User Manual for Decon models including: UDI-DI 735001014SIMCX, SIM001, SIM001 Simplex Segway Singapore, SIM001, Simplex Segway Singapore, Segway Singapore, Singapore
The undersigned, representing the following manufacturer Decon Wheel AB Org.No. 556618-9006 Södra Ekeryd 119, 314 91 Hyltebruk Sweden hereby declares that the product
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DocumentDocumentSimplex User manual 2024-06 Rev1.0 Original manual The undersigned, representing the following manufacturer Decon Wheel AB Org.No. 556618-9006 Södra Ekeryd 119, 314 91 Hyltebruk Sweden hereby declares that the product Simplex with the basic UDI-DI 735001014SIMCX and the reference SIM001 is in conformity with the Medical Device Regulation (MDR) 2017/745 as a class I medical device based on Annex VIII; and the Directive (RoHS) 2011/65/EU. Intended purpose: Simplex is intended to be used in combination with the electrical drive unit E-Drive. Simplex enables caregivers to control E-Drive in an intuitive, smart, and effortless way. This EU declaration of conformity is issued according to Annex IV in MDR and under sole responsibility of the manufacturer. Hyltebruk, 2024-07-11 Benny Andersson COO Contents Security ........................................................................................................................................................... 4 General regulations ................................................................................................................................... 4 Manuals for visually impaired individuals ...............................................................................................4 Purpose and intended use........................................................................................................................4 Not intended use ....................................................................................................................................... 4 Labelling ........................................................................................................................................................5 Warnings ........................................................................................................................................................6 Before you use Simplex for the first time ................................................................................................6 Driving ........................................................................................................................................................ 6 Road conditions ......................................................................................................................................... 7 Storage and transport ............................................................................................................................... 7 Cleaning ..................................................................................................................................................... 7 General use ................................................................................................................................................ 8 Warranty .........................................................................................................................................................9 Product safety and recall information ......................................................................................................9 Product description .................................................................................................................................... 10 Technical data ..........................................................................................................................................10 Scope of delivery ....................................................................................................................................... 11 Adapter set...............................................................................................................................................11 Overview Simplex ...................................................................................................................................... 12 Display......................................................................................................................................................... 13 Using Simplex............................................................................................................................................. 15 Summary ................................................................................................................................................... 15 Calibration ................................................................................................................................................15 Start ...........................................................................................................................................................16 Steering ....................................................................................................................................................16 Passing obstacles.....................................................................................................................................16 Care.............................................................................................................................................................. 17 Cleaning ...................................................................................................................................................17 Corrosion ..................................................................................................................................................17 Maintenance ............................................................................................................................................. 17 Repairs ......................................................................................................................................................18 Waste disposal .........................................................................................................................................18 Troubleshooting ......................................................................................................................................... 19 Errors and warnings from Simplex.........................................................................................................19 2024-06 Rev1.0 Original manual Errors and warnings from E-Drive ..........................................................................................................21 Sida 3 av 26 Security General regulations The user manual applies to Simplex. The user manual is written for users of Simplex. The user manual does not include instructions for the assembly of Simplex. This is provided in a separate assembly guide. Read the user manual and familiarize yourself with Simplex before using it. Manuals for visually impaired individuals Contact your local dealer if you have difficulty reading this user manual. Your local dealer can provide a digital copy of this manual. This allows for enlarging the manual or reading it aloud from your screen reading software. Purpose and intended use. Simplex is an accessory unit that can be integrated with the E-Drive electric drive system, which, in turn, is combined with a manual wheelchair. Simplex is designed to assist a caregiver or a family member in an assisting role while operating a wheelchair. It aims to provide power assistance and enhanced mobility for manual wheelchair users. The prerequisites for using the product are that the individual in question has at least one arm with sufficient strength to operate the handlebar on the product. Furthermore, sufficient cognition and motor skills are necessary for the person to operate the product safely. The assessment of the individual's ability is carried out by Decon or a representative appointed by Decon, such as assistive device centres and dealers. The product can be used both indoors and outdoors. Information about which wheelchair models Simplex can be mounted on can be found at www.decon.se. Not intended use Any use that does not correspond to the description in this user manual. This also includes technical specifications. Sida 4 av 26 Labelling The type plate, as described below, is located on the back of Simplex (forward in the direction of travel). The symbols used on the label are explained below: Pay attention to the user manual! Medical device Serial number Date of manufacture Name and address of the manufacturer Article number Sorted as electronic waste. Simplex is subjected to the European WEEE Directive. Sida 5 av 26 Symbols WARNING! Risk of serious personal injury or death. An operation which, if not performed correctly, may result in injury to the operator or other persons. ! CAUTION! Risk of material damage. An operation that, if not performed correctly, may lead to material damage. INFO Other important or explanatory information. Warnings Before you use Simplex for the first time WARNING! The user shall have read and understood the manual and understand the interfaces of Simplex. WARNING! Practice driving on a level and safe area, until you acquainted yourself with the use of Simplex. Driving WARNING! Do not hang clothes, bags or other equipment on the handle. WARNING! Never operate Simplex while sitting in the wheelchair yourself. WARNING! Check the remaining battery capacity before crossing a road. If the battery capacity is low, Simplex may stop. Sida 6 av 26 INFO If possible, use the parking brake of the wheelchair, when stopping at a pedestrian crossing, or similar. Road conditions WARNING! Do not use Simplex outdoors in heavy rain or snow. Drivers of other vehicles may have difficulty seeing you. If it starts to rain or snow when you are outdoors, make your way indoors as quickly as possible. WARNING! Do not use Simplex on icy surfaces. There is a risk that you won't be able to stop. WARNING! Do not drive in areas with deep snow or standing water. There is a risk that you will lose control. Railroad crossings WARNING! Check the remaining battery capacity before crossing a railroad. If the battery capacity is low, Simplex may stop. Storage and transport WARNING! Do not store Simplex where it may get wet from rain or in places with high humidity. WARNING! Avoid storage in direct sunlight or high temperatures. ! CAUTION! During transport, position the wheelchair to avoid damage to Simplex. Cleaning ! CAUTION! Never wash Infinity with a hosepipe or high-pressure washer. Do not use a steam cleaner. The electronic devices may be damaged, which can lead to serious malfunctions. Sida 7 av 26 ! CAUTION! Do not clean with solvents such as petrol or thinner. This may damage parts of Simplex. INFO Simplex may be disinfected using a cloth soaked in alcohol. General use WARNING! Do not use Simplex near devices that generate strong radio waves. If Simplex is near a radio wave source and starts to function abnormally, turn off the power immediately, and manually move the wheelchair from the current location. The weak electromagnetic waves emitted by Simplex may affect other electronic devices, such as automatic doors and anti-theft systems of the type used in stores. In this case, turn the power of and operate the wheelchair manually. Sida 8 av 26 Warranty The warranty period for Simplex is 2 (two) years from the date of purchase. If there is a material or manufacturing defect on your Simplex during this warranty period, the defective parts will be replaced or repaired free of charge. The warranty covers the Simplex unit, but not the adapter set. This warranty does not cover faults caused either by intentional misuse by the user or careless use, such as faults caused by use other than that specified in this manual. This warranty also does not cover faults that have occurred as a result of modification of the unit or continuous use under conditions other than the specified conditions, for example maximum weight exceeded etc. Scratches, matting and dirt on the surface of the product as a result of normal use are not covered by the warranty. If warranty repairs are necessary, contact the dealer where you purchased the unit. The estimated service life is 6 years, but depends on the usage conditions, environment and usage frequency. The service life denotes the period during which the performance of the product shall be maintained through maintenance and inspections by the dealer. Product safety and recall information Contact your dealer or the manufacturer of Simplex for product safety information and any recalls. Sida 9 av 26 Product description Technical data Compatible drive system Total dimensions, excl. adapter set Total weight, excl. adapter set Environment Operating conditions Temperature Humidity Enclosure integrity (IEC-60529) Wheelchair classification (EN 12184:2022) Other Decon E-Drive 305x137x86 mm (WxLxH) 980 g Indoor and outdoor -25°C to 50°C No condensation IPX4 (resists splashing of water) Class B See E-Drive's documentation for operating instructions and technical specifications. Sida 10 av 26 Scope of delivery The delivery of Simplex includes the following: 1. Simplex 2 2. User manual 1 Adapter set INFO An adapter set is required to mount Simplex on a wheelchair. The adapter set must be installed by a trained technician. The adapter set is ordered separately. Sida 11 av 26 Overview Simplex Simplex is an accessory to E-Drive, which controls the speed based on the force applied to the handle. 3 4 1 1 1. Dead man's switch (start/stop) 2 2. Handle with force sensors 3. Display 4. Switch (on/off) Sida 12 av 26 Display Simplex' display has the following indicators: Indicator Name Switch (on/off) Ready Started Warning/error Status Off Green Green Green Yellow Description Simplex Off Simplex On Simplex is ready to start. E-Drive is started. Indicates a warning, in combination with the battery level indicator. Simplex can still be operated. Sida 13 av 26 Battery symbol Battery level Calibration Red White Yellow/red In combination with the battery symbol, green/yellow/red. In combination with the warning symbol Blue rolling indication White rolling indication White - steady light Indicates an error, in combination with the battery level indicator. Simplex stops and cannot start as long as the error remains. The battery level is shown. Indicates warning/error from the battery. Shows the batter level in 5 steps. Shows error code (See chapter Troubleshooting). Calibration ongoing E-Drive starts Simplex is not ready, calibration is ongoing. White - blink Calibration updated Release the Red steady light Simplex is not ready. Do not touch the handle. handle Red blinking Simplex not ready, release the handle. Yellow/red Indicates warning/error from the left and right Left/right wheel respectively. White Simplex is not ready. Green Simplex is ready. . Sida 14 av 26 Using Simplex Simplex can only be used with Decon's E-Drive. Simplex shall be installed by a trained technician. Summary 1. Use the switch to turn Simplex on. 2. Wait for the indication ready. 3. Activate one or both dead man's switches. 4. When the indication started (green arrow) lights up, E-Drive is active. Control the speed and direction by pushing the handle in the desired direction. 5. Stop by first lowering the speed and then release the dead man's switches. Calibration Simplex is automatically calibrated when the dead man's switch is inactive and the handle is not touched. Before the calibration is done the displays shows the following: When the calibration is done, the indication ready is shown: The calibration continues to be updated in background. For every update, the indication calibration blinks. Depending on temperature changes, etc., the calibration may need to be repeated. If this happens during use, stop, release the handle, and wait until the indication calibration to blinks. Sida 15 av 26 Start When Simplex is ready, E-Drive can be started by activating one of the dead man's switches. The left, right or both hands can be used. The switches have three positions. In the middle position they are activated. Simplex stops if both dead man's switches are released, or if any switch is pressed to its third, fully depressed, position. Steering When E-Drive has been started the indication started is shown. The wheelchair can now be controlled by pushing the handle in the desired direction. Simplex adapts the speed automatically. Only horizontal forces affect Simplex. Do not lift or push the handle downwards. Do not start steering before E-Drive is started. Simplex does not start if the force on the handle is too high. Then the indication release the handle is shown: Passing obstacles INFO Simplex' handle is not intended to be lifted or pushed down. Move one or both hands to the wheelchair's push handles if needed. Sida 16 av 26 Care Cleaning If Simplex becomes dirty due to normal use, clean Simplex with a lightly damp towel. If Simplex is heavily soiled, use a towel and a neutral detergent. Make sure that no detergent remains on Simplex after cleaning. Corrosion Simplex parts that can be exposed to corrosion are made of aluminium, stainless steel or steel. The materials and the transitions between the materials have been surface treated, therefore, there is no increased risk of corrosion. Regardless of this, you should always wipe wet or damp surfaces on Simplex with a dry cloth after use. Maintenance Use a copy of this page to note when and by whom the checks were performed. Save the details. The following checks should be performed every 6 months after the first use. Unit Overview Action Jammed parts Check of adapter set Dirty electrical connectors Cables, visual inspection for damage. Cables, check connections. Note Date Controller Sida 17 av 26 Repairs · The user must not repair or service Simplex. · The user must not remove and send parts of Simplex to the dealer for repair. · If repair is required, contact your dealer even if the fault is of a less serious nature. · If parts are damaged or missing, contact your dealer immediately. Return Simplex to your dealer to have parts replaced or repaired. · For normal maintenance, repair or service, always contact your dealer. If Simplex is not repaired or all parts are not used during assembly, the user, people in its surroundings or property may be injured. · To carry out repairs and service, the dealer uses the service manual, spare parts catalogue and other documentation. This documentation is not available to the user and the public. Waste disposal When Simplex has expired and is to be scrapped, contact your local authorities for recycling information and follow their instructions. Alternatively, you can contact your dealer for recycling of your used Simplex. Sida 18 av 26 Troubleshooting Simplex is an accessory to E-Drive. In some cases, the manual of E-Drive is referred to for further troubleshooting. Errors and warnings from Simplex Simplex displays detected errors and warnings with the warning symbol in combination with the battery level indicator. Warnings allow continued operation and are indicated with yellow. Errors stops E-Drive and are indicated with red. Indication Code Description Action The signals of the dead man's switch are invalid. Release the dead man's S3 This can happen if the switch and activate it dead man's switch is again to start. operated too slowly. The signals of the dead Restart Simplex using the man's switch are invalid. switch. S4 This error is triggered Contact your dealer if the after 4 seconds. error remains. The left dead man's S5 switch is in its third position. Release the dead man's switch. Contact your dealer if the error remains. The right dead man's S6 switch is in its third position. Release the dead man's switch. Contact your dealer if the error remains. S7 Error in the electronics of Simplex. Contact your dealer. S8 Invalid battery voltage. Restart Simplex using the switch. Contact your dealer if the error remains. Sida 19 av 26 S9 Force sensor error Restart Simplex using the switch. Contact your dealer if the error remains. S10 Force sensor error Restart Simplex using the switch. Contact your dealer if the error remains. Restart Simplex using the S11 Temperature sensor error. switch. Contact your dealer if the error remains. Check the cables. Communication error Restart Simplex using the S12 between Simplex and E- switch. Drive. Contact your dealer if the error remains. Check the cables. Communication error Restart Simplex using the S13 between Simplex and E- switch. Drive. Contact your dealer if the error remains. Check the cables. Communication error Restart Simplex using the S14 between Simplex and E- switch. Drive. Contact your dealer if the error remains. E-Drive is already S15 activated by another controller (e.g. joystick). Turn the other controller off. Contact your dealer if the error remains. S16 Program error. Restart Simplex using the switch. Contact your dealer if the error remains. Sida 20 av 26 S17 The calibration is reset. Let Simplex be turned on. A new calibration is automatically saved after 10 min. Contact your dealer if the error remains. Errors and warnings from E-Drive For action and further information, see the user or service manual of E-Drive. Indication Equivalent indication from E-Drive's joystick Description The clutch of the left wheel is C1 disengaged. The clutch of the right wheel is C1 disengaged. C5 E-Drive is stuck or overloaded. C5 E-Drive is stuck or overloaded. C6 E-Drive is stuck or overloaded. C6 E-Drive is stuck or overloaded. Sida 21 av 26 C7 E-Drive is stuck or overloaded. C8 E-Drive is stuck or overloaded. -- Communication error between EDrive motors and battery. 10 Battery level is 10% or less. E The battery is empty. C9 The battery is cold. C9 The battery is cold. C9 The battery is hot. Sida 22 av 26 C9 The battery is hot. There temperature sensor of the C9 battery is faulty. E1-22 The battery voltage is too high. E2-14 / E3-14 See service manual of E-Drive. E2-15 / E3-15 See service manual of E-Drive. E2-16 / E3-16 See service manual of E-Drive. E2-17 / E3-17 See service manual of E-Drive. E2-18 / E3-18 See service manual of E-Drive. Sida 23 av 26 E2-19 / E3-19 See service manual of E-Drive. E2-20 / E3-20 See service manual of E-Drive. E2-21 / E3-21 See service manual of E-Drive. E2-22 / E3-22 See service manual of E-Drive. E2-23 / E3-23 See service manual of E-Drive. E2-24 / E3-24 See service manual of E-Drive. E2-25 / E3-25 See service manual of E-Drive. E2-26 / E3-26 See service manual of E-Drive. Sida 24 av 26 E2-27 / E3-27 See service manual of E-Drive. E2-28 / E3-28 See service manual of E-Drive. E2-29 / E3-29 See service manual of E-Drive. E2-30 / E3-30 See service manual of E-Drive. E2-31 / E3-31 See service manual of E-Drive. E2-32 / E3-32 See service manual of E-Drive. Sida 25 av 26 Decon Wheel AB Södra Ekeryd 119, 314 91 Hyltebruk Tel: +46 (0)345 40880 Fax: +46 (0)345 40895 E-mail: info@decon.se Sida 26 av 26