Tecno-gaz ORION 40 User manual

Operation and
maintenance manual
MU_010_IT
15/06/15
Rev.4
Pag. 1 di 29
Operation and maintenance
manual
ORION 40
ORION 40DS
SECONDARY SURGICAL LAMP (TREATMENT LAMP)
Mobile (LC001LRA)
Wall (LC002LRA)
Single Ceiling (LC003LRA)
Double Ceiling (ORION 40+ORION 40) (LC004LRA)
ORION 40DS Wall (LC001LRD)
ORION 40DS Ceiling (LC002LRD)
ORION 40DS Mobile (LC003LRD)
Double Ceiling (ORION 40DS+ORION 40DS) (LC004LRD)
ORION 40DS Low Ceiling(LC005LRD)
ORION 40DS Ceiling + TVCC Arm (LC006LRD)
ORION 40DS TVCC Ceiling (LC007LRD)
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Introduction
Please read this manual carefully before proceeding to correctly install
the Product, so as to protect “the Service Personnel” and “the
Operator” from any injury.
Marking
This appliance is a Class 1 medical device pursuant to European
Directive on medical devices (MDD) 93/42/EEC (Annex IX) as amended
and integrated.
Conformity
The manufacturer declares that this Product is in compliance with
Annex I (Essential requirements) of Directive 93/42/EEC as amended
and integrated and certifies such conformity by affixing the CE marking.
Validity of manual
This installation manual is valid for the following models:
ORION 40/40DS single-ceiling version
ORION 40/40DS double-ceiling version (ORION 40/40DS+ORION
40/40DS)
ORION 40/40DS mobile version
ORION 40/40DS wall version
Customer service
The customer service is at your disposal in case of Product details,
information concerning its use, identification of spare parts being
required and for any other queries you might have concerning the
appliance, for ordering spares and for matters relating to assistance
and warranty.
TECNO-GAZ
Strada Cavalli, 4
I-43038 Sala Baganza - Parma -
Tel.: [phone]
Fax: [phone]
e_mail: in[email protected]
Copyright
The reproduction and translation, including partial, of any part of this
manual is forbidden without the written permission of TECNO-GAZ.
Translations
The original language of this manual is ITALIAN. For all translations,
reference must be made to the original manual language.
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List of Contents
KEY ..................................................................................................5
1WARNINGS AND SAFETY NOTICES........................................6
2Importance of personal safety..................................................6
2.1 Intended use ..................................................................................... 6
2.2 Safety conditions (secondary effects) ............................................ 7
2.3 Environmental conditions................................................................ 8
3General information...................................................................8
3.1 Operator qualification ...................................................................... 8
3.2Graphic symbols used in this Operation and Maintenance
Manual.................................................................................................... 8
3.3 Graphic symbols used on the Product ........................................... 9
4Precautions for the Product operator....................................10
4.1 Technical safety specifications..................................................... 10
4.2 Personnel training obligation........................................................ 10
4.3 Warranty and liabilities .................................................................. 10
5Product description and operation........................................10
5.1 Product description........................................................................ 10
5.2 Description of operation ................................................................ 12
5.3 Product handling............................................................................ 13
6Cleaning and disinfecting.......................................................16
6.1 Cleaning the Product...................................................................... 16
6.2 Product disinfecting....................................................................... 17
6.3 Sterilizing hand-pieces................................................................... 18
7Adjustments and maintenance...............................................19
7.1 Setting the swinging arm............................................................... 19
7.2 Clutch adjustment .......................................................................... 19
7.3 Periodical checks to be performed on the Product ..................... 20
7.4 Routine maintenance ..................................................................... 20
7.5 Repairs............................................................................................ 21
7.6 Disposal after use........................................................................... 21
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7.7 Spare parts list................................................................................ 21
8Technical properties................................................................22
9 Declaration of Conformity of the Manufacturer..............24
10 Warranty Certificate.................................................................29
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KEY
PRODUCT
THE EM (Electro-Medical) EQUIPMENT to which this manual refers is
a SECONDARY SURGICAL LAMP (TREATMENT LAMP). For ease of
description, in this manual this EM EQUIPMENT will be called
“Product”.
OPERATOR
Person handling the equipment (e.g., professional health personnel,
non-expert person assisting the patient).
RESPONSIBLE
ORGANIZATION
Entity accountable for the use and maintenance of an EM equipment or
EM system (e.g., a hospital, an individual doctor or a non-expert
person). Preparation and training are included in use.
SERVICE
PERSONNEL
Individuals or entity accountable to the responsible organization that
installs, assembles, maintains or repairs the equipment. In certain
circumstances, the safety of such persons depends on their knowledge
and training and ability to take appropriate precautions when gaining
access to hazardous parts partially. By way of example only, the
following professional figures are deemed as SERVICE PERSONNEL:
Construction Engineer, Draughtsman, Building firm duly registered
in the professional Register (for the masonry works)
Electrical Engineer Electro-technical expert qualified to work as an
electrician (for the electrical works)
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1 WARNINGS AND SAFETY NOTICES
WARNING
This manual is an integral part of the Product as indicated by European
Directive 93/42/EEC and subsequent amendments and supplements.
Read and keep this Operation and Maintenance Manual close to the
Product.
WARNING
- The Product is not suitable for use in premises where explosion risks
exist.
- The Product is not suitable for use wherever there are inflammable
mixes of anaesthetics with air, oxygen or NO2(laughing gas).
WARNING
TECNO-GAZ disclaims all liability for any injury to persons or damage
to things caused by the Product having been used and services by
persons who are not OPERATORS or SERVICE PERSONNEL.
WARNING
The Product is an EM electro-medical equipment and therefore falls
within the field of application of the EN 62353 standard.
To avoid any risk of electric shocks, the Product must only be
connected to mains supplies with earth protection.
2 Importance of personal safety
2.1 Intended use
SECONDARY SURGICAL LAMP (TREATMENT LAMP).
The Product is a medical device designed for use in operating theatres
within the PATIENT AREA, with short-term duration, active, non
invasive, designed to locally light up the patient’s body for treatments
and diagnosis which can be interrupted without DANGER for the
PATIENT in case of a power outage.
A combination of two or more surgical lamps used in the operating
theatre and required for treatment and diagnosis makes up a
SURGICAL LAMP SYSTEM.
Operating range
The Product correctly lights up the operating range from a distance of
about 70 –140 cm from the patient area.
DANGER –Electric shock risk
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WARNING –Possibility of tissue dehydration and damage
Undesired effects of
overlapping light fields
In the event of overlapping lamps, a temperature increase would ensue
in the patient area with consequent risk of dehydration and tissue
damage.
In case of a reduction in blood flow with start of tissue dehydration,
reduce light intensity.
2.2 Safety conditions (secondary effects)
CAUTION –Possibility of glare
Optical safety
- Do not direct the light source into the patient’s and/or operator’s eyes.
- When Product use is restricted to the face (maxilla-facial surgery,
plastic surgery, ear-nose-throat surgery) the patient’s eyes must be
covered with adequate protection.
Failure to follow such precautions could cause glare and potential
damage to the retina.
CAUTION –Do not place objects on Product
Incorrect use
Never place and/or hang anything on the Product.
Failure to follow such precaution could result in such objects falling in
the operating area.
CAUTION –Possibility of damaging Product
- Never hang on the Product with the body weight of a person.
Failure to follow such precaution could damage the Product structure.
-Never cover the head of the Product during operation to prevent
overheating.
- Avoid the Product parts colliding with one another or other nearby
equipment.
Knocks could cause the detachment of plastic parts or paint from the
Product which could fall in the patient area
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2.3 Environmental conditions
-The Product is not suitable for use in explosion-risk areas.
-The Product is not suitable for use in the presence of inflammable
mixtures of anaesthetics with air, oxygen or NO2(laughing gas).
-During operation, the ambient temperature must be between 10°C
and 40°C.
-Relative humidity must be between 30% and 75%.
-Atmospheric pressure must be between 700 and 1060hPa.
3 General information
3.1 Operator qualification
Qualification of personnel in charge of operating on the Product
Use
Cleaning
Routine maintenance
Special maintenance
Scrapping
OPERATOR
OPERATOR
SERVICE PERSONNEL
SERVICE PERSONNEL
RESPONSIBLE ORGANIZATION and SERVICE PERSONNEL
3.2 Graphic symbols used in this Operation and
Maintenance Manual
The following safety measures must be put in place during Product
installation, use and servicing.
To emphasize their importance, a number of safety precautions are
repeated throughout the manual.
Follow the safety precautions before using or repairing the Product.
Carefully abiding by the safety precautions improves the ability to use
the Product safely and correctly and helps prevent incorrect
maintenance which could be hazardous and cause damage. The safety
measures are approximate and not exhaustive; the Operator, the
Responsible Organization and the Service Personnel must develop
their capacities to upgrade and integrate them.
Indications such as DANGER, WARNING and CAUTION, preceded by
the symbol indicate the level of “risk” to which the SERVICE
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PERSONNEL, the RESPONSIBLE ORGANIZATION and the
PRODUCT could be exposed.
DANGER
indicates an immediately hazardous situation which could result in
death or serious injuries.
WARNING
indicates a potentially hazardous situation that could result in death or
serious injuries.
CAUTION
indicates a potentially hazardous situation which could result in
moderate or light injuries and Product damage.
The following triangular symbol together with the explanation alongside
indicates the type of hazard to be dealt with.
3.3 Graphic symbols used on the Product
Below are the symbols to be found on the Product:
CE mark indicating the Product conforms to directive 93/42EEC and
subsequent amendments and supplements
Date of manufacture (month and year)
Manufacturer’s address
Fuses used in the device
Compulsory to read the manual
Model
Serial number
Disposal (waste)
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4 Precautions for the Product operator
4.1 Technical safety specifications
Cleaning personnel
The Product cleaning and disinfecting operations described in Chapter
6 must only be performed by the Operator.
Service personnel
The inspection and maintenance operations described in Chapter 7
must only be performed by the Service Personnel.
4.2 Personnel training obligation
Operator Instructions
The Responsible Organization must instruct the Operator on how to
use, clean and service the Product.
The instructions must be provided in written form on the basis of this
manual.
4.3 Warranty and liabilities
TECNO-GAZ disclaims all liability as regards unreliable Product
operation in the following cases:
-The Product has not been used for its intended purpose and in
conformity with the operating instructions.
-Authorized modifications and repairs have not been performed by
SERVICE PERSONNEL.
5 Product description and operation
5.1 Product description
Versions
The Product is available in various versions:
-mobile
-wall
-ceiling
-double ceiling
See drawing 119
MOBILE version: wheel base (1), power supply unit (2), base cover (3),
vertical stem (4), oscillating arm (5), fork (6), lamp cupola (7), function
control keyboard (8), sterilizable handle (9), power supply plug (10),
switching on base (11).
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See drawing 120
WALL version: wall plate (1), power supply unit (2), wall box (3),
horizontal arm (4), oscillating arm (5), fork (6), lamp head (7), function
control keyboard (8), sterilizable handle (9), power supply plug (10).
See drawing 121
CEILING SINGLE version: ceiling cover (1), ceiling anchorage tube (2),
power supply unit (3), horizontal arm (4), oscillating arm (5), fork (6),
lamp head (7), function control keyboard (8), sterilizable handle (9).
See drawing 122
CEILING DOUBLE version: ceiling cover (1), ceiling anchorage tube
(2), power supply unit (3), double horizontal arm (4), oscillating arm (5),
fork (6), lamp head (7), function control keyboard (8), sterilizable handle
(9).
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5.2 Description of operation
Control keyboard
Product control is by means of the control keyboard positioned on the
fork. By pressing the keys, the following functions are started:
-On/Off button (1)
-Sun button (2): light intensity adjustment. The intensity level is
indicated by 5 green microleds
-“K” button (3): color temperature selection 4.500 –5.000K
-“E” button (4): dental care function. Function available only when the
lamp is switched off
-Light field diameter selection (5), increase or decrease the light field
diameter.
Remote control panel
As optional, the lamp can be equipped by a wall control panel: an
additional keyboard control all the functions listed above.
2
3
1
2
4
5
1
2
2
5
3
4
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5.3 Product handling
SINGLE ceiling model
DOUBLE ceiling model
∞
∞
∞
∞
∞
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Wall model
Floor model
180°
∞
10°
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The Product can be moved using the sterilisable grip (fig. A) or by means of the side handles
(fig.B)
By pressing the keys on the membrane keyboard, the previously described control functions are
started (fig. C)
RECOMMENDED WORK DISTANCE
Fig.A
Fig.B
Fig.C
To optimize light intensity, the product ORION40 is best used at a
distance of 1 m, and the product ORION40DS at a distance of
80cm.
The Product nevertheless also ensures a good light intensity at a
distance between 70cm and 140cm.
1m Orion40
80cm Orion40DS
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6 Cleaning and disinfecting
6.1 Cleaning the Product
Frequency
The Product is best cleaned every time before use.
WARNING –Electric shock hazard
Before cleaning the product, make sure it is off and cannot be switched
back on.
Allow the lamp to cool down and only clean it when it is cold.
Protect the Product from water spray and detergents and do not clean it
in direct contact with liquids.
-Do not use sharp, pointed or abrasive objects, to avoid the risk of
damaging surfaces.
-Do not pour liquids directly on the Product.
-Clean the Product with a damp, but not wet, cloth.
-Clean using appropriate detergents, without chlorine. Do not use
abrasive products, petrol, paint thinners, alkaline detergents, acids,
containing alcohol or aldehydes.
-Dose the detergents strictly according to the percentage indications
shown on the manufacturer’s technical sheet, being careful that no
liquids penetrate into the joints of the various Product parts, with
special care give to the reflector and supporting structure.
Failure to comply with the above instructions could cause the paint to
come off with possible accidental dropping of such paint into the patient
area, the early ageing of the plastic parts with consequent weakening
and the possibility of breakages, and the tarnishing of the protection
screens and glass.
CAUTION –Possibility of damaging the Product
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6.2 Product disinfecting
Frequency
The Product is best disinfected daily.
WARNING –Electric shock hazard
Before proceeding to clean the Product, make sure it is off and cannot
be switched back on.
Allow the lamp to cool down and only clean it when it is cold.
Protect the Product from water spray and detergents and do not clean it
in direct contact with liquids.
Disinfectants can contain substances that are harmful for the health;
use disinfectants indicated by the national commission for hygiene
and disinfection, according to the hygienic standards adopted by the
Responsible Organization,
-Do not use sharp, pointed or abrasive objects, to avoid any risk of
damaging the surfaces.
-Do not pour disinfectant liquids directly on the Product.
-Disinfect the Product with a damp but not wet cloth.
-Use appropriate disinfectants with low alcohol content.
-To prevent damaging the stainless-steel and aluminium parts, use
only disinfectants that do not contain chlorine or halogens.
-Dilute the disinfectants in strict accordance with the percentage
indications on the manufacturer’s technical sheet, being careful no
liquids penetrate into the joints of the various parts of the Product,
with special attention for the reflector and supporting structures.
Failure to comply with the above instructions could cause the paint to
come off with possible accidental dropping of such paint into the patient
area, the early ageing of the plastic parts with consequent weakening
and the possibility of breakages, and the tarnishing of the protection
screens and glass.
CAUTION –Possibility of damaging the Product
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WARNING –Hazard for the patient
The hand-pieces are made of plastic material resistant to heat and
knocks (PSU –Polysulphone).
Replace the hand-pieces as soon as these become cracked or
deformed, as these could fall in the patient area.
Hand-piece fitting / removal:
- press the handpiece safety key and remove the handpiece.
- insert the handpiece up fast and turn it until it fastens on and rotation
is blocked.
Sterilization
Clean and disinfect the hand-pieces in the traditional way before
sterilization. They can be cleaned with a mid-alkaline detergent free of
active chlorine. To disinfect the hand-pieces, we suggest using alcohol
or aldehyde-based products. The disinfectants must be approved by the
manufacturer for use on polysulphone (PSU). After disinfecting, rinse off
the detergent residues with plenty of water.
The hand-pieces fit into a suitable sterilization pack (disposable
sterilization pack, e.g., plastic/paper bags; single or double pack),
before being sterilized.
The hand-pieces can withstand about 200 steam sterilization cycles in
accordance with the following parameters:
-steam sterilization at 121°C 1.3 bar from 25 to 30 minutes
-steam sterilization at 134°C 2.3 bar for 4 minutes
Do not exceed a sterilization temperature of 134°C.
Strictly keep to the ISO 17665-1 standard.
When placing in the autoclave, make sure the open side of the hand-
pieces is turned downwards. The hand-pieces must be free and not
burdened by other material being sterilized.
Damaged hand-pieces must no longer be used.
6.3 Sterilizing hand-pieces
Frequency
The hand-pieces must be sterilized before use and can withstand up to
200 cycles.
The operator must comply with the rules of the national commission for
hygiene, disinfection and sterilization.
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7 Adjustments and maintenance
7.1 Setting the swinging arm
See drawing 123
The Product is sold already balanced and does not require further
adjustment. In the event of the spring swinging arm becoming stiff or
loose over time, mechanical intervention is possible by regulating the
compression of the internal spring.
Loosen the two stop dowels (1) which secure the cover (2) and move
this forward. Fit a pin (3) with max diameter of 7 mm in the holes of the
ring nut and turn in the direction indicated by the arrows to
increase/decrease the load on the spring.
If the swing arm drops, this means the elastic force of the spring is
insufficient:
-turn the lever downwards and load the spring.
If the swing arm continues to lift up, this means the elastic force of the
spring is too high:
- turn the lever upwards and release the spring.
After making adjustments, return the covering to its original position.
7.2 Clutch adjustment
See drawing 123
The brakes are set during installation. As for all the mechanic parts,
brakes also are subject to wear and tear.
If the lamp body does not automatically keep the position in which it is
put, it is necessary to adjust the braking force by acting on the screws
of the brakes.
Horizontal arm brakes
Use a cut-suitable screwdriver to increase the braking force, rotating
clockwise the screws (4) and (5) of the horizontal arm.
Fork brakes
To increase the head braking force, rotate clockwise the dowels (6 and
7) of the brake with an Allen key.
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7.3 Periodical checks to be performed on the
Product
CAUTION –Product electrical check
At the time of start up and after each maintenance job, perform
electrical tests and jobs indicated in the IEC 62353 standard.
7.4 Routine maintenance
CAUTION –Interrupt the power supply before doing any maintenance
jobs
CAUTION –Check Product integrity
No.
Period
Job
1
Before using
Make sure there are no pieces or fragments of paint that could
become detached and fall within the operating field. If there are
any, remove them manually.
2
Before using
Make sure the light source protection screens are not damaged.
If they are, contact the Service Personnel and have them
replaced.
3
Every 6 months
Check all the Product joints and make sure there are no noises
or squeaks. If there are, lubricate the clutches involved with
suitable grease for industrial use at a service temperature
between -30°C and + 120°C, type OKS 470 or similar
characteristics.
4
Every 6 months
If the Product fails to maintain a regular position, adjust the
clutches as indicated at points 7.1 and 7.2 (arm and clutch
adjustment).
5
Once a year
Make sure the bar retention screws are tightened properly. Also
check the bar horizontal arm retention screws and the swinging
arm screws.
If these are not properly fastened, adequately tighten.
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