Sternudrive Lite Reprocessing Instructions

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Contents 1

Important Information... 1

2

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

3

Reprocessing - Sterilisable Equipment... 4

4

Limitations on reprocessing... 4 Safety Instructions... 4 Point of Use (before reprocessing)... 5 Containment and Transportation... 5 Cleaning and Disinfection... 6 Maintenance... 8 Inspection and Function Testing... 8 Packaging... 8 Sterilisation of Handpieces and Accessories... 9 Sterilisation of Sterilisable Batteries... 10 Storage... 11 Point of Use (after reprocessing)... 11 Additional Information... 11 Overview... 12

5

Configuring a Handpiece... 13

6

Selecting the Mode... 13 Controlling the Speed... 13 Using Attachments... 14

7

Fitting an Attachment... 14 Removing Attachments... 15 Using a Wire or Pin Driver... 16 Using Accessories... 17

8

Fitting and Removing a Rotary Cutter... 17 Fitting and Removing a Reciprocating Blade... 18 Fitting and Removing a Sternum Guard... 19 Fitting a Sagittal Blade (Lever-release)... 20 Removing a Sagittal Blade (Lever-release)... 21 Fitting a Sagittal Blade (Knob-release)... 22 Removing a Sagittal Blade (Knob-release)... 23 Fitting and Removing an Oscillating Blade (Manual-release)... 24 Fitting a Wire or Pin (WQ-709)... 25 Fitting a Wire or Pin Guard... 26 Powering the Handpiece... 27 Technical and Ordering Information... 28

9

Handpiece Specifications... 28 Attachments... 29 Power Accessories... 30 Sterilisation Accessories... 31 Troubleshooting... 32

10

Further Help... 32 Service and Repair Information... 33 Guarantee and Liability... 33 EMC Information... 34 General Information... 34 EM Compliance (emissions)... 34 EM Compliance (immunity)... 34

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: do not use the CQ-709 attachment without the sternum guard fitted WARNING: when using the CQ-709, ensure the surfaces of the sternum guard are free from

scratches and gouges which may tear soft tissue WARNING: when using the CQ-709, ensure the blade does not rub against the sternum guard 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 reprocess 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

1

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

Intended Use and Benefits The equipment described in this user manual is intended for use by a professional surgeon, in surgical procedures involving the cutting of bone or hard tissue - specifically for sternotomies. There are no known contraindications.

Disposal WARNING: do not dispose of batteries by throwing them into a fire or immersing them in water WARNING: lithium batteries are subject to transportation restrictions WARNING: faulty or suspect lithium batteries must not be returned by air transport. They should be

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

2

Symbols Symbol

Meaning

Symbol

Meaning

Refer to the user manual

Only for use by a physician

Single-use only

Do not immerse

Refer to the user manual for the duty cycle

Dispose of in accordance with local regulations

Suitable for recycling

Type CF protection

Drive in the direction indicated

Pull and/or turn in the direction shown to unlock

Temperature limits to which the equipment can be exposed

Pressure limits to which the equipment can be exposed

Humidity limits to which the equipment can be exposed

Transport - keep away from rain

Transport - fragile, handle with care

Transport - this way up

SN YY/000000

The first two digits (YY) indicate the year of manufacture

Manufacturer

(& 5(3

EC authorised representative

Do not use if packaging is damaged or opened

0'

Medical Device

%65: $:$-&

3

Reprocessing - Sterilisable Equipment These reprocessing instructions are suitable for the sterilisable equipment described in this user manual. • All Handpieces • All Attachments • SB-xxx - Sterile Battery • AH-xxx - Aseptic Housing • AS-xxx - Aseptic Shield

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. WARNING: do not clean any part of this equipment with pressurised air 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 use saline water to rinse the equipment 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.

4

Detergents and Rinse Aids for use on Batteries 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, PPSU and PAEK CAUTION: ensure a pH-neutral enzymatic detergent is used for cleaning batteries. Failure to do so

may adversely affect the battery. Detergents and Rinse Aids for use on all Other Equipment 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, PPSU and PAEK 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) WARNING: do not allow the soil to dry on the equipment WARNING: ensure the equipment is reprocessed as soon as practically possible after use CAUTION: do not use saline water to rinse the equipment CAUTION: only use pH neutral substances prior to reprocessing

Excess soil may be removed with a suitable wipe, or rinsed away with deionised or distilled running water after use (maximum 35°C). CAUTION: do not immerse any part of the equipment

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

5

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. CAUTION: do not use saline water to rinse the equipment 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). CAUTION: do not immerse any part of the equipment

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. CAUTION: when using brushes, extra care must be taken to avoid damaging the equipment

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. CAUTION: the drying cycle should not be used with batteries. The drying cycle will adversely affect

the performance and life of the battery. NOTE: cannulations, blind holes, recesses, and other surfaces which are hard to reach, require

particular attention during reprocessing 1. Place the handpieces, attachments and accessories into an insert tray and/or 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

Neutral Enzymatic Triple Enzyme Detergent

Rinse 1

2:00

55 - 65°C

-

Rinse 2

2:00

55 - 65°C

-

Thermal rinse

5:00

90°C

-

Pure water rinse

1:00

60°C

-

Drying (not suitable for batteries)

20:00

110°C maximum

-

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3. Remove the disinfected equipment from the washer-disinfector and place the equipment in a clean area. CAUTION: ensure the equipment has been sufficiently dried. Check cannulations, blind holes

and recesses for moisture. 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.

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 for damage and wear. NOTE: dispose of worn or damaged and single-use 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 CAUTION: ensure that aseptic battery housings are open, with the open side facing down

Steam Sterilisation Using a Wire Sterilisation Case a

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

Minimum Drying Time b

Cycle

Wrapping

vacuum assisted

wrapped

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

60 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 for the wrapped cycles are based on using 2 layers of 56gsm Crepe paper wrap. If different wrapping is used, the necessary drying time may vary.

Steam Sterilisation Using a Filtered Sterilisation Case CAUTION: filtered sterilisation cases are not suitable for gravity steam sterilisation

Cycle

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

Minimum Drying Time

vacuum assisted

3-4 minutes at 134°C

30 minutes at maximum 110ºC

vacuum assisted (flash)

3-4 minutes at 134°C

none

STERIS Sterilisation Sterilisation System

Cycle

V-PRO® 1

standard

V-PRO® 1 Plus

lumen

V-PRO® maX

lumen

V-PRO® 60

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.

9

Sterilisation of Sterilisable Batteries Steam Sterilisation CAUTION: aseptic batteries (AB-xxx) are not suitable for 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

Cycle

Wrapping

a

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

Drying Time (maximum 110ºC)b

SB-450 SB-600 SB-703

vacuum assisted

wrapped

3-4 minutes maximum at 134°C

vacuum assisted (flash)

unwrapped

3-4 minutes maximum at 134°C

3 minutes maximum 12 minutes maximum

SB-704 SB-xxx

none

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 for the wrapped cycles are based on using 2 layers of 56gsm Crepe paper wrap. If different wrapping is used, the necessary drying time may vary.

STERRAD® Sterilisation CAUTION: insert trays are not suitable for use with the STERRAD® sterilisation process NOTE: STERRAD® sterilisation is only suitable for SB-703 & SB-704 batteries NOTE: prior to reprocessing any medical device in a STERRAD® System, refer to the STERRAD®

System User’s Guide for general reprocessing instructions, and proper cleaning, drying and packaging information NOTE: batteries must be packaged in an approved container and wrap

Sterilisation System

Cycle

STERRAD® 100S

short or longa

STERRAD® NX

standard or advanced

STERRAD® 100NX

standard

a. the STERRAD® 100S long cycle is only available outside the U.S.

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STERIS Sterilisation Sterilisation System

Cycle

V-PRO® 1

standard

V-PRO® 1 Plus

lumen

V-PRO® maX

lumen

V-PRO® 60

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.

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 HTM 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)

Attachment release button (x2)

2)

Trigger

3)

Mode selector

12

Configuring a Handpiece 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. MBC-709

Forward mode

SAFE

Reverse mode

Controlling the Speed The speed of the handpiece is controlled by progressively pressing the trigger.

13

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 Push the attachment into the end of the handpiece until it clicks into place. NOTE: attachments can be used in any of four angular positions

NOTE: all attachments are fitted in the same way

14

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 Press both attachment release buttons and remove the attachment.

NOTE: all attachments are removed in the same way

15

Using a Wire or Pin Driver CAUTION: if the wire is to be removed from the surgical site, ensure the wire is wiped clean before

inserting into the attachment WARNING: if the wire or pin protrudes from the rear of the tool, a wire guard must be fitted CAUTION: do not use bent wires

1. With the wire (or pin) fitted, pull the lever to grip the wire. NOTE: if the wire driver features a manual adjuster, the bite point of the lever can be moved by tightening or loosening the adjuster as required 2. While holding the lever, use the trigger to control the rotation of the wire.





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