Operating Table Model MOT-VS500SK Operators Manual Ver.5 November 2021

Table of contents 1.

Introduction ... 1 1.1 1.2 1.3

2.

Safety precaution ... 4 2.1 2.2

3.

Installation and battery charging ... 16 Turning on/off the power ... 22 Operating the emergency stop switch ... 24 Fixing and unfixing the operating table ... 25 Brake Release ... 27 Tilting the tabletop laterally ... 28 Trendelenburg ... 29 Bending the back plate ... 31 Changing the tabletop height ... 32 Sliding the tabletop ... 33 Flexing or reflexing the tabletop ... 35 Change height of the lift-up unit ... 37 Bending the leg plate ... 38 Reverse mode ... 40 Returning to level ... 47 Adjusting the head plate ... 48 Adjusting the leg plate ... 50

Maintenance and inspection ... 52 5.1 5.2 5.3

6.

Main unit ... 12 Control unit ... 13 Cordless control unit (optional) ... 14 Foot switch (optional) ... 15

Operation ... 16 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15 4.16 4.17

5.

Read thoroughly before using ... 4 Labeling ... 8

Section Introduction ... 12 3.1 3.2 3.3 3.4

4.

This manual ... 1 Intended use and this product ... 1 Accessories ... 2

Inspection before and after use ... 52 Periodic replacement parts ... 54 Version information of the software ... 54

Specification ... 55 6.1 6.2

Specification table ... 55 External view ... 57

7.

Troubleshooting ... 58

8.

Before contacting for repairs ... 59

App.-1 Electromagnetic Compatibility ... 61 App.-2 Glossary ... 64

1. Introduction

Introduction

1.1

1

This manual

This manual contains information for safely and effectively using this product. Before operating this product, read this manual thoroughly to understand how to operate and inspect the product. Failure to follow these instructions could lead to serious injury. The safety information is categorized as per the following so that the contents of warnings and cautions, and the details of warnings and cautions which are labeled on the product may be comprehended.

WARNING

CAUTION

If this indication is ignored and the product is incorrectly used, serious injury or death may result.

If this indication is ignored and the product is incorrectly used, serious injury and/or damage to property may result.

NOTE This notice notes additional information on the product’s functions. The warning and caution notices on this manual relating to operating and inspecting, apply to the intended use (surgical operations) of this product. If the product is used for purposes other than surgery, the user is responsible in regard to safety for performing operations and inspections which are not contained in this manual.

1.2

Intended use and this product

This product is an operating table on which a patient is placed for surgical operations. The product is intended to support a patient during surgical operations. In conforming with the objectives of surgery, the product is equipped with features for adjusting its height, and for freely changing and setting the patient’s body position. The product uses both medical grade outlets and batteries as power sources. This product is to be used by health care professionals, including but not limited to surgeons, nurses and biomedical technicians.

1

1.3

1

Accessories

Introduction

Standard components and accessories Mattresses (for head, back and seat, and leg)

Control unit

Power cord

Operator’s manual

2

Main unit

Optional parts Cordless control unit (*1)

1

Foot switch (*1)

Introduction

Mizuho Original Pad

for Head Section Type A

for Back Section Type A

for Seat Section Type A

for Single Leg Section Type A

for Seat Section Type B

for Back and Seat Section Type A

* 1: The cordless control unit and the foot switch are optional for the MOT-VS500SK-IF.

3

2. Safety precaution 2

2.1

Read thoroughly before using

Safety precaution

Never perform the following when you use the product. Otherwise, damage to the operating table, electrical shock, and/or fire may occur. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority in which the user and/or patient is established. (1)

(2)

(3)

(5)

(4)

(1) Head plate and leg plate Do not step or sit on the head plate or the leg plate(s). The operating table may tip over resulting in injury.

WARNING

CAUTION

CAUTION

Before lowering the table or placing it in a reverse Trendelenburg position, check if there are any devices under the leg plate. If the leg plate comes in contact with devices that are to be subjected to excessive force, the leg plate insertion shaft may be damaged.

When transferring a patient from an operating table (Fig. a) or changing a patient’s body position (Fig. b), do not apply excessive force to the head plate or leg plate. The operating table may get deformed or damaged. Fig. a

Fig. b

Head plate Leg plate

4

Head plate

Leg plate

(2) Control unit

WARNING

Do not forcibly pull the control unit cord. Do not subject the control unit to strong shocks. The control unit may get damaged.

2

CAUTION

Safety precaution

(3) Base Do not place any objects on the base. An object may get caught and the operating table may get damaged.

(4) Power cord

WARNING

Do not place any heavy objects on the power cord. Do not roll over the power cord with a castered device. Do not forcibly pull the power cord. Do not place any objects in the place where the power cord is to be unplugged from the medical grade outlet, which would obstruct it from being unplugged.

Power cord

(5) Installation of the operating table Do not install the operating table

WARNING

on an uneven floor. Do not place a pad under the base for raising the operating table. The operating table may tip over resulting in injury.

Uneven floor

Pad

Patient's position during surgical operation

WARNING

Make sure to always securely attach the mattresses to the operating table so that they do not come off. The mattresses may come off, and the patient may get injured. Position the patient's body 10 mm (0.39 in) or more away from the metal side rail. The side rail may produce high temperatures due to the usage of electric scalpels, etc., which may result in a burn injury.

Positioning the patient Follow the steps below to position the patient.

1. Attach the accessory mattress onto the tabletop with their Velcro fastenings aligned with each other.

2. Put the patient on the mattresses. 3. Position the patient according to the purpose of the surgical operation. 5

CAUTION

2

Have the person who operates the operating table to operate it in a position where the emergency stop switch can be immediately pressed, and the patient’s condition can constantly observed.

Operator position

180°

Patient’s head

Head plate Safety precaution

Back plate

Other

WARNING

Prohibited Do not disassemble and/or modify the operating table. Otherwise, malfunction may occur. Patient position When using the tabletop or accessories to secure a patient’s body position, always observe the patient’s condition. Being in the same position for long periods of time causes neuroparalysis or bedsores. Other medical electrical equipment to be used together with the operating table When using a high-frequency surgical equipment and/or a cardiac defibrillator etc. with the operating table, refer to their operator's manual provided by the manufacturers and observe the precautions and usage. Improper precautions and usage may cause the operator or the patient to get burned and/or devices to malfunction. When using medical electrical equipment etc. with the operating table, check that the operating table does not malfunction before using it. Electromagnetic interference may result in malfunctioning of the operating table. Allowable patient body weight Do not apply loads which exceed the allowable patient body weight (total of the patient and accessories)*. The operating table may not function, which may result in failures. * Lift: 250 kg (550 lbs) / Lateral tilt and Trendelenburg: 250 kg (550 lbs) / Reverse mode: 135 kg (300 lbs) Preventive maintenance and inspections Make sure to inspect and maintain the operating table before and after use. The operating table may require replacement of the parts due to significant wear, deterioration, and/or breakage depending on the length of service and frequency of use. For preventive maintenance and inspections, contact your distributor or Mizuho directly. Antistatic measure Do not use the operating table on floors and/or with accessories that do not possess static electricity countermeasures. This may impede surgical operations.

6

CAUTION

Devices and accessories used together with this product Before using other devices or accessories, thoroughly read the instruction manual of the devices and make sure that the operating table is not affected adversely. Before fitting on accessories from third party companies, contact your distributor or Mizuho. Some accessories cannot be fitted on. While operating the operating table, check the position of other devices or the accessories used with them. They may come in contact with each other during the operation, operating table, devices, and/or accessories may get damaged. For hygiene, be sure to use sterilized drapes on the areas on this product where the patient comes into contact with it. Cleaning and disinfection After using the operating table, make sure to follow the steps below to clean up and disinfect the operating table. 1. Turn off the power and disconnect the power cord from the medical grade outlet. 2. Detach all the mattresses from the operating table. 3. Use a lint-free cloth soaked with proper volume of disinfectant to wipe off the upper, side, and back side of the mattresses. 4. As with step 3, disinfect the surfaces of the tables and side rails. 5. Wipe off the operating table with a clean dry cloth 15 minutes after disinfecting it. Make sure to use Mizuho authorized disinfectants. The disinfectants are as shown below.

2 Safety precaution

a) Sodium hypochlorite 0.1% (halogen containing compound) b) Hypo Alcohol (iodine color removing agent) c) Chlorhexidine (chlorhexidine gluconate 0.5%) d) Benzalkonium chloride (invert soap 10%) e) Povidone iodine f) Ethanol 80% g) Hydrogen peroxide h) Saline (0.9%) i) Isopropyl alcohol (IPA) Moving and transporting Do not move the operating table with a patient on it. Follow the procedures below to move the operating table. * Before moving the operating table, disinfect the entire operating table in order to prevent infection. 1. Turn off the power and disconnect the power cord from the medical grade outlet. 2. Check if the handles and levers are in fixed positions, and each section is fixed firmly. 3. Unlock the brakes, and move the operating table. * Do not move the operating table by pulling on the head plate or leg plate. The operating table should be transported with the following conditions met. 1.Disinfect the entire operating table before transporting it. 2.Take measures to prevent it from tipping over, such as lowering the tabletop to the bottom position. 3.Actuate the brake. 4.Suitably position cushioning on the product to prevent it from getting damaged during transport. 5.Store the product in a container so that it does not get exposed to dust, and the weather. Disposal

In accordance with the European Union Waste Electrical and Electronic Equipment (WEEE) Directive, all electrical components and batteries must be disposed of in accordance with local regulations. Please contact your local distributor for proper disposal.

7

2.2

Labeling

The operating table is labeled at the locations shown as below. Before use, make sure to understand the contents of the labels.

2

Warning and Caution labels

Safety precaution

(9)

(1)

(4)*

(8) (7)

(2)

(3)*

(6)

*: Applied on both sides.

(5)

(1) C656312□

(4) C655732□

(5) C656740□

(6) C643017□

(7) C643016□

(8) C653614□

8

(2) C643011□

(9) C656310□

(3) C653624□

Other labels (1/2) (20)

2 Safety precaution

(10)* (19)

(11)

(18) *: Applied on both sides.

(12) (17) (16) (10) C640029□

(13) (15)

(14)

(11) C600020□

(12) C655648□

or C640030□

(13) C653515□

(14) C653516□

or C640031□

(15) C642002□

(16) C653513□

(17) C655002□

YYYY-MM-DD

(18) C655684□

(19) C655683□

(20) C655001□

9

Other labels (2/2) (21)

(21)

(21)

(21)

(21)

(21)

2 Safety precaution

(22)

(23)

(24) (21) C653620□

(25) (22) C646086□

(26) (23) C646098□ (ASIA) or C646099□

or C646089□

(EU) or C646092□

or C646100□ (US)

(24) PIN 50005M2

(25) PIN 573A6M1

PIN 573A6M1

(26) PIN 360L8M2

10

Symbol mark for labeling Symbol

Description

Label no. (1) (2) (3) (4) (5) (6) (7) (9)

General prohibition sign

(5)

General mandatory action sign

(5)

Emergency stop

(8)

Refer to the operator’s manual

(5) (8) (12) (15) (18) (19)

Indicates AC power supply

(15)

Enclosure Class (Splash-proof)

(15)

Serial number

(15)

Catalogue Number

(15)

Indicates waste disposal information

(15)

European authorized representative

(15)

Medical Device

(15)

Equalization terminal

(16)

Indicates protection against electric shock and defibrillator (Class B)

(21)

Defibrillation - proof Type B applied part

(24) (25) (26)

Date of manufacture

(15)

Manufacturer

(15) (24) (25) (26)

2 Safety precaution

Indicates a possibility of injury or even death if operates the table without following the warning

11

3. Section Introduction 3.1

Main unit Control unit

Head plate(*2)

Back plate

Seat plate

Leg plate(*2)

Mattresses

Lift-up plate

3 Section Introduction

Head plate fixing handle (back of the leg plate)

Head plate flexing lever

Leg plate attaching/detaching lever

Auxiliary switch

Side rail

Slide cylinder

Head plate Emergency fixing handle stop switch

Column Base Control unit connector

Power cord Emergency brake release handle

Caster Power connector

Brake

Light receiving section of the cordless control unit (*1・*3)

Battery indicator Foot switch connector (*1・*3)

Power switch

Equipotential terminal

*1: The cordless control unit and the foot switch are optional for the MOT-VS500SK-IF. *2: The head plate and the leg plate are detachable. *3: The light receiving section of the cordless control unit and the foot switch connector are equipped only on the MOT-VS500SK-IF.

12

3.2

Control unit

Pilot lamp

Power lamp

Reverse mode lamp

Battery lamp

Reverse Trendelenburg: Head up Lateral tilt: Left down

Trendelenburg: Head down

3

Lateral tilt: Right down Back plate bending: Down

Table up (Lock operating table)

Table down

Slide foot

Slide head

Lift-up unit : Up

Lift-up unit : Down

Flex: Center up

Reflex: Center down

Leg plate bending: Up

Leg plate bending: Down Reverse mode switch

Brake unlock E switch

Return to level Power ON/OFF switch

NOTE About 20 minutes of halting will be need when operating the table continuously for about 3 minutes. If the motor gets overheated you will not be able to operate the table. When overheat occurs, about 90 minutes of rest will be need to operate the table as usual. If

is pressed, the pilot lamp lights up for 3 seconds.

13

Section Introduction

Back plate bending: Up

3.3

Cordless control unit (optional) (*1)

Pilot lamp

3

Reverse Trendelenburg: Head up

Section Introduction

Lateral tilt: Left down

Trendelenburg: Head down

Lateral tilt: Right down

Back plate bending: Up

Back plate bending : Down

Table up (Lock operating table)

Table down

Slide foot

Slide head

Lift-up unit: Up

Lift-up unit: Down

Flex: Center up

Reflex: Center down

Leg plate bending: Up

Brake unlock

E switch

Leg plate bending: Down

Return to level

Power ON/OFF switch

*1: The cordless control unit is optional for the MOT-VS500SK-IF.

NOTE About 20 minutes of halting will be need when operating the table continuously for about 3 minutes. If the motor gets overheated you will not be able to operate the table. When overheat occurs, about 90 minutes of rest will be need to operate the table as usual. If

is pressed, the pilot lamp lights up for 3 seconds.

The cordless control unit can be set channels up to three. If you need the setting, contact your distributor or Mizuho.

14

3.4

Foot switch (optional) (*1)

3 Table down Trendelenburg: Reverse Lateral tilt: Head down Trendelenburg: Left down Head up

Section Introduction

Table up

Lateral tilt: Right down

*1: The foot switch is optional for the MOT-VS500SK-IF.

15

4. Operation 4.1

CAUTION

Installation and battery charging Use the equipotential wire to ground the equipotential terminal to the medical grounding terminals. Prepare the equipotential wire yourself. When moving this product, carry it out with two or more persons.

4

Installing the operating table

Operation

1. Move the operating table to a flat area. 2. Check the battery lamp. If the battery lamp (orange) on the control unit flashes, battery charging is required.

Battery lamp (Orange・flash)

3. If the battery indicator shows empty (red), battery charging is required.

Red・light up

E

F

BATTERY INDICATOR

16

Equipotential terminal Equipotential wire

Installation space This product requires the installation space shown as below.

2.5 m (98.43 in) or more

2.5 m (98.43 in) or more

2.5 m (98.43 in) or more

4 Operation

2.5 m (98.43 in) or more

17