CSP-201, BP-201, PS-201 and IC-201 Operating Instructions Ver 1.3

DE SOUTTER MEDICAL CSP-201-A CAST SAW SYSTEM Index SECTION 1: IMPORTANT SAFETY INSTRUCTIONS General Safety Guidelines Environmental Conditions for Use Recommended Duty Cycle

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SECTION 2: GENERAL INSTRUCTIONS Product Description Cast Saw Handpiece CSP-201 Battery Pack BP-201 Power Supply PS-201 Interconnector IC-201 Maintenance and Cleaning Cleaning

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SECTION 3: SYSTEM ASSEMBLY & OPERATION Setting Up the Power Supply Charging the Battery Pack Battery Care Guidance Battery Pack Disposal Saw Blade Assembly Saw Blade Removal Cutting Technique Power Supply Connection to Battery Pack Saw Handpiece Connection to Battery Pack Saw Handpiece Connection to Interconnector Power Supply Connection to Interconnector Saw Handpiece Controls Battery Pack Controls - BP-201 Saw Handpiece not Connected Saw Handpiece Connected and Running Saw Handpiece Connected and not Running

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SECTION 4: TECHNICAL INFORMATION Product and Supplied Accessory Part Number Details Optional Accessories Technical Description Explanation of Symbols Explanation of Display Symbols Returns and Transportation Service Information Repair Information Guarantee & Liability

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SECTION 1: IMPORTANT SAFETY INSTRUCTIONS •

SAVE THESE INSTRUCTIONS - This manual contains important safety and operating instructions for the paediatric cast saw CSP-201, battery pack BP201, power supply PS-201 and interconnector IC-201.

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Do not attempt to use the equipment until all the instructions and cautionary markings on the cast saw, battery pack, power supply and interconnector, have been studied and understood.

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Failure to follow these instructions may result in serious injury to the patient or operating staff.

General Safety Guidelines DANGER!: Possible explosion hazard if used in the presence of flammable anaesthetics. WARNING: Do not insert metal objects into the battery pack receptacles WARNING: Do not charge battery packs BP-201 with other power supplies. WARNING: Do not sterilise the equipment. WARNING: Do not immerse the equipment. WARNING: Do not expose the equipment to rain or use near water. WARNING: Ensure that battery pack is at room temperature before charging. WARNING: Do not attempt to dismantle or remove any parts of the equipment. WARNING: The charger has been tested for electro-magnetic compatibility. If interference occurs, move components further apart and connect charger to a separate outlet. WARNING: Do not attempt to charge any other battery other than the battery pack BP-201 with the power supply PS-201. WARNING: The battery pack contains lithium ion batteries, the battery pack should not be disassembled, crushed, exposed to excessive heat, or incinerated. Never permit untrained personnel to use this instrument. Never drop the instrument or its accessories; always handle with extreme care. Always check that the voltage stated on the power supply identification plate corresponds with the electrical supply. Always inspect all equipment and accessories before use. Always disconnect the power supply from the electrical supply when cleaning or when not in use. Always disconnect the cast saw CSP-201 from the battery pack BP-201 when changing accessories or when not in use. Always use eye protection when cutting to prevent injury from flying debris. Always use De Soutter Medical approved accessories. Do not allow loose articles to be caught by the moving parts of the instrument. Do not use suspect, damaged or worn equipment. Only clean the equipment as directed in these Operating Instructions. Only use sharp cutting accessories

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Follow local recommendations for the avoidance of possible hand-arm vibration damage. The CSP-201 cast saw can produce a HAV weighted vibration level of approximately 6.2ms-2 when the used with the supplied blade (part No. 15310). The HAV weighted vibration level will reduce if a smaller blade is used. Environmental Conditions for Use Temperature:

0ºC to +30ºC

Relative Humidity:

70% maximum.

Recommended Duty Cycle In order to reduce the risk of excessive and undesirable temperature rise of the handpiece it is recommended that the following duty cycle is applied. A usage/cooling ratio of 2 to 3 is recommended with a maximum continuous cutting time of 10 minutes. (i.e. if the tool is used for 2 minutes it should be allowed to rest for at least 3 minutes, if it is used for 6 minutes it should be allowed to rest for at least 9 minutes).

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SECTION 2: GENERAL INSTRUCTIONS Product Description The paediatric cast saw systems are designed for the safe removal of surgical casts. The saw is powered by a rechargeable lithium ion battery pack, and is supplied with one battery, interconnector, power supply and carry case. The power supply can also be used to power the saw directly. Cast Saw System Components Cast Saw Handpiece CSP-201 The cast saw CSP-201 can either be powered by the battery pack or the power supply using the interconnector. Battery Pack BP-201 The battery pack BP-201 provides approximately 2 hours of continuous cutting. Charging time is approximately 3 hours. The display provides user feedback on the residual charge remaining, charging status, battery status and service warnings. The battery pack also has the added functionality: •

Speed control – controls the cutting speed of the saw

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Soft start – gently increases the cutting speed, helping to reduce patient anxiety when the saw first starts

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Noise control – reduces cutting speed when the saw is not in contact with the cast surface, therefore reducing patient anxiety

The system user settings are stored within the saw handpiece, all functionality remains whether the saw is connected to battery pack or running off the power supply. Battery Service Warning – The service warning indicates that approximately 300 complete charging cycles have been completed. It is recommended that the battery pack BP-201 is serviced. Please see section on Returns and Transportation. Power Supply PS-201 The power supply PS-201 is used to charge the battery pack or power the cast saw. Interconnector IC-201 The interconnector IC-201 enables the cast saw to be powered directly from the mains via the power supply using the PS-201.

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Maintenance and Cleaning The system should be visually checked at each use for each of the following: •

Excessive build up of plaster dust/debris

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Blade wear

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Tightness of the blade retainer

Never use any equipment you suspect to be damaged. Cleaning Use suitable disinfecting and cleaning materials as per local decontamination guidelines.

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SECTION 3: SYSTEM ASSEMBLY & OPERATION Setting Up the Power Supply Plug the appropriate mains cordset into the power supply receptacle prior to connecting the battery pack BP-201 or cast saw CSP-201. Charging the Battery Pack Charging can take up to 3 hours depending on the amount of residual charge left in the battery pack. The charging status is summarised in the table below: Status

BP-201 (Display)

Pre-charge

Battery empty icon

Charging

Battery scrolling icon

Complete

Battery full icon

Error

Warning sign icon

Power supply not turned on correctly

No display

When the battery is fully charged and ready for use (shown by either a permanent ) disconnect the power supply connector from the green light or a battery full icon battery pack. Battery pack may get warm during charging and discharging. Battery Care Guidance The performance and life of the battery packs can be considerably enhanced by the following measures: •

Wait for low battery indicator before charging

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Do not leave the power supply connected to the battery when the power supply is switched off

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Do not leave battery pack uncharged for long periods of time

Battery Pack Disposal The battery pack contains Lithium Ion batteries that may be harmful and must be disposed of responsibly and safely. Dispose of them in an environmentally friendly manner, either by returning them to your local De Soutter Medical representative or in compliance with national regulations.

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Saw Blade Assembly • • • •

Ensure the cast saw is turned off Remove the clamp nut using the wrench provided Attach the blade of choice to the cast saw output shaft Refit the clamp nut and tighten using the wrench provided

Saw Blade Removal • • •

Ensure the cast saw is turned off Remove the clamp nut using the wrench provided Remove blade

Always check the condition of the blade before use Cutting Technique Before use, the operator should handle the saw and determine the most convenient grip position. Do not exert excessive working pressure - allow the blade to cut at its own rate. Excessive pressure will overload the motor, without increasing cutting efficiency, and will reduce the output capacity of the battery. CAUTION: Excessive cutting pressure will also cause the blade to overheat which may result in injury to the patient. Likewise badly worn blades will generate excessive heat therefore the blades should be inspected and replaced regularly. A new blade will reduce vibration and the temperature of the blade when cutting. Make the first cut both downwards and slightly sideways, at approximately 30 degrees in order to keep one side of the blade out of contact with the cast. This will allow the operator a greater feedback when the blade eventually breaks through. After the first cut, all cuts should be made straight down into the cast. The cutter should be lifted slightly and moved sideways; the second cut can then be taken straight down, the operator feeling the break through quite easily. Cutting can then proceed in a series of downward cuts, lifting and moving sideways progressively. The blade may touch soft mobile tissue momentarily without harm under a light pressure. However it should never be permitted to be in contact with skin for any length of time

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Power Supply Connection to Battery Pack Attach the appropriate mains cordset into the receptacle on the power supply. To attach power supply: •

Align the key and red dot on the connector with the key on the socket (Fig.1)

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Push firmly until a click is heard

To remove the power supply: •

Grip the connector firmly on the cross-patterned area and pull out (Fig.1)

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Do not attempt to remove the connector by pulling on the cable

Saw Handpiece Connection to Battery Pack To attach saw handpiece: •

Align the key and red dot on the connector with the key on the socket (Fig.1)

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Push firmly until a click is heard

To remove the saw handpiece: •

Grip the connector firmly on the cross-patterned area and pull out (Fig.1)

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Do not attempt to remove the connector by pulling on the cable

Battery socket

Align

Handpiece connector Figure 1

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Saw Handpiece Connection to Interconnector To attach saw handpiece: •

Align the key and red dot on the connector with the key on the socket (Fig.2)

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Push firmly until a click is heard

To remove the saw handpiece: •

Grip the connector firmly on the cross-patterned area and pull out (Fig.2)

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Do not attempt to remove the connector by pulling on the cable Align Interconnector socket

Handpiece connector Figure 2

Power Supply Connection to Interconnector To attach power supply: •

Align the key and red dot on the connector with the key on the socket (Fig.3)

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Push firmly until a click is heard

To remove the power supply: •

Grip the connector firmly on the cross-patterned area and pull out (Fig.3)

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Do not attempt to remove the connector by pulling on the cable Align Interconnector socket

Power supply connector Figure 3

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Saw Handpiece Controls To turn the saw on/off is the same whether the saw handpiece is powered from the mains or the battery pack: To turn saw on: •

Press the button (SB1) once on the back off the handpiece (Fig. 4)

To turn the saw off: •

Press the button (SB1) once on the back of the handpiece (Fig. 4)

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Or press and hold the central button (BB2) on the top of the battery pack (BP-201 only) (Fig.6)

Button (SB1)

Figure 4

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Battery Pack Controls - BP-201 Saw Handpiece not Connected The following section is relevant for when the saw handpiece is not connected to the battery pack (BP-201 only):

Display

Button (BB1)

Button (BB2)

Button (BB3)

Figure 5

To turn battery pack on: •

Press the central button (BB2) once on the top of the battery pack (Fig.6)

To turn battery pack off: •

Press and hold the central button (BB2) on the top of the battery pack until display turns off (Fig.6)

To turn display backlight on: •

Press any button (BB1-3). The backlight will automatically dim if none of the buttons are pressed for a certain period of time. This is to help preserve the battery charge.

Note: The display backlight must be illuminated before any of the following selections are available. To view battery status: •

Press the central button (BB2) on the top of the battery pack. Battery status is indicated as a percentage of the total battery power remaining (Fig.6)

To view service status: •

Press the central button (BB2) on the top of the battery pack. The service status is indicated as either a tick or a cross, indicating that servicing is required immediately or no service is required respectively (Fig.6) 14

Saw Handpiece Connected and Running The following section is relevant for when the saw handpiece is running and connected to the battery pack (BP-201 only): To adjust the saw speed: •

In the default screen, press either the left-hand (BB1) or the right-hand (BB3) button to either decrease or increase cutting speed respectively (Fig.6)

•

Or press the central button (BB2) on the top of the battery pack, followed by the right-hand button (BB3) until ‘Speed control’ is highlighted and then press the central button (BB2) or the right-hand button (BB3) to decrease and increase the speed respectively (Fig.6)

To operate noise control: •

Press the central button (BB2) on the top of the battery pack, followed by the right-hand button (BB3) until ‘Noise control’ is highlighted and then press the central button (BB2) to either turn the function on or off (Fig.6)

To operate soft start: •

Press the central button (BB2) on the top of the battery pack, followed by the right-hand button (BB3) until ‘Soft start’ is highlighted and then press the central button (BB2) to either turn the function on or off (Fig.6)

To view battery status: •

The symbol on the left-hand side of the default screen provides a graphic indication of the battery power remaining

Saw Handpiece Connected and not Running The following section is relevant to when the saw handpiece is not running but is connected to the battery pack (BP-201 only): To adjust the saw speed: •

Press the right-hand button (BB3) on the top of the battery pack until ‘Speed control’ is highlighted and then press the central button (BB2) or the right-hand button (BB3) to adjust the speed accordingly (Fig.6)

To operate noise control: •

Press the right-hand button (BB3) on the top of the battery pack until ‘Noise control’ is highlighted and then press the central button (BB2) to either turn the function on or off (Fig.6)

To operate soft start:

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Press the right-hand button (BB3) on the top of the battery pack until ‘Soft start’ is highlighted and then press the central button (BB2) to either turn the function on or off (Fig.6)

To view battery status: •

Press the left-hand button (BB1) on the top of the battery pack until none of the functions are selected. Press the central button (BB2) once. Battery status is indicated as a percentage of the total battery power remaining (Fig.6)

To view service status: •

Press the left-hand button (BB1) on the top of the battery pack until none of the functions are selected. Press the central button (BB2) once. The service status is indicated as either a tick or a cross, requiring immediate service or no service required respectively (Fig.6)

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SECTION 4: TECHNICAL INFORMATION Product and Supplied Accessory Part Number Details Description Part No. CSP-201-A Cast Saw System... 1286984 Comprising: CSP-201 Cast Saw ... 1286994 BP-201 Battery Pack... 15250 PS-201 Power Supply ... 15280 IC-201 Interconnector ... 15270 Small Blade ... 15310 Large Blade ... 15320 Wrench ... 15300 Carry Case ... 15290

Mains Power Cordsets Description Part No. UK Cordset ... 15610 Euro Cordset ... 15620 US/ Canada Cordset ... 15630 Australia/ New Zealand Cordset ... 15640 Japan Cordset... 15650 Swiss Cordset ... 15660 Optional Accessories Description Part No. Small Blade (23mm) ... 15310 Large Blade (25mm) ... 15320

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Technical Description CSP-201 - Cast Saw Oscillating speed

17,500 cpm

Supply voltage

24 Vdc

Type of protection against electric shock: -

connected to BP-201 battery pack

Internally powered

-

connected to PS-201 power supply

Class 2

Degree of protection against harmful ingress of liquids

IPX0 – Ordinary

Mode of operation

Non-continuous (See recommended duty cycle)

BP-201 - Battery Pack Voltage

24 Vdc

Cell type

Lithium Ion

Capacity

2200mAh

Watt-hour rating

31.7wH

PS-201 – Power Supply Supply voltage

100-240V~

Supply frequency

50-60Hz

Type of protection against electric shock

Class 2 – Double insulated

Degree of protection against harmful ingress of liquids

IP40

Mode of operation

Continuous

Input current consumption

1.1A

Supply Connection

C8 Inlet

Supply cordset (UK) Plug fuse

3A (UK only)

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Fault Finding Fault:

Possible Cause:

Remedy:

Power supply not connected to mains

Check power supply connected to mains and switched on

Fuse blown

Replace power supply

Battery pack charging light does not flash when battery pack is connected to battery charger

Faulty battery pack or battery pack excessively discharged

Replace battery pack

Battery pack not holding its charge

Faulty battery pack

Replace battery pack

Battery pack becomes unusually hot during charging

Faulty battery pack

Replace battery pack

Cast saw cuts out

Battery pack over temperature fuse tripped

Disconnect battery from cast saw and allow to cool

Blade is blunt

Replace the blade

Faulty battery

Replace the battery

Flat battery

Charge the battery

Battery sign flashing

Battery flat

Charge battery pack

Warning sign displayed

Battery too hot

Allow the battery to cool for 30 minutes and retry

Service sign displayed

System requires service

Return system for service

Power supply indicator light does not illuminate

Saw cuts slowly

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Refer also to battery charger indicator light chart on page 9

Explanation of Symbols

Li-Ion

Refer to the Operating Instruction Manual

Do Not Immerse

Class 2 type of protection against electric shock Double Insulated

Alternating Current

~

This tool contains LithiumIon batteries that should be disposed of in an environmentally friendly manner and in compliance with local regulations

Power On/Off

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Direct Current

SN 12/00500

Serial number First two digits indicate year of manufacture

Explanation of Display Symbols

System requires service

Flashing battery indicates low battery power

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Battery too hot

Returns and Transportation The battery pack should not be returned or transported if there are any signs of damage, if in doubt please seek guidance from your local De Soutter Medical representative. When returning a battery pack the lithium battery handling label must be attached to the outer packaging, this can be found on our website at www.desoutter.com. Please see Disposal Section for more information on the disposal of damaged battery packs.

Conditions for Transport & Storage Temperature: -20ºC to +40ºC Relative Humidity: 70% maximum Atmospheric Pressure: 1.5 atmospheres maximum 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. Repair Information For service and repair please contact your De Soutter Medical Authorised Service Centre. To return an instrument for repair: • Disinfect the equipment in accordance with the reprocessing instructions • 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 Warning: All items returned for repair must be accompanied by a declaration of contamination status. 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 Non sterile consumables are guaranteed for their normal expected working life. New battery packs are guaranteed for a period of six months from date of invoice.

This guarantee does not affect your Statutory Rights in accordance with 1999/44/EC. 21