OLYMPUS
TC-C4 COMPACT TROLLEY Instructions Issue 3 Nov 2017
Instructions
108 Pages
Preview
Page 1
INSTRUCTIONS 取扱説明書
COMPACT TROLLEY コンパクトトロリー
TC-C4
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Contents Important Information - Please read before use...
5
Intended use...
5
Instructions for use...
5
Signal words...
5
Chapter 1
Standard sets...
6
1.1
Optional accessories...
7
Chapter 2
Warnings and cautions...
8
Chapter 3
Symbols...
11
3.1
Base shelf...
11
3.2
Top tray...
12
3.3
Column...
12
3.4
Separation transformer...
13
3.5
Scope pole kit...
14
3.6
Packaging symbols...
14
Chapter 4
Preparation for use...
16
4.1
Castors...
16
4.2
Fixing positions of intermediate shelf...
17
4.3
Assembling the scope pole...
20
4.4
Inserting a keyboard...
25
4.5
Water bottle holder...
26
4.6
Removing and attaching the rear panel...
27
4.7
Installing equipment...
28
4.8
Power connector...
31
4.9
General information...
32
Chapter 5
Operation...
34
5.1
Operation...
34
5.2
Manoeuvring...
35
Chapter 6
Reprocessing, inspection, storage and maintenance...
37
6.1
Reprocessing...
37
6.2
Inspection...
39
6.3
Storage...
40
6.4
Maintenance...
40
Chapter 7
Specifications...
42
7.1
TC-C4 compact trolley...
42
7.2
Separation transformer...
43
TC-C4 COMPACT TROLLEY
1
2
7.3
Sliding keyboard tray...
45
7.4
Scope pole...
45
Chapter 8
Customer spare parts...
45
8.1
Compact trolley spare parts...
45
8.2
Replacing the hook and loop assembly...
46
8.3
Replacing the base bumper...
47
8.4
Replacing the water bottle holder...
47
8.5
Replacing the mains cable...
48
8.6
Replacing the IEC cable...
48
8.7
Scope pole kit spare parts...
48
8.8
Replacing the scope support...
48
8.9
Replacing the scope hanger assembly...
49
8.10
Replacing the scope hanger top bar...
49
8.11
Replacing the umbilical holder assembly...
49
8.12
Sliding keyboard tray spare parts...
50
8.13
Rear panel spare parts...
50
Chapter 9
Technical description...
51
Chapter 10
Troubleshooting...
53
Chapter 11
End of life...
53
TC-C4 COMPACT TROLLEY
Important Information - Please read before use
Important Information - Please read before use Intended use The Olympus TC-C4 compact trolley is intended for use in medical facilities under the direction of a trained physician, and has been designed to be used with a range of Olympus endoscopic equipment as part of a system.
Instructions for use Please read these instructions for use carefully before attempting to use the Olympus TC-C4 compact trolley as it contains important information on the proper care, handling and use of the equipment. In addition, read the instructions for use of any other units (light source, endoscope, etc.) that form part of the system. If you have any questions or comments regarding the information in these instructions for use, please contact Olympus. These instructions for use should be retained for reference during the life of the product.
Signal words The following signal words are used throughout this manual: WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. NOTE Indicates additional helpful information.
TC-C4 COMPACT TROLLEY
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Standard sets
Chapter 1 Standard sets The Olympus TC-C4 compact trolley is available in 4 configurations. Refer to the table below to check that all items in the set ordered are present. Contact Olympus if any parts are damaged or missing.
B
A (Voltage compatible variant) C E
D H
J
F
G
Standard set
Item
6
A
TC-C4 Compact Trolley
B
MAJ-2146 Sliding Keyboard Tray
C
MAJ-1684 Scope Pole Kit
D
Separation Transformer (market specific)
E
MAJ-2148 Rear Panel
F
Trolley Fitting Kit
G
Scope Pole Kit Fitting Kit
H
IEC Lead Set 3
J
Instruction Manual
1 UK, Europe, USA, Japan, ROW
TC-C4 COMPACT TROLLEY
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3
4
UK, Europe, USA, ROW
UK, Europe, ROW, USA
UK, Europe, ROW, USA
Standard sets
1.1 Optional accessories WARNING
• Exceeding the maximum load of 14.5 kg of the MAJ-1639 CO2 cylinder holder can result in trolley instability. Code
Description
MAJ-110
Jar Mounting Kit
MAJ-1646
100 V Separation Transformer (Japan)
MAJ-1647
110 V Separation Transformer (USA)
MAJ-1648
240 V Separation Transformer (UK, Europe, ROW)
MAJ-1639
CO2 Cylinder Holder – 140
MAJ-1654
Equipotential Terminal Strip
MAJ-1656
Footswitch Holder
MAJ-1658
Storage Container Universal
MAJ-1663
EUS Arm Mount Kit
MAJ-1665
Camera Head Holder
MAJ-1683
LCD Monitor Mount
MAJ-1684
Scope Pole Kit
MAJ-1686
Drawer Unit
MAJ-2146
Sliding Keyboard Tray
MAJ-2147
Compact LCD Monitor Arm
MAJ-2148
Rear Panel
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Warnings and cautions
Chapter 2 Warnings and cautions Follow the warnings and cautions given below when handling this compact trolley. This information is to be supplemented by the warnings and cautions given in each chapter. WARNING
• The TC-C4 compact trolley should only be used in a medical facility under the direction of a trained physician. • To prevent patient shock, the combination of equipment used on the TC-C4 compact trolley should never be applied directly to the heart. • To prevent patient shock, do not touch the equipment's electrical connectors and the patient simultaneously. • After cleaning, dry the compact trolley and mounted devices thoroughly before using it again. If it is used while still wet, there is the risk of an electric shock. • Use personal protective equipment to guard against dangerous chemicals and potentially infectious material, otherwise, blood, mucus and other potentially infectious material from the patient could pose an infection risk. • During cleaning, wear appropriate protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. • To prevent user or patient cross-contamination, do not hang contaminated endoscopes on the scope hangers. • (USA only): The power cord on this unit is fitted with a ‘hospital grade’ plug. Grounding reliability can only be achieved when this equipment is connected to an equivalent receptacle marked ‘hospital grade’. • (RoW only): The power cable on this unit is terminated in flying leads, for a suitable plug to be fitted according to the area of intended use. The cores of the cable are coloured in accordance with the following code: BROWN LIVE (‘HOT’) BLUE NEUTRAL (‘COLD’) GREEN/YELLOW EARTH (GROUND) Only suitably qualified personnel must fit the power plug to this cable. • To avoid risk of electric shock, this equipment must only be connected to a supply mains with a protective earth. • Do not modify this equipment without authorisation of the manufacturer.
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Warnings and cautions
• Hanging incompatible endoscopes may cause them to become unstable during use, or cause structural impairment of the scope pole kit. Only fit endoscopes as specified in section 7.4. • Only fit keyboards as specified in section 7.3. Overloading may cause structural impairment of the keyboard tray. • The scope pole kit, keyboard tray and rear panel are only compatible with the TC-C4 trolley. Do not attempt to fit them to any other trolley, as its safe use can be compromised. • Exceeding the maximum load of 14.5 kg of the MAJ-1639 CO2 cylinder holder can result in trolley instability CAUTION
• Do not exceed the load capacity of the trolley as specified in Chapter 7. • Do not lean or stand on any part of the trolley or any of its accessories as failure of the product may result. • When attaching equipment to the trolley, the installation should meet the requirements of the safety standard for medical electrical systems, as described in section 4.9. • Before commissioning an installation including a separation transformer, ensure its rating will not be exceeded by the equipment connected to it. • When configuring a system, make sure that there is sufficient spare equipment available so that in the event of a fault in any part of the system, the endoscopy procedure can be completed or terminated without endangering the patient. • If failure of the power supply would subject the patient to an unacceptable risk, supply the trolley from an uninterruptible power supply (UPS) or a supply equipped with a back-up generator. • When installing the mobile compact trolley in the procedure or operating room, ensure that the mains cable has sufficient slack that it cannot be pulled taut as the mobile compact trolley is moved around the working area. If necessary, relocate the mains connector to a nearer supply socket. • Spray type medical agents, such as lubricants, anaesthetic or alcohol, should be used away from the trolley. • Keep open containers of liquid away from electrical equipment used on the mobile compact trolley to prevent operator electrical shock and equipment damage. Do not use the system if liquid has entered the equipment.
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Warnings and cautions
• To minimise risk of injury, it is recommended that heavy items are placed on the mobile compact trolley by two people working together. Ensure electrical items used on the mobile compact trolley are positioned centrally on the shelves. • The electrical resistance of the conductive antistatic castors should be tested at regular intervals in accordance with ISO 22878 to assess antistatic effectiveness. • Avoid contact of the castor wheels with oil and avoid a build up of floor cleaning wax and polish as these will impair the antistatic effectiveness of the castors. • Store and use the TC-C4 compact trolley within the environmental conditions described in Chapter 7. Failure to do so may lead to equipment malfunction or failure. • Before attempting to move the trolley outside the procedure room, ensure that the endoscope and fluid containers are removed and that the scope pole is placed in its stowed position. • There are no operator-serviceable components on the TC-C4 compact trolley. Refer servicing to qualified service personnel. • Before commencing shelf adjustment, ensure equipment is disconnected and removed from the shelf. • To minimise the risk of injury and damage, do not fit accessories other than those described in section 1.1 to the TC-C4 compact trolley. • Before moving the compact trolley, ensure that the keyboard tray is fully located in the storage position. • Check all equipment connectors on a regular basis to ensure there are no loose connections. • Placement of incompatible scopes may cause the scope to become unstable during use. • When not in use, position the scope pole within the footprint of the compact trolley. • Ensure endoscopes are securely retained on the hanger during use.
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TC-C4 COMPACT TROLLEY
Symbols
Chapter 3 Symbols The following symbols are used on the TC-C4 compact trolley.
3.1 Base shelf UNIQUE DEVICE IDENTIFICATION A label required by some countries’ regulations regarding identification of medical device also known as Unique Device Identification. The following information is being coded in the 2-dimensional barcode (GS1 Data Matrix); (01) 14-digit GS1 Global Trade Item number. (11) 6-digit date of manufacture. (21) 8-digit serial number.
(01) 00000000000000 (11) 000000 (21) 00000000
TC-C4 COMPACT TROLLEY
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Symbols
Symbol
240 kg 530 lbs
Description
Source
Fully laden weight
-
Unit complies with relevant European directives
Medical Device Directive 93/42/ EEC
Manufacturer
BS EN ISO 15223-1
3.2 Top tray Symbol
Description Refer to instructions for use
Source ISO 7010-M002
3.3 Column Symbol
Description
Source
No pushing. Do not push the trolley system in the areas indicated. Always ISO 7010-P017 use the handles provided at the front and rear of the trolley.
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TC-C4 COMPACT TROLLEY
Symbols
3.4 Separation transformer Symbol
Description
Source
Warning to observe rules regarding the use of multiple socket-outlets
ISO 7010-W001
Input
IEC 60417-5034
Mains power connected
IEC 60417-5032
Weight
ISO 7000-430
Non-inherently short circuit proof separation transformer
IEC 60417-5220
Unit complies with relevant European directives Medical Device Directive 93/42/EEC (MAJ-1648 only)
Refer to instructions for use
ISO 7010-M002
Manufacturer
BS EN ISO 15223-1
Equipotentiality
IEC 60417-5021
Output
IEC 60417-5035
Remote switch (not fitted on TC-C4)
IEC 60617
Disposal conditions see Chapter 11 End of life (MAJ-1648 only)
IS EN 50419
Indicates the unit has been independently assessed for compliance with American and Canadian standards as a Recognized Component of the compact trolley (MAJ-1647 only)
BS EN 60601
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Symbols
View of the separation transformer rear panel
NOTE MAJ-1648 (220-240V) is shown. Other versions are similar.
3.5 Scope pole kit Symbol
Description
Source
No pushing. Do not push the trolley system using the scope pole. Always use ISO 7010-P017 the handles provided at the front and rear of the trolley.
3.6 Packaging symbols Catalogue number
BS EN ISO 15223-1
Consult instructions for use
BS EN ISO 15223-1
Distribution packages shall be kept away from rain and be kept in dry conditions
BS EN ISO 780
Distribution packages shall not be exposed to sunlight
BS EN ISO 780
Maximum number of identical transport packages/items which may be stacked on the bottom package, where “n” is the limiting number
BS EN ISO 780
Contents of the distribution packages are fragile, BS EN ISO 780 therefore handle with care
14
TC-C4 COMPACT TROLLEY
Symbols
This is the correct upright position of the distribution packages for transport and/or storage Distribution packages shall be stored, transported and handled within temperature limits
BS EN ISO 780
BS EN ISO 780
Serial number
BS EN ISO 15223-1
Batch code
BS EN ISO 15223-1
Manufacturer
BS EN ISO 15223-1
TC-C4 COMPACT TROLLEY
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Preparation for use
Chapter 4 Preparation for use 4.1 Castors 1.
The compact trolley has two diagonally located braked castors. Ensure all brakes are applied prior to use and released before moving the compact trolley. NOTE Brakes should always be applied when the compact trolley is not being maneuvered.
Brake castor in four positions
Figure 4.1 2.
To lock and unlock the castor brake, refer to Figure 4.2.
Figure 4.2
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TC-C4 COMPACT TROLLEY
Preparation for use
4.2 Fixing positions of intermediate shelf The compact trolley columns contain additional sets of fixing holes for the intermediate shelf. The shelf may be repositioned to suit the size of the equipment being mounted.
On delivery The product is delivered with shelves fitted in the positions shown in Figure 4.3.
264 mm
278 mm
Shelf fixing holes
233 mm mm 233
Figure 4.3 TC-C4 COMPACT TROLLEY
17
Preparation for use
Adjusting the shelves CAUTION
• Before commencing shelf adjustment, ensure equipment is disconnected and removed from the shelf. • To avoid damaging the shelf or paintwork, it is recommended that two people adjust the shelf.
1.
Position the compact trolley on a level surface.
2.
Apply all brakes.
3.
Remove any equipment that is on the shelf.
4.
Remove the two cable ducts that are fitted on the rear of the intermediate shelf.
5.
Remove the hook and loop assembly that is fitted at the same height as the shelf by inserting a flat bladed screwdriver behind the stud in the middle of the cable tie and pulling it towards you, as shown in Figure 4.4.
Cable duct
Stud
Hook and loop assembly
Figure 4.4 6.
18
Referring to Figure 4.5, loosen the four M8 screws securing the shelf.
TC-C4 COMPACT TROLLEY
Preparation for use
7.
Take a firm hold of the shelf, then remove the four M8 screws with crinkle and plain washers.
8.
Move the shelf to align with the required fixing holes and replace the four M8 screws with crinkle and plain washers, ensuring each screw is fully tightened.
Shelf
M8 screw M8 crinkle washer M8 plain washer
Figure 4.5 9.
Position the cable duct against the shelf and align the hook and loop assembly (with stud removed) with the shelf hole.
10. Press the stud all the way through the hook and loop assembly into the hole to secure the cable duct (Figure 4.6).
Figure 4.6
TC-C4 COMPACT TROLLEY
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Preparation for use
4.3 Assembling the scope pole NOTE The scope pole can be mounted on either the left hand side or right hand side of the compact trolley. Only one person is needed to install the scope pole.
1.
Position the compact trolley on a level surface.
2.
Apply all brakes.
3.
Referring to Figure 4.7, secure the umbilical to the side of the trolley top tray as shown using two M6 screws, M6 crinkle washers and M6 plain washers.
Umbilical holder
M6 screw M6 crinkle washer M6 plain washer (2 positions)
Scope pole support M6 screw M6 crinkle washer M6 plain washer M6 jet nuts (2 positions)
Figure 4.7
20
4.
Tighten all screws using the 4 mm Allen wrench.
5.
Referring to Figure 4.7, secure the scope pole support to the side of the trolley shelf as shown using two M6 screws, M6 crinkle washers, M6 plain washers and M6 jet nuts.
6.
Tighten all screws using the 4 mm Allen wrench.
7.
Loosen the thumbweel on the umbilical holder.
TC-C4 COMPACT TROLLEY
Preparation for use
Scope pole
Umbilical holder Thumbwheel
Scope pole support
Figure 4.8 8.
Insert the scope pole through the umbilical holder and scope pole support. CAUTION
• Take care not to hit lighting or overhead equipment when installing the scope pole. NOTE • Ensure scope hanger top bar fixing holes on the scope pole are positioned correctly to suit the lengths of endoscopes being used. Typically the lower fixing position should be used for surgical scopes, and the higher fixing position used for GI scopes.
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