CleanCut NS3 and CNS Original Instructions

The product described under “Technical and Ordering Information” is in conformity with the relevant Community harmonisation legislation: Machinery Directive (2006/42/EC)

Contents 1

Important Information... 1

2

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

3

General... 3 Extractor... 3 Control Box... 3 Reprocessing - Non-sterilisable Equipment... 4

4

Limitations on reprocessing... 4 Safety Instructions... 4 Point of Use (before reprocessing)... 4 Containment and Transportation... 4 Manual Cleaning... 5 Reprocessing - Immersible Equipment... 6

5

Limitations on reprocessing... 6 Safety Instructions... 6 Point of Use (before reprocessing)... 6 Containment and Transportation... 7 Cleaning and Disinfection... 7 Inspection and Function Testing... 7 Point of Use (after reprocessing)... 8 Additional Information... 8 Overview... 9

6

Autopsy Saw... 9 Control Box Front... 10 Control Box Side... 11 Extractor Front... 12 Extractor Rear... 13 Configuring the Autopsy Saw... 14

7

Fitting and Removing a Spindle Guard... 14 Configuring the Extractor... 15

8

Fitting and Removing Fuses... 15 Selecting the Mode and Speed... 16 Configuring the Control Box... 17

9

Fitting and Removing Fuses... 17 Fitting the Autopsy Saw... 18 Removing the Autopsy Saw... 19 Setting the Saw Speed... 20 Using Accessories... 21

10

Replacing the Debris Bags... 21 Fitting and Removing a Blade... 22 Using the Autopsy Saw... 23

11

Cutting Technique... 23 Technical and Ordering Information... 24

12

Autopsy Saw Specifications... 24 Extractor Specifications... 24 Control Box Specifications... 25 Accessories... 25 Circular Saw Blades... 26 Segment Saw Blades... 27 Troubleshooting... 28 Further Help... 28 Service and Repair Information... 29 Guarantee and Liability... 29

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: ensure the voltage rating of the electrical supply corresponds with the voltage rating

stated on the equipment label WARNING: this equipment must only be connected to a supply with a protective earth WARNING: ensure that correctly rated fuses are fitted before use WARNING: this equipment is not intended for use in an oxygen rich environment or in the presence

of flammable gases WARNING: do not attempt to dismantle or modify this equipment, except as directed in this user

manual WARNING: ensure the equipment is disconnected from all power sources before cleaning CAUTION: only reprocess this equipment as directed in this user manual CAUTION: do not clean any part of this equipment in an ultrasonic cleaner CAUTION: do not immerse the control box or the extractor in fluids CAUTION: do not clean the control box in an automatic washer-disinfector CAUTION: ensure the vent is not obstructed CAUTION: ensure this equipment is regularly serviced. Refer to the service and repair information section of this user manual. CAUTION: only use Stericut or De Soutter Medical approved accessories CAUTION: only use sharp cutting accessories CAUTION: this equipment is not suitable for cutting metal NOTE: if electro-magnetic interference occurs, causing undesirable operation, increase the

distance between the interfering devices and if possible, connect the items of equipment to separate power outlets

1

Noise and Vibration Information The vibration emission level given has been measured in accordance with BS EN ISO 20643, BS EN ISO 5349-1 and BS EN 12096. The noise and vibration tests were conducted under normal operating conditions. The A-weighted sound pressure level is less than 80 dB(A). Model

NS3

Part no.

1250444

Vibration Emission Value, ahv

11.2 m/s2

Uncertainty, K

4.5 m/s2

Intended Use The saw described in this user manual is intended for mortuary work, specifically for the cutting of bone.

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

2

Symbols General Symbol

Meaning

Symbol

Meaning

Refer to the accompanying warning

Refer to the user manual

Dispose of in accordance with local regulations

Fuse

Type B protection

SN 19/00500

The first two digits indicate the year of manufacture

Do not immerse

Humidity limits to which the equipment can be exposed

Temperature limits to which the equipment can be exposed

Pressure limits to which the equipment can be exposed

Transport - keep away from rain

Transport - fragile, handle with care

Transport - this way up

Extractor Symbol

Meaning

Symbol

Off

a

Meaning On

Alternating current

HI

High speed extraction mode

LO

Low speed extraction mode

MAN

Manual extraction mode

AUTO

Automatic extraction mode

Symbol

Meaning

Control Box Symbol

Meaning

a

Direct current

On

Alternating current

Off

3

Reprocessing - Non-sterilisable Equipment These reprocessing instructions are suitable for the non-sterilisable equipment described in this user manual. • Extractor • NS3 Control Box

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: ensure the equipment is disconnected from all power sources before cleaning WARNING: inspect all equipment before use and do not use suspect, damaged or worn equipment CAUTION: do not immerse any part of this equipment in fluids CAUTION: do not clean this equipment in an automatic washer-disinfector CAUTION: do not clean any part of this equipment in an ultrasonic cleaner CAUTION: do not sterilise this equipment CAUTION: do not spray wash the extractor

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 used is suitable for use on anodised aluminium and

the following plastics: PEEK and PPSU CAUTION: ensure the detergent or rinse aid manufacturer’s guidelines and process parameters

(such as, dilution and temperature) are followed CAUTION: never use detergents with a pH value greater than 11.0 or less than 7.0 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.

4

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

particular attention during reprocessing 1. Remove any attachments and accessories. 2. Where present, clean the fan grill and air vents with a soft brush to remove any dust or debris. 3. Wipe the surfaces of the equipment with a clean, soft cloth, slightly dampened with a mild pH balanced detergent or alcohol. NOTE: avoid fluid ingress 4. Wipe the surfaces of the equipment with a clean, soft cloth, slightly dampened with distilled or sterilised water. NOTE: avoid fluid ingress 5. Dry the equipment with a clean, soft, dry cloth.

5

Reprocessing - Immersible Equipment These reprocessing instructions are suitable for the immersible equipment described in this user manual. • Extractor hose • Autopsy saw • Primary permanent filter • Secondary permanent filter • Outer debris bag NOTE: the outer debris bag, primary permanent filter and secondary permanent filter only require reprocessing after prolonged use or in the event of a split paper bag

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: ensure the equipment is disconnected from all power sources before cleaning WARNING: inspect all equipment before use and do not use suspect, damaged or worn equipment WARNING: do not use corrosive cleaning fluids or hypochlorite based solutions (bleach) CAUTION: do not clean this equipment in an automatic washer-disinfector CAUTION: do not clean any part of this equipment in an ultrasonic cleaner CAUTION: do not sterilise this equipment CAUTION: following a wet cleaning process, ensure that this equipment is dried immediately

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 used is suitable for use on anodised aluminium and

the following plastics: PEEK and PPSU CAUTION: ensure the detergent or rinse aid manufacturer’s guidelines and process parameters

(such as, dilution and temperature) are followed CAUTION: never use detergents with a pH value greater than 11.0 or less than 7.0 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).

6

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.

Cleaning and Disinfection Manual Cleaning 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. Remove any attachments, accessories and the spindle guard, as required and wash them separately. 2. Wash off excess soil with running water (maximum 35°C). 3. Prepare a solution of detergent according to the detergent manufacturer’s instructions. 4. Remove all visible traces of contaminant, using suitable nylon brushes to scrub the equipment thoroughly. i) Ensure any trapped contaminants are removed by flushing through cannulations and other surfaces which are hard to reach. 5. Rinse off all traces of the detergent with deionised or distilled running water (45 - 65°C). 6. Shake off any excess water and dry the surfaces with a lint-free cloth. 7. Visually inspect each item. Verify that all contaminants have been removed in accordance with local reprocessing guidelines. Disinfection 1. Immerse the parts in disinfectant fluid according to the disinfectant manufacturer’s instructions. 2. Rinse off all traces of the disinfectant with deionised or distilled running water (45 - 65°C). 3. Shake off any excess water and dry the surfaces with a lint-free cloth. 4. Visually inspect each item. Verify that all contaminants have been removed in accordance with local reprocessing guidelines.

Inspection and Function Testing WARNING: inspect all equipment before use and do not use suspect, damaged or worn equipment

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 cutting accessories appropriately

7

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

Additional Information Manual cleaning has been validated in accordance with AAMI TIR30. 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.

8

Overview Autopsy Saw





1)

Blade retainer

2)

Power switch

9

Control Box Front



"65014:
4"8
4:45&.







1)

Power switch

2)

Overload warning light

3)

Speed control knob

4)

Ratings label

10

Control Box Side





1)

Fuse holders

2)

Output socket

11

Extractor Front





 

1)

Autopsy Saw Holder

2)

Power switch (Mains isolation)

3)

Trolley

4)

Control Box

12

Extractor Rear





 



1)

Fuse holder

2)

Speed selection switch

3)

Fuse holder

4)

Mode selection switch

5)

Auxiliary outlet (for control box)

13

Configuring the Autopsy Saw Fitting and Removing a Spindle Guard WARNING: ensure the equipment is switched off and the mains supply is disconnected NOTE: a spindle guard is only fitted to autopsy saws without an extractor kit

1. Align the wrench with the notches on the spindle guard. 2. Rotate the spindle guard anti-clockwise to remove. 3. Rotate the spindle guard clockwise to fit.

 



14

Configuring the Extractor Fitting and Removing Fuses WARNING: ensure the equipment is switched off and the mains supply is disconnected

1. Using a screwdriver, rotate the fuse holder anti-clockwise. NOTE: the extractor utilises two identical input fuses 2. Insert or remove the fuses. NOTE: ensure the fuses are correctly rated Supply Voltage

Fuse Rating

230V

T6.3 A

100 - 120V

T15 A

3. Re-fit the fuse holder, using a screwdriver to rotate the fuse holder clockwise until it is secure.





15

Selecting the Mode and Speed 1. Set the mode selection switch to the required mode. 2. Set the speed selection switch to the required speed. Mode

Description

MAN

The extractor is manually controlled by the extractor power switch

AUTO

The extractor will automatically switch on with the autopsy saw, and turn off a few seconds after the saw has stopped

Speed

Description

HI

High-speed extraction mode

LO

Low-speed extraction mode

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