User Manual
28 Pages
Preview
Page 1
International English User Manual CSP-201
Paediatric Cast Saw Manufactured for De Soutter Medical by Zethon Ltd HP22 5WF
Contents 1
Important Information... 1
2
Safety Instructions... 1 Intended Use... 2 Disposal... 2 Symbols... 3
3
General Symbols... 3 User Interface Symbols... 4 Reprocessing - Non-sterilisable Equipment... 5
4
Limitations on reprocessing... 5 Safety Instructions... 5 Manual Cleaning... 5 Overview... 6
5
Handpiece... 6 Battery Pack... 7 Interconnector... 8 Configuring a Battery Pack... 9
6
Switching on the Battery Pack... 9 Viewing the Battery Level and Service Status... 9 Battery Pack Charging Status... 9 Configuring a Handpiece... 10
7
Fitting a Handpiece or Power Supply to the Battery Pack... 10 Fitting the Handpiece to the Interconnector... 11 Fitting the Power Supply to the Interconnector... 12 Setting the Speed... 13 Activating and Deactivating Noise Control... 13 Activating and Deactivating Soft Start Mode... 13 Using Accessories... 14
8
Fitting and Removing a Blade... 14 Cutting Technique... 15
9
Technical and Ordering Information... 16
10
Cast Saw Specifications... 16 Battery Pack Specifications... 16 Power Supply Specifications... 16 Accessories... 17 Troubleshooting... 18
11
Further Help... 18 Service and Repair Information... 19 Guarantee and Liability... 19 EMC Guidance... 20
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 General 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: this equipment is not intended for use in an oxygen rich environment or in the presence
of flammable gases CAUTION: ensure this equipment is regularly serviced. Refer to the service and repair information section of this user manual. CAUTION: only reprocess this equipment as directed in this user manual CAUTION: only use Stericut or De Soutter Medical approved accessories CAUTION: this equipment is not suitable for cutting adult casts CAUTION: only use sharp cutting accessories WARNING: do not attempt to dismantle or modify this equipment, except as directed in this user
manual WARNING: do not insert metal objects into the battery pack CAUTION: ensure the battery pack is at room temperature before charging CAUTION: ensure the cast saw is disconnected from the battery pack and power supply when
changing accessories or when not in use CAUTION: this equipment must only be used in accordance with the EMC guidelines described in
this user manual. Use of accessories other than those approved by De Soutter Medical may result in increased interference or emissions. 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 CAUTION: do not sterilise this equipment CAUTION: do not immerse any part of this equipment in fluids WARNING: ensure the equipment is disconnected from all power sources before cleaning
1
Intended Use The equipment described in this user manual is designed for the safe removal of paediatric orthopaedic casts.
Disposal WARNING: do not dispose of batteries by throwing them into a fire or immersing them in water WARNING: lithium batteries are subject to transportation restrictions WARNING: faulty or suspect lithium batteries must not be returned by air transport. They should be
recycled or disposed of in accordance with local regulations. All equipment should be recycled or disposed of, in accordance with local regulations.
2
Symbols General Symbols Symbol
Meaning
Symbol
Refer to the user manual
Only for use by a physician
Do not immerse
Dispose of in accordance with local regulations
Do not sterilise
Direct current
a
Class 2 equipment On/Off
108&3
SN 17/00500
Meaning
4"8
Alternating current Saw connection
Power connection
Type B protection
Temperature limits to which the equipment can be exposed
Pressure limits to which the equipment can be exposed
Humidity limits to which the equipment can be exposed
Transport - keep away from rain
Transport - fragile, handle with care
Transport - this way up
The first two digits indicate the year of manufacture
3
User Interface Symbols Symbol
Meaning
Symbol
Meaning
Function activated
Function deactivated
Change selection
Increase saw speed
Decrease saw speed
Flashing icon indicates low battery power
Pre-charge
Charging (animated)
Fully charged
Battery too hot / charging error
System requires service
4
Reprocessing - Non-sterilisable Equipment These reprocessing instructions are suitable for the non-sterilisable equipment described in this user manual. • CSP-xxx - Paediatric Cast Saw • BP-xxx - Battery Pack • IC-xxx - Interconnector • PS-xxx - Power Supply
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
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. Using a soft brush, clean the blade area 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
Overview Handpiece
1)
Clamp nut
2)
Power button
6
Battery Pack
1)
Display
2)
Soft keys
3)
Belt clip
4)
Power socket
7
Interconnector
1)
Saw socket
2)
Belt clip
3)
Power socket
8
Configuring a Battery Pack Switching on the Battery Pack 1. To turn the battery pack on press the central soft key. 2. To turn the battery pack off press and hold the central soft key until the display turns off.
Viewing the Battery Level and Service Status NOTE: the backlight will automatically dim if none of the buttons are pressed for a certain period
of time NOTE: the display backlight must be illuminated in order to access the battery and handpiece settings 1. If the display has dimmed, press any soft key to turn the backlight on. 2. To view the battery level and service status press Next.
Battery Pack Charging Status The battery pack is equipped with an indicator to show the status of the battery. The indicator is automatically activated when the battery pack is connected to the power supply. When the battery pack is fully charged, disconnect the power supply connector from the battery pack NOTE: charging can take up to 3 hours depending on the amount of residual charge left in the
battery pack NOTE: the battery pack may get warm during charging and discharging
Indicator
Status Pre-charge
Charging
Fully charged
Error
9
Configuring a Handpiece Fitting a Handpiece or Power Supply to the Battery Pack NOTE: the PS-201 power supply can be used to charge the BP-201 battery pack
1. To charge the battery pack or connect the handpiece to the battery pack, align the red marker on the plug with the red marker on the power socket of the battery pack. 2. Push the plug firmly into the power socket. 3. To remove, hold the plug by the textured section and pull away from the power socket.
10
Fitting the Handpiece to the Interconnector The IC-201 interconnector enables the user to power the cast saw with the PS-201 power supply. NOTE: when the saw is used with the interconnector, the previously configured saw settings will be used. The saw settings cannot be changed while the interconnector is connected. 1. Align the red marker on the handpiece plug with the red marker on the saw socket of the interconnector. 2. Push the plug firmly into the saw socket. 3. To remove, hold the plug by the textured section and pull away from the saw socket.
4"8
11
Fitting the Power Supply to the Interconnector 1. Align the red marker on the power supply plug with the red marker on the power socket of the interconnector. 2. Push the plug firmly into the power socket. 3. To remove, hold the plug by the textured section and pull away from the power socket.
108&3
12
Setting the Speed NOTE: the handpiece must be connected to the battery pack in order to set the saw speed NOTE: the saw speed is saved when the cast saw is turned off NOTE: when the handpiece is not running, the speed settings can be accessed by pressing
until Speed is highlighted 1. To increase the saw speed when the handpiece is running, press 2. To decrease the saw speed when the handpiece is running, press
. .
Activating and Deactivating Noise Control NOTE: noise control settings can only be accessed when the handpiece is connected to the
battery pack and the display is on NOTE: the backlight will automatically dim if none of the buttons are pressed for a certain period of time NOTE: the display backlight must be illuminated in order to access the battery and handpiece
settings Noise control reduces the saw speed when the blade is not cutting to minimise noise. Once in contact with the cast material, the saw speed will increase, and will decrease once removed from the cast. 1. If the display has dimmed, press any soft key to turn the backlight on. 2. Press
until Noise control is highlighted.
3. Press
to activate noise control.
4. Press
to deactivate noise control.
Activating and Deactivating Soft Start Mode NOTE: soft start settings can only be accessed when the handpiece is connected to the battery
pack and the display is on NOTE: the backlight will automatically dim if none of the buttons are pressed for a certain period
of time NOTE: the display backlight must be illuminated in order to access the battery and handpiece
settings Soft start mode gradually ramps up the saw speed to the set speed when the cast saw is switched on. 1. If the display has dimmed, press any soft key to turn the backlight on. 2. Press
until Soft start is highlighted.
3. Press
to activate soft start mode.
4. Press
to deactivate soft start mode.
13
Using Accessories Fitting and Removing a Blade WARNING: ensure the cast saw is turned off before attempting to fit and remove blades CAUTION: only use sharp cutting accessories NOTE: the clamp nut does not need to be fully removed to insert or remove a blade
1. Unscrew the clamp nut using the wrench provided. 2. Fit or remove the blade. 3. Tighten the clamp nut using the wrench provided to secure the blade. CAUTION: do not over-tighten the clamp nut
14
Cutting Technique WARNING: do not exert excessive pressure on the cast when cutting. Excessive cutting pressure
will cause the blade to overheat which may result in injury to the patient WARNING: do not allow the blade to contact the skin CAUTION: do not use worn blades
1. Begin the first cut by holding the blade perpendicular to the surface of the cast. NOTE: for segment blades, hold the blade at an angle of 30° in order to keep one side of the blade out of contact with the cast 2. Apply slight pressure at an angle of approximately 30° until the blade breaks through. NOTE: do not press hard, allow the blade to cut at its own rate 3. Lift the blade away from the cast. 4. Make subsequent cuts straight down into the cast, lifting and moving sideways progressively.
15
Technical and Ordering Information Cast Saw Specifications Model
CSP-201
Part no.
1286994
Maximum Speed
17,500 cpm
Enclosure Protection
IPX0 - ordinary equipment
Mode of Operation
Intermittent - usage to cooling ratio of 2:3 (such as, 2 minutes on, 3minutes cooling period) with a maximum continuous cutting time of 10 minutes.
Battery Pack Specifications Model
BP-201
Part no.
15250
Voltage
14.8 Vdc
Capacity
2600 mAh
Watt-hour rating
38.48 Wh
Enclosure Protection
IPX0 - ordinary equipment
Power Supply Specifications Model
PS-201
Part no.
15280
Supply Voltage
100 - 240 Vac
Supply Frequency
50 - 60 Hz
Protection Class
Class 2 - double insulated
Enclosure Protection
IP40
Environmental Conditions Environment
Operating
Storage and Transport
Temperature (°C)
Relative humidity (%)
Atmospheric pressure (kPa)
16
Accessories Cast Saw System Model
Description
Part No.
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
Switzerland cordset
15660
17