instructions for your safety - medezine · 2017-01-19 · standard for medical electrical equipment...

The Medezine 5000 System has been examined and found to be in compliance with thestandard for Medical Electrical Equipment IEC/EN60601-1

INSTRUCTIONS FOR YOUR SAFETY

Please read carefully and retain for future referenceIt is a requirement of IEC/EN 60601-1 that theseinstructions are made available to the operator and qualified maintenance staff at all times.

Autopsy Saw93/42/EECIEC/EN 60601-1EMC 2004/108/EC

Autopsy Saw

MODE OF OPERATION CONTINUOUS WITH AUTO -REST OVERLOAD PROTECTION

CONSTRUCTED TO IEC 6061-1

POWER SUPPLY PROTECTED TO IP65

93/42/EECIEC/EN 60601-1EMC 2004/108/EC

DANGER HIGH VOLTAGEISOLATE FROM MAINS SUPPLY

BEFORE REMOVING THIS COVER

FOREWORD

The filtration unit is designed for dry particles only and must never be used for extracting liquids.

When not in use or during maintenance always isolate the equipment from the electrical supply by removing the mains plug from the socket.

PREPARATION FOR USE

Unpack and check equipment against the delivery note.

Check the details on the equipment rating label conform to your electrical supply.

For assembly instructions please refer to page 3.

IMPORTANT. THIS EQUIPMENT MUST BE EARTHED.

The wires in the mains lead of this equipment are coloured in accordance with the following code:

GREEN AND YELLOW EARTHBLUE NEUTRALBROWN LIVE

In the event of the wire colours in the mains lead not corresponding with the terminal markings of your plug, proceed as follows:

The wire which is coloured green and yellow must be connected to the terminal marked with either the letter E, or coloured green and yellow, or the earth symbol.

The wire which is coloured blue must be connected to the terminal marked with the letter N, or coloured black.

The wire which is coloured brown must be connected to the terminal marked with the let-ter L, or coloured red.

If a 240V model is to be fitted with a plug of the 13 amp. fused type to BS1363 then a 13 amp. fuse must be fitted.

If a 110V model is to be fitted with a 110V plug to BS4343 the supply must be provided with a 16 amp. protective device.

Environmental conditions for transport and storage.

Temperature Humidity AtmosphericPressure

1

Medezine LimitedChurchill Way Chapeltown Sheffield EnglandS35 2PY

TF +44 (0)114 257 6222E [email protected] www.medezinesaws.com

+44 (0)114 257 6002

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CONTENTS

Foreword 1

Equipment Classification 3

Assembly Instructions 3

Safety and Warnings 3

General Description 4

Sequence of Operation 4

Medezine 5000 System 5

Medezine 5000 Power Supply 6

Fuse Replacement 5000 Power Supply 6

Medezine 5000 Saw Unit 7

Fitting Accessories and Detachable Parts 8

Preventive Maintenance and Inspection 9

Troubleshooting 10 -11

Disinfection and Sterilization 12

Cutting Hints 12

Accessories and Detachable Parts 13

5000 Schematic Wiring Diagram 14

Filter Service Record 15

Conditions of Warranty 16

Electrical Test Certificate 16

Equipment Ratings 16

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EQUIPMENT CLASSIFICATION

Class 1 Equipment

Type B Equipment - Protection against electrical shock

Not AP/APG Equipment

Saw Unit Watertight Equipment IP67

Power Supply Splash Proof Equipment IP65

Filtration Unit Drip Proof Equipment IP44

Mode of Operation:-Continuous with Intermittent Loading up to 3 mins. Duty Cycle 50%

ASSEMBLY INSTRUCTIONS

DO NOT CONNECT TO ELECTRICAL SUPPLY UNTIL ASSEMBLY IS COMPLETED

1 Place chassis on level surface and ensure wing nut is loosened.2 Lower base of filtration unit into the clamp ring positioning wing nut central about the power supply.3 Tighten wing nut.4 Fit appropriately fused plug to mains input supply lead. This plug is not supplied by Medezine Ltd.5 To fit blade see page 8.

When only a Saw Unit and Power Supply have been purchased commence assemblyinstructions at (4)

SAFETY AND WARNINGS

1 This equipment must be earthed before use.2 Trained personnel must only use this product.3 Please read all the instructions before use.4 Check all equipment before use.5 Use the appropriate safety equipment.6 Do not immerse the Power Supply and Vacuum unit in liquid.7 Use good quality disinfectants as approved by the Hospital Infection Control.8 Do not use corrosive cleaning materials or Hypochlorite as these will damage the units.9 Do not leave the Hand Piece soaking in cleaner for prolonged periods of time as will cause an ingress of fluid.

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GENERAL DESCRIPTION

The Medezine 5000 Oscillating Saw with Vacuum Filtration has been developed to help minimize the risk of cross infection in sensitive areas, providing it is used in accordance with the manufacturer’s instructions.

The complete system comprises three basic units.

THE SAW UNIT

This unit is fed from the power supply. It is hermetically sealed allowing disinfection and appropriate sterilization without dismantling. The enclosed motor cannot become contami-nated , consequently there is no hazardous aerosol effect. All external materials used in its construction are non corrosive.

THE FILTRATION UNIT

This unit is fed from the power supply. It gives highly efficient three stage filtration by way of a paper filter, cloth filter and highly efficient cartridge filter (Hepa filter) respectively. It is quite capable of filtering dry and partially damp material but must never be used to extract liquids. This unit is not watertight and not designed for liquid extraction.

THE POWER SUPPLY

This unit is fed from the mains supply and in turn delivers the appropriate electrical cur-rents to the saw unit and the vacuum filtration unit. The complete system is activated by the momentary switch on the saw unit. An intelligent current limiting device (which resets itself automatically) is incorporated in the power supply to prevent overload usage of the saw unit. This unit is watertight.

User preference may require the equipment to be supplied in its basic form which comprises the saw unit and power supply only. A filtration unit may be easily added by the customer at a later stage.

The complete Medezine 5000 system is capable of handling health endangering dusts, making it suitable for use in hospitals and industrial environments where the collection and disposal of such debris is subject to stringent control.

This equipment is not suitable for use in an environment where an explosion risk is present.

The equipment should only be moved by using the handle provided and never by pulling on the saw unit or mains lead.

SEQUENCE OF OPERATION

Warning: This equipment is designed for use by properly trained personnel only.Medezine Ltd accepts no liability whatsoever for inappropriate or untrained usage.

1 Plug equipment into appropriate mains supply. Check ‘mains on’ indicator on power supply is lit.2 Remove the saw unit from ‘park’ position and depress and release the on/off button. The complete system will then start.3 Depress and release the on/off button once again and the system will then stop.4 Return the saw unit to the ‘park’ position.5 Always disconnect the equipment from the mains supply when not in use.

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Supply Lead Mains Input

Saw Unit

ON/OFF ButtonFull System

Supply LeadSaw Unit

VacuumHose

Hose/FiltrationUnit Connector

Filtration UnitTop Cover

Hose/CowlingConnector

ToggleClamp

VacuumCowelling

FiltrationUnit

Filtration UnitChassis

Supply LeadFiltration Unit Filtration Unit Clamp Ring

Handle

Autopsy Saw




93/42/EECIEC/EN 60601-1EMC 2004/108/EC



Cable Clip

Power Supply Enclosure

Status Indicatorlights

MEDEZINE 5000 Autpsy Saw

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ISOLATE FROM ELECTRICAL SUPPLY BEFORE REMOVING COVER

The two mains supply fuses are located on the underside of the board in the position shown.

The third fuse is an anti surge fuse. Fuse type and ratings are marked adjacent to the fuse holders or alternatively see page 14. Undo the four captive retaining screws to remove the cover. Prior to replacement ensure that the rubber seal set into the underside cover has not been disturbed.

Retighten cover fully ensuring that the cover is seated properly.

Status IndicatorFiltration Unit Outputenergized when lit.

Captive Retaining ScrewsEnclosure Cover

Status IndicatorSaw Unit Outputenergized when lit.

Status IndicatorMains Supplyenergized when lit.

Status IndicatorSaw Unit overload detectedwhen flashing. Complete system will shut down. ThenAuto-reset to “System off”status in approx. 20 seconds.

Waterproof ElectricalConnectorsScrew Locking-NonInterchangeable

Waterproof ElectricalConnectorScrew Locking-NonInterchangeable

Autopsy Saw




93/42/EECIEC/EN 60601-1EMC 2004/108/EC



MEDEZINE 5000 POWER SUPPY

FUSE REPLACEMENT

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Blade Clamp Retaining Screw

Spring Washer

Blade Clamp

Square Drive

Saw Unit Body

On/Off (I/O)Momentary Button

Watertight Grommet

Saw Unit Suppy Cable

MEDEZINE 5000 SAW UNIT

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FITTING OF ACCESSORIES AND DETACHABLE PARTS

BLADE REPLACEMENT

1 Pull vacuum hose complete with hose/cowelling connector from the vacuum cowelling.2 Pull vacuum cowelling from saw unit body.3 Unscrew blade clamp retaining screw with nutwrench provided and remove retaining screw, spring washer and blade clamp.4 Replace or index blade as required, ensuring it is seated properly on the square drive shaft. If not, discard, or resulting damage or inefficiency of the saw could result.5 Refit blade clamp, spring washer and retaining screw. Note ! It is imperative the spring washer is in place or the blade may loosen whilst in use.6 Firmly retighten clamp retaining screw with nutwrench provided. Note ! use of the nutwrench alone will clamp the blade sufficiently, additional leverage is not necessary as this could result in damage to the internal mechanism.7 Refit vacuum cowelling. This will pass over a 64mm blade if compressed to an oval shape and fitted as shown.

8 Refit hose/cowelling connector, complete with hose, to cowelling.

HOSE REPLACEMENT.

1 Remove hose/cowelling connector from cowelling. Remove connector from vacuum hose by pulling and screwing (clockwise) simultaneously. Remove vacuum hosing from hose/filtration unit connector similarly.2 Refit vacuum hosing to hose/cowelling connector by pushing and screwing (clockwise) simultaneously until fully engaged. Refit vacuum hosing to hose/filtration unit connector similarly.3 Refit hose/cowelling connector, complete with hose, to vacuum cowelling.

PAPER FILTER REPLACEMENT USING NEGATIVE PRESSURE FEATURE.

1 Ensure saw unit is in its cradle. (park position).2 Switch system on from the saw unit.3 While the system is running, release the two toggle clamps and remove the top cover.4 The paper filter and support flange can now be removed without loss of contents. Note ! The cloth filter is not removed.5 The paper filter can now be sealed and disposed of in the appropriate manner. Please refer to your Safety Officer.6 Switch system off from the saw unit.7 Insert new paper filter ensuring it is ‘expanded’ to fill the cloth filter. ‘Neck’ the top of the paper filter so that the support flange may be fitted over the ‘necked’ portion. Fan out edge of paper filter over the support flange. Ensure that entry to the paper filter is not restricted.8 Refit top cover and reaffix toggle clamps.

REPLACEMENT OF CLOTH FILTER AND HIGH EFFICIENCY CARTRIDGE FILTER WILL BE FOUND IN PREVENTIVE MAINTENANCE SECTION PAGE 9.

Normal Fitting

h h

hh

Compressed

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PREVENTIVE MAINTENANCE AND INSPECTION

THE EQUIPMENT SHOULD BE DISCONNECTED FROM THE ELECTRICAL SUPPLYWHILE THE FOLLOWING TASKS ARE BEING PERFORMED.

THE SAW UNIT

DailyClean thoroughly with recommended disinfectant using soft nylon brush, not wire or hard bristle type. Rinse down and dry thoroughly.

WeeklyLubricate retaining screw, blade clamp and square drive with light engineering or silicone based grease. Graphite based grease is not recommended. Inspect equipment for signs of damage.

AnnuallyFull service of Saw Unit is strongly recommended. Note! To retain warranty cover and any further warranty issued against the saw unit, it can only be serviced or repaired by Medezine Ltd. or their appointed agent. Any attempt to do so, by any other party, will invalidate the warranty.

THE FILTRATION UNIT

The filter elements must be renewed periodically, as filtration efficiency is grossly impaired if they become heavily contaminated. Your Safety Officer will advise the correct procedure for disposal of the collected particles and redundant filter elements. Environmental considerations must also be observed when deciding their frequency but the following intervals should be regarded as a minimum requirement.

A filter service record has been provided on page 15 to assist in monitoring this procedure and to provide documented evidence when required.

DailyChange paper filter - See fitting of accessories page 8.

WeeklyClean thoroughly with recommended disinfectant using soft damp cloth. Dry thoroughly. Inspect vacuum hood, hose. hose connections and cloth filter for any clogging or signs of damage. Clean or replace if necessary. Note! The cloth filter should never be washed. Remove any snagged fibres, cottons or foreign matter from the chassis castors.

Six monthsReplace cloth filter and micron filter. 1) Release two toggle clamps and remove top cover.2) Remove paper filter and support flange.3) Remove cloth filter and discard.4) Unscrew retaining nut and washer then remove micron filter and discard.5) Refit micron filter with rubber seal facing downwards re-tighten nut and washer.6) Refit new cloth filter.7) Refit new paper filter and support flange.8) Refit top cover and re-affix toggle clamps.

THE POWER SUPPLYWeeklyClean thoroughly with recommended disinfectant using soft damp cloth. Dry thoroughly and inspect for damage and ill fitting connections

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TROUBLESHOOTING

The information contained in this section covers common problems and suggests solutions. If your system’s problem is not covered here, or you still need help, please contact the agent/manufacturer. See page 19.

Note. Disconnect equipment from the mains electrical supply before attempting to implement any solutions of an electrical nature

Possible Cause

System does not start. Mains supply indicatornot lit.

Note. The following solutions mustonly be carried out by a quali�ed electrician.Check mains plug fuse.Check power supply fuses. See page6 to access.Check all electrical connectors aremated correctly.

Bad connection.

SolutionSymptom

Fuse blown.

Fuses blow repeatedly.Incorrect supply voltage.

Note. The following solutions mustonly be carried out by a quali�ed electrician.Check equipment rated voltage is compatible with the electrical supply.

Disconnect �ltration unit connector from the power supply. If fuses do notblow when saw unit is switched on then the �ltration unit is defective.

Filtration unit has been usedto extract liquids.

System shuts downrepeatedly.

Overload indicator is on.Distorted blade. Discard immediately.

Blunt blade. Index blade so new portion comes incontact with the workplace.

Incorrect �tted blade. Check blade is �tted in accordancewith the manufacturer’s instructions.See page 8.

See cutting hints, page 12.

System shuts down.Overload indicator is on. Wait until yellow overload indicator is

o� (approx 20 seconds) and retry.

Check connections for the saw unitand �ltration unit are engaged correctly with the power supply.

Faulty connection.

Filtration unit statusindicator lit but notrunning although saw unit does.

Faulty connection. Check the power supply connection is properly engaged.

Defective motor. Contact manufacturer.

Excessive pressure onworkpiece.

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TROUBLESHOOTING- continued

Possible Cause

Saw unit status indicator lit but not running although �ltration unit does.

Check the power supply connectionis properly engaged.Contact manufacturer.Defective motor.

SolutionSymptom

Faulty connection.

Excessive noise fromsaw unit. Distorted blade.

Badly �tting or loose blade.

Filtration unit runsbut does not extracte�ciently.

Vacuum hose is kinkedblocked or disconnected. Repair or replace hosing. For �tting

see page 8.

Filter elements notassembled correctly.

Ensure cloth �lter is seated correctly.Ensure paper �lter and support �angeare �tted and seated correctly.

Ensure top cover is seated correctly and toggle clamps are properly engaged.

Filtration unit doesnot extract. Filtration unit not running. Check the power supply connection

is properly engaged and the �ltrationunit indicator is lit whenthe saw unit is running.

Renew blade.

Check blade is �tted in accordancewith the manufacturers instructions.See page 8.

Contact manufacturer.

Renew paper �lter, see page 8.

Renew paper �lter and checkcloth �lter for contamination.

Renew cloth �lter, see page 9.

Renew cloth �lter and check micron�lter for choking.

Renew micron �lter, see page 9.

Paper �lter is full.

Paper �lter is split.

Cloth �lter is choked.

Cloth �lter is split.

Micron �lter is chocked.

Bearing service required.

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CUTTING HINTS

The Medezine 5000 oscillating saw has been designed and constructed to provide effortless and highly efficient cutting in its appropriate areas of usage. We suggest a trial cutting period applying the least pressure possible to the workpiece until fully accustomed with the efficiency. Excessive pressure is not required as this will reduce the speed of cut.

If you experience difficulty then consult the Troubleshooting Causes and Solutions on pages 10 and 11.Suitable safety protection must be worn at all times during cutting.

DISINFECTION AND STERILIZATION

The saw unit only is capable of withstanding temperatures between - 20 degrees C to +70 degrees C. This must be born in mind when considering a disinfection or sterilization method.

Autoclaving of this equipment is not recommended.

Only use cleaning agents that are safe for use on metals. We do not recommend the use of Hydrochloride or corrosive cleaners as possible corrosion could result.

We advise gentle scrubbing with a soft non metallic brush, rinsing with clean water and drying where necessary. Do not direct high pressure water jets at any part of the equipment, this could invalidate the warranty.

All cleaning agents should be mixed, stored and applied according to the manufacturers instructions.

Note. Normal safety precautions should be observed when mixing or applying any cleaning agents, such as the wearing of suitable eye protection, protective clothing and gloves. Always refer to the manufacturer’s recommendations.

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ACCESSORIES AND DETACHABLE PARTS

MSYS 4000 Medezine 5000 Complete with Filtration System Each

MSYSPORT Medezine 5000 Power Supply and Hand Piece Portable Unit Each

MHPC 4000 Medezine 5000 Hand Piece Only Each

MPS 4000 Medezine 5000 Power Supply Only Each

MFIL 4000 Medezine 5000 Filtration Unit Only Each

MBC 64M Saw Blade Circular 64mm Autopsy Pack 10

MBC 64P Saw Blade Circular 64mm Plaster Pack 10

MBC 76 Saw Blade Circular 76mm Autopsy Pack 10

MBS 51 Saw Blade Segmented 51mm Pack 10

MVH Medezine 5000 Vacuum Hoods Pack 10

MVP Medezine 5000 Vacuum Pipe 1.6m Each

MPF50 Vacuum Unit Paper Filter Pack 50

MCF Vacuum Unit Cloth Filter Each

MMF Vacuum Unit Micron Filter Each

MVPEX Vacuum Hose Extension 4.0 metres long Each

MEL Saw Unit Extension Lead used with above Each

MVP40 Vacuum Extension Kit - both above parts Each

MKITSQ Blade Clamp Kit Each

MKITSERV Medezine 5000 Service Kit Each

MKITCONT Medezine 5000 Filter Service Annual Each

MML Medezine 5000 Mains Supply Lead Each

MCONFU Hose Connector – Vacuum Hose to Filtration Unit Each

MCONVU Hose Connector – Vacuum Hose to Vacuum Hood at Hand Piece Each

MHPCEX Medezine 5000 Service Exchange Hand Piece Each

Order Code Description Quanitity

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MEDEZINE 5000 SCHEMATIC WIRING

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FILTER SERVICE RECORD

This page is provided to document your filter service history to meet the requirements of the C.O.S.H.H. legislation. Although the complete filter service kit (MKITSERV) includes Vacuum Cowellings (MVH) and Paper Filters (MPF50), provision for these are not included in the service record as they are regarded more consistent with the day to day servicing of the equipment.

Vaccum Pipe MVP replaced

Cloth Filter MCF replaced

Micron Filter MMF replaced

Signed

Date of Service 1




Signed

Date of Service 2




Signed

Date of Service 3




Signed

Date of Service 4




Signed

Date of Service 5




Signed

Date of Service 6




Signed

Date of Service 7




Signed

Date of Service 8




Signed

Date of Service 9




Signed

Date of Service 10

15

CONDITIONS OF WARRANTY

Should the equipment covered by this warranty become inoperative because of defective material(s) or workmanship, Medezine Limited undertake at their own discretion to repair or replace it at no charge to the purchaser, subject to the following conditions :-

1 That the equipment has been used with care and shows no sign of abuse, neglect or accidental damage.2 That the equipment has only been used for the purpose(s) for which it was designed.3 That the preventive maintenance has been performed in accordance with the manufacturer’s instructions.4 That no attempt to repair or dismantle any part of the equipment has been made, except by a Medezine representative or an appointed agent of Medezine Limited.5 That any claim for repair or replacement be made within one calendar month of the problem arising.6 The conditions of this warranty remain in force for a period of twelve months from the date of purchase.7 This warranty does not affect your statutory rights.

The policy of Medezine Limited is one of continuous product development, and ensuring our customers the best possible service. To achieve this, specifications and details may be subject to change without prior notice.

Equipment owners outside the United Kingdom should consult the distributor/agent from whom they purchased the equipment regarding spare parts and repair facilities. The distributor/agent will advise on the best course of action to take.

CERTIFICATE OF ELECTRICAL TEST

The following tests have been performed with a Megger PAT 2 portable appliance tester and apply only to the combination of equipment whose serial numbers are identified as being supplied against this warranty.

Earth bond test 6V a.c.r.m.s. pass max. 1ohmInsulation test 500V dc. pass max. 2 MohmFlash test 1.5 kV a.c.r.m.s. (class 1) pass max. 3mALoad test 6V pass max. / green zone / appliance testerOperation test Normal running. pass max. 1kVA

EQUIPMENT RATINGS

Equipment Serial No. Supply Voltage Auxiliary Socket Output

5000 Power Supply V-50/60HZ 75VA V-50/60HZ 750 W

5000 Saw Unit 40V Not Applicable

5000 Filtration Unit V-50/60HZ 750 W Not Applicable

Tested by Dated

Purchased by Dated

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TECHNICAL INFORMATION

Power Supply

Transformer manufactured to IEC – EN60742Output – Saw 40 VDCEnclosure –to IEC529, DIN40050Protected to IP65Protection- Electronic Current LimitingDevice Double Pole FusedConstructed –to IEC60601-1Weight 1.7kgInput voltage – 230Vac or 110 VacCable 4.0m fitted

Vacuum Unit

Motor – Rated 750 WattContainer Capacity – 7.0 litreAir Volume Open (max) – 90 litres/secMax Vac Closed – 1650mm WGFiltration-99.997% at 0.6 micron Dimensions – Height 940mm including handle Width 530mm Chassis Base Weight 11.5kgAudio Output – 66Db at 1 metre

Hand Piece

Motor –DC Permanent magnetSpeed –no load 13200 cycles per minCurrent – no load 40Vdc 0.75ampTypical load 1.5 ampsConstruction – Anodised Aluminium body with 5 bearing sealed mechanismProtected to – IP67Audio Output – 37 dB (A) no bladeVibration Value – 4.12 m/s²Weight – 1.3kg

Technical Requirements

93/42/EECIEC/EN 60601-1EMC 2004/108/EC

Issue1 - 1.5.2011

instructions for your safety - medezine · 2017-01-19 · standard for medical electrical equipment...

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