990 | Pulse modulation 217Hz, 28V/m 1970 2430 2400-2570 | Pulse modulation 217, 28Vim S240 3500 5100-5800 | Pulse modulation 217Hz, 9V/m 5785 Table 4 — Input a.c. power Port Phe Basle EMC stat Tmamunity test levels Professional healthcare facility en Electrical fast| 2kV TEC 61000-4-4 transients/burst 100k repetition frequency Surges TEC 61000-4-5 | +05 kV, =I kV Line-to-line Surges 5 TEC 61000-4-5 | 20.5 kV, =I KV, 22 kV Line-to-ground 3V, 0.15MHz-80MHz Conducted disturbances 6V in ISM bands and amateur radio bands between 0.1 MHz. TEC 61000-4-6 induced by RF fields and 80MHz SY-UM-01 10Voltage dips 0% Ur; 05 eyele ALO, 45°, 90%, 135%, 180°, 25°, 270" and 315° TEC 61000-4-11 0% Ur Te) and 70% Ur; 25130 eyeles Single phase: at 0° Voltage interruptions TEC 61000-4-11 0% Ur, 2501300 eycles Table 5 - Signal input/output parts Port Phenomenon Immunity test levels Basic EMC standard Professional healthcare facility environm Conducted disturbances induced by RF fields TEC 61000-4-6 3V, 0.1SMHz-80MHz 6V in ISM bands and amateur radio bands between 0.1SMtlz and SOMILz SY-UM-01 "