Steris ARCH Instructions For Use Manual
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Steris ARCH Instructions For Use Manual

Steris ARCH Instructions For Use Manual

Orthopedic leg positioner
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INSTRUCTIONS FOR USE
STERIS ARCH Orthopedic Leg Positioner
Instructions for Use

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  • Page 1 INSTRUCTIONS FOR USE STERIS ARCH Orthopedic Leg Positioner Instructions for Use...
  • Page 2 Innovative Orthopedic Technologies (IOT) AG. Noncompliance may result in a liability to indemnify. Please carefully preserve these operating instructions Product STERIS ARCH Orthopedic Leg Positioner Order number BF00401 GTIN 00724995220563...

  • Page 3: Table Of Contents

    4.3. Installing the ARCH .................... 22 4.3.1. Mounting the height setting device on the chassis ........... 22 4.3.2. Installing the C-arch onto the height setting device ..........24 4.4. Transporting the product ..................27 4.5. Final examination ....................28 Operation .................... 29 5.1.
  • Page 4 Transport ......................47 7.3. Storage ......................48 7.4. Disposal ......................48 Technical data ..................49 8.1. Technical data of the ARCH .................. 49 8.2. Adjustable ranges ....................50 Information for ordering ..............51 9.1. Accessories ....................... 51 RD-PT-6813010-07en_V01 4 (51)
  • Page 5 Fig. 4-15: ARCH Orthopedic Leg Positioner .................. 28 Fig. 5-1: Hand wheel for height adjustment .................. 30 Fig. 5-2: Distance between C-arch and hip joint ................31 Fig. 5-3: Geometrical conditions (schematic illustration) .............. 32 Fig. 5-4: Traction boot ........................34 Fig.

  • Page 6: Notes For Users

    If you have questions regarding the operation of the product and the accessories, please contact STERIS. In combination with the accessories designed for the ARCH, the product has to be used in accordance with the documentation supplied with the accessories.

  • Page 7: Warning And Danger Symbols

    INSTRUCTIONS FOR USE 1.3. Warning and danger symbols DANGER Danger of death or serious bodily injury Failure to observe WILL lead to death or serious bodily injury. WARNING Danger of death or serious bodily injury Failure to observe CAN lead to death or serious bodily injury. CAUTION Danger of slight bodily injury A hazard which CAN lead to slight bodily injury.
  • Page 8 INSTRUCTIONS FOR USE u Read the User Manual. u Observe important notice in the operating instructions. u Read the operating instructions before installing and using the device. Read the User Manual! Serial number Catalog number Manufacturer Unique Device Identifier Prescription Only Non-Sterile Device CAUTION: SEE INSTRUCTION MANAUL READ THE INSTRUCTIONS...

  • Page 9: Typographical Conventions And Symbols

    Listing 2 1.6. Acronyms and abbreviations Acronym/Abbreviation Meaning ARCH ARCH Orthopedic Leg Positioner 1.7. Figures in this user manual Some of the figures in this user manual are schematics where the colors do not necessarily correspond to the final product. RD-PT-6813010-07en_V01 9 (51) ©...

  • Page 10: Product Description

    INSTRUCTIONS FOR USE Product description 2.1. Overall illustration Fig. 2-1: ARCH Orthopedic Leg Positioner Hand wheel for height adjustment Interior rotation apparatus Hand wheel for fine level traction Traction boot Accessory rail Clamping lever Abduction/Adduction 10 Castors, lockable (4x) C-arch...

  • Page 11: Scope Of Delivery

    INSTRUCTIONS FOR USE 2.2. Scope of delivery The ARCH is delivered in a box. In the crate the ARCH is disassembled in three pieces: • C-arch with sliding carriage • Height setting device • Chassis The traction boot is packed in a separate carton box, which is added to the crate.

  • Page 12: Warranty And Guarantee

    INSTRUCTIONS FOR USE 2.6. Warranty and Guarantee The warranty provisions form a part of the manufacturer’s General Terms and Conditions. If you use unauthorized replacement parts, you void the manufacturer’s warranty. RD-PT-6813010-07en_V01 12 (51) © IOT AG...

  • Page 13: General Safety Notes

    INSTRUCTIONS FOR USE General Safety Notes 3.1. Intended use The ARCH is designed for hip replacement. The product is used as an accessory for operating tables. It has been designed exclusively for positioning of the patient’s leg during operation. The patient must be supine.

  • Page 14: Hazards When Used According To Intended Use

    INSTRUCTIONS FOR USE • Use of the device outside spaces that have been created according to instruction as per the valid provisions and guidelines for erection of medical spaces • Use of a damaged device • Use of an incorrectly assembled device •...
  • Page 15 CAUTION Risk of injury The pulling force exerted by ARCH during traction exceeds the adhesion of the operating table to the floor. The surgery is delayed or cannot be carried out using the device. u Before the surgery, ensure that the operating table is adequately fixed to the floor.
  • Page 16 INSTRUCTIONS FOR USE WARNING Risk of contamination from the device This device is not shipped in sterile condition. There is a risk of contamination. u Please clean and disinfect the product according to the procedures approved by your organization. u The product has to be covered during the surgery. u The operator has to remain in the non-sterile area behind the product during the surgery.
  • Page 17 INSTRUCTIONS FOR USE WARNING Risk of infection from the boot Pathogens can accumulate in the boot. u Avoid direct contact with the patient. u Apply a bandage to avoid direct contact between patient and traction boot during patient preparation and before the traction boot is fitted to the leg to be operated on.
  • Page 18 Select optimal boot size and pad the feet appropriately. CAUTION Risk of injury from the ARCH breaking The ARCH may break in case of heavy patients over 227 kg( 500lb.). u Use product only for patients of max 227 kg (500 lb.).

  • Page 19: Qualifications Of Operating, Assembly And Maintenance Personnel

    This is true for maintenance, repairs and for modifications. 3.6. Notes on product liability Manufacturer’s liability STERIS shall only be liable for safe operation, reliability and performance of the device if: • maintenance is done solely by persons authorized to do this by STERIS •...

  • Page 20: Conformity

    Medical Devices. Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements Medical Device Class The ARCH is classified as: Class I general, non-sterile, no measuring function. RD-PT-6813010-07en_V01 20 (51) © IOT AG...

  • Page 21: Preparing The Device For Operation

    Unpack and assemble the device and its parts only with two persons. Note Please note that the packaging is reusable. 4.2. Unpacking the ARCH u Open the package. u Successively withdraw the chassis, height setting device and c-arch with sliding carriage.

  • Page 22: Installing The Arch

    INSTRUCTIONS FOR USE 4.3. Installing the ARCH 4.3.1. Mounting the height setting device on the chassis u Place chassis on the castors. u Lock castors so that the chassis will not roll away. Fig. 4-1: Chassis u Carry the height setting device with two people to the chassis.

  • Page 23: Fig. 4-3: Chassis Centering Pin

    Then make sure that both screws are firmly tightened. Fig. 4-5: Tighten height setting device u Ensure the height setting device is oriented as shown. Next, the C-arch is installed onto the height setting device. Fig. 4-6: Correct Orientatio RD-PT-6813010-07en_V01 23 (51)

  • Page 24: Installing The C-Arch Onto The Height Setting Device

    INSTRUCTIONS FOR USE 4.3.2. Installing the C-arch onto the height setting device First, the fine level traction on the height setting device must be prepared. u At the hand wheel, unscrew the fine level traction to -40 mm. Fig. 4-7:...

  • Page 25: Fig. 4-10: C-Arch With Sliding Carriage

    INSTRUCTIONS FOR USE CAUTION Risk of injury The C-arch is very heavy. If it falls down, it may cause severe injury. u Carry the C-arch with sliding carriage with two persons to the chassis. u Carry the C-arch with sliding carriage with two persons to the chassis.

  • Page 26: Fig. 4-11: C-Arch Installation 1

    INSTRUCTIONS FOR USE u Have two persons lift the C-arch (1) and introduce it into the square profile of the fine level traction (2). u Push C-arch into the fine level traction until the threaded holes are above the boreholes.

  • Page 27: Transporting The Product

    CAUTION Risk of injury when moving the assembled product The product has a high center of gravity. If the C-arch is not in the vertical zero position, there is danger of tipping. A tipping ARCH LPS can cause serious injury.

  • Page 28: Final Examination

    Prior to use in the operating room, the product must be fully cleaned and disinfected. CAUTION Risk of injury from ARCH breaking A The ARCH may break in case of heavy patients over 227 kg (500 lb.). u Use product only for patients of max 227 kg (500 lb.) Fig. 4-15:...

  • Page 29: Operation

    CAUTION Risk of injury when moving the assembled product The product has a high center of gravity. If the C-arch is not in the vertical zero position, there is danger of tipping. A tipping ARCH LPS can cause serious injury.

  • Page 30: Determine The Correct Patient Orientation

    INSTRUCTIONS FOR USE 5.1.1. Determine the correct patient orientation The chart below shows the correct patient orientation to be used on various STERIS surgical tables. STERIS GENERAL SURGICAL TABLE PATIENT ORIENTATION (See Hand Control) 3000 SERIES Surgical Table REVERSE Patient Orientation...

  • Page 31: Positioning The Product

    Distance between C-arch and hip joint Hip joint C-arch If the rotational center of the product C-arch (3) and that of the hip joint (1) coincide, the leg can be freely moved along the C-arch without additional tensile or compressive forces acting on the leg.

  • Page 32: Fig. 5-3: Geometrical Conditions (Schematic Illustration)

    INSTRUCTIONS FOR USE Since the C-arch of the product (3) has a radius of 1300 mm, the product must be positioned so that the hip joint rotational center comes to lie 1300 mm from the C-arch (3) of the product.
  • Page 33 INSTRUCTIONS FOR USE CAUTION Risk of injury If the distance between the arch radius (3) and the hip joint (1) is less than 1300 mm, both upon flexion and extension additional traction is exerted on the patient's leg. u The distance between C-arch radius and hip joint must be 1300 mm (51.2 inches).

  • Page 34: Mounting The Traction Boot

    INSTRUCTIONS FOR USE 5.2.3. Mounting the traction boot Knurled nut Threaded bolt Traction boot Fig. 5-4: Traction boot Knurled nut Threaded bolt Mounting hole in the boot holder Traction boot u Push the traction boot with the threaded bolts (2) through the mounting holes of the boot holder (3).

  • Page 35: Traction Boot Maintenance Notes

    INSTRUCTIONS FOR USE Threaded bolt Knurled nut Slot in the mounting hole of the boot holder u Push the boot down until the threaded bolts (2) reach the stop in the slots (3). Fig. 5-6: Push traction boot down into slots u Screw the knurled nuts (2) on the threaded bolts (1) and tighten them.

  • Page 36: Adjusting The Position Of The Boot Holder

    INSTRUCTIONS FOR USE 5.2.5. Adjusting the position of the boot holder 1 Boot holder 2 Clamping lever u Use the boot holder (1) to set the correct foot position as described in section 5.2.2. u Securely clamp the boot holder in the desired position with the clamping lever (2).

  • Page 37: Adjusting The Fine Level Traction

    INSTRUCTIONS FOR USE 5.2.7. Adjusting the fine level traction u Adjust by turning the traction hand wheel Fig. 5-10: Hand wheel for fine level traction u Adjust the traction during the surgery using the gauge attached to the housing; you may reset it if necessary to the initial value.

  • Page 38: Sliding Carriage For Flexion And Extension

    Sliding carriage for flexion and extension CAUTION Risk of injury from tipping ARCH LPS If the C-arch is in a horizontal position and the sliding carriage extended to the maximum, the ARCH LPS may tilt. u At approximately horizontal position of the C-arch (greater than 60°), the sliding carriage may be deflected by...

  • Page 39: Fig. 5-12: Flexion/Extension Setting

    INSTRUCTIONS FOR USE CAUTION Risk of injury The sliding carriage is very heavy. If it falls down it may cause personal injury. u Do not pull the red locking pins (2) before the handle (1) is held firmly. u Ensure before releasing that at least one of the red locking pins is fully engaged.

  • Page 40: Internal And External Rotation Of The Leg

    The sliding carriage is very heavy. A foot can be squeezed if the sliding carriage is dropped unintentionally. u Do not stand with your feet in the danger area (2) directly under the C-arch. u Make sure that at least one of the red locking pins is fully engaged.

  • Page 41: Abduction And Adduction

    CAUTION Risk of injury when moving the assembled product The product has a high center of gravity. If the C-arch is not in the vertical zero position, there is danger of tipping. A tipping ARCH LPS can cause serious injury.

  • Page 42: Accessory Rail

    INSTRUCTIONS FOR USE 5.2.11. Accessory rail 1 Accessory rail Accessory devices can be attached to the accessory rail (1). The accessory rails may only be used for in-house transport and storage of accessories. Fig. 5-16: Accessory rail RD-PT-6813010-07en_V01 42 (51) ©...

  • Page 43: Maintenance And Service Operation

    INSTRUCTIONS FOR USE Maintenance and service operation 6.1. Important information Like every technical device, this device also requires • proper operation in accordance with these operating instructions • regular checks by the operator • regular maintenance and repair Through these precautionary measures, you will keep the device in an operationally capable and safe state.

  • Page 44: Maintenance And Service

    INSTRUCTIONS FOR USE 6.3. Maintenance and service The device contains the following mechanical components that are subject to operational wear: • castors • threaded spindles • locking pins • hand wheels • sliding carriage CAUTION Danger due to defective components Defective parts may cause a risk of injury.

  • Page 45: Maintenance

    INSTRUCTIONS FOR USE 6.5. Maintenance 6.5.1. Cleaning WARNING Danger of contamination This device is not sent in sterile condition. u Please clean and disinfect the device according to the procedures prescribed by your organization. WARNING Explosion hazard The use of cleaning agents containing alcohol can lead to the formation of explosive mixtures.

  • Page 46: Disinfection

    INSTRUCTIONS FOR USE 6.5.2. Disinfection The methods used for disinfecting have to comply with the valid legal provisions and guidelines for disinfecting and for explosion protection. Disinfectants that can be used For disinfection, use only surface disinfectants on the basis of the following active agent combinations: •...

  • Page 47: Transport, Storage, And Disposal

    A suitable transportation box must be used at any time to prevent possible structural damage to the ARCH during transportation by e.g. truck, plane, or ship. u Make sure that the ARCH and all its moving parts are firmly secured. ATTENTION...

  • Page 48: Storage

    For this reason, this product may not be disposed of with ordinary industrial or household waste. Dispose of the individual component parts separately. STERIS will, if necessary, will provide support to you regarding proper disposal. RD-PT-6813010-07en_V01 48 (51)

  • Page 49: Technical Data

    INSTRUCTIONS FOR USE Technical data 8.1. Technical data of the ARCH Designation or name ARCH Overview Service life, years General information Length, mm / in. from traction hand 1420/55.91 wheel to front of chassis Width, mm/in. 820/32.28 Height, mm/in. 1620/63.78 Weight, kg/lb.

  • Page 50: Adjustable Ranges

    INSTRUCTIONS FOR USE 8.2. Adjustable ranges 7.87 Height adjustment 1050+200 41.34+7.87 Height adjustment of fine level traction axis from floor +100/-40 +3.94/-1.57 Fine level traction 360° 360° Rotation range for abduction/adduction -20°-+41° -20°-+41° Flexion/extension 360° 360° Internal/external rotation 15.75 Boot holder position range RD-PT-6813010-07en_V01 50 (51) ©...

  • Page 51: Information For Ordering

    INSTRUCTIONS FOR USE Information for ordering 9.1. Accessories Only use accessories on the ARCH Leg Positioning System that have been officially approved by STERIS. Order number Description BF00410 Traction Boot ARCH size Medium (Standard size) (Blue) BF00409 Traction Boot ARCH size Small (Blue) *For additional accessory options, please visit www.STERIS.com...

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