ERGO plus ECV-220 and 221 Operating Instructions

DE SOUTTER MEDICAL ECV INSTRUMENT SYSTEM

Index Item

Page

Section 1: General Instructions ... 2 Warnings and Safety Rules... 2 Duty Cycle... 3 Product Description ... 4 Reprocessing Instructions ... 6 Section 2: ECV System Assy ... 9 Attachment fitting/removal... 9 System Optional Accessories... 10 Power Cord connection ... 10 Section 3: Handpiece ... 11 ECV-220 controls ... 11 Handpiece information & part numbers ... 11 Section 4: ECV System Attachments ... 12 BV-220 Drill/Burr Attachment ... 12 DV-220 Universal Drill Attachment ... 15 DV-220 AO Drill Attachment (Cannulated) ... 16 QV-220 Quick Release Burr Attachment (ISO: 6360) ... 17 SV-220 Sagittal Saw Attachment ... 18 MV-220 Mini Sagittal Saw ... 18 OV-220 Oscillating Saw Attachment ... 19 CV-220 Reciprocating Saw Attachment ... 20 NV-220 Quick Release Sagittal Saw Attachment... 21 Sagittal Saw Attachment speed recommendations ... 22 Section 5: Explanation of Symbols... 22 Section 6: System Fault Finding ... 23 Conditions for Transport & Storage ... 24 Repair and Service Information... 24 Guarantee and Liability ... 24

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IMPORTANT •

SAVE THESE INSTRUCTIONS - This manual contains important safety and operating instructions.

•

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

•

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

•

Refer also to operating instructions for other parts of the System listed on page 5.

SECTION 1: GENERAL INSTRUCTIONS Warnings & Safety Rules Never permit untrained personnel to use this instrument system. 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. 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. Always place the instrument on a safe, secure surface when not in use. Only permit trained personnel to reprocess (clean and sterilize) this equipment. Do not immerse the instrument in fluids. Always use Stericut or De Soutter Medical approved accessories.

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Environmental Conditions for Use Temperature: Relative Humidity:

0ºC to +30ºC 90% maximum.

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. North America/Canada Only: A usage/cooling ratio of 1 to 6 is recommended with a maximum continuous cutting time of 2 minutes. (i.e. if the tool is used for 1 minute it should be allowed to rest for at least 6 minutes, if it is used for 2 minutes it should be allowed to rest for at least 12 minutes). EU/Rest of the World: 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.

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Product Description The ECV system is a modular corded electric instrument system for small bone and trauma surgery, designed to operate with the PS-450/1 and PC-450/1 Power Consoles. It is intended for use in small bone and trauma surgery. The system consists of: ECV-220 Lever Operated Handpiece: These handpieces feature a powerful electric motor, which acts as the power plant for the ECV system. These handpieces may be fitted with the following attachments: BV-220 – Burr Attachment

DV-220 – Universal (Jacobs) Drill

DV-220 – AO Drill Attachment

QV-220 – Quick Release Burr Attachment

SV-220 – Sagittal Saw Attachment

OV-220 – Oscillating Saw Attachment

MV-220 – Mini Sagittal Saw

CV-220 – Reciprocating Saw Attachment

NV-220 – Quick Release Sagittal Saw

DV-225 – High Speed Drill

ECV-221 Foot Operated Handpiece: These handpieces feature the same powerful electric motor as the ECV-220 and fits all the same attachments but is operated by foot control. PS-450 Power Console: The PS-450 serves as the power plant for the system. It offers a wide range of user programmable functions for all handpieces, excluding the ACZ. PS-451 Power Console: The PS-451 includes all the features of the PS-450 with the additional function of irrigation. PC-450 Power Console: The PC-450 serves as the power plant for the system. It offers a wide range of user programmable functions for all handpieces. PC-451 Power Console: The PC-451 includes all the features of the PC-450 with the additional function of irrigation. T10-100 Irrigation Kit Disposable irrigation kit for use with ECV handpiece, BV-220 Burr & PC-451 or PS451 power consuls. MCZ-450 Handpiece: Modular Pistol Grip instrument DxV-220/1 Handpieces: Dedicated Straight Case handpieces. ACZ-400 and ACZ-450 Handpieces: Shaver instruments. FS-220 Foot Control Pedal: Foot Pedal for use with the Straight case and Shaver instruments 4

For more detailed information on individual parts of the system please refer to the appropriate user manual. PS-450/1 Power Console

Ref: 1807

PC-450/1 Power Console

Ref: 2057

MCZ-450 Pistol Grip Handpiece

Ref: 1817

DxV-220/1 Dedicated Straight Case Handpieces

Ref: 1837

ACZ-400 Shaver Handpiece

Ref: 2107

ACZ-450 Shaver Handpiece

Ref: 2077

FS-220 Foot Control Pedal

Ref: 1847

T10 Irrigation kits

Ref: 1887

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Reprocessing Instructions Warnings: Limitations on reprocessing:

Do not immerse the handpiece 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 has minimal effect on these instruments. End of life, is normally determined by wear or damage during use.

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 minimize risks

Preparation for cleaning:

Remove all cables, 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 Neutral pH Enzymatic detergents such as Klerzyme 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) Scrub the components thoroughly using a neutral pH enzymatic 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 when cleaning. 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.

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Automatic Cleaning

Equipment: Automatic Washer/Disinfector capable of meeting relevant national and international cleaning and disinfection standards i.e. BS2745 and HTM2030; Neutral pH Enzymatic detergent such as HAMO Liquid 52. 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: It is recommended that chucks are set to a middle position following the above pre-wash. This facilitates the automatic washer/disinfection process. 2. Place the handpiece, cable, attachments and accessories onto the

wire basket. Ensure all items are separated. 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. 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 minute).
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, chucks and 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 ECV Sterilization case (part No. 14390). 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 microorganisms 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)

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Section 2: ECV System Assembly Attachments All the attachments for the ECV system connect to the handpiece in the same way. Attachment Connection: • Grip the handpiece and attachment as shown. • Locate the attachment spigot pins in the motor locking ring slots. • Gently press the attachment towards the handpiece. • When the attachment is correctly located the locking ring will snap round and retain the attachment. • Give the attachment a gentle pull to ensure correct location 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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Power Cord Connection To attach the cord: • Align the key and red dot on the plug with the key and red dot on the handpiece. • Push firmly into socket until a click is heard. To remove the cord: • Grip the plug firmly on the cross-patterned area of the plug and pull out. • Do Not attempt to remove the plug by pulling on the cable

Align

Lever Assembly

Lever Retaining Nut

System Optional Accessories Sterilization Accessories: Description:

Part No.

Sterilisation Case Complete With Metal Tray Metal Insert Tray Only

14390 14410

Case/tray will hold:-

Quantity

ECV-220/221 MCZ-450

Modular Handpiece Modular Handpiece

1 1

Plus Various Various

ECV System Handpiece Attachments MCZ System Handpiece Attachments

5 8

Other Optional Accessories: Description FS-220 Foot Switch Replacement Cable Irrigation Kit – Burr

Part No. 12830 12850 T10-100

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Section 3: ECV-220 Handpiece Controls Lever

The lever control has a progressive action, increasing the handpiece speed as it is depressed. The lever also incorporates a sliding extension. This can be extended by holding the extension and pulling out gently.

Note:

The ECV-220 may be used with the foot pedal while the lever is attached but the lever may be removed with the supplied wrench for easier handling to the instrument

Safety catch:

The lever can be made inoperable by sliding the safety catch towards the front of the lever. In this position the tool cannot run Safe

Lever Retaining Nut

Run

Extension

Wrench Lever Assembly Release Lever Retaining Nut ECV-221 Handpiece The ECV-221 is for use with the foot switch. For this reason it does not have any controls on the handpiece. Technical Description and Part Number Details: Part No. Speed Control Type Speed

ECV-220 1284334 Lever 0 - 35,000

ECV-221 1284224 Foot Pedal 0 - 35,000

Supplied Accessories: Description Wrench

Part No. 14770

Optional Accessories: Description Replacement Lever Assembly Lever Retaining Nut

Part No. 14870 636303

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Section 4: ECV Attachments BV-220 Burr attachment

Burr Operation Insertion • Rotate locking sleeve anti-clockwise to release Burr clamp. • Insert Burr completely into attachment. • Rotate locking sleeve fully clockwise until it clicks and locked symbol is aligned. (See Below) • Gently pull Burr to ensure it is secure Removal • Rotate locking sleeve anti-clockwise to release Burr clamp. • Gently pull burr from attachment The Burr attachment incorporates a brake mechanism to prevent the tool running when the locking sleeve is unlocked. Never attempt to run the tool without a Burr locked in the handpiece and the locking sleeve secured in the locked position. Important Information:

25mm max

Align Lock Symbol

Never operate the attachment if the burr extends more than 25mm from the burr guard. Never operate the attachment without wearing suitable eye protection. Always leave the attachment unlocked when there is no burr fitted Always use a suitable burr guard if required. Always ensure the burr guard is securely tightened using the wrench provided. Technical Description and Part Number Details: BV-220 12780 0 - 35,000 3/32” (2.38mm) 14770

Part No. Speed Burr/Drill Shank Diameter Blade Wrench (Supplied)

Only use De Soutter Medical approved burrs. For full details refer to Stericut data sheets.

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Supplied Accessories Burr Guard - Standard Wrench

Part No. 14780 Part No. 14770

Burr Guard Standard 14780

Part No.

Long 14810

Extra Long 14820

Additional Cleaning Information for BV-220: To assist with the cleaning process the Burr Guard and Collet may be removed from the BV-220 Attachment. Burr Guard Fitting/Removal Burr Guard Removal: Release Burr Guard anti clockwise with wrench 14770 and unscrew Burr Guard Connection: Screw Burr Guard clockwise and tighten with wrench 14770

Remove

Tighten

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Wrench Ref: 14770

Collet Fitting/Removal: Warning: Do not attempt to remove the collet without following these instructions. Failure to follow these instructions will result in damage to the collet and Attachment Collet Removal: - You will need two off, Wrench 14770 • Ensure BV-220 Attachment Locking sleeve is rotated to the unlock position. • Insert a clean burr into the collet but do not lock the burr in place. • Using one Wrench, lock the spindle in place using the fork end. • Place the other wrench over the hexagon on the collet and gently rotate anticlockwise to release the collet. • Keeping the Burr in place, unscrew the collet completely. Collet Fitting: - You will need two off, Wrench 14770 • Ensure BV-220 Attachment Locking sleeve is rotated to the unlock position. • Using one Wrench, lock the spindle in place using the fork end. • Insert a clean burr into the collet and keeping the Burr in place, screw the collet completely in. • Place the other wrench over the hexagon on the collet and gently rotate clockwise to secure – Do Not over tighten. This will result in damage to the collet

Remove

Tighten

Insert Burr

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DV-220 Universal Drill Attachments (Jacobs) Chuck Operation Universal (Jacobs): • Insert the accessory into the chuck and tighten with the chuck key. Refer to the diagram below.

Technical Description & Part Number Details

Part No. Speed Chuck Capacity

DV-220 Universal 0-4mm (Jacobs) 14560 0 - 1500 rpm 0 - 4 mm

Supplied Accessories DV-220 Universal (Jacobs): Chuck Key for 0-4mm Chuck

Part No. 8780

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DV-225 Universal 0-4mm (Jacobs) 15950 0 - 5000 rpm 0 - 4 mm

DV-220 AO Drill Attachments Chuck Operation Quick Release (AO): Insertion: • 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 (DV-220 Shown).

Removal: • Pull the chuck sleeve back and remove the drill bit. • Release the chuck sleeve.

Technical Description & Part Number Details

Part No. Speed Cannulation

DV-220 AO Drill Cannulated 12790 0 - 1500 rpm 2.2 mm

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DV-225 AO Drill Non Cannulated 15960 0 - 5000 rpm 2.2 mm

QV-220 Quick Release Burr Attachments Chuck Operation Quick Release (ISO: 6360): Insertion: • Pull the chuck sleeve back (Rotate Anti-Clockwise to lock in open position) • Insert the Burr. • Rotate the Burr until it enters the chuck fully. • Release the chuck sleeve. (Rotate Clockwise to unlock if required) • Check that the burr is locked in the chuck by pulling the burr away from the attachment.

Refer to the diagram below.

Lock Open

Removal: • Pull the chuck sleeve back and remove the drill bit. • Release the chuck sleeve.

Technical Description & Part Number Details

Part No. Speed

QV-220 Quick Release Burr (ISO: 6360) 14620 0 - 5000 rpm

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SV-220/MV-220 Sagittal Saws

SV-220

MV-220

Blade Clamp Operation Insertion • Rotate the blade clamp anti-clockwise with the tool provided. • Insert Blade into the blade holder. • Rotate the blade clamp clockwise, with the tool provided, to tighten blade clamp mechanism. Check that the blade is correctly located whilst tightening clamp screw. • Check that the blade is secure. Removal • Rotate clamp screw anti-clockwise to release blade. • Gently pull blade from attachment Technical Description and Part Number Details: MV-220 SV-220 Part No. 14570 14610 Speed 0 - 30,000 0 – 30,000 Stericut Blade Hub Type S86 S85 Blade Wrench (Supplied) 9930 9930 For full details of suitable saw blades refer to Stericut data sheets.

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OV-220 Oscillating Saw Blade Clamp Operation

Insertion • Rotate locking sleeve anti-clockwise to release blade clamp. • Insert blade completely into attachment. • Rotate locking sleeve clockwise • Gently pull blade to ensure it is secure Removal • Rotate locking sleeve anti-clockwise to release blade clamp. • Gently pull blade from attachment The Oscillating saw attachment incorporates a brake mechanism to prevent the tool running when the locking sleeve is unlocked. Never operate the attachment without a blade fitted.

Technical Description and Part Number Details: OV-220 14580 0 - 24,000 S86

Part No. Speed Blade Hub Type

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

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