ergo_plus_ecv-220_and_221_operating_instructions_ve.pdf
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Operating Instructions
International
English
ECV-220/221
Small Bone Corded System
Straight Case Modular
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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
0120
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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
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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:
Part No.
Description:
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
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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
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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
16
DV-225 AO Drill
Non Cannulated
15960
0 - 5000 rpm
2.2 mm
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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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CV-220 Recip Saw
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
Never operate the attachment without a blade fitted.
Technical Description and Part Number Details:
CV-220
14550
0 - 17,000
S92
1/8” (3.17mm)
9940
Part No.
Speed
Stericut Blade Hub Type
Rasp Shank Diameter
Blade Wrench (Supplied)
For full details of suitable saw blades refer to Stericut data sheets.
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NV-220 Quick Release Sagittal Saw Attachment
Blade Clamp Operation
•
•
•
-
Insertion:
Push the release button, when fully depressed rotate the blade clamp. The
blade clamp is now locked open.
With the blade clamp in the open position insert the blade.
Rotate the blade clamp without depressing the release button. The clamp will
snap into position, firmly clamping the blade.
Removal:
• Push the release button, when fully depressed rotate the blade clamp. The
blade clamp is now locked open.
• Lift the blade slightly and remove it from the clamp.
.
Technical Description & Part Number Details
Part No.
Speed
Blade Hub Type
NV-220
14790
0-30,000 cpm
De Soutter Medical S88
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Sagittal Saw Attachment speed recommendations
When using sagittal saw attachments it is recommended that the Saw attachment
settings, on the power console being used, are selected or that the maximum
handpiece speed is set to 30000rpm or 80%.
SECTION 5: Explanation Of Symbols
Explanation of Symbols
or
Refer to the Operating
Instruction Manual
Vacuum Steam Sterilize.
Rotate to Lock Blade
Rotate to release
Attachment
Safe
Run
2
Do Not Immerse
22
Single Use Only
Page 25
SECTION 6: SYSTEM FAULT FINDING
Fault Finding
Fault:
Possible Cause:
Remedy:
Instrument does not
run.
Lever or Pedal Safe/Run
Mode selector incorrectly
set
Power Console not ON
Check mode selector
Cable not connected
properly
Faulty Handpiece
Check unit is connected to a
suitable power supply and
switched on.
Refer to PS-450/1 or PC-450/1
system fault finding for further
information
Check connections
Faulty Cable
Try alternative handpiece or
return handpiece for service
Return for Service
Attachment will not
fit into handpiece.
Drive spindle misaligned.
Retry attachment assembly.
Accessory will not fit
into attachment
Debris inside chuck/ collet/
blade clamp
Clean with small brush
Accessory is damaged
Replace the accessory.
Do not force a damaged
accessory into the attachment
Instrument seems to
cut slowly
Worn accessory
Replace accessory.
If any problem persists then contact De Soutter Medical Ltd.
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Conditions for Transport & Storage
Temperature:
Relative Humidity:
Atmospheric Pressure:
-20ºC to +40ºC
90% maximum.
1.5 atmospheres maximum.
Repair & Service Information
All powered instruments and attachments 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 sterilized.
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
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