HAAG-STREIT
HAAG-STREIT Operating Microscopes
HS Hi-R NEO and ALLEGRA series Operating Instructions March 2014
Operating Instructions
76 Pages
Preview
Page 1
Operating instructions Operating microscopes HS Hi-R NEO 900 / HS Hi-R NEO 900A, HS ALLEGRA 900 / 590 / 90
Carrier units FS 2-21 / FS 2-25, FS 2-11 / FS 2-15
668 200 02 e, 03 / 2014
- Content -
Content 1
Important notes ... 1
2
The microsurgical operating system... 3
2.1
Overview of warning and information signs... 3
2.2
Intended use... 5
2.3
Typical abuse ... 5
2.4
General warnings ... 5
2.5
Combination possibilities... 7
2.6
Microsurgical operating system’s equipment ... 7
3
Installation, transport and storage ... 9
3.1
Installation of the carrier units ... 9
3.2 3.2.1 3.2.2
Installation of the operating microscope... 9 FS 2-25 / FS 2-21... 9 FS 2-15 / FS 2-11... 10
3.3
Installation of accessories on the tray ... 11
3.4
Deinstallation of the microsurgical operating system ... 11
3.5 3.5.1 3.5.2
Transport and storage ... 12 FS 2-25 / FS 2-21... 12 FS 2-15 / FS 2-11... 14
4
Operating the microsurgical operating system... 17
4.1
Before each operation ... 17
4.2
Typical set-up of the microsurgical operating system ... 17
4.3
Disconnection from the power supply ... 18
4.4
Important information regarding sterile use... 18
4.5
Important information regarding ophthalmology... 19
4.6 4.6.1 4.6.2
Carrier units... 21 FS 2-25 / FS 2-21... 21 FS 2-15 / FS 2-11... 27
4.7 4.7.1 4.7.2 4.7.3 4.7.4 4.7.5
Operating microscopes ... 29 HS Hi-R NEO 900A ... 29 HS Hi-R NEO 900 ... 33 HS ALLEGRA 900... 37 HS ALLEGRA 90... 39 HS ALLEGRA 590... 41
5
Disposable materials and spare parts... 43
6
Maintenance and service... 44
6.1
Cleaning, disinfection and sterilisation ... 44
6.2
Maintenance... 44
6.3 6.3.1 6.3.2 6.3.3
Exchange of lamps... 44 FS 2-25... 44 FS 2-21... 45 FS 2-15... 46
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6.3.4
FS 2-11... 47
6.4
Emergency lighting... 48
6.5 6.5.1 6.5.2
Resolving defects ... 49 FS 2-25 / FS 2-21... 49 FS 2-15 / FS 2-11... 52
6.6
Contact ... 54
7
Disposal ... 54
8
Technical Data ... 55
8.1
Microsurgical operating system... 55
8.2
Carrier units... 56
8.3
Operating microscopes ... 58
9
Appendix ... 64
9.1
Guiding principles and manufacturers declaration ... 64
9.2
ESD protective measures... 67
9.3
Instruction „Cleaning and disinfection“ ... 68
9.4
Instruction „Reprocessing of sterilisable operating elements“... 70
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- Important notes -
1
Important notes
Proper use
To ensure the safety of patients, users and third parties, the microsurgical operating system may only be operated under observance of the currently valid operating instructions. The microsurgical operating system is exclusively intended for use as described in the currently valid operating instructions. Store the operating instructions for later use in a location that is accessible at all times.
Proper maintenance and repair
To ensure the safety of the user and patient, adhere to all maintenance instructions and recordkeeping procedures as described in this document. Even if no regular maintenance is prescribed, it is recommended that a precautionary safety inspection be conducted annually. The manufacturer or manufacturer's authorized agent is to be contacted at least once every three years to implement any possible safety-related upgrades. The microsurgical operating system may only be repaired or upgraded in accordance with current technical specifications of the manufacturer. A repair or modification of the microsurgical operating system may only be carried out by persons expressly authorized by the manufacturer. In the event of repairs, only original parts of the manufacturer may be used. Following repairs or technical modifications, the equipment is to be recalibrated in accordance with current technical specifications of the manufacturer.
1
Disclaimer of liability
Improper use, improper repair, and/or improper maintenance shall immediately void any liability on the part of the manufacturer.
Proprietary rights
The contents of these Operating Instructions are copyright-protected. A translation is not permitted without the written authorization of the manufacturer.
Regarding these Operating instructions
The pictures and illustrations shown herein may not be an accurate representation of the device that was delivered, as a result of ongoing research and development.
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- Important notes -
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- The microsurgical operating system -
2
The microsurgical operating system
2.1 Overview of warning and information signs In the Operating Instructions
DANGER
Warnings
Will lead to serious injury or death. •
WARNING
May lead to serious injury or death. •
CAUTION
Follow the instructions.
May lead to light to moderately serious injury. •
Attention
Follow the instructions.
Follow the instructions.
May lead to material damage and / or operating error. •
Follow the instructions.
Handling instructions
Attention
•
Pull the mains plug.
Attention
•
Switch on the unit.
Attention
•
Switch off the unit.
On the microsurgical operating system
/
• •
Use the microscope only when balanced. Pay attention to the loading capacity of the carrier unit.
Attention
•
Pay attention to the disposal information in the instructions.
Attention
•
Do not push.
Attention
Achtung
Achtung
Attention
3
Warning and handling instructions
Electrostatically endangered components • Apply appropriate protective measures before you touch components or connect cables to components that are marked with the ESD warning label (see page 67). Electromagnetic Interference • In the vicinity of equipment marked with this symbol interference are possible (see page 66). Maximum permissible angle of inclination of the microsurgical operating system in the operating position
Attention
Transport position
Attention
•
Remove mains plug from the socket before opening the equipment.
Attention
•
Follow the instructions.
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- The microsurgical operating system -
Attention
Heat
Attention
•
Do not set down any containers with liquids.
Operating elements
Attention
Releasing
Attention
Mechanical clamping
Attention
Display of the focus shift and the tilt of the microscope
Attention
Restore the basic settings for the XY coupling and the focus module
Attention
Light source
L1 / L2 Halogen lamp 1 / Halogen lamp 2 LED 1 / LED 2
Achtung
/
Achtung
Attention
/ Attention Attention
Attention
E
Switch for emergency lighting Balancing Redreflex amplifier Connections Equipotential, connection possibilities of potential equalisation line according to EN 60601-1:2006 Socket to supply auxiliary devices • Pay attention to additional information regarding the maximum output power Socket for electrical power supply • Pay attention to additional information regarding the maximum power consumption
Attention
Microscope connection
Attention
Foot switch connection
Attention
Camera connection
Attention
Socket for RS 232 interface
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- The microsurgical operating system -
2.2 Intended use The microsurgical operating system consists of the operating microscope HS Hi-R NEO 900 / HS Hi-R NEO 900A /HS Hi-R NEO 900A NIR or HS ALLEGRA 900 / 590 / 90, a carrier unit FS 2-25 / FS 2-21 or FS 2-15 / FS 2-11 and further accessories as authorised by the manufacturer. A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900 / HS Hi-R NEO 900A / HS Hi-R NEO 900A NIR and HS ALLEGRA 900 / 590 / 90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high manoeuvrability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities. The carrier units FS 2-25 / FS 2-21 and FS 2-15 / FS 2-11 have different light sources (LED / halogen) and the operation and the expansion possibilities that correspond to surgical requirements. The microsurgical operating system is intended • for use in hospitals, clinics and doctor's surgeries. • for use within a patient environment. • to be installed in an environment where operating conditions are appropriate for microsurgical procedures: • Little vibration • Careful handling • Clean environment • Use with sterilisable operating elements; a sterile cover (drape) may be used in addition. Only trained personnel familiar with the functions and the controls of this operating microscope are permitted to operate and handle the device. The operator must ensure compliance with the steps required for cleaning, sterilisation, disinfection and changes in the equipment configuration according to instructions. Portable and mobile high frequency communication devices such as mobile telephones can interfere with the microsurgical operating system.
2.3 Typical abuse Xenon light sources are not authorised for ophthalmology. Serious eye damage is possible.
2.4 General warnings DANGER
Explosions danger: •
WARNING
Risk of electrical shock: • •
5
Use in explosive atmosphere is not permissible! To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with a protective earth. The microsurgical operation system must only be positioned so that a disconnection from the supply net can be made easily at any time.
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- The microsurgical operating system -
WARNING
Danger to persons by improper use: • • • • • •
WARNING
Danger to persons by defective equipment: • •
WARNING
Follow the operating instructions! Avoid an extreme mechanical loading of the microsurgical operation systems! Pay attention that the microsurgical operation system is balanced. When transporting the microsurgical operating system it must be in its transport position. In ophthalmology use exclusively manufacturer approved light sources. Never look directly into the light guide. Pay attention before use that all mechanical and electrical connections are fitted properly and that they are undamaged. Do not begin an operation if a technical defect is present or if a defect is supposed.
Safety shortfalls through wrong accessories and replacement parts: The use of other accessories, other transducer and lines than those specified, with the exception of transducers and lines that the manufacturer supplies as spare parts for internal components, can lead to an increased electromagnetic emission or a reduced system interference immunity. • Use exclusively authorised accessories from the manufacturer! • The maximum carrier unit load-capacity may not be exceeded! • The following is valid for all system extensions and changes: • Only devices are permissible whose compatibility has been determined. • Without additional protective measures, dangerous leakage current or contact current can arise. • An additional multiple power socket or an extension cable may not be connected. • Changing, the attaching of new elements, the removing, updating or upgrading of equipment that is still connected to a network / data sharing, can lead to new risks. • The requirements of EN 60601-1:2006 are to be fulfilled! • After the system has been changed, appropriate examinations and tests must be carried out to guarantee safe use.
Attention
Possible material damage by improper use: • • • • •
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Only transport the microsurgical operating system in a balanced condition. Proceed slowly. Avoid collision with equipment that is mounted on the ceiling and walls. Put the carrier unit down only on an even surface. Store the microsurgical operation system only in the transport position and apply firmly two of the brake levers. Apply appropriate protective measures before you touch components or connect cables to components that are marked with the ESD warning label (see page 67).
6
- The microsurgical operating system -
2.5 Combination possibilities FS 2-25 LED
FS 2-21 Halogen
FS 2-15 LED
FS 2-11 Halogen
HS Hi-R NEO 900
x
x
x
x
HS Hi-R NEO 900A
x
x
x
x
HS ALLEGRA 900 / 590
x
x
x
x
HS ALLEGRA 90
-
-
x
x
HS Hi-R NEO 900A
HS ALLEGRA 900
HS ALLEGRA 590
HS ALLEGRA 90
Equipment
HS Hi-R NEO 900
2.6 Microsurgical operating system’s equipment
Motorised zoom
x
x
x
x
-
Manual changer
-
-
-
-
x
x
x
x
x
x
XY coupling
x
x
x
x
o
Assistant microscope
-
x
-
-
-
internal camera module
-
-
o
x
o
Redreflex module, adjustable
x
x
-
-
-
Redreflex module, fixed
-
-
x
x
x
Eyepiece 200°, 10 x
x
x
-
-
-
Eyepiece 160°, 10 x
o
o
x
x
o
Eyepiece fix, 60°
-
-
o
o
x
Eyepiece 160°, 12,5 x
-
x*
-
-
-
Magnification
Focusing Z-Focusing Other
Accessories
Eyepieces
x = standard, included, o = optional, - = not foreseen, a = on inquiry * Assistant microscope
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HS Hi-R NEO 900
HS Hi-R NEO 900A
HS ALLEGRA 900
HS ALLEGRA 590
HS ALLEGRA 90
- The microsurgical operating system -
BS 50:50 / 30:70
o
o
o
-
o
VERTISCOPE T / U
-
-
o
-
o
DIPLOSCOPE T / U
-
-
o
-
o
LR 1000 / 1000i
o
o
-
-
-
Secondary stereoscopic observers
o
o
o
-
o
M.DIS
o
o
o
o
o
Various camera attachments
o
o
o
-
o
Foot switch EF 5001
o
o
o
o
o
Foot switch EF 5000
o
o
o
o
o
Foot switch EF 2000
-
-
-
-
-
EIBOS 2
o
o
o
o
o
TOCULAR
o
o
o
o
o
Motorised slit lamp
o
o
-
-
-
Keratoscope
o
o
o
-
o
Tray
o
o
o
o
o
MIOS 4
o
o
o
o
o
Co-observation
Microscope control
Other
Due to the wide variety of equipment combinations, deviations from the above are possible. For information about the compatibility of your microsurgical operation system please contact your local sales representative. x = standard, included, o = optional, - = not foreseen, a = on inquiry * Assistant microscope
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- Installation, transport and storage -
3
Installation, transport and storage Possibility of interference caused by electromagnetic incompatibility
Attention
Medical Electrical Equipment needs special precautions regarding its electromagnetic compatibility. • Observe the instructions on the electromagnetic compatibility of the microsurgical operation system (see page 64).
3.1 Installation of the carrier units The installation of the carrier units should be performed by a manufacturer appointed service technician.
Possible material damage to electronic components:
Attention
•
Connect the microsurgical operating system to the power supply only after installing all components.
3.2 Installation of the operating microscope 3.2.1 FS 2-25 / FS 2-21 Danger to persons from sudden uplifting of the suspension arm:
CAUTION
•
Keep the carrier unit’s arm vertical and still when installing.
1.
2.
WARNING
Danger to persons from falling components: •
9
Ensure that all components are firmly fixed to each other.
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- Installation, transport and storage -
3.
4.
5.
Damage to the light guide possible:
Attention
•
Make sure that the light cable is long enough after installation on the microscope receiver, that the operation microscope is not limited when rotating.
6.
3.2.2 FS 2-15 / FS 2-11 CAUTION
Danger to persons from sudden uplifting of the suspension arm: •
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Keep the carrier unit’s arm vertical and still when installing.
10
- Installation, transport and storage -
1.
Danger to persons from falling components:
WARNING
•
Ensure that all components are firmly fixed to each other.
2.
3.
Attention
Damage to the light guide possible: •
Make sure that the light cable is long enough after installation on the microscope receiver, that the operation microscope is not limited when rotating.
3.3 Installation of accessories on the tray Maximum load bearing capacity 20 kg Supply lines to accessory articles, maximum output of the isolation transformer: 120 VA Connection cable to the carrier unit
3.4 Deinstallation of the microsurgical operating system Attention
Damage to material can possibly occur through improper deinstallation: • •
11
Before a deinstallation of equipment, make sure that all corresponding electrical and optical connections (connecting cable, light guide) are disconnected. Work through the installation instructions backwards.
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- Installation, transport and storage -
3.5 Transport and storage 3.5.1 FS 2-25 / FS 2-21 WARNING
1.
Danger to persons by tipping over of the microsurgical operating system: If the working position of the microsurgical operating system is inclined by more than 5° then it can tip over. • When transporting the microsurgical operating system it must be in its transport position.
Danger to persons from the sudden uplifting of the suspension arm when the carrier unit is unbalanced: •
Transport the carrier unit with the operating microscope attached.
1.
2. Press and hold the electromagnetic brake button released
3.
Pull lock pin Turn the carrying arm to the lock in the direction as illustrated
4.
Pull lock pin Turn the suspension arm to the lock in the direction as illustrated
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- Installation, transport and storage -
5.
Move the suspension arm in the horizontal
6.
7.
8.
9.
13
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- Installation, transport and storage -
10.
Possible material damage through collision and tipping of the microsurgical operating system:
Attention
• • • • •
Move the carrier unit only by moving the handling frame. Do not lean on the carrier unit housing. Proceed slowly. Place the carrier unit only on a flat an even surface. Avoid collisions.
•
Protect the microsurgical operation system from dust and other contaminants by using the appropriate protective covers.
11.
12.
3.5.2 FS 2-15 / FS 2-11 WARNING
1.
Danger to persons by tipping over of the microsurgical operating system: If the working position of the microsurgical operating system is inclined by more than 5° then it can tip over. • When transporting the microsurgical operating system it must be in its transport position.
Danger to persons from the sudden uplifting of the suspension arm when the carrier unit is unbalanced: •
Transport the carrier unit with the operating microscope attached.
1.
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- Installation, transport and storage -
2. Pull lock pin Turn the suspension arm to the lock in the direction as illustrated
3. Pull lock pin Turn the carrying arm to the lock in the direction as illustrated
4.
5.
6.
15
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- Installation, transport and storage -
7.
8.
9.
10.
Possible material damage through collision and tipping of the microsurgical operating system:
Attention
• • • • •
Move the carrier unit only by moving the handling frame. Do not lean on the carrier unit housing. Proceed slowly. Place the carrier unit only on a flat an even surface. Avoid collisions.
•
Protect the microsurgical operation system from dust and other contaminants by using the appropriate protective covers.
11.
12.
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- Operating the microsurgical operating system -
4
Operating the microsurgical operating system
4.1 Before each operation Make sure that
see
1. all mechanical and electrical connections are fitted properly and that they are undamaged. 2. ensure that the floor stand is connected to a nearby power supply so that it can be easily disconnected. 3. at least two of the brake levers on the carrier unit are on.
page 21, page 27
4. the microsurgical operating system is level. 5. the microsurgical operating system is balanced.
page 26, page 28
6. the microsurgical operating system is in the preferred working position and neither the suspension arm or the carrier arm is in the transport position. 7. the suspension arm is free to move around the vertical and the horizontal axis when the brake released. 8. the light source functions perfectly.
page 22, page 28
9. the operator settings necessary for the operation are loaded.
page 23
10.
the microsurgical operation system is equipped with sterilisable operating elements and is wrapped in a sterile cover in accordance with the relevant requirements.
page 18
11.
all microsurgical operating systems ventilation slits are open and that, for example, no clothes cover them.
4.2 Typical set-up of the microsurgical operating system
17
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