Desoutter DPX-170 User manual
Operating Instructions
Pneumatic
Oscillating Saw
International
English
Sternum Saw
DPX–170
De Soutter Medical DPX-170 Pneumatic Oscillating Sternum
Saw
Index
Page
Warnings and Safety Instructions 2
Product Description 2
Air Supply 2
Reprocessing Instructions 3
Air Supply Hose 6
Controls 7
Blade Clamp Operation 8
Conditions for Transport and Storage 8
Explanation of Symbols 9
Fault Finding 9
Repair and Service Information 10
Guarantee and Liability 10
0120
2
Warnings & Safety Rules
Failure to follow these instructions may result in serious injury to the patient
or operating staff.
Do not attempt to use the equipment until all the instructions have been
studied and understood.
Never permit untrained personnel to use this instrument system.
Always operate the instrument at the correct air pressure as specified in these
instructions.
Always ensure that the hose is securely connected prior to use.
Always inspect all equipment and accessories before use. Do not use suspect,
damaged or worn equipment.
Always ensure accessories are correctly connected to the instrument before use.
Always set the instrument safety catch 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 notimmerse the instrument in fluids.
Always use Stericut or De Soutter Medical approved accessories.
Product Description
The DPX-170 is a pneumatic surgical oscillating saw.
Air Supply
Use only 99.97% pure, dry compressed air or nitrogen filtered to 5 microns.
Lower pressures may be set for lower speed requirements.
Operating Pressure: 6 bar (87psi)
Flow Rate: 3.3l/s (7 cu.ft./min)
Never exceed 7 bar (100psi) pressure.
3
Reprocessing Instructions
Warnings:
Limitations on
reprocessing: Do notimmerse the handpiece in water other than when automatic
reprocessing, and only then, when fitted the correct washing caps.
Do not exceed temperatures 140°C.
Do notclean 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 minimise risks.
Preparation for
cleaning: Remove all 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 Klerzymeand 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)
avoiding fluid ingress via the air hose inlet. 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. 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.
4
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.
2. Place the handpiece, attachments and accessories onto the wire
basket. Ensure all items are separated and washing caps are securely
fitted to the handpiece and air supply hose.
Note:
The placement of item 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 minutes).
§Drying cycle
4. Remove disinfected instruments from the washer/disinfector to a clean
area. Remove the washing caps.
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: Lubrication of the motor is not essential but will enhance the life and
performance of the instrument.
1. Apply 3 drops of surgical instrument oil (part no. 30982- Non-sterile)
into the instrument air inlet after cleaning.
2. Connect the instrument to an air supply and run for at least 20 seconds
to ensure adequate dispersal of lubricant.
3. Lubricate collets, chucks and hose connectors 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
5
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 DPX
Sterilization case (part No. 9350). 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 micro-organisms 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 non-
repeatability.
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)
Accessories
Description Part No.
Washing cap 608073
Hose Washing Cap 8950
Sterilisation Case 9350
6
Air Supply Hose
The air supply hose is self sealing when disconnected from the instrument. The hose
connects to the instrument with a quick release bayonet connection.
To attach the hose:
•Grip the hose connector and push it on to the instrument spigot.
•Twist the connector clockwise. The connector will come to a stop - the hose is now
connected.
•Pull gently on the hose to check that the hose is securely connected to the
instrument.
To remove the hose:
•Hold the instrument and grip the hose connector.
•Twist the hose connector anti clockwise, pushing the hose connector towards the
instrument.
Refer to the diagram.
Optional Accessories
Air Supply Hoses
Type 3m length 4m length 5m length
BOC MA7 5300 5310 5320
A. O. 5330 5340 5350
AGA 5360 5370 5380
Draeger 5390 5400 5410
7
Blades
Stericut saw blades are sterile packed in packs of 5 blades.
Part No. Blade
Thickness
(mm)
Cut
Thickness
(mm)
Tooth
Pitch
(mm)
Depth of
cut
(mm)
Blade
Radius
(mm)
S81-100 0.5 1.0 1.5 16 25
S81-101 0.5 1.0 1.8 23 32
S81-102 0.5 1.0 1.5 29 38
S81-103 0.5 1.0 1.5 13 22
S81-104 0.5 1.0 1.5 42 51
S81-105 0.5 1.0 1.8 23 32
S81-106 0.5 1.0 1.4 15 25
For full details of suitable saw blades refer to Stericut data sheets.
Controls
Lever - The lever control has a progressive throttle action, increasing the saw speed
as it is depressed.
Safety catch - The lever can be made inoperable by rotating the safety catch so the
cut out is positioned above the hole in the lever. In this position the tool can
not run
Refer to the diagram.
8
Blade Clamp Operation
Assembly:
•Using the spanner provided, remove the clamp nut on the end of the oscillating
shaft in an anti clockwise direction.
•Insert the blade onto the oscillating shaft, and locate the splined hole in the blade
over the spline on the shaft.
•Replace the clamp nut and tighten
Removal:
•Using the spanners provided, remove the clamp nut on the end of the oscillating
shaft in an anti clockwise direction.
•Remove the blade.
•Replace the clamp nut.
Refer to the diagram below.
Conditions for Transport & Storage
Temperature: -20ºC to +40ºC
Relative Humidity: 90% maximum.
Atmospheric Pressure: 1.5 atmospheres maximum.
9
Explanation of Symbols
Refer to the Operating
Instruction Manual Vacuum Steam
Sterilise.
Do Not Immerse Safe
Fault Finding
Fault: Possible Cause: Remedy:
Instrument does not
run. Air supply faulty Check air supply
Check hose connections
Lever Mode
Selector set to
Safety
Rotate Lever Mode Selector to run
position
Instrument runs
slowly, or seems to
lack power
Insufficient
lubrication Refer to Lubrication section of manual
Insufficient air supply
pressure and/or flow
rate
Check air supply pressure at regulator
(bottled air only).
Check hose for possible restriction.
Regulator
malfunctioning. Check air supply regulator.
Blade will not fit onto
oscillating shaft Debris inside blade
clamp Clean with small brush
Blade is damaged Replace the blade.
Do Notforce a damaged blade onto
the oscillating shaft
Instrument seems to
cut slowly Worn accessory Replace accessory.
If any problem persists then contact De Soutter Medical Ltd.
Repair & Service Information
All powered instruments `should be periodically checked and cleaned. Annual
servicing is recommended for normal use. Due to the specialist techniques used in
the manufacture and maintenance of De Soutter instruments, user servicing is not
possible. For service and repair please contact your nearest De Soutter Medical
Authorised Service Centre.
To return an instrument for repair:
•Record the serial number of the instrument being returned. Enclose a brief
statement describing the reason for returning the instrument.
•Enclose the purchase order number for the instrument if warranty is being
claimed. It will be helpful to include a contact name.
•Pack the instrument securely and send to the address below.
Please ensure that the instrument has been properly decontaminated and sterilised.
Guarantee & Liability
De Soutter Medical guarantees all instruments, attachments and accessories to be
free from defects in material and workmanship for one year from the date of
purchase. De Soutter Medical is not liable by warranty or otherwise in the case of
any of the following:
•Abuse, misuse or use in other than a surgical environment;
•Disassembly, alteration or unauthorised repair;
•If the product has not been used in a reasonable manner and in full
compliance with the written instructions.
This guarantee does not affect your Statutory Rights in accordance with
1999/44/EEC
De Soutter Medical Ltd.
River Park, Billet Lane,
Berkhamsted, Herts. HP4 1HL, United Kingdom.
Tel: +44 (0) 1442 860300 Fax: +44 (0) 1442 860333
Ref: 1167en – 4.1
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