MBQ-700 and 701, DBC-700 and 701, DBK-700 and 701 orthodrive User Manual Ver 11

UKPA GB1304019.1 WO 2014/135868



Contents 1

Important Information... 1

2

Safety Instructions... 1 Intended Use... 2 Disposal... 2 Symbols... 3

3

Reprocessing - Sterilisable Equipment... 4

4

Limitations on reprocessing... 4 Safety Instructions... 4 Point of Use (before reprocessing)... 4 Containment and Transportation... 5 Cleaning and Disinfection... 5 Maintenance... 7 Inspection and Function Testing... 7 Packaging... 7 Sterilisation of Handpieces and Accessories... 8 Sterilisation of Sterilisable Batteries... 9 Storage... 9 Point of Use (after reprocessing)... 9 Additional Information... 10 Overview... 11

5

Configuring a Handpiece... 12

6

Selecting the Function... 12 Selecting the Mode... 13 Controlling the Speed... 14 Using Attachments... 15

7

Fitting an Attachment... 15 Removing Attachments... 16 Fitting and Removing a Chuck... 17 Using a Wire or Pin Driver... 18 Using Accessories... 19

8

Fitting and Removing a Rotary Cutter... 19 Rotating a Reciprocating Head... 20 Fitting and Removing a Reciprocating Blade... 21 Rotating a Sagittal Head... 22 Fitting a Quick-release Sagittal Blade... 23 Removing a Quick-release Sagittal Blade... 24 Fitting a Quick-release S89 Sagittal Blade... 25 Removing a Quick-release S89 Sagittal Blade... 26 Fitting a Wire or Pin... 27 Fitting a Wire or Pin Guard... 28 Powering the Handpiece... 29 Technical and Ordering Information... 30 Handpiece Specifications... 30 Attachments... 32 Power Accessories... 33

9

Sterilisation Accessories... 34 Troubleshooting... 35

10

Further Help... 36 Service and Repair Information... 36 Guarantee and Liability... 37 EMC Guidance... 38

Important Information Save this user manual. This user manual contains important safety and operating instructions for this equipment. Throughout this user manual, the words WARNING, CAUTION and NOTE are used to highlight important information. WARNING: WARNING information identifies conditions or practices that could result in injury CAUTION: CAUTION information identifies conditions or practices that could result in damage to

the equipment or system NOTE: NOTE information is provided to clarify or supplement procedural information

Safety Instructions WARNING: do not attempt to use this equipment until this user manual and all cautionary markings

have been studied and understood WARNING: this equipment should only be used by personnel with appropriate training WARNING: inspect all equipment before use and do not use suspect, damaged or worn equipment WARNING: always allow the handpiece to stop before removing from the surgical site WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece

configuration, and before fitting or removing attachments and accessories WARNING: never reuse items marked for single-use

. Risks associated with reuse include: • cross contamination between patients • bone necrosis due to extra heat generation • inaccurate cutting. WARNING: cutting accessories can get hot during use. Saline solution can be used to cool the cutting site. WARNING: when using dedicated saws or saw attachments, follow local recommendations for the

avoidance of possible hand-arm vibration damage and long-term hearing damage. (Under certain circumstances, hand-arm vibration levels exceeding 5ms-2 can be produced and maximum sound levels can exceed 80dB(A). However, when the equipment is used for the purposes intended this poses no threat to long-term health.) WARNING: this equipment is not intended for use in an oxygen rich environment or in the presence

of flammable gases CAUTION: this equipment must only be used in accordance with the EMC guidelines described in

this user manual. Use of accessories other than those approved by De Soutter Medical may result in increased interference or emissions. CAUTION: ensure this equipment is regularly serviced. Refer to the service and repair information

section of this user manual. CAUTION: only clean and sterilise this equipment as directed in this user manual CAUTION: do not immerse any part of this equipment in fluids except as required by an automatic

washer-disinfector cycle CAUTION: only use Stericut or De Soutter Medical approved accessories CAUTION: always remove batteries when the handpiece is left unused for an extended period of

time

1

Intended Use The equipment described in this user manual is intended for use in surgical procedures involving drilling, reaming, wire or pin driving, and cutting bone or hard tissue.

Disposal WARNING: do not dispose of batteries by throwing them into a fire or immersing them in water WARNING: SB-703 and SB-704 batteries contain lithium-ion cells and are subject to transportation

restrictions All equipment should be recycled or disposed of, in accordance with local regulations.

2

Symbols Symbol

SN 12/00500

Meaning

Symbol

Meaning

Refer to the user manual

Only for use by a physician

Single-use only

Do not immerse

Dispose of in accordance with local regulations

Suitable for recycling

Vacuum steam sterilise

Push in the direction shown to release

Drill function

Ream function

Normal mode

Screwing mode

Drive in the direction indicated

Drive in the direction indicated (high-speed mode)

Pull and/or turn in the direction shown to unlock

Type BF protection

The first two digits indicate the year of manufacture

3

Reprocessing - Sterilisable Equipment These reprocessing instructions are suitable for the sterilisable equipment described in this user manual.

Limitations on reprocessing Repeated processing as specified in these instructions has minimal effect on this equipment. Equipment end-of-life is normally determined by wear or damage during use.

Safety Instructions WARNING: never reuse items marked for single-use

. Risks associated with reuse include: • cross contamination between patients • bone necrosis due to extra heat generation • inaccurate cutting. CAUTION: following a wet cleaning process, ensure that this equipment is dried immediately CAUTION: correct internal drying of sterilisable equipment can only be achieved by using a vacuum

steam autoclave with the vacuum assisted drying period activated CAUTION: do not immerse any part of this equipment in fluids except as required by an automatic

washer-disinfector cycle CAUTION: do not exceed temperatures of 140°C CAUTION: do not clean any part of this equipment in an ultrasonic cleaner CAUTION: do not wash or sterilise aseptic batteries, power supplies or battery chargers. Refer to

separate reprocessing instructions. CAUTION: ensure that aseptic battery housings are reprocessed in the open position NOTE: ensure that attachments and handpieces with collet mechanisms are fully open when

reprocessing NOTE: cannulations, blind holes, recesses, and other surfaces which are hard to reach, require

particular attention during reprocessing NOTE: STERIS processes will affect the appearance of equipment with coloured anodizing. The

discolouration caused by the processes will not affect the performance of the product. Detergents and Rinse Aids WARNING: the choice of detergent or rinse aid, and the manner in which they are used, is critical

to sustaining the reliability of the equipment. Failure to follow the instructions given in this user manual may cause premature failure of the equipment and may compromise patient safety. CAUTION: ensure the detergent or rinse aid manufacturer’s guidelines and process parameters (such as, dilution and temperature) are followed CAUTION: ensure the detergent or rinse aid used is suitable for use on anodised aluminium and

the following plastics: PEEK and PPSU CAUTION: never use detergents with a pH value greater than 11.0 NOTE: the use of pH-neutral enzymatic detergents is highly recommended

Point of Use (before reprocessing) Remove excess soil with a disposable cloth or other suitable wipe.

4

Containment and Transportation It is important that this equipment is reprocessed immediately after use. In order to minimise contamination risks, the handling, collection and transportation of soiled equipment should be strictly controlled.

Cleaning and Disinfection Manual Cleaning • Remove all attachments and accessories and wash them separately. • Dispose of single-use accessories in accordance with local guidelines. Manual cleaning should only be carried out where an automatic washer-disinfector is not available, or in order to remove large contaminant deposits. Manual cleaning should be conducted in a dedicated area, by trained personnel who are wearing protective clothing, for example: gloves, a waterproof apron, and goggles or a visor. NOTE: the use of dedicated sinks with temperature controlled water, ideally deionised or distilled, is recommended NOTE: cannulations, blind holes, recesses, and other surfaces which are hard to reach, require

particular attention during reprocessing 1. Wash off excess soil with running water (maximum 35°C). NOTE: avoid fluid ingress 2. Prepare a solution of detergent according to the detergent manufacturer’s instructions. 3. Remove all visible traces of contaminant, using suitable nylon brushes to scrub the equipment thoroughly. i) Manually open and close chucks and blade clamps. ii) Ensure any trapped contaminants are removed by flushing through cannulations and other surfaces which are hard to reach. 4. Rinse off all traces of the detergent with deionised or distilled running water (45 - 65°C). 5. Shake off any excess water and dry the surfaces with a lint-free cloth. 6. Visually inspect each item. Verify that all contaminants have been removed in accordance with local reprocessing guidelines.

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Automatic Cleaning • Remove large contaminant deposits by manual cleaning. • Remove all attachments and accessories and wash them separately. • Dispose of single-use accessories in accordance with local guidelines. An automatic washer-disinfector, capable of meeting the relevant national and international cleaning and disinfection standards (such as, ISO 15883 or HTM 2030), should be used. NOTE: cannulations, blind holes, recesses, and other surfaces which are hard to reach, require particular attention during reprocessing CAUTION: the drying cycle should not be used with batteries. The drying cycle will adversely affect

the performance and life of the battery. 1. Place the handpieces, attachments and accessories into a wire basket. i) Set chucks and blade clamps to a middle position. ii) Ensure that sterile batteries are inverted (that is, contacts facing down). iii) Ensure that aseptic battery housings are empty and open, with the open side facing down. iv) Fit washing spacers and end caps as required. v) Ensure that all items are separated. NOTE: the placement of items in automatic washer-disinfector baskets can be a critical

factor in achieving effective cleaning. The basket type and the position of the items within the basket should be managed by suitably trained personnel and be in accordance with the washer-disinfector instructions. 2. Follow the washer-disinfector manufacturer’s loading instructions and select the appropriate cycle. The cycle should include the following:

Cycle Stage

Minimum Recirculation Time (min:secs)

Temperature

Detergent

Pre-wash

5:00

< 35°C

-

Enzyme wash

5:00

55 - 65°C

Endozime AW Triple Plus a

Rinse 1

2:00

55 - 65°C

-

Rinse 2

2:00

55 - 65°C

-

Thermal rinse

1:00

90°C

-

Pure water rinse

0:10

66°C

-

Drying (not suitable for batteries)

20:00

110°C maximum

-

a. other brands of detergent may be used provided the suitability of the detergent is verified before use.

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3. Remove the disinfected equipment from the washer-disinfector and place the equipment in a clean area. 4. Remove any washing spacers and end caps, if fitted. 5. Visually inspect each item. Verify that all contaminants have been removed in accordance with local reprocessing guidelines. Disinfection Thermal disinfection is recommended and included in the automatic cleaning process. Where the use of an automatic washer-disinfector is not possible, the equipment should be wiped with a suitable disinfectant.

Maintenance Lubricate collets and chucks using a suitable surgical instrument oil.

Inspection and Function Testing WARNING: inspect all equipment before use and do not use suspect, damaged or worn equipment WARNING: never reuse items marked for single-use

. Risks associated with reuse include: • cross contamination between patients • bone necrosis due to extra heat generation • inaccurate cutting. 1. Ensure the equipment is in good working order. i) Note any unusual sounds, vibrations or operating speeds. NOTE: if operating difficulties are experienced, refer to the troubleshooting section of this

user manual 2. Inspect reusable cutting accessories (such as, drill bits and reamer shells) for damage and wear. NOTE: dispose of worn or damaged cutting accessories appropriately

Packaging Place the disinfected equipment into a sterilisation container. NOTE: if wrapping is required, use a material suitable for the chosen sterilisation method

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Sterilisation of Handpieces and Accessories Steam Sterilisation CAUTION: these sterilisation instructions are not suitable for sterilisable batteries CAUTION: ensure that aseptic battery housings are open, with the open side facing down

a

Exposure Time and Temperature (-0°C / +3°C)

Drying Time b

Cycle

Wrapping

vacuum assisted

optional

3-4 minutes at 134°C

30 minutes at maximum 110ºC

vacuum assisted (flash)

unwrapped

3-4 minutes at 134°C

none

wrapped

15 minutes at 134°C

30 minutes at maximum 110ºC

wrapped

50 minutes at 121°C

20 minutes at maximum 110ºC

gravity

a. for reasons of non-repeatability during transport and storage, processes involving unwrapped equipment cannot be validated beyond the sterilisation procedure. b. the drying times specified are for a full, wrapped sterilisation case containing 3 handpieces. If different quantities are used, the necessary drying time may vary.

STERIS Sterilisation Sterilisation System

Cycle

V-PRO® 1

standard

V-PRO® 1 Plus

lumen

V-PRO® maX

lumen

NOTE: STERIS processes will affect the appearance of equipment with coloured anodizing. The

discolouration caused by the processes will not affect the performance of the product.

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Sterilisation of Sterilisable Batteries Steam Sterilisation CAUTION: high temperature can affect the performance and life of a battery. The specified drying

times should not be exceeded. CAUTION: ensure that sterile batteries are fitted to the holder in the sterilisation container. The

contacts should be facing downwards to allow any liquid to drain away freely. Model

Exposure Time and Temperature (-0°C / +3°C)

a

Cycle

Wrapping

Drying Time (maximum 110ºC)

SB-450

3 minutes

SB-600

maximum

SB-703 SB-704

vacuum assisted

12 minutes

3-4 minutes maximum at 134°C

optional

maximum

AB-450 AB-600

not suitable for sterilisation

AB-701 AB-702

a. For reasons of non-repeatability during transport and storage, processes involving unwrapped equipment cannot be validated beyond the sterilisation procedure.

STERRAD® Sterilisation Sterrad NX Advanced cycle, wrapped. STERIS Sterilisation Sterilisation System

Cycle

V-PRO® 1

standard

V-PRO® 1 Plus

lumen

V-PRO® maX

lumen

NOTE: STERIS processes will affect the appearance of equipment with coloured anodizing. The

discolouration caused by the processes will not affect the performance of the product.

Storage To preserve sterility, wrap the sterilised equipment with a suitable material, capable of presenting a barrier to micro-organisms and particulate contamination.

Point of Use (after reprocessing) CAUTION: do not operate this equipment while it is still warm from reprocessing CAUTION: this equipment should not be placed in a refrigerator or similar

Following sterilisation, allow this equipment to cool to room temperature before being used.

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Additional Information Manual cleaning has been validated in accordance with AAMI TIR30. Automated cleaning has been validated, in accordance with HTM 2030 and AAMI TIR30, using an automated washer-disinfector. Vacuum and gravity steam sterilisation have been validated in accordance with HTM 2010, AAMI TIR12, ANSI/AAMI ST79, ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2. Sterrad sterilisation has been validated in accordance with ANSI/AAMI/ISO 14937. Steris sterilisation has been validated in accordance with AAMI TIR12. The reprocessing instructions provided in this user manual are compatible with the requirements of CFPP 01-01. The reprocessing instructions provided in this user manual have been validated by De Soutter Medical as being capable of preparing a device for reuse. It remains the responsibility of the reprocessor to ensure that the reprocessing as actually performed, using equipment, materials and personnel in the reprocessing facility, achieves the desired result.This normally requires validation and routine monitoring of the process. Likewise, any deviation by the reprocessor from the instructions provided in this user manual, should be properly evaluated for effectiveness and potential adverse consequences.

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Overview







  



1)

Release ring

2)

Function selector ring

3)

Blade clamp (sagittal saw)

4)

Trigger

5)

Mode selector

6)

Blade clamp (reciprocating saw)

7)

Adjuster (wire/pin driver)

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Configuring a Handpiece Selecting the Function WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece

configuration, and before fitting or removing attachments and accessories Rotate the function selector ring until the indicator dot is aligned with the function marker. NOTE: the function selector ring will click into place. It may be necessary to rotate the output shaft slightly Function

Description Drill - Use this function with all attachments except when reaming.

Ream - Use this function for reaming. NOTE: the higher torque of this function also makes it suitable for

removing screws WARNING: never use the ream function to insert screws or wires, or to tap

threads

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Selecting the Mode WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece

configuration, and before fitting or removing attachments and accessories Slide the mode selector to choose the required mode. MBQ-700

Forward mode

SAFE

Reverse mode

MBQ-701 











SAFE

Screwing mode

Normal mode (high-speed) 1: Reverse 2: Forward Both: Oscillating

(low-speed) 1: Locked 2: Locked Both: Locked

1: Reverse 2: Forward Both: Tapping

WARNING: tapping mode should be used with care. To minimise the risk of damage, tapping and

screwing in delicate materials should be performed with hand tools instead.

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DBC-700, DBK-700 and DBK-701 Dual-speed handpiece

High-speed mode

SAFE

Low-speed mode

Single-speed handpiece

Run mode

SAFE

Run mode

Controlling the Speed The speed of the handpiece is controlled by progressively pressing the trigger. Oscillating and Tapping Oscillating and tapping modes are utilised by pressing both triggers together. The speed of the handpiece is determined by the trigger which is pressed the least. NOTE: release both triggers to return to using independent trigger control CAUTION: ensure the triggers are only pressed independently when using a saw attachment

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Using Attachments Fitting an Attachment WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece

configuration, and before fitting or removing attachments and accessories 1. Push the attachment into the end of the handpiece, aligning the lugs on the attachment with the corresponding slots in the handpiece. NOTE: saw attachments can be used in any of four angular positions 2. Twist the attachment clockwise until it clicks into place.





NOTE: all attachments, other than chucks, are fitted in the same way

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Removing Attachments WARNING: ensure the handpiece is set to SAFE mode before attempting to change the handpiece

configuration, and before fitting or removing attachments and accessories 1. Pull back the release ring. 2. Twist the attachment anti-clockwise and remove.

 

NOTE: all attachments, other than chucks, are removed in the same way

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