Page 1
Wagner & Guder Medical GmbH refraction unit cubeONE Directions for use GA2020_09_08ENG issue September 2020...
Page 2
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE To this manual The instructions for use are part of the scope of delivery. Please read manual before use refraction unit Make yourself familiar with the safety regulations ...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Table of contents Content Safety instructions ..........................5 Description of symbols ........................5 Application area ..........................6 Informations for the operator ......................7 Requirements for operation ......................9 Before the first operation ......................9 Before the operation ........................
Page 4
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Maintenance of the device ......................29 Safety check ..........................29 Change of the main fuses ......................29 Maintenance of the device ......................30 Cleaning ............................. 30 Environmental protection regulations ..................30 Device details ..........................
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Safety instructions Description of symbols sign “Follow instructions for use“ especially read the safety instructions and follow the enclosed documents Equipment labelling „nameplate“ - Unit name - Load capacity instrument table...
Any use other than that specified is not permitted. Intended use The cubeONE examination unit is a versatile device for positioning a sitting patient and/or customer in front of ophthalmic examination equipment. Both manual and electromotive adjustment options are available for positioning.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Informations for the operator Before using the device, make yourself thoroughly familiar with the contents of the operating instructions. Also observe the operating instructions for accessories and other system components.
Page 8
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE The examination unit may only be put into operation at a correctly installed grounded contact socket 230V/AC mains voltage with the mains cable supplied or in connection with the wall connection box.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Requirements for operation Before the first operation Check the stability of the examination unit Check the fixing points of the installed equipment Pay attention to the maximum permissible weights of the devices ...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Positioning and installation instructions Correct adjustment of the refraction unit Tough floor 6x adjustable legs Create stability After transport, Remove safety caps from legs Wagner & Guder Medical GmbH issue September 2020...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Notes on device installation Refraction unit with single device working 1. Working position 1: max. 30kg 2. Working position 2: Keep space free Attention! Single device working Fix the 2nd table position with a suitable fixing...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE General structure Mounting of projector, D=30mm Reading Spot/ reading lamp Phoropter rail with mounting hole, D=22mm Functional column with slot system Working table with control panel, application part Lens case Patient chair with tiltable armrests...
Page 13
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE cable exit functional column eyewear desposit Mains connection refraction unit, In case of error disconnect HERE! Mains connection with fuses 2x T 6,3 A / H Nameplate Manufacturer Specification Wagner & Guder Medical GmbH...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Working table The instrument table enables smooth and safe swivelling in front of the patient. When the end position is reached, an electromagnet locks automatically. The table is swivelled back by releasing the holding magnet by pressing the table button.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Swivel mounted phoropter arm Clamp handle Cable guide Phoropter mount Make sure that the phoropter head with the corresponding safety screw is fixed correctly! Handle to loose and adjust working heigh (gas spring system)
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Drawers with lens case holder The drawer is designed in such a way that it can contain a measuring glass insert. This is included in the scope of delivery (space for 238 glasses).
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Sliding seat position Seat rotation, 4x 90°=360° Foot rest, tiltable Please make sure that the patients do not put their feet under the footrest! The lifting column does not recognize any obstacle as a...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Electric connection The electrical connection of the examination unit is made to a properly installed grounded contact socket or the wall mounting box included in the delivery. Please use only the included power cable, connection length 2,5m, cable cross-section 1mm or the connection cable of the wall connection box.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Operation Control panel The operating switch with the control lamp is located at the instrument table, see page 14 (position 15). The examination unit is ready for operation as soon as the button is pressed and the lamp lights up green.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Slit lamp installation Example description Slit lamp assembly on base plate with integrated chin rest socket 1 Slit lamp assembly on base plate with or without integrated chin rest socket 1...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Phoropter arm Slot nut, to mount phoropter rail on function pillar Mount Phoropter rail Swivel mounted arm Basic mount Adjustable screw for weight control Slot nut, to mount phoropter rail on function pillar Clamping lever for rotation Wagner &...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Patient chair Seat shell Arm rest mount Spacers basic base plate for seat shell seat moving forward/ backward (option) Turning seat position (optional) Base plate sliding seat shell Electric pillar Foot rest Reading light/ Reading spot Mount of reading lamp –...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Technical structure Basic frame Table bearing Holding magnet instrument table in working position plate of control unit (page 25) spring loaded thrust piece End switch Holding magnet fixation plate – turning instrument table Wagner &...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Control unit Base plate control unit cubeONE 3times power socket, swiched, 230VAC – max. 4A Basic board - BLP Reading spot 230VAC, switched over control panel power socket 230VAC, switched by working position...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Basic board - BLP fuse Si2 (230V T 4 A / H) switch between 1. and 2. Table position of outlet 6V / 12V (socket 1) fuse Si3 (230V T 4 A / H) RESET - buttom 6V outlet (max.5,5A), switch position 1,2,3,4,5 according to: 3V, 4V, 5V, 6V, 7V...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE External termial block connection to blind control, External voltage switchable to 8 A connection to rommlight control connection to free switch AUX, Potential free Push button or switch (by software) GND – ground terminal Wagner &...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Patient Surrounding The area marked above is considered the patient surrounding. In this area, the patient is guaranteed the maximum possible protection. In the area of the patient's environment dangerous spots can occur. Here the treating physician or optician has a special duty of care, especially in connection with the installed devices.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Maintenance of the device Safety check The examination unit is maintenance-free and designed for a service life of 6 years. To ensure safe and proper operation and a long service life at all times, regular preventive maintenance must be carried out.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Maintenance of the device Disconnect the examination unit from the power switch and pull the power plug! Avoid that cleaning material or other liquids can get into the examination unit or on installed examination devices during cleaning work.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Device details Technical Data Feature Permitted values 230 VAC ±10% Nominal power input Frequency 50 Hz Protection class Type of device Connection load 6,3 A Reading lamp 6 VA Low voltage...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Environmental conditions 1. For operations Feature Permited value range +5°C … +40°C Temperature 30% … 75% no condensation Relative humidity Operating height till 2000m a.n.z 2. For Transport and storage Feature Permited value range -20°C …...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Electromagnetic compatibility (EMC) Medical electrical equipment is subject to special precautions with regard to EMC and must be installed and commissioned in accordance with the following guidelines. Portable and mobile HF equipment (e.g.
Page 34
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Guidance and manufacturer’s declaration – Electromagnetic immunity This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment.
Page 35
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Guidance and manufacturer’s declaration – Electromagnetic immunity This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should assure that it is used in such an environment.
Page 36
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broad-cast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Technical error in the system Solve technical errors For your safety If an error occurs, shut down the system and use the following error list to correct the error. If this does not remedy the error, mark the device as non-functional and inform the person who put your entire system into operation.
Page 38
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Malfunction Possible cause Remedy Link Installed Look, no working 230VAC device without working Fuse on circuit board Contact distributor defective Fuse of device defective Change fuse for device Operating manual of...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Malfunction Possible cause Remedy Link Instrument table Ball locking jams or is Contact distributor page 21 not in moveable incorrectly adjusted in working Table bearing damaged Contact distributor page 21 positon...
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE System combination medical and non- medical device In order to guarantee the electrical safety of medical devices and non-medical devices (e.g. printers), a safe separation according to IEC 60601-1 with 2x MOPP is required.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Warranty and warranty conditions If defects due to material or processing faults occur within 24 months after delivery, we guarantee the fastest possible and free repair of the refraction unit or, at our decision, a free exchange. For electronic components such as power supplies or motherboard, defects will be repaired free of charge within 12 months.
Gebrauchsanweisung Untersuchungseinheit cubeONE, directions for use, refraction unit cubeONE Purchase order details Spare parts Description Order number Power cord 2,5m MC-B1D12500 Fuse T 4 A / H - Littelfuse 0215004.TXP Fuse T 6,3 A / H - Littlefuse 021506.3TXP Power supply 12VDC...