CC7 and CC8 CLEANCAST User Manual Ver 13.2 July 2020

( 0(',&$/*(1(5$/0(',&$/(48,30(17 $672(/(&75,&$/6+2&.),5($1'0(&+$1,&$/ +$=$5'621/<,1$&&25'$1&(:,7+$16,$$0, (6&$$,(& $&$1&6$&1R &$1&6$&1R$

Contents 1

Important Information... 1

2

Safety Instructions... 1 Intended Use and Benefits... 2 Disposal... 2 Symbols... 3

3

General... 3 Extractor... 3 Power Supply... 3 Cast Saw... 4 Reprocessing - Non-sterilisable Equipment... 5

4

Limitations on reprocessing... 5 Safety Instructions... 5 Manual Cleaning... 5 Overview... 6

5

Cast Saw... 6 Extractor... 7 Configuring the Extractor... 8

6

Fitting the Castor wheels... 8 Fitting the Tray... 9 Fitting and Removing the Hose from the Cast Saw... 10 Fitting the Hose to the Extractor... 11 Removing the Hose from the Extractor... 12 Selecting the Mode... 13 Configuring the Cast Saw... 14

7

Connecting a Saw Cable... 14 Disconnecting a Saw Cable... 15 Using Accessories... 16

8

Fitting a Wall Mount... 16 Replacing the Dust Bag... 17 Fitting and Removing a Blade... 18 Technical and Ordering Information... 19

9

Cast Saw Specifications... 19 Extractor Specifications... 19 Power Supply Specifications... 19 Accessories... 20 Saw Blades... 21 Troubleshooting... 23

10

Further Help... 23 Service and Repair Information... 23 Guarantee and Liability... 24 EMC Information... 25 General Information... 25 EM Compliance (emissions)... 25

EM Compliance (immunity)... 25

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 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: do not use this equipment to cut wet plaster WARNING: do not use this equipment with wet hands WARNING: do not expose this equipment to rain or use near water WARNING: ensure the voltage rating of the electrical supply corresponds with the voltage rating

stated on the equipment label WARNING: this equipment must only be connected to a supply with a protective earth WARNING: do not position the equipment so that it is difficult to disconnect from the mains supply WARNING: this equipment is not intended for use in an oxygen rich environment or in the presence

of flammable gases WARNING: do not attempt to dismantle or modify this equipment, except as directed in this user

manual WARNING: do not allow the blade to contact the skin WARNING: ensure the equipment is disconnected from all power sources before cleaning 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: when using cast saws, follow local recommendations for the avoidance of possible

hand-arm vibration damage and long-term hearing damage. (Under certain circumstances, hand-arm vibration levels exceeding 5ms-2 can be produced and maximum sound levels can exceed 80dB(A). However, when the equipment is used for the purposes intended this poses no threat to long-term health.) WARNING: always use extraction when operating the CC7 cast saw WARNING: apply the brakes when the extractor is not in transit CAUTION: do not immerse any part of this equipment in fluids CAUTION: ensure the vent is not obstructed CAUTION: only reprocess this equipment as directed in this user manual CAUTION: do not clean this equipment in an automatic washer-disinfector

1

CAUTION: do not clean any part of this equipment in an ultrasonic cleaner CAUTION: ensure this equipment is regularly serviced. Refer to the service and repair information

section of this user manual. CAUTION: only use De Soutter Medical approved accessories CAUTION: only use sharp cutting accessories 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

Intended Use and Benefits The equipment described in this user manual intended for use by a clinical professional, within an approved clinical setting. The equipment is intended to provide an efficient means of removing orthopaedic casts. There are no known contraindications or limitations on patient target group.

Disposal All equipment should be recycled or disposed of, in accordance with local regulations.

2

Symbols General Symbol

a

Meaning

Symbol

Refer to the user manual

Dispose of in accordance with local regulations

Type BF protection

The first two digits (YY) indicate the year of manufacture

SN YY/000000

Alternating current

Do not immerse

Humidity limits to which the equipment can be exposed

Temperature limits to which the equipment can be exposed

Pressure limits to which the equipment can be exposed

Transport - keep away from rain

Transport - fragile, handle with care

Transport - this way up

(& 5(3

EC authorised representative

Meaning

Symbol

Meaning

Off

I MAN

Manual extraction mode

Manufacturer

0'

Meaning

Medical Device

Extractor Symbol

I AUTO

Warning. Refer to the accompanying text

Automatic extraction mode

Power Supply Symbol

Meaning

Symbol

Direct current

Meaning Input

3

Cast Saw Symbol

Meaning

Symbol

Stand-by

4

Meaning

Reprocessing - Non-sterilisable Equipment These reprocessing instructions are suitable for the non-sterilisable equipment described in this user manual. • Extractor • PSx - Power Supply • CCx - Cast Saw

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: 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 CAUTION: do not sterilise this equipment

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 air vents and 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 Cast Saw 





1)

Extraction Hood (CC7 only)

2)

Extractor Hose (CC7 only)

3)

Blade clamp lever

4)

Stand-by button



6

Extractor 











1)

Tray

2)

Extraction hose stowage

3)

Vacuum nozzle

4)

Cable stowage

5)

Auxiliary outlet (for power supply)

6)

Mode selection switch (mains isolation)

7)

Cast saw connector

8)

Brakes

7





Configuring the Extractor NOTE: before initial use, the castor wheels and tray must be fitted to the extractor base.

Fitting the Castor wheels Push the castor wheels into the base of the extractor until they click into place. NOTE: ensure the castor wheels are securely fitted

8

Fitting the Tray 1. Open the catches on each side of the extractor and place the extractor head to one side. NOTE: ensure the auxiliary plug is removed before placing the extractor head to one side 2. Insert the tray into the extractor base. 3. Secure in place with the wing nut provided.

 



9

Fitting and Removing the Hose from the Cast Saw WARNING: ensure the equipment is switched off

1. To fit: push the hose over the barbed connector on the cast saw. NOTE: ensure the hose is secured in place 2. To remove: pull the hose away from the cast saw.

 

10

Fitting the Hose to the Extractor WARNING: ensure the equipment is switched off

Push the hose into the extractor inlet until it clicks into place. NOTE: ensure the hose is secured in place

11

Removing the Hose from the Extractor WARNING: ensure the equipment is switched off

Press the release button and pull the hose away from the extractor.





12

Selecting the Mode Set the mode selection switch to the required mode. Mode

Description

I AUTO

The extractor will automatically switch on with the cast saw, and turn off a few seconds after the cast saw has stopped

O I MAN

Off The extractor is on and the cast saw is disabled

13

Configuring the Cast Saw Connecting a Saw Cable 1. Align the arrow on the plug with the catch on the socket. 2. Push the plug firmly into the socket. NOTE: ensure the plug is securely fitted 3. Use the clips provided to attach the saw cable to the hose (CC7 only).





NOTE: this procedure applies to the CC7 and the CC8

14

Disconnecting a Saw Cable 1. Press the catch on the socket. 2. Pull the plug away from the socket. NOTE: do not attempt to disconnect the saw by pulling the cable



NOTE: this procedure applies to the CC7 and the CC8

15

Using Accessories Fitting a Wall Mount WARNING: do not position the wall mount more than 1m from the ground WARNING: the wall plugs provided are only suitable for solid walls

Using the screws and wall plugs provided, fix the wall mount to the wall.

16