Operating Table Model MOT-6302 Operators Manual Ver 5 February 2018

Page 1

TABLE OF CONTENTS Title

Page

WARRANTY ·················································································································································· 2 EQUIPMENT LABELS ·································································································································· 3 SAFETY & HEALTH SYMBOLS ···················································································································· 4 TABLE SPECIFICATIONS ····························································································································· 6 INSPECTIONS PERFORMED PRIOR TO PLACING UNIT INTO USE ························································· 8 SPECIAL USER ATTENTION ························································································································ 9 SECTION I INTRODUCTION ··················································································································· 17 1-1. General ········································································································································· 17 1-2. Power Requirements ···················································································································· 17 1-3. Pendant Control Unit ···················································································································· 18 1-4. Floor Lock/Brake System ·············································································································· 19 SECTION II OPERATION ························································································································· 20 2-1. Electrical Power ···························································································································· 20 2-2. AC Operation ································································································································ 20 2-3. Battery Operation ························································································································· 21 2-4. Automatic Shut-Off ························································································································ 21 2-5. Charging the Battery····················································································································· 22 2-6. Positioning Functions ···················································································································· 23 2-7. Emergency Switch ························································································································ 27 2-8. Emergency Back-up Controls ······································································································· 27 2-9. Emergency Brake Release ··········································································································· 28 2-10. Head Section ······························································································································ 28 2-11. Leg Section Removal ·················································································································· 29 2-12. Table Top Rotation ······················································································································ 29 2-13. Kidney Lift ··································································································································· 30 2-14. Positioning ·································································································································· 31 SECTION III MAINTENANCE ··················································································································· 33 3-1. Cleaning Recommendations ········································································································· 33 3-2. Routine Inspections ······················································································································ 34 3-3. Preventive Maintenance ··············································································································· 35 3-4. Operator Troubleshooting ············································································································· 36 3-5. Maintenance Checks & Services ·································································································· 37 3-6. Maintenance Matrix ······················································································································ 39 3-7. Service ········································································································································· 41 3-8. Disposal Instructions ···················································································································· 41 SECTION IV

ELECTROMAGNETIC EMISSIONS ···················································································· 42

Although current at time of publication, MIZUHO's policy of continuous development makes this manual subject to change without notice.

Page 2 WARRANTY MIZUHO Corporation will repair defective parts of this product without charge for one year from the date of delivery/installment except for cases of damage caused by a third party's repair, act of nature, improper use or damage on purpose. All other warranty terms and conditions are subject to regulations of MIZUHO Corporation.

Page 3 EQUIPMENT LABELS

Page 4 SAFETY & HEALTH SYMBOLS Used On Product

Used In Manual

Indicates important facts or helpful hints

‫ۑ‬

‫ۑ‬

General warning sign (WARNING, CAUTION)

‫ۑ‬

‫ۑ‬

Type B applied part

‫ۑ‬

Enclosure class (Splash-proof)

‫ۑ‬

Indicates waste disposal information

‫ۑ‬

Refer to instruction manual

‫ۑ‬

Alternating current

‫ۑ‬

Manufacturer

‫ۑ‬

‫ۑ‬

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

‫ۑ‬

‫ۑ‬

Catalogue number

‫ۑ‬

Serial number

‫ۑ‬

Equipotentiality

‫ۑ‬

Symbol

Description

NOTE

ISO 7010-W001

IEC 60417-5840

IPX4 IEC 60529

WEEE

Blue ISO 7010-M002

IEC 60417-5032

ISO 15223-1-5.1.1

ISO 15223-1-5.1.2

ISO 15223-1-5.1.6

ISO 15223-1-5.1.7

IEC 60417-5021

Page 5 SAFETY & HEALTH SYMBOLS

Symbol

Description Red

Used On Product

General prohibition sign

٤

General mandatory action sign

٤

Emergency stop

٤

Protective earth (ground)

٤

Defibrillation-proof Type B applied part

٤

Earth (ground)

٤

ISO 7010-P001

Blue ISO 7010-M001

IEC 60417-5638

IEC 60417-5019

IEC 60417-5841

IEC 60417-5017

Used In Manual

Page 6 TABLE SPECIFICATIONS 240 mm

455 mm

463 mm

TOP VIEW

585 mm

326 mm

1900 mm 60° 500 mm 100 mm

MAX 1012 mm

52 mm

90°

MIN 634 mm

483 mm

FRONT VIEW

923 mm

SIDE VIEW

Maximum Lifting Capacity: 450kg Unit Weight: 320kg Maximum Articulating Capacity: 270kg Maximum Patient Weight: 450kg The height and width to be able to pass by: Height 10 mm/Width 80 mm (0.4m/s±0.1m/s) Electrical Specifications Power Requirements: 100 - 240 VAC, 50 - 60 Hz, 400 VA Current Leakage: Less than 500 micro amps Power Cord : 4.5 m w/hospital grade connector (removable) Duty Cycle: 3 min on, 7 min off Battery Power: 24VDC (12Vx2) <model: FML12170-12V17Ah/Furukawa Battery> Classification Class I Equipment Applied Parts: Table Top/Type B Applied Parts Mattress/Defibrillation Proof, Type B Applied Parts IPX4 Rated 㺃 Equipment not suitable for use in the presence of flammable anesthetic mixture with AIR, OXYGEN or NITROUS OXIDE. 㺃 This product does not intend to sterilize.

Page 7 TABLE SPECIFICATIONS Environmental Condition Condition of Use

Condition of Transport and Storage

Ambient Temperature

10 - 40°C

-10 - 50°C

Relative Humidity

30 - 75%

10 - 85% (No Condensation)

Atmospheric Pressure 700 - 1060 hPa Operating altitude㸸2000 m max above sea level

700 - 1060 hPa

Page 8

After long period of storage - these items should be checked:

INSPECTIONS PERFORMED PRIOR TO PLACING UNIT INTO USE Description: 1. Mains Power Function - ON/OFF Operation and LED battery function 2. Battery Power Function / Mode 3. Hand Control Operation & Back Light 4. Table Caster movement & condition 5. Operational movement of each function with load to full stroke 6. Condition of hydraulic floor lock brake cylinders & pads 7. Stability of table top 8. Stability while table floor lock brakes are activated 9. No hydraulic oil leaks 10. Hydraulic oil level 11. Table top is horizontal level when using level function 12. Operation of locking levers & locking knobs on back, leg & head sections 13. Overall appearance and cleanliness

Completed

Page 9 SPECIAL USER ATTENTION Prior to use, all personnel that may operate this table must be instructed in the correct operational procedures. This table is designed for use by trained and qualified personnel for human medical purposes only. Initial use should not begin until after the users have been instructed by the manufacturer's representative.

In case of use with other devices near the table, verify that such devices comply with electromagnetic compatibility medical standards. Table must always be equipped and operated with (2) 12V lead acid sealed batteries available only through MIZUHO.

CAUTION A routine instructional program must be implemented by the facility for proper usage instructions for all personnel that may operate this table.

Remove possible obstacles before lowering or tilting the operating table.

The maximum lifting capacity of the MOT-6302 table is 450kg and the maximum articulation weight capacity is 270kg. When lifting or articulating large patients, pay close attention to the patient position as well as the positioning guidelines and limitations listed in the operation instructions. This equipment is intended for use by healthcare professionals only. This equipment may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the table or shielding the location. The extreme positioning capabilities of the MOT-6302 table requires special attention for possible interference points when using multiple function positioning. As with the operation of any surgical table, a certain amount of care should be exercised to position the patient safely. Although the thick pads and sheets substantially protect the patient, pinch points, located at the joints of the top section should always be considered. BE SURE THAT THE ARMS, HANDS AND FINGERS OF THE PATIENT AND THOSE OF THE OPERATING ROOM PERSONNEL ARE CLEAR OF ALL MOVING PARTS BEFORE MOVING THE TABLE. Refer to Pinch/Crush Point Diagram. Proper restraints should always be used for patient safety.

CAUTION Do not place objects on the base of the table, a danger of damage exists during positioning.

Certain accessories such as the Uro-Drain Tray, Armboards and X-Ray top can be damaged when changing the position of the table top sections. Always look first to see if a desired movement is going to interfere with any accessories in use. The operator has the ultimate responsibility of preventing damage to the table and surrounding equipment or possible injury to the patient or staff. The operator must ensure proper positioning is maintained to prevent compromising respiration, nerve pathways or circulation. In general, common sense will dictate when there is a potential hazard.

Page 10 SPECIAL USER ATTENTION

WARNING Possible Pinch / Crush Points

HEAD & BACK SECTION CAN COLLIDE WITH BASE

LEG SECTION AND ELEVATION COLUMN CAN COLLIDE

LEG SECTION AND FLOOR CAN COLLIDE

Page 11 SPECIAL USER ATTENTION Throughout this manual there are WARNING, CAUTION and NOTE headings. The following is a review of the precautions contained within the manual and should be reviewed by all personnel prior to operating the table.

CAUTION Comply with the following transportation instructions when moving the MIZUHO 6302 Surgical Table. 1. Remove the power cord. 2. Place the power switch in the OFF position. 3. Tighten all handles and knobs.

CAUTION Comply with the following packaging instructions when shipping the MIZUHO 6302 Surgical Table. 1. The MIZUHO 6302 Surgical Table shall be shipped in a suitable container, sealed from the outside atmosphere. 2. The shipping container shall employ appropriate reinforcement to prevent table vibration or movement during shipment. 3. Ensure the table brakes are locked during shipment.

CAUTION Contact an authorized MIZUHO representative for disposal instructions for the MIZUHO Surgical Table that are in accordance with current environmental regulations for medical products.

NOTE x Grounding reliability can only be achieved when the equipment is connected to a properly grounded receptacle. Where the integrity of the external Protective Earth Ground is compromised equipment must be operated on battery mode. x Use only MIZUHO Replacement Parts for power cord and pendant control. Refer to Replacement Parts Section.

NOTE If any of the buttons on the control unit are pressed continuously for longer than 4 minutes, the thermal protector of the solenoid valve will actuate and the operation will be stopped. The thermal protector will reset in approximately 30 minutes.

NOTE The operating table a built-in self-diagnosis function to check if the operating table and control unit work properly. 1. Connect the power cord. 2. Press the BATTERY ON/OFF button on the pendant control. 3. Press the ENERGIZE button and then one of the function buttons on the pendant control. If two green battery indicators are lit, the pendant control works properly.

NOTE Activating any function button will activate the brake system. Using the TABLE UP function to set the brakes provides a visual assurance that the brakes are locked without altering the table position, except when emergency brake is released.

Page 12 SPECIAL USER ATTENTION

WARNING Prior to operating the table, observe all table caution labels and review the SPECIAL USER ATTENTION section in the front of this manual.

NOTE Battery Operation must be turned OFF at the pendant control. It cannot be turned OFF using the main power switch.

NOTE WARNING Possible explosion hazard exists if table is used in the presence of FLAMMABLE ANESTHETICS.

Turning the base Main Power Switch ON will change the table operation to AC power.

NOTE NOTE An equalization terminal is located under the main power panel. This is provided as an alternate pathway to reduce the risk of static shock hazards. Always follow recommended grounding procedures to ensure patient and staff safety.

WARNING To avoid the risk of electric shock, this equipment must only be connected to a supply main with Protective earth. Power Cord has to be used the one which has a logotype of MIZUHO.

WARNING Please don't position the surgical table in such way that the operator has difficulty to disconnect the Equipment by plug or appliance outlet.

NOTE Prior to all surgical procedures, make sure the battery charge is sufficient for anticipated duration and use.

When the red Battery Power Indictor light starts to blink (indicating low power in battery) the table will operate for approximately 5 continuous minutes, typically long enough to use the table for the rest of the day.

NOTE The charging system operates ONLY when the table is in AC operation mode. While charging a battery, the operation of Power on/ off can be performed with a BATT ON/OFF switch.

NOTE The table can be operated on AC power while the battery is being recharged.

WARNING If the table is stored for a period greater than 6 months, the batteries should be removed and stored in a dry, clean condition at a storage temperature of 68°F (20°C). Batteries should be recharged every 6 months of product storage.

NOTE

WARNING

The table will operate correctly on battery power with the power cord connected to a wall outlet or disconnected.

A operator of operating table has to perform his/her activity at the position which is indicated in below drawing where he/she can push the emergency stop switch immediately and observe his/her patients.

Page 13 SPECIAL USER ATTENTION

WARNING Please confirm that the operating table is fixed stably after applying the brakes.

NOTE With an evenly distributed patient weight load, all table positioning functions will operate smoothly and quietly with a patient weight of up to 270kg.

WARNING DO NOT unlock brakes when a patient is on the table. An uneven patient weight load may cause instability.

WARNING To maximize patient safety, utilize proper restraint methods during extreme Trendelenburg positioning.

WARNING If circumstances demand table brakes to be unlocked, the patient must be centered and evenly distributed on the table top (i.e. supine or prone position) with the table lowered to its lowest height position. The maximum patient weight should not exceed 230kg. Table top rotation must be in normal orientation, that is, the back section over the long end of the table. Patient's head must be on the head section. Head section must be attached in its normal orientation to the table's back section.

WARNING To maximize patient safety, utilize proper restraint methods during extreme lateral tilt positioning.

WARNING The Leg section may hit the table base or the floor if both the leg and elevation systems are placed in their full down position.

NOTE WARNING x Prior to unlocking brakes, check for obstructions on the floor that might prevent the table from moving smoothly to new location. Re-lock the brakes immediately once the final position is reached and before commencing surgery. To move the table safely one staff member should be positioned at the head end and one at the foot end. If the patient weight exceeds 115kg, four staff members are required to move the table and ensure patient safety. Table brakes should remain locked at all times if patient weight exceeds 230kg. x Don't move a table with patient carried. There is a risk that patient may fall and injure or staff may injure. x Don't move a table with heavy object carried. There is a risk that heavy object may fall and damage or staff may injure.

Elevation and brake system functions are not affected by the return to level function.

CAUTION Please use the emergency switch at the urgent case only.

CAUTION The safety interlock system is not operational when the emergency back-up control switches are used.

CAUTION The EMERGENCY BRAKE LOCK switch does not activate the brake system timer. The switch must be held until the brakes are completely locked, approximately 10 seconds.

Page 14 SPECIAL USER ATTENTION

NOTE The emergency back-up control switches will function when the table is operating on AC power, battery power, or turned off.

NOTE x The Emergency Brake Release Valve must be closed and tightened (counter-clockwise) before activating any hydraulic function. x If the Emergency Brake Release Valve has been operated, the BRAKE UNLOCK button on the pendant control will have to be pressed to reset the timer circuit before brakes will lock again.

NOTE The leg section with the x-ray top + pad attached weighs 14kg. It is recommended that the x-ray top and pad be removed before detaching the leg section.

WARNING

WARNING x Make sure the TOP ROTATION LOCK HANDLE is tightened and the brakes are set before transferring the patient. x Exercise caution with the table top rotated 90° to the base since an improperly distributed patient load may cause the table to be tipped over.

WARNING Consult manufacturer's instructions when using high frequency surgical equipment, cardiac defibrillator and cardiac defibrillator monitors. Improper operation procedures might cause a burn on an operators or patient, and also cause the malfunction of the product.

WARNING x When a patient is put on a mattress and his/her position is set up, a patient shall be set up to more than 1 cm apart from a side rail so that a patient dose not touch on side rails (metal).

Ensure that the Leg section is properly engaged and secured to pins before use to prevent injury.

x The mattress should be attached in order not to come off while being in use.

NOTE

WARNING

Normal table top position is with the head (and back) section over the power cord end of the base.

When an antistatic pathway is required, the table has to be used on an antistatic floor.

WARNING

WARNING

Always lock the table top in position after rotation. DO NOT rotate the top with an unevenly distributed patient weight load as instability may result.

The antistatic properties of the table are dependent on the use of the original pad set which was furnished with the table or an alternate approved replacement.

Page 15 SPECIAL USER ATTENTION

CAUTION

CAUTION

To prevent damage to the kidney lift, make sure the kidney lift is completely down before raising the back section.

Do not use worn or damaged accessories, they represent an injury hazard.

WARNING WARNING Certain accessories may limit weight capacities. Check with your MIZUHO representative.

WARNING MIZUHO Products are guaranteed for proper performance with the use of genuine MIZUHO accessories.

Set up a patient's position in order not to touch the metal parts like table board or side rail of table top directly. Metal part might cause a burn.

NOTE x A mattress is an applied part. x Usable mattresses are as following. 50005M2

Accessories and products not furnished by MIZUHO have not been tested for proper performance and safety. Such applications or use are at the discretion of the user to ensure patient and staff safety.

CAUTION x MIZUHO surgical tables are designed to be used by trained healthcare professionals only. x Place a patient on the table after a 70mm minimum thickness mattress is certainly attached onto the table top for safeness of a patient.

671G6M2 360L8M2 Mattress's shape is suitable for each table board. x Tag which indicates that a mattress is an applied part and is made by MIZUHO is attached on a mattress.

WARNING Personal injury to Patient or Staff may result from a lack of proper maintenance of this equipment.

CAUTION x Attach a mattress onto the table properly in order not to slip off or come off the table during operation. x Install a table board in order not to recognize the fixing screws. x Put a patient on the table after the mattress is changed to proper position when the mattress is found to be out of proper position.

Caution should be taken when cleaning the table to prevent excessive fluid entry into electrical connectors.

WARNING Always follow the national blood-borne pathogens standards for protective clothing, including gloves, masks and eye protection when cleaning the surgical table.

Page 16 SPECIAL USER ATTENTION

NOTE

CAUTION Thoroughly read and follow the manufacturer's directions for all cleaning fluids. DO NOT use cleaners containing phenolics. Avoid use of oxidizing products with Chloric derivatives such as bleach or Peracetic Acid.

CAUTION When using spray cleaners DO NOT spray fluids directly into electrical receptacles or micro switches.

CAUTION Before replacing pads on the table, make sure the pads and all mating surfaces are completely dry. Moisture trapped between the pads and mating surfaces may cause distortion of table tops.

WARNING x DO NOT dissemble the table. Unauthorized disassembling may cause electric shock or malfunction. x Please contact your local distributor or manufacturer for maintenance or repair. The operating table should only be serviced or maintained by a factory trained personnel.

Technical description of this product is due to the Maintenance Manual. The contents of Maintenance Manual are as follows. SECTION I

HYDRAULIC SYSTEM

SECTION II

MECHANICAL TABLE ADJUSTMENTS

SECTION III

HYDRAULIC TROUBLESHOOTING

SECTION IV

ELECTRICAL SYSTEM

SECTION V

ELECTRICAL TROUBLESHOOTING

Maintenance Manual can be obtained only by the person who has had the service training of MIZUHO.

CAUTION Do not use the table if any of the inspection points fail.

CAUTION Always inspect product prior to use to ensure safe and correct operation. Any product deemed to be malfunctioning should be removed from service immediately and labeled inoperable. Refer all service to a MIZUHO authorized service representative.

NOTE The elevation cylinder should be completely down, the brakes released and all the other control functions in their neutral position when checking hydraulic oil level.

Page 17 SECTION I

INTRODUCTION MATTRESS

MATTRESS MATTRESS

HEAD SECTION 630CU01

BACK SECTION

KIDNEY SECTION

REMOVABLE LEG SECTION 632AU12

SEAT SECTION

Tokyo, Japan

PIN 50005M2

Tokyo, Japan

PIN 671G6M2

Tokyo, Japan

PIN 360L8M2

LEG SECTION RELEASE LEVER SIDE RAIL PENDANT CONTROL

HEAD SECTION LOCKING KNOB TOP ROTATION HANDLE

‫ۻ‬Accessories y POWER CORD y PENDANT CONTROL y MATTRESS

SERVICE ACCESS COVER

POWER CORD

‫ۼ‬Detachable parts y HEAD SECTION y LEG SECTION

EMERGENCY BRAKE RELEASE

MAIN POWER SWITCH

FLOOR/LOCK BRAKE (4)

Figure 1-1. MOT-6302

1-1. General

1-2. Power Requirements

a. Intend Use. This Product is intended for holding a patient on the surgical operation.

The MOT-6302 Surgical Table requires a 100-240VAC, 50-60Hz electrical power supply. The table is equipped with a removable 4.5m long power cord. The main power ON/OFF switch is located on the electrical panel on the front edge of the table base. See figure 1-2.

b. A place to use this product should be an operating room in the hospital. c. The user of this product should be doctors or nurses or medical engineers who have sufficient knowledge of this product.

The battery charging indicator and an area for an optional foot control connector are also located on the electrical panel.

MIZUHO’s MOT-6302 Surgical Table is an electrohydraulically operated, general purpose surgical table. See figure 1-1. The electro-hydraulic positioning functions operated by the hand-held, push button, pendant control unit are: Trendelenburg, lateral tilt, back section, elevation, leg section, flex/reflex, return to level, beach chair and the floor lock/brake system. Manual controls are provided for head section positioning, table top rotation, emergency brake release, kidney lift and leg section removal.

E

POWER CORD

POWER CORD

POWER SWITCH

MAIN POWER SWITCH

F

BATTERY INDICATOR FOOT SWITCH

BATTERY CHARGE INDICATOR

Figure 1-2. Electrical Panel

Page 18 SECTION I

INTRODUCTION

NOTE

NOTE

x Grounding reliability can only be achieved when the equipment is connected to a properly grounded receptacle. Where the integrity of the external Protective Earth Ground is compromised equipment must be operated on battery mode.

If any of the buttons on the control unit are pressed continuously for longer than 4 minutes, the thermal protector of the solenoid valve will actuate and the operation will be stopped. The thermal protector will reset in approximately 30 minutes.

x Use only MIZUHO Replacement Parts for power cord and pendant control. Refer to Replacement Parts Section.

1-3. Pendant Control Unit The hand-held pendant control unit (figure 1-3) has a non-slip rubber cover which assures a positive grip during use. A spring clip hanger is located on the back of the control for storage. When the Pendant Control is not in use, it should be stored on a convenient side or end rail.

SIDE RAIL CLIP

NOTE The operating table a built-in self-diagnosis function to check if the operating table and control unit work properly. 1. Connect the power cord. 2. Press the BATTERY ON/OFF button on the pendant control. 3. Press the ENERGIZE button and then one of the function buttons on the pendant control. If two green battery indicators are lit, the pendant control works properly.

POWER INDICATOR

REVERSE TRENDELENBURG LATERAL TILT LEFT FUNCTION BUTTONS

BACK UP

BACK DOWN

TABLE UP (BRAKE LOCK)

TABLE DOWN

LEG UP

LEG DOWN

FLEX

REFLEX

BRAKE UNLOCK

BEACH CHAIR LEVEL

Figure 1-3. Pendant Control Unit ENERGIZE

The function push buttons are identified with Internationally recognized symbols and abbreviated descriptions for all functions. See figure 1-4. When illuminated the Trendelenburg and table up buttons are red, the remaining buttons are all green.

POWER ON INDICATOR LIGHT AC (GREEM) BATTERY (GREEN/RED) TRENDELENBURG LATERAL TILT RIGHT

BATTERY ON/OFF

Figure 1-4. Function Buttons

Page 19 SECTION I 1-4. Floor Lock/Brake System The floor lock/brake system consists of four self-leveling, hydraulic brake cylinders which raise and support the table base off from the casters. Press the TABLE UP button on the pendant control to set the table’s brakes. An electronic timer will activate the brake system until the brakes are completely set, approximately 8-10 seconds.

NOTE Activating any function button will activate the brake system. Using the TABLE UP function to set the brakes provides a visual assurance that the brakes are locked without altering the table position, except when emergency brake is released.

INTRODUCTION