Mizuho 08-077-70 Instructions For Use

Instruction for Use Trade Name: Leg-side Reversal Adapter 1/3 Be sure to read this instruction manual before using this product. Keep this manual available for reference when needed. Warning 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. Contraindication/Prohibition 1. This product is only validated for use with Mizuho operating tables. 2. Do not exceed the Maximum patient weight specified in [Specifications], Item 4. Doing so could cause the product to break. 3. Do not apply an unbalanced load to the tip of the board. The product may fall or be damaged. Symbol mark for labeling MD : Medical Device Specifications 1. Shape 1-1．Leg-side Reversal Adapter A Unit: mm 1-2．Leg-side Reversal Adapter B, B(R1) & B(R2) Unit: mm 1-3．Leg-side Reversal Adapter C, C(R1) & C(R2) Unit: mm 1-4．Digital Radiographic Table Top for Leg-side Reversal Adapter Mizuho Original Pad for Leg-side Reversal Adapter Unit: mm Code No. Product Description No. 08-077-70 Leg-side Reversal Adapter A  08-077-60 Leg-side Reversal Adapter B  08-077-60-R1 Leg-side Reversal Adapter B (R1) ⑪ 08-077-60-R2 Leg-side Reversal Adapter B (R2) ⑫ 08-077-50 Leg-side Reversal Adapter C  08-077-50-R1 Leg-side Reversal Adapter C (R1) ⑪ 08-077-50-R2 Leg-side Reversal Adapter C (R2) ⑫ 18-097-00 Digital Radiographic Table Top for Leg-side Reversal Adapter  18-042-90 Mizuho Original Pad for Leg-side Reversal Adapter  Note: The numbers match the ones that are used in Fig. 1-4. 2. Weight 08-077-70: 4.0 kg 08-077-60/R1/R2: 5.8 kg 08-077-50/R1/R2: 6.0 kg 18-097-00: 0.5 kg 18-042-90: 0.2 kg Fig. 1 Fig. 2 Fig. 3 Fig. 4

 Insertion shaft A: Stainless steel rod  Insertion shaft B: Stainless steel rod  Velcro fastening: Nylon  Unlock button: Polyacetal ⑪⑫ Bracket: Stainless steel rod  Fixing handle: Stainless steel rod  Cassette board: Thermosetting resin laminated board  Radiographic top leg: Polycarbonate  Pad: Urethane foam Note: The numbers match the ones that are used in 1. Shape, Fig. 1-4. 4. Maximum patient weight 135 kg Intended purpose This is an accessory which is supplied with the operating table. The adapter makes it possible to attach the back plate side mounting accessories onto the leg plate sides by attaching them onto the waist plate with the leg plates detached. Intended user This product is to be used by health care professionals, including but not limited to surgeons, nurses and biomedical technicians. Instructions for use 1. 08-077-70/-60/-60-R1/-60-R2  Insertion shaft  Radiographic top  Pad  Unlock button 1-1. Insert the Leg-side Reversal Adapter insertion shaft  into the leg plate insertion hole of the operating table. 1-2. Pull on the Leg-side Reversal Adapter to make sure it is firmly inserted. 1-3. Attach the pad . 1-4. If radiography is required, attach the radiographic top  between the Leg-side Reversal Adapter and pad . 1-5. When detaching the Leg-side Reversal Adapter, then pull the Leg-side Reversal Adapter straight out while pressing the unlock button ④. 2. 08-077-50/-50-R1/-50-R2  Pad  Bracket  Radiographic top  Fixing handle 2-1. Insert the bracket  of the Leg-side Reversal Adapter into the side rails of the seat board on the operating table. 2-2. Make sure that the Leg-side Reversal Adapter is completely inserted, and then tighten the fixing handle  to fix it. 2-3. Attach the pad . 2-4. If radiography is required, attach the radiographic top  between the Leg-side Reversal Adapter and pad . 2-5. When detaching the Leg-side Reversal Adapter, then loosen the fixing handle ⑥, and pull the Leg-side Reversal Adapter straight out. 3. Applicable operating tables Mizuho operating tables Warning / Caution 1. Important caution 1-1. For hygiene, be sure to use sterilized drapes on the areas on this product where the patient comes into contact with it. 1-2. Ensure that all of the fastener components are tied up. Failure to do so may result in a patient injury. 1-3. When working with an operating table, take care not to allow this product to make contact or interfere with the table top or with other tools and appliances used in combination with this product. 2. Interaction [Precautions when using with other items] If the operating table’s slide is slid the maximum amount with this product and accessories attached to it, then the operating table’s operations might be slowed down. Storage / Life 1. Do not store the device in areas where there are high temperatures or high humidities, nor in places where there are drastic temperature or humidity fluctuations. 2. Service life of this product: 7 years (When it is maintained and inspected as specified, and when it is properly stored.) Fig. 5 Leg-side Reversal Adapter A Fig. 6 Leg-side Reversal Adapter A Fig. 7 Fig. 8