USER MANUAL Operating Table SU-03 Operating Table SU-03 User Manual Page 1 of 40
OAKWORKS, Inc. Corporate Office: 923 East Wellspring Rd. New Freedom, PA 17349 USA Tel: (717) 235-6807 Fax: (717) 235-6798 For ims Sales and Service: Tel: (717) 227-3100 CustomerService@oakworks.com www.inspiritmed.com All inquiries should be directed to OAKWORKS, Inc., the initial importer. This manual is approved, in English, by FAMED ŻYWIEC Sp. z o.o., the Manufacturer. All rights are reserved. No part of this document may be photocopied or translated to another language without the prior written consent of OAKWORKS, Inc. ims inspirit MEDICAL SOLUTIONS is a registered trademark of OAKWORKS, Inc. Page 2 of 40
TABLE OF CONTENTS 1.0 INTENDED USE... 5 2.0 CONTRAINDICATIONS... 5 3.0 WARNINGS AND PRECAUTIONS... 5 4.0 DESCRIPTION OF SU-03 OPERATING TABLE... 7 4.1 Components of SU-03 Operating Tables... 8 4.2 SU-03 Operating Table Drawings Standard... 9 4.3 SU-03 Operating Table Drawing Super Mobile... 10 5.0 UNPACKING THE SU-03 OPERATING TABLE... 11 6.0 INSTALLATION OF SU-03 OPERATING TABLE... 12 6.1 Installation Checklist... 12 7.0 ACCESSORIES... 12 8.0 OPERATION... 15 8.1 Controlling Elements Wired Remote Control... 15 8.2 Controlling Elements Alternative Drive (Option)... 16 8.3 Raising and Leveling of Tabletop... 17 8.4 Longitudinal Tilt Adjustment... 18 8.5 Tabletop Side Inclination... 18 8.6 Zero Position... 18 8.7 Tabletop Longitudinal Shift... 18 8.8 Changing the Angular Position of the Backrest Segment... 19 8.9 Changing the Angular Position of the Kidney Bench... 20 8.10 Insertion and Removal of the Footrest Segments... 20 8.11 Changing the Angular Position of the Footrest... 20 8.12 Rotation of the Footrest Segments... 20 8.13 Installation, Changing of Angular Position, and Rotation of Divided Footrest Segments... 21 8.14 Installation and Operation of Plate Footrest... 21 8.15 Installation and Operation of the Headrest... 22 8.16 Switching Footrests with Headrests... 22 8.17 Installation and Dismounting of Pads... 23 8.18 Table Mobility... 23 8.19 Anti-static Properties... 23 8.20 Potential Equalizing Clamp... 24 Page 3 of 40
8.21 Collisions... 24 8.22 Battery Charging... 24 9.0 DAILY INSPECTIONS... 25 10.0 CLEANING AND CARE... 25 11.0 MAINTENANCE AND SERVICING... 26 11.1 Storage... 26 11.2 Troubleshooting... 26 11.3 Every 6 Month Inspection: Technical Condition Check... 27 11.4 Every 12 Month Inspection / Preventative Maintenance: Technical Condition Check... 27 11.5 Repairs... 28 12.0 TECHNICAL SPECIFICATIONS... 29 12.1 Functional Parameters... 30 12.2 Critical Parameters... 31 13.0 ELECTROMAGNETIC INFORMATION... 31 13.1 Electromagnetic Environment... 31 13.2 Electromagnetic Compatibility... 33 14.0 SYMBOL AND LABEL IDENTIFICATION... 33 14.1 Placement of Labels on the SU-03 Operating Table... 39 15.0 DISPOSAL... 39 Page 4 of 40
1.0 Intended Use The SU-03 Operating Table is intended to be used for supporting patients during general surgical procedures, vascular surgical procedures, cardio surgical procedures, neurosurgery, urology procedures, gynecology procedures, proctology procedures, endoscopy procedures, laparoscopy procedures, ophthalmology procedures, trauma surgical procedures, oncology procedures, dental surgical procedures, and plastic surgery. 2.0 Contraindications The SU-03 Operating Table is not intended to be used with x-ray equipment where the x-ray passes through the patient prior to going through the top and mattress of the stretcher, (x-ray generator above the patient) and then to the image receptor. If x-rays are performed while the patient is on the stretcher, (1) the x-ray generator must be below the stretcher top or (2) the x-ray generator must be positioned in such a way that it does not pass through the stretcher top and to the image receptor after going through the patient, (i.e. x-ray generator above the patient and image receptor underneath the patient but above the mattress). 3.0 Warnings and Precautions Please read this user manual carefully and completely prior to operating the SU-03 Operating Table. Operating, maintaining and/or servicing of the SU-03 Operating Table in any way other than what is instructed within this manual is not permitted. By doing so, there is a potential for damage(s) to the SU-03 Operating Table. Should damages occur under such circumstances, the manufacturer will not be responsible for the damage(s) nor will the damage(s) be covered under the established warranty at the time of purchase. Every repair of the product must be done by an Oakworks authorized Service Provider with records maintained. Disregarding this requirement will cause the warranty for the product to be invalid. The use of the SU-03 Operating Table is prohibited if any mechanical defects are found during the initial installation and/or initial operation of the product. Please use the contact information provided within this User Manual to report all mechanical and physical defects that are found upon initial installation and/or initial operation. The use of different accessories, additional equipment, cables, and spare parts other than those offered and/or recommended by the manufacturer may cause an increase of emission and/or decrease of resistance to all electromagnetic phenomena. Accessories must be properly installed/fixed to the tabletop. The wired remote control is a mandatory accessory for the SU-03 Operating Table. The wired remote control must be within reach of the user in case it is to needed to be used due to a malfunction of the wireless remote control. Although it needs to be within reach of the user, it does not have to be connected permanently if the table is fitted with a wireless remote control or control panel In order to prolong the life of the battery, the user should properly charge the battery often (when the yellow and red LEDs have lit up). Any accessories, other than those recommended, must be approved by the manufacturer prior to being used with the SU-03 Operating Table. Any objects must be removed from below the table s surface prior to adjusting the angles or the height of the table. Page 5 of 40
Avoid endangering a patient s respiratory system, neural pathways and circulatory system by ensuring the patient is in proper position and by observing their condition. Throughout surgical procedures, the table must be connected to the installation of potential equalization in the operating room. Do not connect the SU-03 Operating Table to main power outlet in places where there is a danger of an explosion. Do not lay the patient s torso on the footrest segment. Do not use the cable when it is damaged or if the insulation is worn out. Do not shift the SU-03 Operating Table s position when any of the following attachments are installed due to the potential danger of capsizing the table: Orthopedic attachment, Proctology attachment, Gynecological Segment, and Shoulder Operation attachment. Do not store the SU-03 Operating Table that contains flat batteries. Flat batters will have a red diode that is illuminated on a controlling device during any movement. During procedures, the table wheels should be blocked. Lock the SU-03 Operating Table in the given position prior to transporting the patient. The SU-03 Operating Table has been designed to support 200 kg (441 lbs). The SU-03 Operating Table should not be placed into an area where there is a possibility that the connection to the main power outlet could be obstructed. The tabletop segment should not extend below or between elements of the tabletop when changing the tabletop segment s positioning. Throughout surgical procedures, the SU-03 Operating Table must be connected with a potential equalization cable within the operating room. When reverse-trendelenburg function is in use, the footrests may collide with the base. When changing the position of the SU-03 Operating Table, collisions between the table and any/all accessories must be avoided. When performing longitudinal tilt (Trendelenburg or reverse Trendelenburg) and lateral tilting, the patient should be secured to prevent them from sliding down from the operating table. Use shoulder supports, supporting rollers, side supports, belts and grips as securing elements. When the SU-03 Operating Table is supporting 135 kg (298 lbs) or more, functions that are performed and supported using electro-hydraulic systems can be used, but extra caution should be taken. When utilizing the SU-03 Operating Table close to medical equipment working on high frequencies and defibrillators, ensure the operating instructions for the equipment is followed correctly at all times. Improper operation may cause serious injury by burning the patient through the contact with the metal parts of the table and/or its equipment. Take extra caution when performing functions if the weight on the table is more than 135kg (298 lbs). Notes concerning start up, operation and use of the SU-03 Operating Table: Do not roll the SU-03 Operating Table over any electric cables, ramps, etc. Make sure the floor below the table is free from any/all objects. The backrest should be in the zero position or tilted above the level position while the Trendelenburg or reverse-trendelenburg function is activated. The longitudinal shift function should not be used with longitudinal tilt (Trendelenburg and reverse-trendelenburg) of more than ±6. The angular position of the backrest is manually changed by the user applying force. The SU-03 Operating Table must be connected to the appropriate main power outlet specified on the product label. The SU-03 Operating Table must be moved by at least 2 people. The SU-03 Operating Table should not be placed into an area where there is a possibility that the connection to the main power outlet could be obstructed. Page 6 of 40
When moving the table, it must be at the lowest height setting. While rolling the table, avoid any/all potential collisions. When performing the Trendelenburg function, the backrest should be in the zero position or protruded above the level position in order to avoid any collisions. Throughout surgical procedures, the table must be connected to the installation of potential equalization in the operating room. If the zero position is reached when the table is not horizontal, the inclination sensor on the SU-03 Operating Table must be calibrated. During repositioning of the tabletop, the user must hold the top with both hands using the handles. When the patient weights over 90kg (198 lbs.), extra caution should be taken when changing the angular position of the backrest segment. Be prepared to use significant force in order to raise the patient or to absorb a patient s weight after releasing the lever (Drawing 3, Item 21). Make sure that the backrest segment lever is locked in order to prevent any movement. When the patient s weight is more than 200kg (441 lbs), the user is not to change the angular position of the Kidney Bench. When performing the Trendelenburg and/or reverse-trendelenburg function or inclination function, the patient must be properly secured using shoulder supports, semi-bolsters, side supports, straps and grip handles to prevent the patient from slipping off of the SU-03 Operating Table When the alternative drive function is not in use, the lever should be set to the Zero Position. In order to use the alternative drive, the user should not hold up the pressed foot pump lever. After finishing the pumping, the user should lower the foot pump lever. When the alternative drive is not in use, the alternative drive should be placed in a position with an empty field. This is a precaution in order to avoid undesirable changing of the tabletop position due to accidental pressing the foot pump lever. 4.0 Description of SU-03 Operating Table The SU-03 Operating Table consists of a table base and tabletop. This specific table consists of a standard mobile base or a super mobile base which incorporates a large wheel. The mobile base is equipped with a central blockade that is released with a foot lever. The tabletop of the SU-03 Operating Table consists of segments. The number of segments as well as the configuration is based on the order from the customer. The tabletop consists of the specific order from the customer. The segments are radiolucent. Adjusting the position of the individual segments, in addition to the column movements, are performed by mechanical, electrical, electro-hydraulic, and hydraulic systems. As an option, the SU-03 Operating Table can be equipped with emergency alternative hydraulic drives which would enable the table s steering capability while the main driving system is non-functional. There are side rails on both sides of the tabletop which allow for the installation of accessories. Polyurethane mattresses accompany the tabletops. The standard version of the SU-03 Operating table can be controlled by a hard wired controller, wireless controller, foot controller, side control panel, or remote controlled/foot operated panel. The main power outlet is connected to the table by the power cord. In order to disconnect, the user must unplug the power cord from the main power outlet. Page 7 of 40
4.1 Components of SU-03 Operating Tables Components of SU-03 Operating Table Item Number Listed on the Drawings in Description Section 4.2, 4.3, and 4.4 1 Headrest 2 Backrest segment 3 Kidney bench 4 Seat segment 5 Footrest segment 6 Base 7 Column 8 Side rails 9 Kidney Support 9.1 Crank storage position 9.2 Crank for Kidney Support Adjustment 10 Kidney support crank handle 11 11.1 11.2 11.3 Pedal of central wheel locking system / locking feet ejection Wheels unlocked position / locking feet elevated Wheels locked position / locking feet lowered Directional wheel movement lock 12 Wheels 13 Base locking feet 14 Screw mechanism of the kidney support 15 Cable remote 16 16.1 16.2 16.3 16.4 16.5 16.6 Side panel Power socket Fuses Led indicators Main switch Internal power supply fuse Potential Equalizing Clamp 17 Wired remote control socket 18 Infrared sensor 19 Lever of headrest segment angle adjustment 20 Level or Trendelenburg and reverse-trendelenburg tabletop adjustment 21 Lever of backrest segment angle adjustment 22 Blockade of the Trendelenburg and reverse-trendelenburg tabletop shift adjustment lever 23 Blockade of the backrest segment angle adjustment lever 24 24.1 24.2 24.3 Footrest lock lever 25 Screw of the footrest spreading ankle locking system 26 Lever of legrest support segment angle adjustment 27 Lever of alternative drive pump (option) 28 Lever to change the alternative drive function (option) 29 Left Handle 30 Right Handle Page 8 of 40
4.2 SU-03 Operating Table Drawings Standard Page 9 of 40
4.3 SU-03 Operating Table Drawing Super Mobile Page 10 of 40
5.0 Unpacking the SU-03 Operating Table The SU-03 Operating Table is shipped by the manufacturer in an assembled form within a wooden crate or a cardboard box. The shipping container weighs 250 kg (551 lbs) and has the following dimensions: Length: 1340 mm (52.76 in) x Width: 700 mm (27.56 in) x Height: 890 mm (35.04 in) In order to avoid damage, the table should be unpacked and installed inside the building. It is highly recommended to unpack the SU-03 Operating Table after room temperature has been reached. The temperature gradient should be less than 10 C (18 F) per hour during storing and unpacking. To unpack the SU-03 Operating Table, the following actions must be completed: Read the completely and entirely Remove the fastening tape Remove the package Remove the materials used for protecting the table during transit Remove the equipment from the shipping container The SU-03 Operating Table packaging may be marked with the following symbols: Multiuse Package Package for Recycling LDPE Low-Density Polyethylene Packaging Disposal of the packaging must be compliant with the applicable regulations and requirements of the local state environmental protection agency, state health agency, Centers for Disease Control (CDC), Occupational Safety and Health Administration (OSHA), U.S. Food and Drug Administration (FDA) as well as any other local authorities that apply to each type of packaging. Page 11 of 40
6.0 Installation of SU-03 Operating Table After unpacking the SU-03 Operating Table, the below steps must be followed in order to prepare the table for operation: Step 1: Take out the equipment Step 2: Remove blocking elements of the table Step 3: Place the footrests horizontally (Section 8.13 Changing the Angular Position of the Footrests and Section 8.15 Changing the Angular Position of Separated Footrests). Step 4: Release the central blockade of the wheels (Section 8.20 Table Mobility) Step 5: With the assistance of a few people, carefully and slowly remove the table from the pallet. Then, immediately block the wheels. Step 6: Add the headrest (Section 8.17 Installation and Operation of the Headrest) Step 7: Connect the wired controller to the socket on the table column. Step 8: Place the table in the designated area which meets the requirements described in beginning of Section 8.0 Operation. Step 8: Refer to Section 9.0 Assessment of the Table Operation If the product is not fully functional, i.e. the output parameters differ from those described within this user manual, the SU-03 Operating Table must not be used! This situation should be reported to OAKWORKS, Inc. The use of an improperly functioning product may result in damages that will not be covered under the assigned warranty for the table. 6.1 Installation Checklist Check the locking and unlocking of the wheels leave wheels locked Turn on the table using main switch in the table base Turn on the remote control (inform about two wire remote control connecting sockets in the table column) Check all electric functions (concerns OT with electro-hydraulic and electromechanical drive): o Trendelenburg / reverse-trendelenburg o Lateral Tilts o Height Adjustment Check all manual functions including any purchased options o Headrest o Backrest Section o Kidney Elevation o Longitudinal Shift o Legrest Section up/down regulation and horizontal adjustment Disassembling and assembling of headrest segment and legrest segment Exchanging of the tabletop segments: headrest and legrest Installation of Accessories installation, adjustment and removal of the fixing clamps Inform client about safety/mail power supply batteries and charging procedures Daily inspections should be performed in accordance to the instructions specified in Section 9.0 Daily Inspections of this user manual. 7.0 Accessories Extra Accessories That May Be Provided with the SU-03 Operating Table Table Accessory Orthopedic table top /with head rest WS-45.06 and orthopedic attachment Hand support SO-12 (1 pce) without + WS-17.6 additional (1 pce) equipment/ for SU-03 Part Number BL-20.0 PR-01.5 Page 12 of 40
Foot support (1 pce) concerns SU-04 SG-42.0 Foot support (1 pce) concerns SU-02, SU-03, SU-05 SG-42.5 Gynecological-urological section (1 pce) concerns SU-04 SG-44.0 Gynecological-urological section (1 pce) concerns SU-02, SU-03, SG-44.6 SU-05 Drip bottle holder (1 pce) + WS-16.5 (1 pce) WK-01.5 Anesthetic frame (1 pce) + WS-17.6 (1 pce) WS-01.5 Anesthetic frame equipped with width regulation (1 pce) + WS-17.6 (1 pce) WS-01.6 Knee rests (2 pcs) + WS-17.6 (2 pcs) WS-05.5 Arm supports (left and right) + WS-16.5 (2 pcs) WS-06.5 Angle support (1 pce) + WS-16.5 (1 pce) WS-07.5 Large side support (2 pcs) + WS-16.5 (2 pcs) WS-08.5 X-ray tray under seat section (1 pce) concerns SU-02, SU-03, SU- 04, SU-05, WS-11.7 Mobile hanger for equipment (1 pce) WS-13.5 Stand for orthopedic attachment (1 pce) WS- 13.7 Holder for anesthetic tubes (1 pce) + WS-16.5 (1 pce) WS-14.5 Tray for accessories (1 pce) +WS-16.5 (1 pce) WS-15.5 Clamp mechanism (1 pce) WS-16.5 Multiposition clamp mechanism (1 pce) WS-17.6 Multiposition clamp mechanism (1 pce) WS-17.7 X-ray cassette tray under the back rest section (1 pce) concerns SU-05, SU-04, SU-03, SU-02 WS-19.7 Specialistic head rest (1 pce) concerns BL-20, SU-14 WS-21.11 Specialistic head rest (1 pce) concerns SU-02, SU-03, SU-04, SU- 05, SU-10 /for SU-02, SU-03, SU-05, SU-10 obligatory add WS- 84.7/ Specialistic head rest (1 pce) concerns SZ-01, SU-02, SU-03, SU- 04, SU-05, SU-10 /for SU-02, SU-03, SU-05, SU-10 obligatory add WS-84.7/ Head rest for neck bone operation (1 pce) concerns SU-02, SU-03, SU-04; SU-05; SU-10 /for SU-02, SU-03, SU-05, SU-10 obligatory add Specialistic WS-84.7/ head rest (1 pce) concerns SU-02, SU-03, SU-04; SU- 05; SU-10 /for SU-02, SU-03, SU-05, SU-10 obligatory add WS- 84.7/ Hand support (1 pce) + WS-17.6 (2 pcs) Abdominal strap (1 pce.) Gynecological attachment (1 pce) concerns SU-02, SU-03, SU-05, SU-10, SU-14 Urological attachment (1 pce) concerns SU-02, SU-03, SU-05, SU- 10, SU-14 Proctological attachment (1 pce) + WS-17.6 (2 pcs) concerns SU- 02, SU-03, SU-04; SU-05, SU-10 Side rails (1 set) Side holder for x-ray tray (1 pce)+ WS-16.5 (1 pce) Wristlet (1 pce) Arthroscopic treatment attachment (1 pce) + WS-17.7 (1 pce) Attachment for meniscus treatment (1 pce) + WS-17.7 (1 pce) Abdominal strap (1 pce) Leg strap (1 pce) Leg strap (1 pce) Hand holder(1 pce) (hanged on the anesthetic frame ) Thigh holder (1 pce) Thigh holder (1 pce) Specialistic plate head rest (1 pce) concerns SU-10, SU-05, SU-04, SU-03, SU-02 /for SU-02, SU-03, SU-05, SU-10 obligatory add WS- 84.7/ Wide specialistic head rest (1 pce) concerns SU-10, SU-05, SU-14, SU-03, SU-02 /for SU-02, SU-03, SU-05, SU-10 obligatory add WS-84.7/ Attachment for hand operation (1 pce) + WS-17.6 (2 pcs) WS-21.4 WS-21.5 WS-21.8 WS-21.9 WS-22.5 WS-23.0 WS-28.7 WS-29.7 WS-29.7 WS-30.5 WS-30.5 WS-32.5 WS-33.0 WS-34.5 WS-39.5 WS-40.5 WS-41.0 WS-42.0 WS-42.1 WS-43.0 WS-44.0 WS-44.1 WS-45.5 WS-45.6 WS-47.5 Page 13 of 40
Support for hand operation (1 pce) Pubic support (1pce) + WS-17.7 (1 pce) Side support (2 pcs) + WS-16.5 (2 pcs) Side support with lever (1pce) + WS-16.5 (1 pce) Chest support (1 pce)+ WS-16.5 (1 pce) Attachment for side rail (1 pce) Side shoulder support (2 pcs) + WS-16.5 (2 pcs) Wire hand controller (1 pce) concerns SU-03 Wireless hand controller (1 pce) concerns SU-03 Wireless hand controller (1 pce) concerns SU-03 power supply 120 Arthroscopic V treatment attachment (1 pce) + WS-17.7 (1 pce) Attachment for meniscus treatment (1 pce) + WS-17.7 (1 pce) Abdominal strap (1 pce) Leg strap (1 pce) Leg strap (1 pce) Lithotomy stirrups (2 pcs) + WS-17.6 ( 2 pcs) Mattress for backbone operation (1 pce) Half roll (1 pce) Under neck roll (1 pce ) Head rest (1 pce) Support for plastering (1 pce) for SU-02,-03, -05,-10 Orthopedic attachment - leg abducence holder CWS8207. It works with Arthroscopic treatment attachment WS-39.5 or Meniscus treatment attachment WS-40.5 mounted on left or right arn of Orthopedic attachment SO-11 i SO-12. Headrest segment seating - add for SU-02, SU-03, SU-04, SU-05 with WS-21 specialistic head rests Attachment for knee operation (1 pce) for SU-02, -03, -05, -10 Support for shoulder surgery (1 pce) Roller lift (1 pce) concerns WS-21.11, WS-21.5, WS-21.8 Strainer for urological bowl (1 pce) Attachment for shoulder surgery with head rest WS-21.11 (1 set) concerns SU-02, SU-03, SU-05 Bag holder + WS-16.5 (1 pce) Hip support (1 pce) Attachment for backward nailing concerns SU-02, SU-03, SU-04, SU-05, SU-10, SU-14 Attachment for the leg abduction with WS-17.6 Additional Equipment for the SO-11 Orthopedic Attachment Support for plastering (1 pce) Foot supports (2 pcs) + support grips WS-82.5 (2 pcs) Bar supports (2 pcs) + support grips WS-82.5 (2 pcs) Support grip (1 pce) Foot grips (2 pcs) concerns Heel holders (2 pcs) Hip support (1 pce) Attachment for knee operation (1 pce) Stand for orthopedic attachment (1 pce) Orthopedic attachment trolley (1 pce ) WS-48.5 WS-49.5 WS-50.5 WS-50.6 WS-52.5 WS-53.0 WS-59.5 WS-62.10 WS-63.10 WS-63.103 WS-64.5 WS-65.0 WS-66.0 WS-68.0 WS-69.0 WS-64.5 WS-65.0 WS-66.0 WS-68.0 WS-69.0 WS-70.6 WS-82.7 WS-84.7 WS-85.6 WS-87.5 WS-88.5 WS-89.5 WS-91.7 WS-92.5 WS-93.5 WS-95.5 WS-96.5 Part Number WS-70.5 WS-71.5 WS-72.5 WS-82.5 WS-73.5 WS-74.5 WS-60.5 WS-85.5 WS-13.6 WS-80.5 Additional Equipment for the SO-12 Orthopedic Attachment Support for plastering (1 pce) Foot supports (2 pcs) + support grips WS-82.5 (2 pcs) Bar supports (2 pcs) + support grips WS-82.5 (2 pcs) Support grip (1 pce) Foot grips (2 pcs) concerns Part Number WS-70.6 WS-71.5 WS-72.5 WS-82.5 WS-73.5 Page 14 of 40
Heel holders (2 pcs) Knee support (1 pce) Hip support (1 pce) Support holder (1 pce) Attachment for knee operation (1 pce) Orthopedic attachment arm support Stand for orthopedic attachment (1 pce) Orthopedic attachment trolley (1 pce ) Support for plastering (1 pce) Foot supports (2 pcs) + support grips WS-82.5 (2 pcs) WS-74.5 WS-75.5 WS-60.6 WS-82.5 WS-85.6 WS-86.6 WS-13.7 WS-80.7 WS-70.6 WS-71.5 The hand controller is a mandatory accessory for surgical tables. 8.0 Operation The SU-03 Operating Table is designed to be used indoors within a climate consisting of a temperature of +10 Celsius (50 Fahrenheit) to +40 Celsius (104 Fahrenheit). Acceptable change of temperature within an 8 hour period should not exceed 20 Celsius (68 Fahrenheit). The relative humidity in the surroundings of which the SU-03 Operating Table will be functioning must range from 30% to 80%. The range of atmospheric pressure inside the area of operation can be 700 to 1060 hpa. 8.1 Controlling Elements Wired Remote Control 3 2 1 5 6 9 7 8 Drawing 6 4 Page 15 of 40
Wired Remote Control Functions (See Drawing 6) ITEM FUNCTION 1 ON Button 2 Action Button Up 3 Action Button Down 4 Zero Position 5 Tabletop Height 6 Lateral Tilt 7 Longitudinal Tilt 8 Tabletop Orientation 9 Trendelenburg Position The SU-03 Operating Table wired remote control can be connected to the head of the table or foot of the table. To connect the wired remote controller, insert the plug into the socket of choice and tighten the ring on the plug. To activate the table press ON button [1] and hold for a moment. During operation, the display is active and buttons are backlighted. The remote control display shows the battery status, the status of the table and the currently operated function with parameters. The table is automatically deactivated after about 12s from the last time the button was pressed. To control the position or functions of the table select the desired function on the remote control. On the remote control display the selected function icon will appear. Then using buttons + [2] and/or - [3] adjust table top position. Trendelenburg function button [9] works independently from + / - buttons. Pressing Trendelenburg function button leads to immediate adjustment of that function, if the remote control is activated. The wired remote control is a mandatory accessory for the SU-03 Operating Table. The wired remote control must be within reach of the user in case it is to needed to be used due to a malfunction of the wireless remote control. Although it needs to be within reach of the user, it does not have to be connected permanently if the table is fitted with a wireless remote control or control panel. 8.2 Controlling Elements Alternative Drive (Option) Drawing 7 Alternative Drive (Option) Functions (See Drawing 7) ITEM FUNCTION 1 Tabletop Height Adjustment - Up 2 Tabletop Height Adjustment - Down 3 Lateral Tilt Left 4 Lateral Tilt - Right 5 reverse-trendelenburg Tilt Page 16 of 40
6 Trendelenburg Tilt 7 Zero Position of the Function Selection Lever 8 LED Diodes Indicating Condition of Alternative Drive Batteries 9 LED Diodes Indicating Charging of Alternative Drive Batteries The alternative drive is a second independent table drive which serves as a back up to the electro-hydraulic drive, also independent. In order to change the tabletop height, angular tabletop positions (Trendelenburg, reverse-trendelenburg and lateral tilt) as well as the adjustment of the backrest segment, the user should adjust the lever of the alternative drive functions (Drawing 5, Item 28) of the desired function specified in positions 1-6 of Drawing 9 by using their foot. Next, press on the foot pump level (Drawing 5, Item 27) until the desired tabletop position is obtained. The movement of the tabletop occurs while the user is pressing the foot pump lever only and 5 seconds after the user is finished pumping. When the lever for a desired function is in use by a different function other than the locked position (Drawing 4, Item 11.2), the controlling of the tabletop functions by means of a remote control or side panel are not possible. Once the user positions the tabletop as desired, the alternative drive should be set to the Zero position (Drawing 7, Item 7). With the alternative drive, the user has the capability of monitoring the charging rate of the alternative drive battery based on the color of the LED diodes (Drawing 7, Item 8). Batteries are fully charged when the diodes are green. When the diodes are yellow, this signifies the recommendation that the battery needs to be charged. When the battery is charging, a separate diode LED will light up (Drawing 7, item 9). If the diodes are red, that informs the user that the battery is dead and needs to be charged. In this case, the alternative drive function should not be used. In addition to the red light, there is also an interrupted sound signal. If the alternative drive function is disabled, the SU-03 Operating Table tabletop can still be be changed by means of a wired remote control or side panel. The SU-03 Operating Table is equipped with a buffer charger that enables the concurrent battery to charge while the table is in use. Once the SU-03 Operating Table is switched from wirless to electric, the battery automatically begins to charge. In order to prolong the life of the battery, the user should properly charge the battery often (when the yellow and red LEDs have lit up). When the alternative drive function is not in use, the lever should be set to the Zero Position. In order to use the alternative drive, the user should not hold up the pressed foot pump lever. After finishing the pumping, the user should lower the foot pump lever. When the alternative drive is not in use, the alternative drive should be placed in a position with an empty field. This is a precaution in order to avoid undesirable changing of the tabletop position due to accidental pressing the foot pump lever. 8.3 Raising and Leveling of Tabletop The height of the SU-03 tabletop can be changed within the range listed in Section 12.0 Technical Specifications, the user must press function button [5] and then press the button + [2] or button - [3] depending upon the desired position. When the desired position is reached, the tabletop will automatically stop. Take extra caution when performing functions if the weight on the table is more than 135kg (298 lbs). Page 17 of 40
8.4 Longitudinal Tilt Adjustment To adjust the SU-03 Operating Table s tabletop longitudinal angle, within the range listed in Section 12.0 Technical Specifications, the user must press function button [7] and then press the button [2] or button [3] depending upon the desired position (Trendelenburg position adjustment is performed directly by pressing button 9). Once the desired position is acquired, the user must let go of the button. If the Trendelenburg or reverse-trendelenburg reaches the maximum tilting range as specified in Section 12.0 Technical Specifications, the tabletop will automatically stop moving. Take extra caution when performing functions if the weight on the table is more than 135kg (298 lbs). When performing the Trendelenburg and/or reverse-trendelenburg function, the patient must be properly secured using shoulder supports, semi-bolsters, side supports, straps and grip handles to prevent the patient from slipping off of the SU-03 Operating Table. When performing the Trendelenburg function, the backrest should be in the zero position or protruded above the level position in order to avoid any collisions. 8.5 Tabletop Side Inclination To adjust the SU-03 Operating Table s tabletop side inclination within the range listed in Section 12.0 Technical Specifications, the user must press function button [6] and then press the button [2] or button [3] depending upon the desired position. Once the desired position is acquired, the user must let go of the button. If the maximum tilting range as specified in Section 12.0 Technical Specifications is reached, the tabletop will automatically stop moving. Take extra caution when performing functions if the weight on the table is more than 135kg (298 lbs). When performing the side inclination function, the patient must be properly secured using shoulder supports, supporting rollers, side supports, belts and grip handles to prevent the patient from slipping off of the SU-03 Operating Table. 8.6 Zero Position To get to the zero position of the SU-03 Operating Table s tabletop (i.e. zero angle of the Trendelenburg, reverse-trendelenburg, and said inclination functions), the user should press button [4] on the wired remote control, wireless remote control, or side panel designated for the zero position. The button should be pressed until the zero position is reached (i.e. the moment when the tabletop movement has stopped). If the user fails to continue to press the button prior to reaching the zero position, the tabletop shall remain in that position. Take extra caution when performing functions if the weight on the table is more than 135kg (298 lbs). If the zero position is reached when the table is not horizontal, the inclination sensor on the SU-03 Operating Table must be calibrated. 8.7 Tabletop Longitudinal Shift In order to change the position of the SU-03 Operating Table s tabletop longitudinal shift, the user must stand behind the backrest and grab the handles with both hands (Drawing Page 18 of 40
3, Items 29 and 30). Then, using the side of the index finger on their left hand, the user must press the blockade button (Drawing 2, Item 22) and pull the lever (Drawing 3, Item 20). Next, the user must place the tabletop in the desired position within the range specified in Section 12.0 Technical Specifications, and release the lever. After releasing the lever, the blockade is automatically locked and further adjustment of the tabletop is disabled. The user can check to make sure it is locked by pulling the lever again. If the blockade is properly locked, the user will not be able to pull the lever without releasing the blockade first. During repositioning of the tabletop, the user must hold the top with both hands using the handles (Drawing 3, Items 29 and 30). This function is not allowed to be performed if the patient weights more than 200kg (441lbs). While performing this function, take extra caution in preventing collisions between table segments, surface, and/or table base. 8.8 Changing the Angular Position of the Backrest Segment Changing the angular position of the backrest segment (Drawing 1, Item 2) is performed by using force and support from gas springs. In order to adjust the angular position of the backrest segment, the user must press the locking button (Drawing 3, Item 23), lift the lever (Drawing 3, Item 21), and then place the segment in the desired position. Once in the desired position, the user must release the lever (Drawing 3, Item 21). After releasing the lever, the backrest segment mechanism is blocked and further adjustment is disabled. Remember to hold the backrest segment with both hands while adjusting the position. Due to the central position of the lever, the backrest segment can be utilized from the right side, the left side, as well as behind the backrest. When the patient weights over 90kg (198 lbs.), extra caution should be taken when changing the angular position of the backrest segment. Be prepared to use significant force in order to raise the patient or to absorb a patient s weight after Page 19 of 40
releasing the lever (Drawing 3, Item 21). Make sure that the backrest segment lever is locked in order to prevent any movement. 8.9 Changing the Angular Position of the Kidney Bench Changing the angular position of the kidney bench (Drawing 1, Item 3) is performed with the use of the crank (Drawing 1, Item 9.1), placed in the sleeve (Drawing 1, Item 10) which is located on the left side of the tabletop. To adjust the position of the kidney bench, place the crank on the screw mechanism of the kidney bench (Drawing 3, Item 14). Next, obtain the desired position by turning the crank left or right. If the crank is not in use, it s important to store it in the sleeve. When the patient s weight is more than 200kg (441 lbs), the user is not to change the angular position of the Kidney Bench. 8.10 Insertion and Removal of the Footrest Segments The footrest segments (Drawing 1, Item 5) can be installed and removed from the seat segment due to the mechanism moved by the lever (Drawing 2, Item 24). In order to remove the footrest segment, the user should take the segment by its bottom, pull the lever until it is level and take the segment out of the wedge pin of the seat segment (Drawing 1, Item 4). To install the footrest segment, the user should raise lever until it is level and place wedge socket of the footrest segment on the wedge pin of the seat segment until they are level. When the segment is installed, the user should lower the lever (Drawing 1, Item 24) to its starting position and pushed down. Before pulling the lever the segment should be grabbed by the user! Make sure that the lever is in the correct position. 8.11 Changing the Angular Position of the Footrest Changing the angular position of the footrest, within the range listed in Section 12.0 Technical Specifications, occurs by simultaneous lowering of the lever (Drawing 1, Item 26) and raising/lowering of the footrest segment to the desired level. When the pressure is removed from the lever, the mechanism is locked and the position of the footrest is determined. When the reverse-trendelenburg function is performed, the footrests may collide with the base when lowering significantly below the level! 8.12 Rotation of the Footrest Segments In order to move the footrest segments apart from one another, the user must unscrew the footrest spreading ankle locking system (Drawing 1, Item 25) counterclockwise until the rack is released. This allows the rotation of the segment, the rotation of the footrest segment to the desired angle as long as it is within the range specified in Section 12.0 Technical Specifications, as well as locking the segment by turning the knob. The racks must be fitted with each other properly. When the knob is being tightened, pay extra attention to the racks Page 20 of 40
8.13 Installation, Changing of Angular Position, and Rotation of Divided Footrest Segments Divided footrest segments (Drawing 13) can be installed and removed from the seat segment with the use of the lever activation mechanism. In order to remove the footrest segment, the user should pull the lever towards them until it reaches the horizontal position (Drawing 13, Item 1). Next, life the footrest segment until it is removed from the pin in the seat segment (Drawing 13, Item 4). The footrest segment is installed by lifting the lever until level (Drawing 13, Item 1) and putting the mortise of the footrest segment on the pin of the seat segment until there is equal leveling between the mortise and the pin. After putting the segment on, lower the lever (Drawing 13, Item 1) to the initial position and push it. To change the angular position and rotation swing of the short part (Drawing 13, Item 3) or long part (Drawing 13, item 5) of the divided footrest, the user should, with the use of one hand, hold the segment by its bottom and press the blockade (Drawing 13, Item 6) with the use of the thumb of the other hand. Pushing the blockade enables the opening of the handle (Drawing 13, Item 2 or 4). Once the handle is open, place the selected footrest segment in desired position in relation to the two rotation axes. Lock it by closing the handle. After closing the handle, it should return to its initial position, preventing repeated opening of the handle. After determining the position of the footrest and closing the handles, make sure that the blockades for the handles return to the correct position. This can be done by trying to open the door handle as the door handles should not be able to open if this is done correctly! It is prohibited to change position of footrests with the position of headrest in the case of divided footrests Configuration B. 8.14 Installation and Operation of Plate Footrest The plate footrest (see Drawing 14, Item 1) is installed on the pins placed at the end of the seat segment with the use of blockades located in the middle of the footrest (see Drawing 14, Item 2). Before mounting the footrest to the seat segment, the user should pull out both footrest blockades and turn them approximately 90. Additionally, the user should put the mortise on the pins located on the seat segment and position it correctly by turning back the footrest blockade until the automatic blockade will return to its initial position. To remove the footrest, pull out both footrest blockades and turn them approximately 90. Next, remove the footrest from seat segment pins. Changing the angular position of the footrest (see Drawing 14, item 3) is possible due to the lever controlling the gas spring mechanism. When the lever is pressed, the required angle of the footrest may be chosen. The release of the lever locks the footrest in the desired position. Page 21 of 40
To ensure that the footrest is properly installed, the user should attempt to remove the blocked footrest. If it was installed correctly, it should not be removable! 8.15 Installation and Operation of the Headrest The headrest (see Drawing 15, Item 1) is fastened on installation wedges, which are situated at the end of the backrest segment. They are fastened by using a knob and two blockades that are placed in the middle of back of the headrest (see Drawing 15, Item 2). Before installing the headrest to the backrest segment, the user should remove both headrest blockades and turn them approximately 90. Next, the user should install the wedge sockets of the headrest on the wedge chop of the backrest and determine the position by turning back the rest blockades until the automatic blockade returns to its initial position. To remove the headrest, pull out both headrest blockades and turn them approximately 90. Remove the headrest from the chop wedge of the backrest segment. The angle of the headrest is changed in a manner very similar to the backrest segment. Specifically, by using the lever which controls the gas springs. When the lever is pressed, the required angle of the headrest may be chosen. When the lever is released, it locks the headrest in the desired position. To ensure that the headrest is properly installed, the user should attempt to remove the blocked headrest. It should not be able to be removed by doing so if it was installed correctly! 8.16 Switching Footrests with Headrests With the SU-03 Operating Table, the user has the option to switch footrests and headrests. This is known as Configuration B. With this configuration, a headrest is installed on pins for the seat segment. Footrests are installed on pins provided for the backrest segment. The method of installation and removal of these segments are identical to the Configuration A. Configuration A consists of a headrest from the backrest segment s side as well as leg rests from the seat segment s side. For Configuration B, the Trendelenburg and reverse-trendelenburg functions labels should be interpreted the other way around. This means that Trendelenburg should be interpreted as reverse-trendelenburg and the label referring to the backrest should be interpreted as referring to the seat segment. Page 22 of 40
8.17 Installation and Dismounting of Pads All pads can be removed without the use of any tools as they are fixed on pegs. 8.18 Table Mobility The table may move in all directions due to the wheels that are fastened onto the base. The SU-03 Operating Table is equipped with movement blockades that are used during operations and procedures. SU-03 Operating Table - Standard Model The SU-03 Operating Table, in the standard model is equipped with two feet (Drawing 1, Item 13). Lowering of the feet will cause the wheels to elevate and lose contact with the floor. This prevents the table from being able to roll. The height of the feet, which is a direct correlation to the preventative element they provide, can be adjusted by screwing and unscrewing the feet themselves. In order to lower the feet, push the pedal toward the floor until the resistance is felt (Drawing 1, Item 11.2). In order to elevate the feet, lift the pedal to the upright position (Drawing 1, Item 11.1). SU-03 Operating Table Super Mobile Model The SU-03 Operating Table, in the super mobile model, is equipped with a central blockade. The pedal that controls the central blockade has the following three positions: Upper Lock of direction for 2 wheels Middle Unlocked Lower All wheels are locked While in the upper position for direction lock, the wheels are aligned to roll in a straight direction. This specific position is used to roll the table through long, straight distances as well as facilitate the turning of the table. When the pedal is set to the lower position for all wheels locked mode, this makes the table immobilized. Throughout surgical procedures, table wheels should be blocked. The SU-03 Operating Table must be moved by at least 2 people. While patient is on the table, do not roll it over ramps. Trundle table is the minimum amount. Do not roll the SU-03 Operating Table over any electric cables. Make sure the floor below the table is free from any/all objects. While rolling the table, avoid any/all potential collisions. When moving the table, it must be at the lowest height setting. 8.19 Anti-static Properties The SU-03 Operating Table s construction allows grounding of static charge through the following routes: By anti-static wheels to conducting floor By potential equalization clamp The SU-03 Operating Table should be used on anti-static floor. If this is not feasible, a static charge is grounded through the cord for potential equalization. The potential equalizing conductor is a standard table accessory. The anti-static properties of the table shall be maintained if the pad that is being used with the SU-03 Operating Table is manufactured by the manufacturer of the table. Page 23 of 40
8.20 Potential Equalizing Clamp The SU-03 Operating Table has a system of potential equalization leading to the clamp (Drawing 2, Item 16.6). This is marked by the following symbol:. The cable is provided in standard table accessories. Throughout surgical procedures, the table must be connected to the installation of potential equalization in the operating room. 8.21 Collisions In some extreme positions of the SU-03 Operating Table, specifically when accessories are installed on the side(s) of the table, mechanical collisions may take place. Because of this, the user should protect the table and accessories from any/all damages that may occur as a result. The following scenarios also increase the risk of collision: Lowering the backrest when the Trendelenburg function is actively being used may cause collision between the backrest and column. Lowering the SU-03 Operating Table s height or footrest while the Trendelenburg or anti-trendelenburg poses a risk for collision. When reverse-trendelenburg function is in use, the footrests may collide with the base. 8.22 Battery Charging The SU-03 Operating Table has a built-in charger which makes it possible to charge the batteries in the table. In order to charge the batteries, the user must connect a power supply cord to a socket in the table and set the switch (Drawing 2, Item 16.4) in position l. When the power is on, this is indicated by green LED diodes on a connection panel (Drawing 2, Item 16.3). Batteries are charged automatically. The charging process consists of two phases: 1. First Phase: This is indicated by yellow LED diodes on a connection panel, which signifies that there is high-current charging taking place. 2. Second Phase: Upon completion of the first phase, the diodes go out (show no color) and the second phase then begins. This phase is stricturly for supporting charging. After high-current charging, the batteries should be charged for approximately 4 hours. This makes the total charging time approximately 12 hours. Charging time may be prolonged without any damage to the battery. When the batteries are full, the supply cable should be disconnected. If after 12 hours of charging both diodes on the connection panel are still on, this means that the table is damaged. Please refer to the contact information section of this user manual to contact the customer service department promptly. The SU-03 Operating Table can perform approximately 80 surgeries from full batteries. One cycle is considered the execution within the whole movement range, of all of the moves, which ae operated electrically. It is best to charge the batteries when the yellow diodes on the remote control is on. It is required to charge batteries when the red diodes turn on. If the batteries are always charged after they are fully discharged (the red diodes are on), the time of every fifth charging should be twice as long. This is why it is recommended to charge halfdischarged batteries (when the yellow diodes are on). Batter life time is 3 years. Page 24 of 40
The SU-03 Operating Table may not be stored with low batteries (during any movement with red diodes on the wired remote control on). If the batteries need to be changed, also change a set of two batteries. Changing a single battery limits the operating time of the table and causes quick wear of a new battery. 9.0 Daily Inspections The SU-03 Operating Table should be checked every day prior to use to ensure it is operating/functioning properly! Below are the steps that must be followed for assessing the operation of the table and ensuring that it is operating/functioning properly: 1. Check the stability of the table when the feet are down by trying to move the table manually. Pushing the table in any direction should not cause tilting or moving. 2. Check all mechanisms used for adjusting segments that are controlled by gas springs by a change of position and the lock (see Section 8.0 Operation). The mechanism should work without jamming. After locking the segment, the user should not be able to change the position. Check this requirement by manually pressing on the segment which is locked. 3. Verify that there is no mechanical play by manually moving the top of the table. 4. Check the level of the batteries on the diodes which are on the control. 5. Check the electro-hydraulic system by raising the table column using the foot pump. If the table underwent the above described tests with positive results and there were no disturbing sounds (squeaks and grinds), the table can be used safely. If they do not pass the checks, please see Section 11.0 Maintenance and Servicing.. If the product is not fully functional, i.e. the output parameters differ from those described within this user manual, the SU-03 Operating Table must not be used! 10.0 Cleaning and Care For cleaning and disinfecting use those that are recommended by the manufacturer, refer to document List of Cleaning Agents and Disinfectants for inspirit Medical Solutions Products. After disinfecting, wash the product with water to remove remnants of disinfectant. After disinfecting dry thoroughly. Dry with hot air (max. temp. 60 C or 140 F) or by wiping with a soft sterile cloth. Agents containing alcohol cannot be used on parts made of polyurethane (pads). Do not disinfect the product within disinfection chambers. Elements made of plastic cannot be treated with any cleaning or disinfecting agents that contain ingredients which would destroy the linkage structure. An example of such ingredients would be organic solvents. Prior to disinfecting the SU-03 Operating Table, ensure the table is disconnected from the main power outlet. No bleaching agents (containing active chlorine or oxygen), caustic or corrosive chemicals are allowed to be used on the SU-03 Operating Table. No disinfecting agents containing alcohol are allowed to be used in the cleaning of the polyurethane mattresses. The hand controls, both wired and wireless, cannot be submerged in disinfectants. The product must not be disinfected in disinfecting chambers. Page 25 of 40
Disregarding the above requirements for cleaning and disinfecting shall result in loss of the warranty for the SU-03 Operating Table. 11.0 Maintenance and Servicing Hand supports should be fixed on the table strip with a multi-position grip. This enables the support of angular movements. If it is necessary to replace oil, the user should follow the appropriate environmental protection regulations. The electrical conductivity must be checked once a year. This activity must be performed by a trained service professional. The hand controller must be properly maintained and serviced when necessary as it is used as a back up to operate the SU-03 Operating Table should the wireless hand controller fail to function properly. When batteries need to be changed, it s important to change 2 batteries at a time as changing a single battery will cause quick wear of the new battery. As a result, this will hinder the operating time of the table. 11.1 Storage If the product is not to be used for a long period of time, it should be stored in the below mentioned climatic conditions: temperature: 25º (77 F) ±10ºC (18 F) relative humidity: 50% ± 25%. During storing, the operating table must be turned off. The switch must be in the 0 position. If the table is stored for a longer period of time, it must be connected to the power supply for 24 hours every 6 months to charge the batteries. The table may not be stored when the batteries are low (during any movement the red diodes on the wired remote control are illuminated). 11.2 Troubleshooting If damage(s) and/or defect(s) are found on/in the product or product accessories, the product and/or accessories should be taken out of service and not used until properly repaired. Problem Possible cause Action - Locked wheels - Unlock blockade pedal - The table feet are - Tighten the table feet twisted too much The table cannot be moved The Trendelenburg mechanism does not work The table is not stable Play in screw joints The Trendelenburg wire is wrongly adjusted Wrong adjustment of table feet Plays appeared during product operation Adjust the wire according to the directions listed within this user manual. Unscrew or screw down feet with the appropriate wrench Screw down the joints using the appropriate wrenches If the problem cannot be eliminated, please contact OAKWORKS, Inc. for service. Page 26 of 40
11.3 Every 6 Month Inspection: Technical Condition Check In order to ensure safe and proper technical condition of the product, the product should undergo periodical technical inspections to be carried out by authorized and trained technical staff. (Six (6) months is the maximum time allowed in-between inspections). Technical inspections of the product must be performed and recorded. Proof of 6 Month Inspections are required prior to approval of a Warranty Claim In order to provide safe and correct operation during product life, the user should perform the following activities every six months: Scope of technical condition check Functionality check carried out by executing all movements according to ranges provided in Section 12.0 Technical Specifications Check of screwed joints visible without removing covers Check whether there are any mechanical clearances and whether all interlocks work properly Power lead condition check Wire-control unit insulation condition check Column bellows condition check Pad condition check Check of central wheel s interlock efficiency 11.4 Every 12 Month Inspection / Preventative Maintenance: Technical Condition Check In order to provide safe and correct operation during product life, the user should perform the following activities every 12 months: 12 Month Technical Inspection Check Range of Technical Inspections - checking functionality - checking general technical condition - checking the conductivity of the table to ensure compliance with IEC 62352 standard Frequency Every 12 months An inspection consists of a visual inspection and the noticed malfunctions resolved prior to using the product. In order to ensure safe and trouble-free operation of the product during its lifetime, the user should perform tests of compliance within the IEC 62353 Standard, according to the following table. Tests should be performed in the following situations: - after repairs - periodically (every 12 months) Visual Inspection Measurements Functional Test Technical Condition Check Scope of Inspection Checking all fuses accessible from the outside, and their conformity with documentation (fuse capacity, characteristics) Checking if all markings and labels are in place and legible Checking if all mechanical parts are in place Checking for damages and checking for cleanliness of the device checking accessories Checking product documentation and documentation of previous inspections Measurement of protective earthing resistance Measurement of leakage currents Measurement of patient s leakage current Measurement of insulation resistance The functional test should be performed in the presence of a person with appropriate qualifications and training to operate the given device The functional test and the results of specific tests and measurements should be documented. Page 27 of 40
No Name Qt. Code number Category 1 Battery 2 S11112000012120 3 2 Battery (SU-03.5) 2 S11112000000485 3 3 Control system of table SU-03 1 R60050-SU0300000 1 4 Control system (SU-03.5) 1 R60050-SU0314000 1 5 Control unit of one way pump 1 S11155000044180 1 6 Standard, antistatic wheels Ø125 4 S06549041250XSX 1 7 Standard, antistatic wheels Ø80 1 S06549040803470 1 8 Antistatic wheels Ø125 (SU-03.14) 1set. R60012-125-10000 1 9 Footer set (SU-03.9) 4 C047301060000/A01/ 2 10 Blockade pedal (SU-03.9) 1 C212201030000/-02/ 1 11 Spring 2 C047301000008/A00/ 1 12 Block of electric valves TLC3 1 S091660010BZ030 1 13 Micro-set 1 S091660010MA030 1 14 Harmonic like protection 1 S13732133000034 3 15 Infrared sensor 2 C00TF125 1 16 Attachable panel 1 C218801110000 2 17 Servo-motor top-bottom 1 S091660010SHGD3 1 18 Servo-motor for Trendelenburg 1 S091660010SHT03 1 19 Servo-motor of heel side 1 S091660010SHPB3 1 20 Hydraulic rope l=390 1 C213322010100/-01/W1 1 21 Hydraulic rope l=490 2 C213322010100/-01/W2 1 22 Hydraulic rope l=450 1 C213322010100/-01/W3 1 23 Hydraulic rope l=430 1 C213322010100/-01/W4 1 24 Hydraulic rope l=410 1 C213322010100/-01/W5 1 25 Hydraulic rope l=280 2 C213322010200W01 1 26 Blockade set L+R 2 C191906000000L/-01/ 1 27 Motive system of back rest 2 C216304000000/-01/ 1 28 Seat mattress 1 C216500000012 3 29 Back rest mattress 1 C080203000000/-02/ 3 30 Mattress set I 1 C080300000042/-01/ 3 31 Mattress set II 1 C080300000043/A01/ 3 32 Crank set 1 C067204000000/A00/ 2 33 Motive system of footrest L+R 1 C191903000000 1 34 Mattress of footrest L+R 1 C080805000000L/-01/ 3 35 Motive system of head rest section 2 C216103000000 1 36 Mattress of head rest section 1 C080105000000/-01/ 3 Category Legend1 1 - Items expected to wear out or need to be replaced during 10-year life 2 - Items that may wear out or need to be replaced during 10-year life 3 - Items that wear or need to be replaced based on usage. 11.5 Repairs Repairs are performed by an OAKWORKS Inc. authorized service provider. The user cannot carry out any repairs unless they have undergone special training and authorized by OAKWORKS Inc. The Manufacturer only allows the use of original spare parts. Worn out parts shall be removed and disposed of per local environmental protection regulations. All repairs are required to be documented and maintained for the life of the product. Page 28 of 40
12.0 Technical Specifications Technical Specifications Total tabletop length (with headrest) 2035 mm ± 15 mm 80.2 in ± 0.6 in Tabletop width 500 mm ± 5 mm 19.7 in ± 0.2 in Total table-top width 550 mm ± 5 mm 21.7 in ± 0.2 in Minimum height of top from the floor 750 mm ± 20 mm 29.5 in ± 0.8 in Maximum height of the top from the floor: 1150 mm ± 20 mm 45.3 in ± 0.8 in Lifting angle of backrest 85 ± 5 Lowering angle of backrest 40 ± 3 Raised kidney support height 150 mm ± 5 mm 5.9 in ± 0.2 in Lifting angle of leg segment 25 Lifting angle of leg segment 45 Lowering angle of Footrest 90 Spreading angle of footrests 180 Angle of lateral tilt ± 30 Head section lifting angle up 55 Head section lifting angle down 50 Table top longitudinal shift 340 mm ± 15 mm 13.4 in ± 0.6 in Trendelenburg 40 Reverse-Trendelenburg 40 Table weight 250 kg (551 lbs) Maximum dynamic load 200 kg (441 lbs) Maximum static load 350 kg (772 lbs) Power supply 24V Battery charging time < 12 hours Working time without charging batteries About 80 operations Battery charger Built-in Battery charger power supply ~120V 60Hz Electric power Standard Model Super Mobile Model Alternative Drive Model 250 VA 250 VA 250 VA Class of protection before electric paralysis I Type of part application B Degree of protection before influence of IP-X4 environment Usage time 10 Years Radiolucency of Top Radiolucency of the Pad Flammability 0,55 [mmal] 0,67 [mmal] Meets the following requirements: NFPA 261 Standard Method of Test for Determining Resistance of Mock-Up Upholstered Page 29 of 40
Furniture Material Assemblies to Ignition by Smoldering Cigarettes ASTM E 1537 Standard Test Method for Fire Testing of Upholstered Furniture CA TB 117 CA TB 133 12.1 Functional Parameters Page 30 of 40
12.2 Critical Parameters Configuration A Critical Parameters Configuration B Maximum Work Load for Individual Segments 200 kg (441 lbs) Maximum Work Load for Individual Segments 135 kg (298 lbs) Maximum Authorized Segment Load: Maximum Authorized Segment Load: Headrest 16kg (35 lbs) Headrest 10 kg (22 lbs) Backrest Segment 76 kg (168 lbs) Backrest Segment 60 kg (132 lbs) Seat Segment 68 kg (150 lbs) Seat Segment 50 kg (110 lbs) Footrest (Simple) 20 kg (44 7.5 kg (16.5 Footrest (Simple) lbs) lbs) Footrests (Both loaded at 40 kg (88 Footrests (Both loaded the same time) lbs) at the same time) 15 kg (33 lbs) 13.0 Electromagnetic Information 13.1 Electromagnetic Environment Electromagnetic Emissions Medical device operating table SU-03 is to be used in electromagnetic environment specified below. The customer or the user of medical device the SU-03 should assure that it is used in such an environment. Emission type Classification Electromagnetic environment guidance emission RF CISPR 11 emission RF CISPR 11 Harmonic emission IEC 61000-3-2 Voltage fluctuation, flickering IEC 61000-3-3 Group 1 Class B Class A Complies Medical device operating table SU-03 produces energy with radio frequency only for its internal function. Therefore, its RF emission are very low and are not likely to cause any interference in nearby electronic equipment. Medical device operating table SU-03 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Electromagnetic Immunity Medical device operating table SU-03 is to be used in electromagnetic environment specified below. The customer or the user of medical device the SU-03 should assure that it is used in such an environment. Immunity test IEC 60601-1-2 Test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC 61000-4-2 6 kv contact 8 kv air 6 kv contact 8 kv air In the location of SU-03 use the floor should be wooden, concrete or covered with ceramic tiles. If the floor is covered with a synthetic material, the relative humidity should be at least 30%. Page 31 of 40
Surge IEC 61000-4-5 Series of quick transitory stages IEC 61000-4-4 Voltage dips, short interruption and voltage variations on power supply input lines IEC 61000-4-11 1 kv differential mode 2 kv common mode 2 kv for power supply lines 1 kv for input/ output lines < 5% U T (>95% dip U T) for 0.5 cycle 40% U T (60% dip U T) for 5 cycles 70% U T (30% dip U T) for 25 cycles < 5% U T (>95% dip U T) for 5 seconds 1 kv differential mode 2 kv common mode 2 kv for power supply lines 1 kv for input/ output lines < 5% U T (>95% dip U T) for 0.5 cycle 40% U T (60% dip U T) for 5 cycles 70% U T (30% dip U T) for 25 cycles < 5% U T (>95% dip U T) for 5 seconds NOTE U T is the a.c. main power outlet voltage prior to application of the test level The main power outlet power quality should be that of a typical commercial or hospital environment The main power outlet power quality should be that of a typical commercial or hospital environment. The main power outlet power quality should be that of a typical commercial or hospital environment. In normal use operating table SU-03 is battery operated. Connect to the main power outlet network only for battery charging. Electromagnetic Immunity Continued Medical device operating table SU-03 is to be used in electromagnetic environment specified below. The customer or the user of medical device the SU-03 should assure that it is used in such an environment. Immunity test IEC 60601-1-2 Test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be not used closer to any part of the operating tables SU-03, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separating distance: Transmitted disturbances induced by fields with radio frequencies IEC 61000-4-6 3 Vrms 150 khz to 80 MHz 3 Vrms d 1, 2 P Electromagnetic field with radio frequency IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m d 1, 2 P 80 MHz to 800 MHz d 2, 3 P 800 MHz to 2.5 GHz where P is the maximal output power of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance in each frequency range. b Interference may occur in the vicinity of equipment marked with following symbol: a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, amateur radio, AM and FM radio broadcast 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. If the measured field strength in the location in which medical device the operating table SU-03 is used exceeds the applicable RF compliance level above, the operating table SU-03 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SU-03 Operating Table. b Over the frequency range 150 khz to 80 MHz, field strength should be less than 3 V/m. NOTES: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Page 32 of 40
13.2 Electromagnetic Compatibility The SU-03 Operating Table is an electrical appliance. Electrical appliances are a source of electromagnetic radiation and they are under its influence. Therefore, use of an electrical appliance requires some safety precautions connected with electromagnetic compatibility. Table Recommended Distances Between Portable Radio Transmitters and the SU-03 Operating Table, provides recommendations as well as warnings for the user to follow in order to ensure the table is being used within the appropriate electromagnetic environment. Recommended Distances Between Portable Radio Transmitters and the SU-03 Operating Table Rated Maximum Output Power of Transmitter (W Watts) 150 khz to 80 MHz d 1, 2 Distance in Meters (ft - Feet) P (khz Kilohertz) (m Meters) (MHz Megahertz) 150 khz to 800 MHz d 1, 2 Distance in Meters (Feet) P (khz Kilohertz) (MHz Megahertz) 800 MHz to 2.5 GHz d 2, 3 Distance in Meters (Feet) (MHz - Megahertz) P (GHz - Gigahertz) 0.01W 0.1m (0.3ft) 0.1m (0.3ft) 0.2 (0.7ft) 0.1W 0.4 (1.3ft) 0.4 (1.3ft) 0.7 (2.3ft) 4W 1.2 (3.9ft) 1.2 (3.9ft) 2.3 (7.5ft) 10W 4 (13.1ft) 4 (13.1ft) 7 (23ft) 100W 12 (39.4ft) 12 (39.4ft) 23 (75.5ft) For transmitters, the maximum output of power, which is not listed above, the separation distance should be calculated according to the formulas provided. P is a power to watts (W) according to the declaration of the transmitter manufacturer. NOTE: The above guidelines may not be applicable to all cases. Propagated electromagnetic waves are absorbed and reflected from buildings, objects and people. The use of different accessories, additional equipment, cables, and spare parts other than those offered and/or recommended by the manufacturer may cause an increase of emission and/or decrease of resistance to all electromagnetic phenomena. 14.0 Symbol and Label Identification Device Label Indicates the specific device and other information such as manufacturer, importer, serial number, manufacturing date, and part number. Page 33 of 40
Transport Position of the Table Method of Battery Charging Connecting Panel Description For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table - Drawing 18, Item 1. This label is used as a visual indicator for the transport position of the SU-03 Operating Table should be. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 2. This label is used as a visual indicator for the method of battery charging for the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table (Drawing 18, Item 3). This label is used as a visual indicator for the description of the Connecting Panel of the SU- 03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 4. Page 34 of 40
Cleaning and Disinfecting Caution Label Maximum Weight Limit Label Caution This label is used to caution the user not to use agents containing active oxygen and chlorine when cleaning and disinfecting the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 5. This label is used as a visual indicator for the maximum weight limit allowed of the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 6. Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. This label will be placed on any part(s) or mechanism(s) which may prove to be harmful to the patient or user if the directions within Page 35 of 40
this manual are not followed appropriately. Foot Extension (Standard Base) Central Wheel Lock Label Infrared Sensor Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 7. This label is used as a visual indicator for the locking and unlocking of the foot extension on the standard base model of the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 8a. This label is a visual indicator for the central wheel lock on the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 8b. This label is a visual indicator for the Infrared Sensor on the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 9. Page 36 of 40
Headrest Adjustment Leg Rest Adjustment Longitudinal Shift Backrest Adjustment This label is a visual indicator for the headrest adjustments on the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 10. This label is a visual indicator for the leg rest adjustments on the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 11. This label is a visual indicator for the longitudinal shift on the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 12a. This label is a visual indicator for the backrest adjustments on the SU-03 Operating Table. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 12b. Page 37 of 40
LDPE Kidney Support Adjustment Label Follow the Instructions Label Multiuse Package Package for Recycling Low-density Polyethylene Packaging This label is a visual indicator for the Kidney Support mechanism adjustments. Only the SU-03 Operating Tables that have the Kidney Support mechanism adjustment will have this label. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 13. This label is a visual indicator for the user to follow the instructions provided within this manual. For the location of this label, see Section 14.1 Placement of Labels on the SU-03 Operating Table Drawing 18, Item 14. This symbol may be located on the packaging of the SU-03 Operating Table when being transported. This symbol may be located on the packaging of the SU-03 Operating Table when being transported. This symbol may be located on the packaging of the SU-03 Operating Table when being transported. Page 38 of 40
14.1 Placement of Labels on the SU-03 Operating Table 15.0 Disposal Disposal of the SU-03 Operating Table must be compliant with the applicable regulations and requirements of the local state environmental protection agency, state health agency, Centers for Disease Control (CDC), Occupational Safety and Health Administration (OSHA), U.S. Food and Drug Administration (FDA) as well as any other local authorities that apply to this medical device. The SU-03 Operating Table contains materials which may be dangerous to the environment such as, oil (gas spring, hydraulic system) and a gel battery. Follow local environmental protection agency regulations for disposal. Page 39 of 40
As provided in the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, this device is a Class I medical device per Rule 12. The manufacturer declares that the product meets the essential requirements of the directive contained in Annex I. The compliance procedure was carried out in accordance with Annex VII of the directive. 2274 Manufactured by: FAMED ŻYWIEC Sp. z o.o. 34-300 Żywiec, ul. Fabryczna 1 POLAND Imported by: Oakworks Inc., 923 East Wellspring Rd New Freedom, PA 17349, USA Page 40 of 40