Operating Table Model MOS-1302B Operators Manual Ver.4 June 2021

Contents 1 Introduction...1 2 Before use...5 3 Component identification...15 Main unit...16 Control unit...17

4 Operation...19 Installation and battery charging...20 Switch On/Off power...25 In case of emergency...27 Lock and unlock the operating table...28 Brake Release...29 Lateral tilt...30 Trendelenburg ...32 Tilt the back plate...33 Change height of the tabletop...34 Tilt the seat plate...35 Return to level...37 Adjustment of head plate...38 Adjustment of seat plate...40 Adjustment of leg plate...41

1

Introduction

2

5 Using the leg traction device ...45 The leg traction device components...46 Examples of combination of various leg traction device components...47 Femoral neck fracture procedure position ...47 Femoral shaft fracture procedure position ...51

Before use

3

Component identification

4

Operation

5

Using the leg traction device

6

Maintenance and inspection

7

Leg fracture procedure position ...56

Specifications

Attaching the lower limb support right/left...60

When the control unit can not be used

Attaching/Detaching the traction shoe...61

6 Maintenance and inspection...63 Inspection before and after use...64 Periodic replacement parts...65 Version information of the software...65

7 Specifications...67 Specifications...68 Appearance...70

8 When the control unit can not be used...71 9 Troubleshooting...73 Troubleshooting...74 In case of malfunction...75

App. Electromagnetic compatibility...77 Electromagnetic Compatibility...78

8

9

Troubleshooting

APP

Electromagnetic compatibility

1 1

Introduction

1 Introduction

2 1

Introduction

3 1

Introduction

Introduction

This Manual is intended to support the safe and effective operation of the operating table. Read this Manual carefully and familiarize yourself thoroughly with its contents (operation, inspection, adjustment, servicing) before operating the table. Using the table without following the instructions contained in this Manual may cause a serious accident. Safety information in this Manual and on the labels attached to the table is given in the following three forms for easy and full understanding:

WARNING

A WARNING notice indicates a situation which can result in death or serious injury to a person if the notice is ignored and the table is handled improperly.

CAUTION

A CAUTION notice indicates a situation which can result in injury to a person and/or damage to property if the notice is ignored and the table is handled improperly.

NOTE

Description under this heading gives supplementary explanation of the functions of the table.

The WARNING and CAUTION notices in this Manual relating to the operation, inspection, adjustment, or servicing of the table apply in using the table for surgical operations. The user is solely responsible for safety if the table is operated, inspected, adjusted, or serviced in a way not specified in this Manual.

nAbout this product This product is designed to support patients during surgical procedures. This product has a functions to adjust the height of the tabletop and to position a patient's body. Both a medical grade AC power and a battery are available as a power source. This product is to be used by health care professionals, including but not limited to surgeons, nurses and biomedical technicians.

4 1

Introduction

Accessories Mattresses (for head, back, seat, and legs)

Control unit

Main unit

Operator’s manual

5 2

Before use

2 Before use

6 2

Before use

Please read carefully before use When the operating table is in use, never commit any of the following actions. It may cause damage of the operating table, electric shock or fire. 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.

Head plate or leg plate

WARNING - Do not sit on the head plate or the leg plate(s). Otherwise it may cause a person to tumble off or to get injured.

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

Fig b w  hen changing a patient’s body position

head plate head plate

leg plate

head plate

leg plate

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

Power cord

WARNING -Do not place any heavy object on the power cord. -Do not ride over the power cord with a castered device. -Do not pull the power cord forcefully. -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 power cord being unplugged.

Control unit

WARNING - Do not pull a cord of control unit forcefully. - Do not apply strong shock to the control unit. It may get damaged.

7

Patient's position during surgical operation

WARNING

2

- Do not rest the patient on the head side and leg side with the orientations reversed. Doing so may cause the leg plate to get damaged. - Make sure to attach the provided mattresses securely. Improper attachment may cause a patient to get injured. - Position a patient's body at least 10mm(0.39in) away from the side rails. When using the electric scalpel, they may become hot and if the body touches the rails, it may cause the patient to get burned. Positioning the patient Follow the steps below to position the patient. 1. Attach the accessory mattresses onto the tabletop. 2. Put the patient on the mattresses. 3. Position the patient according to the purpose of the surgical operation.

Installation of the operating table

CAUTION - Do not install the operating table on an uneven floor. - Do not put a pad under the column base for raising the table. It may cause the table falling down and injury.

uneven floor surface

pad

Before use

8 2

Before use

Others

WARNING Prohibition of disassembling and modification - Do not attempt to disassemble or modify the table. It may cause a malfunction. When used together with other medical electrical equipment - Before using together with other equipment, make sure to check that it is not affected by electromagnetic interference. Electromagnetic interference from other medical electrical equipment may cause malfunction. - 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 usage may cause the operator or the patient to get burned and/or devices to malfunction. Patient's body position - When using operating table accessories, always pay close attention to the patient. Patients left in the same posture for an extended period of time are at risk for developing nerve paralysis and/or bedsores. Allowable load - Do not exceed the allowable load 135kg(300lbs). The table may become inoperable and cause malfunction. Preventive maintenance and inspection - Make sure to perform inspection before and after use, and appropriate preventive maintenance inspection. The table may not survive its useful life depends on number of years and frequency of use. - For preventive maintenance inspection, please contact your distributor or us 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.

CAUTION When used together with other medical equipment or accessories - Before using another devices or accessories, read carefully the instruction manual of the device and make sure that the operating table will not be affected adversely. Before fitting an accessory of third party company, make sure to contact your distributor or us. Some accessories cannot be fitted. - When using the operating table, make sure to check the positions of other devices or accessories. They may come in contact with each other during the operation, and may get damaged. - For hygiene, be sure to use sterile drapes on the areas on this product where the patient comes into contact with it.

Others

CAUTION Cleaning and disinfection - Make sure to clean and disinfect the operating table after each use. Disinfection - The following procedure should be followed when disinfecting an operating table. 1. Power off and remove the power cord from medical grade wall outlet. 2. Remove all table pads from the operating table. 3. Apply a proper quantity of disinfectant on a clean and lint-free cloth, and wipe the top and sides and bottom of the pads with the cloth. A proper quantity of disinfectant means a quantity such that the cloth with disinfectant does not dry when wiping. 4. Disinfect the table board of the table top and the surface of the side rail in the same way. 5. Wipe all disinfected parts with dry, clean and lint-free cloth within 15 minutes after disinfecting.

Usable disinfectant solutions which we have already confirmed as compatible. 1 2 3 4 5 6 7 8 9

Sodium hypochlorite 0.1% (halogen containing compound) Sodium thiosulfate Chlorhexidine (chlorhexidine gluconate 0.5%) Benzalkonium chloride (invert soap 10%) Povidone iodine Ethanol 80% Hydrogen peroxide Saline 0.9% Isopropyl alcohol (IPA) 99.5%

Moving and transportation - Do not move the table while a patient is on it. - Follow the procedure below for moving the table. 1. Power off and remove the power cord from medical grade wall outlet. 2. Check if handles and levers are in the fixed position, and each section is fixed firmly. 3. Unlock a brake to move the table. Note: Before moving the operating table, disinfect the whole operating table in order to prevent infection. - Transportation should be carried out with the following conditions met. 1. Disinfect the whole operating table before transportation. 2. Take measures against falling down, like moving down the table to the lowest position. 3. Actuate a brake. 4. Use cushioning materials to prevent damage during transportation. 5. Protect against dust, wind and rain. 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.

9 2

Before use

10 2

Before use

Warning label: details and position Warning label is attached on the following area of the operating table. Before using it, make sure to check the contents of the warning label.

nWARNING, CAUTION labels

C653624

C665732

C651304

C651310

C651321

C655803 or C651313

or C651314

or C651318

or C651317

C600020

C657333

C600162

C653516

C653515

C655648

C653614 C642002

C651305

C657306

C653513 C656740

11 2

Before use

C655752

C653620

C600187

C651312

C651311

or C651316

or C651315

or C651320

or C651319

C600516

C651306

C651309

PIN 50005M2

PIN 132A6M1

PIN 132A7M1

PIN 132A7M2

PIN 132A7M3

PIN 132A8M1

12 2

Before use

nSymbol mark for labeling Symbol

Referent

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

Label No.

② ③ ⑥ ⑦ ⑱ ⑲

General prohibition sign

⑱

General mandatory action sign

⑱

Emergency stop

⑬

Refer to the operators manual

⑪ ⑬ ⑮ ⑱

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

Manufacturer

⑮ ㉗ ㉘ ㉙ ㉚ ㉛ ㉜ ㉜

Equalization terminal

⑰

Medical Device

⑮

Type B

⑳

Defibrillation - proof Type B applied part

㉗ ㉘ ㉙ ㉚ ㉛ ㉜

ON (Power)

⑯

OFF (Power)

⑯

13 nLabels of the leg traction device components Lower Limb Support, Right/Left

Lower Thigh Support for Traction in Lateral Posture

Lower Limb Support Clamp

Lateral Pad

Inner Thigh Support with Pad for Traction in Lateral Posture, Height Adjusting Collars L-shaped Knee Rest with Pad

Extension Arm, Right/Left Traction Device Arm

Inner Thigh Column (Large)

Inner Thigh Column (Small) Pad (Large) Pad (Small)

Pad (Large)

Cart for Traction Arm

Traction Device, Traction Shoe, Right/Left

Wide Pelvis Support

Pad (for Wide Pelvis Support)

Accessory Cart for Traction Device

2

Before use

14 2

Before use

16 Main unit Mattress Leg plate

3

Component identification

Control unit Head plate

Seat plate

Back plate Leg plate flexing handle Leg plate fixing handle Seat plate fixing handle

Emergency stop switch Side rail

Column Actuation limit line Base

Auxiliary switch

Control unit connector Emergency brake release handle Caster

Brake

Power connector

Power switch Battery indicator

Equipotential terminal

Note: The head plate, back plate, and leg plates are detachable.

Traction Device Arm fixing handle

17 Control unit 3

Component identification

Power lamp Pilot lamp

Battery lamp Trendelenburg: Head down

Reverse Trendelenburg: Head up Lateral tilt: Left down

Lateral tilt: Right down

Back up

Back down

Table up (Lock operating table)

Table down

SEAT UP

SEAT DOWN

Brake unlock Return to level E button

Power ON/OFF switch

CAUTION ATTENTION KEEP CORD CLEAR OF MOVING PARTS. MAINTENEZ LE CORDON D’ ALIMENTATION ÉLOIGNÉ DES PIÈCES EN MOUVEMENT.

NOTE

- About 7 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 60 minutes of rest will be need to operate the Table as usual. - If

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

19

4

Operation

4 Operation ON Installation and battery P20 charging

Switch On/Off P25 power

LOCK RELEASE

In case of emergency P27

Lock and unlock the operating P28 table

Brake Release

Trendelenburg P32

Tilt the back plate

P33

Change height of the tabletop P34

Tilt the seat P35 plate

Return to level

Adjustment of head plate P38

Adjustment of seat plate P40

Adjustment of P41 leg plate

P37

P29

Lateral tilt

P30