MULTIDRIVE MDX-600, KDX-600 and CDX-600 Operating Instructions Ver 1.1

DE SOUTTER MEDICAL MDX, KDX & CDX INSTRUMENT SYSTEM Index

Page

Section 1: Important Safety Instructions ... 2 General Safety Instructions ... 2 Recommended Duty Cycle ... 2 Section 2: General Instructions ... 3 Product Description ... 3 Reprocessing Instructions ... 4 Sterilization Accessory Part Number Details ... 8 Section 3: System Assembly ... 9 Battery/Corded Module Connection to Handpiece ... 9 Battery/Corded Module Removal from Handpiece ... 9 Attachment Connection ... 10 Section 4: MDX-600 Handpiece ... 11 Controls ... 11 Section 5: MDX-600 Handpiece Attachments... 12 DX-600 Drill Attachments ... 12 RX-600 Reamer Attachments... 13 HX-600 High Torque Reamer Attachments ... 13 WX-600 Wire Driver Attachment ... 14 WX-610 Wire Driver Attachment ... 14 WX-620 Wire / Pin Driver Attachment ... 14 PX-610 Pin Driver Attachment ... 14 OX-600 Oscillating Drill Attachment ... 16 NX-600 Mini Quick Release Sagittal Saw... 17 CX-650 Reciprocating Saw Attachment ... 18 Section 6: KDX/CDX-600 Handpieces ... 19 KDX-600/601 Sagittal Saw ... 19 CDX-600/601 Reciprocating Saw ... 21 Section 7: System Fault Finding ... 22 Handpiece fault finding ... 22 System Technical Description ... 23 Explanation of Symbols ... 23 Conditions for Transport & Storage ... 24 Service Information... 24 Repair Information ... 24 Guarantee and Liability... 24

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SECTION 1: IMPORTANT SAFETY INSTRUCTIONS 1.

SAVE THESE INSTRUCTIONS - This manual contains important safety and operating instructions for the MDX Instrument System.

2.

Do not attempt to use the equipment until all the instructions and cautionary markings have been studied and understood.

3.

Failure to follow these instructions may result in serious injury to the patient or operating staff.

General Safety Guidelines Never permit untrained personnel to use this instrument system. Always check that the voltage stated on the identification plate corresponds with the electrical supply. Always check correctly rated fuses are fitted to the battery charger and power supply fuse holder. Always inspect all equipment and accessories before use. Do not use suspect, damaged or worn equipment. Always ensure accessories are correctly connected to the handpiece before use. Only use sharp cutting accessories Always set the instrument trigger 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 sterilise the instrument and accessories as directed in these instructions. Do not immerse any part of the equipment in fluids. Always use Stericut or De Soutter Medical approved accessories. Never reuse items marked for single use, risks if reused include: Cross contamination between patients, Bone necrosis due to extra heat generation. Inaccurate cutting When using dedicated sawing tools or saw attachments: Follow local recommendations for the avoidance of possible hand-arm vibration damage. (The instrument can produce a HAV weighted vibration level of approximately 5ms-2.) Follow local recommendations for the avoidance of long-term hearing damage. (When used for the purposes intended the sound level produced when sawing poses no threat to long-term health however maximum sound levels can exceed 80dB(A).) Recommended Duty Cycle In order to reduce the risk of excessive and undesirable temperature rise of the cutting surfaces it is recommended that the tool is used in short bursts. A usage/cooling ratio of 1 to 4 is recommended with a maximum continuous cutting time of 3 minutes. (i.e. if the tool is used for 1 minute it should be allowed to rest for at least 4 minutes, if it is used for 3 minutes it should be allowed to rest for at least 12 minutes). Additionally it is recommended that a suitable cooling means, such as irrigation with saline solution, is employed wherever practical. 2

SECTION 2: GENERAL INSTRUCTIONS Product Description The MDX, KDX & CDX systems are modular electric instrument systems for large bone and trauma surgery, which are powered by sterile or aseptic rechargeable battery packs or by a mains operated power supply via a low volt corded module. The systems consist of: The Large Bone Modular Electric Systems consist of: MDX-600 Modular Rotary Handpiece: The MDX-600 Handpiece features a powerful reversible motor, which acts as the powerplant for the MDX system. The handpiece may be fitted with the following attachments:             

DX-600 RX-600 HX-600 OX-600 WX-600 WX-610 WX-620 PX-610 NX-600 CX-650 LX-600 UX-600 MI-600

Drill Attachments Standard Reamer Attachments High Torque Reamer Attachments Oscillating Drill Attachment Wire Driver Attachment Wire Driver Attachment Wire / Pin Driver Attachments Pin Driver Attachment Mini Quick Release Sagittal Saw Attachment Reciprocating Saw Attachment Pulse Lavage Attachment Radiolucent Angle Drill Attachment Minimal Invasive Reamer Attachment

(See separate (operating (instructions

KDX/CDX Handpieces: Dedicated saws to complete the 600 series instrument system. • KDX-600 Sagittal Saw Handpiece • CDX-600 Reciprocating saw Handpiece PS-600 Power Supply and CM-600 Corded Module: The PS-600 and CM-600 make up the corded power source for the system. The PS600 is designed to run two handpieces simultaneously. BC-600 Battery Charger and Batteries: The BC-600 Battery Charger and Batteries are used as an alternative to the PS-600 Power Supply and Corded Module For more detailed information on individual parts of the system please refer to the appropriate user manual. PS-600 Power Supply and Corded Module BC-600 Battery Charger and Batteries MDX, KDX & CDX Handpieces LX-600 Pulse Lavage Attachment UX-600 Radiolucent Angle Drill Attachment MI-600 Minimal Invasive Reamer

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Ref: 1927 Ref: 2267 Ref: 2277 Ref: 1747 Ref: 1727 Ref: 1717

REPROCESSING INSTRUCTIONS WARNINGS: Limitations on reprocessing:

The following reprocessing instructions refer to the instruments, attachments, and accessories described in these operating instructions. When reprocessing electric handpieces it is essential that the handpiece is subsequently thoroughly dried internally as soon as possible after reprocessing otherwise reduced performance, malfunction and/or premature failure may result. Note: Correct internal drying and sterilisation can only be achieved by using a Vacuum Steam Autoclave with the vacuum assisted drying period activated. Do not wash or sterilise Aseptic Battery Packs, Power supplies, or Battery Chargers. Refer to separate cleaning and maintenance instructions following this section for more detail. Ensure that Aseptic Battery Housings are sterilised in the open position. Ensure that attachments with collet mechanisms are fully open when reprocessing. Do not immerse the handpieces in water other than when automatic reprocessing. 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 as specified in these instructions 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 anodised 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 important that instruments are 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.

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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 deionised or distilled and a Lint-free cloth for drying. Method: 1. Wash off excess contaminant with running water (maximum 35 °C) avoiding fluid ingress. 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. 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-ionised 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.

Automatic

Equipment:

Cleaning:

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 and cannulations. Note: It is recommended that chucks be set to a middle position following the above pre-wash. This facilitates the automatic washer/disinfection process. 2. Place the handpiece, attachments and accessories onto the wire

basket. Ensure that the Sterile battery packs are inverted (i.e. contacts facing down). Ensure that empty Aseptic battery housings are open with the open side down. Note: The placement of items 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.

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3. Follow manufacturers loading instructions and select the appropriate

cycle recommended. The cycle should include: 

Pressurised cold water rinse (maximum 35 °C).



Hot water wash (minimum 55 °C) See note regarding detergents



Warm water rinse.



Disinfection rinse (minimum 80 °C for 1 minute) with deionised water



Drying cycle

4. Remove disinfected instruments from the washer/disinfector to a clean

area. 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:

Lubricate collets and chucks using mineral oil such as Blitz

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 (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 appropriate sterilization container. If wrapping is used, material conforming to EN868 allowing rapid penetration of steam should be used.

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Sterilization: Handpieces and accessories (not battery packs)

Preferred Method. • Vacuum steam autoclave, Wrapped or Unwrapped, minimum 3 minutes @ 134°C (+3°C/ -0°C), 8 minute minimum drying time. Other Validated methods. • Gravity steam autoclave, wrapped 35 minutes at 134°C (+3°C/ -0°C), 8 minute minimum drying time. • Gravity steam autoclave, wrapped 50 minutes at 121°C (+3°C/ -0°C), 8 minute minimum drying time. • Gravity steam autoclave, unwrapped 10 minutes at 134°C (+3°C/ -0°C), 8 minute minimum drying time. Always ensure that the Aseptic battery housings are open with the open side down.

Sterilization: Sterilisable battery pack

Wrapped or Unwrapped. Vacuum steam autoclave, 3-4 minutes @ 134°C (+3°C/ -0°C). Note: High temperature may affect the performance and life of the battery. It is recommended, the drying cycle, if necessary, is kept to a minimum or omitted, longer than 3 minutes is NOT recommended. Always ensure that the Sterile battery packs are inverted (i.e. contacts facing down).

Storage:

Wrapping sterilised instruments in accordance with EN868 is recommended to preserve sterility. The material should present a barrier to microorganisms and particulate contamination.

Additional Information:

Automated cleaning was validated in accordance with HTM 2030 using an automated washer/disinfector. Vacuum steam sterilization was validated in accordance with HTM2010. Gravity sterilisation was validated based on AAMI guidelines. Note: Manual cleaning is not validated for reasons of non-repeatability.

The instructions 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 reprocessor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.

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Sterilization Accessory Part Number Details Description:

Part No.

Sterile System Sterilisation Case

11670

Case will contain:Any combination of Handpieces (Maximum of 3) MDX-600 Modular Handpiece KDX-600 Dedicated Sagittal Saw Handpiece CDX-600 Dedicated Reciprocating Saw Handpiece Plus SB-600 Sterile Battery Pack Various MDX System Handpiece Attachments

Quantity

3 7

Aseptic System Sterilisation Case (2 Handpieces) Case will contain:Any combination of Handpieces (Maximum of 2) MDX-600 Modular Handpiece KDX-600 Dedicated Sagittal Saw Handpiece CDX-600 Dedicated Reciprocating Saw Handpiece Plus AH-450 / 600 Aseptic Battery Housing AS-450 / 600 Sterile Shield Various MDX System Handpiece Attachments

14440 Quantity

2 2 7

Aseptic System Sterilisation Case (3 Handpieces) Case will contain:Any combination of Handpieces (Maximum of 3) MDX-600 Modular Handpiece KDX-600 Dedicated Sagittal Saw Handpiece CDX-600 Dedicated Reciprocating Saw Handpiece Plus AH-450 / 600 Aseptic Battery Housings Various MDX System Handpiece Attachments

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12170 Quantity

3 7

SECTION 3: HANDPIECE ASSEMBLY Battery Pack/Corded Module Connection to Handpiece Insert the battery pack into the handpiece as shown in the diagram below.

Battery Pack/Corded Module Removal from Handpiece Depress the catch and slide the battery pack towards the rear of the handpiece until fully disengaged.

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MDX-600 Handpiece Attachments Attachment Connection: 

 

Grip the handpiece and attachment as shown, with the attachment spigot pins located in the handpiece locking ring slots Rotate the attachment and gently press the attachment towards the handpiece. When the locking ring reaches full rotation the attachment will locate into the handpiece.

Attachment Removal:   

Grip the handpiece and attachment as shown. Using thumb and forefinger rotate the locking ring. When the locking ring reaches full rotation pull the attachment away from the handpiece. Do Not drop the attachment out of the handpiece.

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SECTION 4: MDX-600 HANDPIECE Controls Trigger Mode Selector The mode selector determines how the instrument can be operated and allows the handpiece to be safely locked whilst changing accessories or being passed to another person. Trigger The trigger has a progressive action and controls the speed and power of the handpiece.

Trigger

Mode Selector

Reverse

Safe

Forward

Technical Description & Part Number Details Part No. Speed

MDX-600 1282444 0-950 rpm

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SECTION 5: MDX SYSTEM ATTACHMENTS DX-600 Drill Attachments Chuck Operation Keyed:

Insert the drill bit into the chuck and tighten with the chuck key.

Keyless:

Insert the drill bit into the chuck, grip the smaller chuck ring and rotate the chuck body to tighten.

Warning:

- Do not operate in reverse, as this will untighten the chuck - Do not use handpiece power to tighten or un-tighten chuck

Quick Release (QR):

AO, Trinkle, Hudson, Zimmer - Pull the chuck sleeve back and insert the drill bit. - Rotate the drill bit until it enters the chuck fully. - Release the chuck sleeve - Check that the drill bit is locked in the chuck by pulling the drill bit away from the attachment.

Refer to the diagram below.

Technical Description & Part Number Details Part No. 11710 11720 11730 11740 11750 11780 11770 12420 11790 14480 11860

DX-600 0.7 – 7.4mm Keyed DX-600 0-4mm keyed DX-600 Small AO Synthes DX-600 Keyless 0 - 3.2mm DX-600 Keyless 0.6 - 7.4mm DX-600 Large AO Synthes DX-600 Hudson DX-600 Zimmer DX-600 Trinkle DX-600 Hudson / Zimmer DX-600 Hi Torque 0.7- 7.4mm Keyed Supplied Accessories

Optional Accessories

Speed rpm

0-950

0-450

Capacity mm 0.7 - 7.4 0-4 QR shank 0 - 3.2 0.6 – 6.4 QR shank QR shank QR shank QR shank QR.shank 0.7 – 7.4

DX-600 Keyed: Chuck Key for 0.7-7.4mm Chuck Chuck Key for 0-4mm Chuck DX-600 Quick Release: Quick Release AO to 0 -4.0mm Keyed Adaptor Note: This adapter is not cannulated. 12

Cannulation mm 4.1 3.1 2.0 2.4 4.1 4.1 4.1 4.1 4.1 4.1 4.1

Part No. 30062 Part No. 8780 Part No. 6270

RX-600 Reamer Attachments & HX-600 High Torque Reamer Attachments Chuck Operation The Hudson, AO, Zimmer and Zimmer/Hudson reamer chucks operate in the same manner. • Pull the chuck sleeve back and insert the reamer shaft. • Rotate the reamer shaft until it enters the chuck fully. • Release the chuck sleeve. • Check that the reamer is locked in the chuck by pulling it away from the attachment. Refer to the diagram below.

Technical Description & Part Number Details RX-600 Hudson RX-600 Large AO RX-600 Zimmer RX-600 Jacobs 6.4 RX-600 Zimmer/Hudson HX-600 Large AO HX-600 Zimmer/Hudson

Part No. 11810 11820 11830 11800 12900 11840 11850

Cannulation Diameter

Speed

4.1mm

0-260 rpm

-

0-150 rpm

Adapter Chucks Description 0.7-7.4 Keyed Chuck Zimmer Chuck Harris Chuck Hudson Chuck Trinkle Chuck AO Synthes Small AO Synthes Large DIN 58 809 Reamer Chuck DHS Chuck

Hudson Drive Part No. 5440 5450 5460 N/A 7910 5470 5480 5490 11260 13

AO Drive Part No. 7970 6590 6550 6560 6580 7980 N/A 6570 7770

Zimmer Drive Part No. 8800 N/A 10090 10000 10220 10260 10170 10130 N/A

WX-600 Wire Driver Attachment WX-610 Wire Driver Attachment WX-620 Wire / Pin Driver Attachment Px-610 Pin Driver Attachment Wire /Pin Driver Controls Adjustment Sleeve:(WX-600-WX-620 ONLY) The adjustment sleeve is graduated to correspond with the wire diameter to be gripped. Push & rotate the sleeve to the required wire diameter. Actuating Lever: Pull the lever back to grip the wire. Release the lever to release the wire.

Wire Driver Operation Warning: The wire must be clean before inserting into the instrument, even when removing wire from a fixation. Warning: Do Not use bent wires. Wire Insertion: • Insert the wire into the front of the wire driver to the required position. Do Not grip the actuating lever whilst inserting the wire. • Test that by operating the lever the wire is gripped and the wire is free when the the lever is released. 14

Wire Driving - Insertion: • Set the Trigger Mode Selector to Forward. • Pull back the lever to grip the wire. • Depress the trigger to rotate the wire. • Expose more wire after penetration by releasing the trigger and the actuating lever, and sliding the instrument up the wire. Repeat the driving process. • Ensure easy wire / pin removal by providing sufficient protrusion of the wire / pin if trimmed. Wire Driving - Removal: • Set the Trigger Mode Selector to the required mode. • Slide the instrument over the exposed wire. • Pull back on the actuating lever to grip the wire. • Depress the trigger to rotate the wire in the required direction. Pull the instrument away from the fixated site to remove the wire. • Take care not to bend the wire during removal. Immediately after use, clean the attachment to remove debris. Technical Description & Part Number Details

Part No. Speed Cannulation Diameter Acceptable wire / pin diameters

WX-600 11930 0-950 rpm 3.3mm

WX-610 14850 0-950rpm 3.1mm

WX-620 16100 0-950 rpm 4.1mm

PX-610 14840 0-950 rpm 4.1mm

0.6-3.2mm

1.0-3.0mm

0.8-4.0mm

2.0-4.0mm

Supplied Accessories Cleaning Brush

Part No. 8120 WX-600 & WX-610 Part No. 15090 WX-620 & PX-610

K- Wires For details of sterile packed k-Wires, refer to Stericut data sheets.

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OX-600 Oscillating Drill Attachment Chuck Operation • • • •

Pull the chuck sleeve back and insert the drill bit. Rotate the drill bit until it enters the chuck fully. Release the chuck sleeve. Check that the drill bit is locked in the chuck by pulling the drill bit away from the attachment. Refer to the diagram below.

Technical Description & Part Number Details OX-600 11760 0-950 cpm De Soutter Medical OX Quick Release

Part No. Speed Chuck Type Optional Accessories Tri Fluted Drill Bits Standard Part No. 9370 9380 9390 9400 9410 9420 9430 9440 9450 9460 9470 9480

Long Series Diameter (mm) 1.1 1.5 2.0 2.5 2.7 3.0 3.2 3.5 4.0 4.5 5.0 6.0

Length (mm) 35 60 75 85 100 120 120 120 120 120 120 120

Part No. 12010 12020 12030 12040 12050 12060 12070

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Diameter (mm) 2.0 2.5 2.7 3.2 3.5 4.0 4.5

Length (mm) 195 195 195 195 195 195 195

NX-600 Mini Quick Release Sagittal Saw Attachment Blade Clamp Operation Insertion: • Fit the Sagittal Saw attachment to the handpiece. • With the blade clamp in the open position insert the blade. • Push the blade clamp down. • Tighten the blade clamp using the clamp nut. • Check that the blade is secure in the blade clamp. Refer to diagram below.

Removal: • Grip the instrument and pull the clamp nut and turn anticlockwise to unscrew the blade clamp. • Lift the blade slightly and remove it from the clamp. Refer to the diagram below.

Technical Description & Part Number Details

Part No. Speed Blade Hub Type

NX-600 12300 0-25000 cpm De Soutter Medical S88

For full details of suitable saw blades refer to Stericut data sheets. 17

CX-650 Reciprocating Saw Attachment Blade Clamp Operation Insertion: • 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 attachment. Removal: • Grip the instrument and rotate the blade clamp sleeve clockwise. • Remove the blade. • Release the sleeve. Refer to the diagram below.

Technical Description & Part Number Details CX-650 12600 0-7200 cpm De Soutter Medical S22

Part No. Speed Blade Shank Type

For full details of suitable saw blades refer to Stericut data sheets.

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SECTION 6: KDX-600 & CDX-600 Saw Handpieces KDX-600 Sagittal Saw Trigger Mode Selector The mode selector determines the maximum running speed and allows the handpiece to be safely locked whilst changing accessories or being passed to another person.

The speed range with High selected is 0 – 14000 cpm The speed range with Low selected is 0 – 9500 cpm Low

Safe

High

Blade Clamp Operation Insertion: • With the blade clamp in the open position insert the blade (1). • Push the blade clamp down (2) • Tighten the blade clamp using the clamp nut (3) • Check that the blade is secure in the blade clamp. Refer to diagram below.

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