Microsurgery Operating Table Model MST-7300B and BX Operators Manual Ver.6 October 2021

Table of contents 1.

Introduction…………………………………………………………… 1 1.1 1.2 1.3 1.4

2.

Safety precaution…………………………………………………… 4 2.1 2.2

3.

Main unit……………………………………………………………………………13 Touch screen...……………………………………………………………………14 Control unit…………………………………………………………………………19 Foot switch (optional)………………………………………………………………21

Installation……………………………………………………………22 4.1 4.2 4.3 4.4

5.

Read thoroughly before using…………………………………………………… 4 Labeling…………………………………………………………………………… 9

Section Introduction…………………………………………………13 3.1 3.2 3.3 3.4

4.

This manual………………………………………………………………………… 1 Intended use and this product…………………………………………………… 1 Operation of this product………………………………………………………… 2 Accessories………………………………………………………………………… 2

Installation of the operating table…………………………………………………22 Attaching/Detaching the control unit……………………………………………23 Turning on/off the power…………………………………………………………26 Charging the battery………………………………………………………………30

Settings…………………………………………………………………31 5.1 5.2 5.3 5.4

Setting the pause functions at the level and center positions…………………31 Changing the movement of the lateral tilt (MST-7300BX only)………………32 Activating buzzer at limit of travel…………………………………………………34 Switching speed……………………………………………………………………36

6.

Operation………………………………………………………………37 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10 6.11 6.12 6.13 6.14 6.15 6.16

7.

Maintenance and inspection………………………………………65 7.1 7.2 7.3

8.

Display the monitor…………………………………………………………………37 Operating the emergency stop switch……………………………………………38 Fixing and unfixing the operating table…………………………………………39 Tilting the tabletop laterally………………………………………………………40 Trendelenburg………………………………………………………………………41 Bending the back plate……………………………………………………………43 Bending the leg plate………………………………………………………………45 Changing the tabletop height……………………………………………………46 Sliding the tabletop (MST-7300BX only)…………………………………………48 Operating/Registering memory…….…………………………….……………..50 Checking the current position of the tabletop……………………………………54 Returning to level…………………………………………………………………55 Adjusting the head plate…………………………………………………………56 Attaching/detaching the auxiliary back plate……………………………………59 Attaching/detaching the back plate………………………………………………61 Attaching/detaching the leg plate…………………………………………………63 Inspection before and after use…………………………………………………65 Periodic replacement parts………………………………………………………67 Version information of the software………………………………………………67

Specification…………………………………………………………68 8.1 8.2

Specification table…………………………………………………………………68 External view………………………………………………………………………72

9.

Troubleshooting………………………………………………………73

10.

Before contacting for repairs………………………………………80

App.-1 Electromagnetic compatibility……………………………………84 App.-2 Glossary………………………………………………………………88

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

Operating table „„ This product is an operating table on which a patient is placed for surgical operations. The product is intended to support a patient during neurosurgical 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.

„„ Touch screen This product is provided with a touch screen. The touch screen displays a status of the operating table and its error status. For the details of the touch screen, refer to Page 14.

1

1

1.3

Operation of this product

Introduction

The description of the operations written in this manual focuses mainly on those to be done by the control unit. For some operations operable only by the touch screen, however, those by the touch screen are described. The pictures of the control unit which are depicted in this manual are using the MST-7300BX.

1.4

Accessories

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

Control unit Main unit

Power cord

Operator's manual

2

Optional „„

1 Introduction

Foot switch

Control unit charging adapter

3

2. Safety precaution 2 Safety precaution

2.1

Read thoroughly before using

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)

(6) (5) (4)

(2)

(3)

(1) Head plate and leg plate WARNING

CAUTION

4

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

• 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 the operating table is put into the Trendelenburg or the back plate/tabletop is moved down with any accessory such as a head frame attached, do not operate the table until the accessory contacts with the floor. It may get damaged.

CAUTION

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

Safety precaution

Head plate Leg plate

2 Leg plate

(2) Touch screen

CAUTION

• Do not push the touch screen by any sharps such as a pen and a screw driver. The touch screen may get damaged. • Do not apply great impact or pressure to the touch screen. The touch screen may get damaged. • Do not use organic solvents such as paint thinner to wipe the display and the protective cover. They may get damaged. To wipe the display and the protective cover, use a natural detergent diluted with water. • The touch screen does not accept simultaneous multiple-key pressing and flicking operations. When operating the touch screen, press the switch one by one.

(3) 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

(4) Installation of the operating table WARNING

• Do not install the operating table on an uneven floor (more than 5°). • 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

(5) Base

CAUTION

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

(6) Control unit

CAUTION

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

5

Patient's position during surgical operation „„

2

WARNING

Safety precaution

• 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 zz 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. (Do not reverse the head side and the leg side and put the patient on them.)

3. Position the patient according to the purpose of the surgical operation. CAUTION

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

Other „„

● Prohibited WARNING

• 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 allowable patient body weight (total of the patient and accessories)*. The operating table may not function, which may result in failures. * 360 kg (800 lbs)

●

●

●

6

● Preventive maintenance and inspections WARNING

• 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.

2

●

Safety precaution

● Devices and accessories used together with this product CAUTION

• 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.

●

a) b) c) d) e) f) g) h) i)

Sodium hypochlorite 0.1% (halogen containing compound) Hypo Alcohol (iodine color removing agent) Chlorhexidine (chlorhexidine gluconate 0.5%) Benzalkonium chloride (invert soap 10%) Povidone iodine Ethanol 80% Hydrogen peroxide Saline (0.9%) Isopropyl alcohol (IPA)

7

● Moving and transporting CAUTION

2 Safety precaution

• 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.

●

8

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

(1)

(9)

(2)

(7) (8) (6)

(5) (4)

(1) C643013

(5) C656740

(7) C655803

(2) C643012

(3) C657332

(3) (4) C657312

(6) C657331

(8) C657333

(9) C653624

9

Other labels (1/2) „„ (11)

2 Safety precaution

(10)

(24)(25)

(12) (14)

(13) (14) (18)

(21)

(23)

(22)

(10) C657337 (MST-7300BX)

(17) C657307

(18) C657306

(24) C657341 (MST-7300BX)

10

(12) C657343

(15) C657309

(21) C656741

(17) (16)

(10) C657335 (MST-7300B)

(11) C657334 (MST-7300B)

(14) C657313

(19)

(20)

(11) C657336 (MST-7300BX)

(13) C642002

(16) C657308

(19) C657318

(22) C657311

(25) C657340 (MST-7300B)

(15)

YYYY-MM-DD Made in ＊＊＊

(20) C655711

(23) C657310

Other labels (2/2) „„ (30)

(30)

(30)

(30)

(30)

2 Safety precaution

(26)

(27)

(31) (32)

(28)

(33)

(29)

(34)

(35)

(26) C657305 (ASIA)

(27) C657303 (ASIA)

(28) C657302 (ASIA)

(29) C657301 (ASIA)

or

or

or

or

or

C657348 (EU)

C657344 (US)

or

C657351 (EU)

C657347 (US)

or

C657349 (EU)

C657345 (US)

or

C657350 (EU)

C657346 (US)

(30) C653620

(31) PIN 50005M2

(32) PIN 722B6M4

(33) PIN 722B6M3

(34) PIN 722B7M2

(35) PIN 722B8M2

11

Symbol mark for labeling „„ Symbol

2 Safety precaution

12

Description

Label no.

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

(1) (2) (3) (5) (6) (7) (8) (9)

General prohibition sign

(3) (5)

General mandatory action sign.

(3) (5) (6)

Emergency stop

(4)

Refer to the operator's manual

(5) (13) (14)

Indicates AC power supply.

(13) (17)

Enclosure Class (Splash-proof)

(13)

Serial number

(13)

Catalogue Number

(13)

Indicates waste disposal information

(13)

European authorized representative

(13)

Manufacturer

(13) (31) (32) (33) (34) (35)

Equalization terminal

(15)

Indicates protection against electric shock and defibrillator (Class B)

(26)

Defibrillation - proof Type B applied part

(31) (32) (33) (34) (35)

Medical Device

(13)

USB

(16)

POWER ON

(18)

POWER OFF

(18)

3. Section Introduction 3.1

Main unit Auxiliary back plate (*1)

Head plate (*1)

Back plate (*1)

Head plate flexing lever

Seat plate

3

Leg plate (*1)

Head plate fixing handle

Section Introduction

Leg plate attaching/ detaching lever Mattresses

Auxiliary back plate fixing handle Back plate

attaching/detaching lever

Fig. B

Side rail

Fig. C

Base

Control unit

Emergency stop switch Touch screen

Brake Caster Emergency brake release handle

Fig. A

Brake lamp

Fig. A

Power cord

Fig. B

Fig. C

Power switch for the touch screen

Light receiver

Equipotential terminal

USB terminal (*2)

Power connector Main power switch

Control unit connector

Foot switch connector (*3)

Auxiliary switch

Light receiver

*1: The head plate, auxiliary back plate, back plate, and the leg plate are detachable. *2: The USB terminal is intended to be used for maintenance. Do not connect a device such as a personal computer to the USB terminal. *3: The foot switch is optional.

13

3.2

Touch screen

TOP PAGE screen „„

Power source (AC/BATTERY)

3 Section Introduction

Operation speed (LOW/HIGH) Position in operation Memory mode being used Completion of memory position ISO CENTER mode (MST-7300BX only) CAUTION/WARNING screen (Refer to Fig. E-1, E-2)

Battery indicator BACK-UP CONTROLS screen (Refer to Fig. B-1) Select Stop at Level screen (Refer to Fig. D) MEMORY FUNCTION screen (Refer to Fig. C) SUPPORT screen (Refer to Fig. F) Fig. A (MST-7300BX)

BACK-UP CONTROLS screen (1/2) „„ Current positional direction Position (Travel (in/mm), angle (deg))

Reverse Trendelenburg: Head up

Trendelenburg: Head down

Lateral tilt: Right down in the view from the leg

Lateral tilt: Left down in the view from the leg

Back plate bending: Up

Back plate bending: Down

Table up Table down

Slide foot (MST-7300BX only)

Slide head (MST-7300BX only)

Slide right in the view from the leg (MST-7300BX only)

Slide left in the view from the leg (MST-7300BX only)

Leg plate bending: Up

Leg plate bending: Down

TOP PAGE screen

Page (Refer to Fig. B-2)

Fig. B-1 (MST-7300BX)

14

BACK-UP CONTROLS screen (2/2) „„

Brake unlock (Tap more than 1 second)

Level Low speed

High speed

Buzzer at limit of travel

Reset memory

MEMORY FUNCTION screen

3 Section Introduction

ISO CENTER mode (MST-7300BX only)

Setup memory Page TOP PAGE screen Fig. B-2 (MST-7300BX)

MEMORY FUNCTION screen „„

Settings of the position

Page TOP PAGE screen Fig. C (MST-7300BX)

NOTE For the details of the MEMORY FUNCTION, refer to Page 51

15

Select Stop at Level screen „„

Trendelenburg

3

Lateral tilt

Section Introduction

Back plate bending

Pause ON/OFF

Head-to-foot slide (MST-7300BX only) Right-to-left slide (MST-7300BX only) Leg plate bending

TOP PAGE screen Fig. D (MST-7300BX)

NOTE • With the default setting, all functions are set to ON. • For the details of the Select Stop at Level screen, refer to Page 31.

16

CAUTION/WARNING screen „„ CAUTION No. Title

3

Content

Go to the previous screen TOP PAGE screen Fig. E-1

Fig. E-2

NOTE • To prevent damages, the operating table may stop during operation and a caution/warning screen such as in Fig. E-1 appears on the touch screen. For specific recovery procedures after the operating table stopped, refer to Page 77. • Fig. E-2 appears, if you click CAUTION in Fig. A while any caution or warning has occurred. When one caution/warning occurred, the screen of Fig.E-1 appears.

17

Section Introduction

Details (Refer to Fig. E-1)