DirectDrive DPX Sternum Saws Operating Instructions Ver 5.5

DE SOUTTER MEDICAL DPX-577 & DPX-677 PNEUMATIC STERNUM SAWS

Index Page Warnings and Safety Rules Description Air Supply Reprocessing Instructions

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Air Supply Hose Controls Operation Sternum Guard Attachment and Removal Technical Description and Part Numbers Optional Accessories

6 7 8 9 10 10

Fault Finding Explanation of Symbols Conditions for Transport & Storage

11 12 12

Repair and Service Information Guarantee and Liability

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Warnings & Safety Rules Failure to follow these instructions may result in serious injury to the patient or operating staff. Do not attempt to use the equipment until all the instructions have been studied and understood. Never permit untrained personnel to use this instrument system. Always operate the instrument at the correct air pressure as specified in these instructions. Always ensure that the hose is securely connected prior to use. Always inspect all equipment and accessories before use. Do not use suspect, damaged or worn equipment. Always ensure accessories are correctly connected to the instrument before use. Always set the instrument mode selector to the SAFE position when changing accessories or when not in use. Always use eye protection when cutting to prevent injury from flying debris. Do not allow loose articles to be caught by the moving parts of the instrument. Never drop the instrument or it’s accessories; always handle with extreme care. Always allow the instrument to stop before removing from the surgical site. Only clean and sterilize the instrument and accessories as directed in these instructions. Do not immerse the instrument in fluids. Always use Stericut or De Soutter Medical approved accessories. Always take care when handling the blade to avoid nicking or tearing of gloves. Never operate the sternum saw without the sternum guard. Always ensure that, before each use, the sternum guard is properly locked to the handpiece. If the instrument is activated without the sternum guard properly connected, the guard could be thrown from the instrument with great force. Do not operate the Sternum Guard Retainer during use. Never re-use any accessory marked as Single Use Only. Always use correct sternum guard for chosen blade length Never reuse items marked for single use, risks if reused include: Cross contamination between patients, Bone necrosis due to extra heat generation. Inaccurate cutting Description The DPX-577 and DPX-677 are dedicated pneumatic reciprocating Sternum saws designed for the safe cutting of the sternum during primary cardiothoracic surgery. Warning

This instrument is not suitable for revision sternotomies. For revision sternotomies, De soutter Medical recommend model DPX-170

Air Supply Use only 99.97% pure, dry compressed air or nitrogen filtered to 5 microns. Lower pressures may be set for lower speed and torque requirements. Operating Pressure: Flow Rate:

6 bar (87psi) 3.3l/s (7 cu.ft./min)

Never exceed 7 bar (100psi) pressure.

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Reprocessing Instructions Warnings: Limitations on reprocessing:

Do not immerse the handpiece in water other than when automatic reprocessing, and only then, when fitted the correct washing caps. Do not exceed temperatures 140 °C. Do not clean any part of the equipment in an ultrasonic cleaner. Long narrow cannulations and blind holes require particular attention during cleaning. Repeated processing has minimal effect on these instruments. End of life is normally determined by wear or damage during use. DETERGENTS Only use detergents that are declared by the manufacturer as safe for use on anodized aluminium components. Only use detergents with a maximum pH value of 11.0. Ensure the detergent manufacturers guidelines are closely observed.

Instructions Point of Use

Do not operate the equipment while still warm

Containment and transportation:

It is recommended that instruments be reprocessed immediately following surgical use. The handling, collection and transportation of soiled equipment should be strictly controlled to minimise risks.

Preparation for cleaning:

Remove all attachments and accessories for cleaning, wash separately, or dispose of as per instructions.

Manual Cleaning

Equipment: Manual cleaning should only be carried out where automatic washer/disinfection is not available. It should be conducted in a dedicated area by trained personnel wearing protective clothing e.g. gloves, waterproof apron and goggles or visor. Use suitable detergents (see note on detergents) and Nylon scrubbing brushes. Dedicated sinks with temperature controlled water, ideally de ionized or distilled and a Lint-free cloth for drying. Method: 1. Wash off excess contaminant with running water (maximum 35 °C) avoiding fluid ingress via the air hose inlet. Scrub the components thoroughly using a suitable detergent and nylon brushes to remove all visible traces of contaminant. Pay attention to recesses, blind holes and cannulations. Note: Manually open and close chucks and blade clamps. Use suitable nylon brushes to reach difficult surfaces and inside cannulations. Flush through these areas to ensure any trapped contaminants are removed. 2. Rinse off all traces of the detergent with de ionized or distilled running water (45-65 °C). 3. Shake off excess water and dry surfaces with a lint-free cloth. 4. Visually inspect each item to verify that all contaminants are removed in accordance with local reprocessing guidelines. 3

Automatic Cleaning

Equipment: Automatic Washer/Disinfector capable of meeting relevant national and international cleaning and disinfection standards i.e. ISO 15883 or HTM2030. Method: 1. Large contaminant deposits should be removed manually using the

method described in Manual Cleaning:- item 1. Pay particular attention to recesses, blind holes, chucks, clamps and cannulations. Note: Remove and clean the Sternum Guard for cleaning. 2. Place the handpiece, attachments and accessories onto the wire

basket. Ensure all items are separated and washing caps are securely fitted to the handpiece and air supply hose. Note: The placement of item in automatic washer/disinfector baskets can be a critical factor in achieving effective cleaning. Selection of the basket type and position of the items to be cleaned should be done by suitably trained personnel in accordance with the manufacturer’s instructions for the washer/disinfector. 3. Follow manufacturers loading instructions and select the appropriate

cycle recommended. The cycle should include:  Pressurized cold water rinse (maximum 35 °C).  Hot water wash (minimum 55 °C) using a neutral pH enzymatic detergent.  Warm water rinse.  Disinfection rinse (minimum 80 °C for 1 minutes).  Duty cycle. 4. Remove disinfected instruments from the washer/disinfector to a clean area. Remove the washing caps. 5. Visually inspect each item and verify the cleaning process is

complete and all contaminants have been removed in accordance with local reprocessing guidelines. Disinfection:

Thermal disinfection is recommended and included in the automatic washer/disinfection cycle. See above.

Maintenance:

Lubrication of the motor is not essential but will enhance the life and performance of the instrument. 1. Apply 3 drops of surgical instrument oil (part no. 30982- Non-sterile) into the instrument air inlet after cleaning. 2. Connect the instrument to an air supply and run for at least 20 seconds to ensure adequate dispersal of lubricant. 3. Lubricate collets, chucks and hose connectors using mineral oil such as Blitz.

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Inspection and Function Testing:

Ensure the handpiece, attachments and non-cutting accessories are in good working order. Note any unusual sounds, vibrations or operating speeds. If operating difficulties are experienced and are not already covered in these operating instructions, refer to the Repair and Servicing Information section of this manual. Re useable cutting accessories (saw blades, drill bits, reamer shells etc.). Inspect for damage and wear. Cutting edges should be sharp and free from damage. Discard worn or damaged cutting accessories into a suitable sharp’s disposal bin. Single use accessories (Sterile saw blades, burrs, K wires etc.). Accessories marked for single use only must not be re used. Dispose of these items in a sharp’s bin or other suitable disposal method.

Packaging:

Place cleaned instruments, attachments and accessories into the DPX Sterilization case (part No. 9350). If wrapping is used, material conforming to EN868 allowing rapid penetration of steam should be used.

Sterilization:

Wrapped or Unwrapped. Vacuum steam autoclave, minimum 3 minutes @ 134°C (+3°C/ -0°C). The equipment is capable of withstanding a standard drying cycle.

Storage:

Wrapping sterilized instruments in accordance with EN868 is recommended to preserve sterility. The material should present a barrier to micro-organisms and particulate contamination.

Additional Information:

Automated cleaning was validated in accordance with HTM 2030 using an automated washer/disinfector and Neutral Ph enzymatic detergent. Sterilization was validated in accordance with HTM2010 using a 134 °C (+3°C/ -0°C) vacuum steam autoclave. Note: Manual cleaning: Not validated for reasons of nonrepeatability.

The instruction’s provided above have been validated by De Soutter Medical Ltd. as being capable of preparing a device for re-use. It remains the responsibility of the reprocessor to ensure that the reprocessing as actually performed using equipment, materials and personnel in the reprocessing facility achieve the desired result. This normally requires validation and routine monitoring of the process. Likewise any deviation by the preprocessor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. (07/2002)

Accessories Description

Part No.

Washing cap

608073

Hose Washing Cap

8950

Sterilisation Case

9350

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Air Supply Hose The air supply hose is self sealing when disconnected from the instrument. The hose connects to the instrument with a quick release bayonet connection. To attach the hose: • Grip the hose connector and push it on to the instrument spigot. • Twist the connector clockwise. The connector will come to a stop - the hose is now connected. • Pull gently on the hose to check that the hose is securely connected to the instrument. To remove the hose: • Hold the instrument and grip the hose connector. • Twist the hose connector anti clockwise, pushing the hose connector towards the instrument. Refer to the diagram below.

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Controls Trigger Mode Selector: The mode selector determines how the instrument can be operated: Required Function Off/ Safety Forward

Trigger Mode Selector Safety Forward Only

Top Trigger Locked Depress to run

Trigger: The trigger controls the speed of the speed of the instrument. The speed of the instrument increases progressively as the trigger is depressed. Refer to the diagram below.

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Operation Before assembling the blade and sternum guard consider the desired cutting direction. The saw may be configured for cutting in either a push or pull direction. Blade Clamp Operation

Insertion: • Ensure trigger mode selector is set to “SAFE”. • Grip the instrument and rotate the blade clamp sleeve clockwise. • Insert the blade fully into the blade slot. • Release the sleeve. • Check that the blade is locked in by pulling the blade gently away from the instrument. Refer to the diagram below.

Locked

Unlocked

Removal: • Grip the instrument and rotate the blade clamp sleeve clockwise. • Remove the blade. • Release the sleeve.

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Sternum Guard Attachment And Removal Warning: Never operate the sternum saw without the sternum guard.

Warning: Before each use, ensure that the sternum guard is properly locked to the handpiece. If the instrument is activated without the sternum guard properly connected, the guard could be thrown from the instrument with great force. Warning: Before each use, check: • the surface of the blade guard for nicks and scratches that can tear tissue, • The guard stem for straightness. Check carefully that the blade does not rub against the guard. • Blade end is located within blade guard foot slot. Warning: During use, do not operate the Sternum Guard Retainer. Warning: Take care not to snag gloves on the saw blade. Sternum Guard Attachment: • Slide the Sternum Guard Safety Catch and move the Sternum Guard Retainer to its unlocked position. • Grip the instrument and slide the guard over the nose of the instrument, so that the stem of the guard is on the non tooth side of the blade. • Slide the guard fully onto the tool. • Slide the Sternum Guard Retainer to it’s locked position. Safety Check: Check that the guard is locked on to the instrument by :• Pushing the Guard Retainer firmly in the direction of arrow 5. The Guard Retainer must remain in the locked position. • Pulling the guard away from the instrument.

Refer to the diagram below. GUARD FOOT

Guard Retainer Unlocked

Guard stem

Guard retainer

Safety catch

Guard Retainer Locked

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Sternum Guard Removal: • Slide the Sternum Guard Safety Catch and move the Sternum Guard Retainer to its unlocked position. Grip the instrument and slide the guard away from the instrument. Technical Description & Part Number Details

Part No. Speed Blade Shank Type

DPX-577 224664 0-14000 cpm De Soutter Medical S84

DPX-677 226404 0-14000 cpm De Soutter Medical S84

Optional Accessories Sternum Guards Part No.

Use With Blade

616203

Standard

S 84-100/101

622553

Long

S 84-200/201

Part No.

Length (mm)

S84-100 S84-101 S84-200 S84-201

54 54 74 74

Saw Blades Cut Width (mm) 1.0 1.0 1.0 1.0

Stericut saw blades are sterile packed in boxes of 5 blades. For full details of suitable saw blades refer to Stericut data sheets. Air Supply Hoses Type BOC MA7 A. O. AGA Draeger

3m length 5300 5330 5360 5390

4m length 5310 5340 5370 5400

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5m length 5320 5350 5380 5410

Fault Finding Fault: Instrument does not run. Trigger cannot be depressed

Possible Cause: Air supply faulty

Instrument runs slowly, or seems to lack power when cutting.

Insufficient lubrication

Refer to Lubrication section of manual

Insufficient air supply pressure and/or flow rate

Check air supply pressure at regulator (bottled air only).

Regulator malfunctioning.

Check air supply regulator.

Worn blade

Replace blade

Debris inside blade clamp

Clean with small brush

Blade is damaged

Replace blade.

Blade will not fit into instrument

Remedy: Check air supply Check hose connections Set Trigger Mode Selector to desired mode.

Trigger Mode Selector set incorrectly

Check hose for possible restriction.

Do Not force a damaged blade into the instrument Sternum guard will not fit onto instrument

Sternum Guard Retainer in locked position

Set Blade Retainer in unlocked position.

Blade is bent/ damaged

Replace blade

Debris inside blade guard/ around tool spigot

Clean with a small brush

Sternum guard stem is bent

Replace sternum guard

Sternum Guard Replace sternum guard damaged If any problem persists then contact De Soutter Medical Ltd.

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Explanation of Symbols Refer to the Operating Instruction Manual

Vacuum Steam Sterilise.

Do Not Immerse

Sternum Guard locked

Speed Control

Sternum Guard unlocked

Conditions for Transport & Storage Temperature: Relative Humidity: Atmospheric Pressure:

-20ºC to +40ºC 90% maximum. 1.5 atmospheres maximum.

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Repair & Service Information All powered instruments and attachments should be periodically checked and cleaned. Annual servicing is recommended for normal use. Due to the specialist techniques used in the manufacture and maintenance of De Soutter instruments, user servicing is not possible. For service and repair please contact your nearest De Soutter Medical Authorised Service Center. To return an instrument for repair: • Record the serial number of the instrument being returned. Enclose a brief statement describing the reason for returning the instrument. • Enclose the purchase order number for the instrument if warranty is being claimed. It will be helpful to include a contact name. • Pack the instrument securely and send to the address below. Please ensure that the instrument has been properly decontaminated and sterilized.

Guarantee & Liability De Soutter Medical guarantees all instruments, attachments and accessories to be free from defects in material and workmanship for one year from the date of purchase. De Soutter Medical is not liable by warranty or otherwise in the case of any of the following: • Abuse, misuse or use in other than a surgical environment; • Disassembly, alteration or unauthorized repair; • If the product has not been used in a reasonable manner and in full compliance with the written instructions. This guarantee does not affect your Statutory Rights in accordance with 1999/44/EEC

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