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9 Led Pi+bat GB
9 Led Pi+bat GB
9 Led Pi+bat GB
Operative Manual
Installation – Use – Maintenance
Introduction
Dear Client,
RIMSA congratulates you for having purchased a product from its range and invites you to read carefully
every part of the present Operative Manual, subdivided into installation, use and maintenance phases.
You will find all the necessary instructions for a correct use of the product within. Please observe the
warnings contained carefully, keep it unaltered and easy to find and be accessible to the operator. In
case of sale or transfer of the used apparatus, this manual and its attachments must always accompany it.
Rimsa can modify the content of the present Manual, without previous notice or further obligations, in
order to include variations and improvements.
The reproduction or translation of any part of the present manual is forbidden without the written
agreement of RIMSA.
We inform you that our Company remains completely at your disposal for further information and
clarifications of everything concerning the installation, use and maintenance of the product.
I The symbol to the side and used in the present manual is to be considered as advice and
requires particular attention.
The symbol to the side and used in the present manual means that it is to be considered
“compulsory” in order to install and use the device correctly.
There is a guarantee coupon attached (green page) to compile and return to RIMSA.
This coupon includes:
the re-traceability of the Medical Device as required by the 93/42/CEE European
Directive.
the Guarantee of the Product as shown on page 10.
the confirmation of the complete reading of the manual by the installer as a
necessary and sufficient clause in order to be declared SUITABLE for the task of
installing the apparatus (having all the necessary information available for
installation with the use of the present manual).
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CONTENTS Page
Chapter 5 – Maintenance
Chapter 6 – Diagrams
RIMSA does not assume any responsibility for eventual damage to people or things as a
result of failure to respect the safety regulations and recommendations contained in the
present document.
The (PENTALED EV) IX LED mobile+battery secondary scialytic lamp for surgery is designed and
constructed according to the provisions of the 93/42/CEE directive.
Conformity is documented by the plate with the EC mark (portrayed below) and by the declaration of
conformity accompanying the present manual.
The plate is positioned on the tube of the horizontal arm near the central rotating element.
The re-traceability of the (PENTALED EV) IX LED Medical Device is guaranteed by the series number
positioned on the label in fulfilment of the internal company PO 7.5 Operative Procedure.
Description of the symbols on the plate, the product and in the present manual:
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Operative Manual Rev.0 Page 6 of 27
Type B apparatus. Indicates the level of protection against direct and indirect contact.
Fragile package.
Package weight.
Danger of burning.
I Attention → ADVICE
Warning → COMPULSORY
All electrical and electronic products should be disposed of separately from the municipal
waste stream via designated collection facilities appointed by the government or the local
authorities.
Classification of the medical devices in terms of the 93/42 EEC directive (attachment IX)
Short-term, active and not invasive medical device destined for local illumination of the patient. In terms
of the above, the device is considered as falling into class I, according to rule 1.
The incorrect use and non-observance of the precautionary measures reported here can provoke
serious accidents. You must, therefore, understand the functions of the (PENTALED EV) IX LED
scialytic lamp using these instructions for installation, use and maintenance.
Do not look directly at the lit lamp and do not insert reflecting objects in the way of the rays. There
is the danger of blinding due to the high potency of illumination.
The distance between the surface of emission of the light of the lamp and the surface of the patient
should not be less than 80 cm so as to guarantee an efficient illumination.
The lamp must not be switched on if the closure glass or the filtering system (parabola) is damaged
or broken. Thermal radiation may arrive in the operation area and the tissue of the wound of the
surgical intervention might overheat and dry up. There is indeed the danger of necrosis of the tissue
with prolonged use over time.
Do not place any objects on the body of the lamp nor hang objects on the arm or the body of the lamp
because, in this way, a safe position cannot be guaranteed and the danger exists that these objects
might fall into the operation area. The weight of heavy objects (the weight of the body of a person)
can damage the apparatus.
The head of the lamp must not be covered while functioning because this way the thermal exchange
with the environment is prevented and the lamp might overheat.
Avoid collisions with the mobile+battery arms and the body of the lamp. The lamp might be
damaged with a violent collision or pieces of paint might break off and fall into the operating field of
the patient zone.
The main switch must be used to remove the tension of the electrical plant of the premises to the
scialytic apparatus for any kind of maintenance.
Whenever changing the burnt-out bulb immediately, be particularly careful to avoid burning, which
would be caused to the user’s accidental contact with the high temperature parts of the lamp and the
bulb to be changed.
RIMSA P. LONGONI S.r.l. Via Monterosa, 18/20/22 - 20038 SEREGNO (MI) - ITALIA
declares on its own responsibility that the Medical Illumination Device for surgical and diagnostic use:
ATTACCARE
ETICHETTA
constructed by RIMSA P.LONGONI S.r.l., conforms to the Attachment VII of the 93/42 EEC Directive
of June 14th 1993 and applied in Italy by the Legislative Decree N° 46 of February 24 th 1997 and
successive variances moreover, it is in conformity with the following safety regulation EN 60601-2-41.
1.6 Guarantee
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1. The product is covered by guarantee for a period of 12 months, including the electrical parts.
2. The guarantee initiates from the date of installation of the lamp at the client’s premises only and
exclusively if RIMSA personnel carry out the installation. In all other cases the guarantee starts from
the date of forwarding the lamp from the RIMSA store to the client.
3. In case of dispute, the date indicated on the “Transport Document” that accompanies the goods is
retained valid.
4. The reparation or substitution, under guarantee, of a detail, is undertaken for well-ascertained
manufacturing cause and at the unchallengeable judgement of the RIMSA Company. The guarantee
does not include the transfer of personnel, packing expenses or transport.
5. Components subject to normal wear are not included in the guarantee (non-exhaustive e.g. halogen
lamps, fuses, relays, ball-bearings etc.).
6. Not included in the guarantee:
- damage and defects due to installation errors;
- damage or faults caused by carelessness, negligence, abnormal use of the apparatus or other
causes not attributable to the manufacturer;
- interventions for presumed defects or convenience checks.
7. The right to the substitution of the complete Lamp is not recognised.
8. The guarantee does not lead to any direct or indirect compensation of any kind towards people or
things due to the inefficiency of the lamp.
9. RIMSA does not accept responsibility for faults or damage caused by the improper use of the product
or upon which ordinary maintenance has not been practised or the elementary principles of good
maintenance have been neglected (negligence).
10. Compensation for the Lamp lock is not recognised.
11. The guarantee is forfeited automatically whenever the lamp is mishandled, repaired or modified by
the purchaser or third parties not authorised by RIMSA.
12. For interventions, the purchaser must apply to the retailer or the assistance centres indicated by
RIMSA.
13. The components substituted in guarantee must be restituted to RIMSA carriage free.
14. Failure to restitute leads to debiting the cost of the element to the applicant.
15. RIMSA does not accept returns from the final users.
16. Returns to RIMSA for repair must be managed by the retailer or the assistance centre chosen by the
final user in conformity with the Company PO 7.2 Operative Procedure.
17. Returns to RIMSA must be documented and authorised in conformity to the internal procedure.
18. Products returned to RIMSA must have the authorisation document attached at return and a document
describing the fault.
19. All the products for repair must be sent to RIMSA free port and adequately packaged (it is
compulsory to use the original packing).
20. The manufacturer does not consider himself responsible for the effects on safety, reliability and
performance of the apparatus if:
- montage, added calibration or repairs are not carried out by personnel previously authorised by
RIMSA;
- the electrical plant of the environment (premises) in which installation has taken place is not in
conformity with the CEI 64-8 regulations (regulations for electrical plant for premises utilised for
medical use) and similar regulations;
- the apparatus is not used in conformity with the usage instructions.
21. The green voucher completes the guarantee on the product and, besides, is important for the purpose
of re-traceability and as part proof of having read and understood the present manual.
The following table describes the life of the scialytic lamp in chronological order and the qualifications
requested by RIMSA.
RIMSA does not accept any responsibility for eventual damage to people or
things as a result of employing unqualified operators.
Qualified Installer/Maintenance operator means a male or female person/or
male or female people who has/have completed a course at the RIMSA
company or has/have made an attentive study of the present manual and as
confirmation of this has/have returned the attached green guarantee voucher
The packing for the (PENTALED EV) IX LED mobile+battery model consists of one box:
Dimensions Weight
Packing Content LxDxH (Kg)
1 Scialytic lamp + Operative Manual 73x175x43 46
Transport is carried out by RIMSA or by any carrier as long as the following characteristics are respected:
Temperature (-20/+60)°C
Humidity (30/90) % (including condensation)
Atmospheric pressure (500/1060) h/Pa
Stockage (storage) of the packaged devices must take place in a dry place and at the following
temperature:
Temperature (+5/+40) °C
Humidity (30/90) % (including condensation)
Atmospheric pressure (500/1060) h/Pa
The premises designated for setting up the apparatus must have the following characteristics:
Temperature (+10/+40) °C
Relative humidity (30/75) %
Atmospheric pressure (700/1060) h/Pa
Before proceeding with installation, check that all the packages are present and in good
condition, without damage due to transportation and that the contents coincide with what
has been reported above.
Complaints will be considered only if the vendor or the forwarder is immediately advised.
Every complaint must be made in written form. The goods always travel at the risk and
danger of the purchaser.
Keep the original packing in case there is the need to return the lamp.
The preparatory masonry and electrical work for installing the Product is at the total
expense of the Final Client.
The work of preparing the electrical plant of the premises designated for medical use for
the electrical supply to the Product must be carried out safely according to good rules by
qualified personnel.
Qualified personnel means, as non-exhaustive examples, the following professional
figures:
Expert electro-technicians, qualified to exercise the profession of electrician
Before installing the scialytic lamp make sure of the following conditions:
The electrical plant of the environment (premises) in which the installation will be carried out
must conform to the CEI 64-8 regulations (regulations for electrical plant for premises designated
for medical use) and the national laws and/or regulations in force.
An electrician qualified to issue the certificate of conformation must certify the electrical plant.
The check of the grounding must be certified, as foreseen in the regulation in force.
After making sure of the correspondence with the above-listed requisites, identify which of the following
types of electrical plant you are facing.
Remove the bolt with washer from the bottom of the bent pipe. Insert
the cover of the pipe on the upper part paying attention not to damage
the painting. Fix the cover at approximately 15cm fixing screwing
without force (otherwise you risk causing undesired scratches on tube
1 painting) a single screw of the three screws placed on the collar (1).
IMPORTANT:
The battery is disconnected for the delivery. Remember to connect it
exactly.
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3
Using the bolt (1) previously unscrewed from the pipe, join the tube (3)
to the base (2) and lock the bolt with some turns. Insert the plug of the
2
lock of the pipe in the appropriate hole of the base.
1
Join the electrical contacts coming from base to those of the cover.
ATTENTION: Every six month you have to control the bolt is
loked.
1
Lock with force the bolt from the lower part using one pipe wrench (1)
or a similar tool (force of serration c.ca 60 Nm).
Lower the cover until the bottom of the base while the switch is in
frontal position and centred. Lock the three screws of the collar (1).
Join the electrical connectors (2) respecting the colours of the electrical
cables:
yellow/green with yellow/green
blue with blue
brown with brown
Align the hinge (1) of the vertical oscillating arm with the bent tube (2).
Keep the parts to couple aligned on the same axis and align the hole of
the iron pin (3) with the threaded hole of the bent pipe.
Screw down the special screw with a mechanical key of 7 measure
until the end of the screw (torque force around 8Nm).
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In order to remove the detention of the arm, lower it and remove the
detention.
Close the hole with its own plastic plug attached in the equipment.
ONLY AFTER
3.3 Checking the installation and testing the scialytic operations before use
The following notes are to be considered as compulsory during the phase of checking the
installation as it proves the correct verification of all the points indicated .
For this reason every single point should be looked at when treated together with the
guarantee sheet proving the correct installation of the device.
E.g.: Check the removal of the stop inserted in the oscillating arm ڤ
Checking installation:
1 Check the removal of the stop inserted in the oscillating arm once installation is completed ڤ
Check the supply tension on the transformer output terminals and verify that is between 17,5
2 ڤ
and 18,5 Volt
3 Check the correct insertion of the halogen bulb (flush on the lamp-holder and on the vertical) ڤ
Scialytic test:
__________________________________
The presence of electro-scalpels, defibrillators and other devices functioning at high
frequence can disturb the scialytic lamp. Their influence will be possibly detectable from
variations in luminous intensity.
Before proceeding to the cleaning operations, remove the supply to the lamp from the
main line switch dedicated to the scialytic lamp
All the parts of the lamp can be cleaned with ordinary detergents on all the external surfaces and can be
disinfected with ordinary disinfectants in use in the operating department (no corrosive liquids and
containing chlorine) using a soft wet cloth.
DO NOT pour the contents of detergent and disinfectant containers directly over the
lamp even with vaporisers and never spray liquids inside the head or clean the internal
reflecting parabola.
Only disinfectants authorised by the manufacturer should be used for use on the following materials: rigid
polyurethane (PUR), polyamide +glass fibre (PA6) white Teflon (PTFE), and epoxy-polyester based
paint.
Simple cleaning: the handles that can be sterilised consist of thermo-hardened material, resistant to hear
and shock resistant. They can be cleaned with slightly alkaline cleaners without active chlorine. Remove
the detergent by rinsing with abundant water.
Alternatively the handles can be mechanically cleaned through thermal disinfection up to a temperature of
93°C for 10 minutes.
Disinfection: we advise alcohol or aldehyde based products for disinfecting the handles
Sterilisation: the handles can be sterilised with steam.
For sterilising, keep to the instructions contained in the following steam cycle sterilisation table
134 °C
(if the handle has come into
134 °C 2 18 min 30 min
contact with infective agents -
BSE)
134 °C
(if the handle has not come into
134 °C 2 4 min 30 min
contact with infective agents -
BSE)
When the steriliser is loaded, check that the open part of the handle is turned downwards. The handles
must be positioned freely, avoid covering them with other accessories.
The handle should be sterilised whenever it is necessary and in always following any internal protocols or
national or local directives.
The handles that can be sterilised are subject to natural wear. Normally they last about
200 cleaning cycles. Damaged handles can no longer be used. The user must take into
account the demands of the competent national body on hygiene and disinfection.
The Rimsa Company does not advise hot air sterilisation. If, however, it becomes necessary, the handle
must be sterilised, unpacked, at 134°C for 3 minutes.
Handle disposal:
sterilise the now worn-out handle to avoid contamination and eliminate it according to the normal
procedures for non biologically infected materials.
Before proceeding to the operations of changing fuses, remove the supply to the electric
panel from the main line switch dedicated to the scialytic lamp
The fuses are placed on the cover of the slab. Unscrew the fuse and replace the out-of-order fuse with one
new with identical characteristics, respecting the face on the label.
The fuses are located on the cover of the base. Unscrew the fuse and replace the out-of-order fuse with
one new with identical characteristics, respecting the face on the label.
(PENTALED EV) IX
Technical data on the light
LEDMobile+battery
Reflector in vacuum treated aluminium
Technology of the reflecting mirror
for covering metal
Diameter of the luminous field d10 and d50 [mm] d10=150, d50=90
General data
Dimensions
Certificates
In conformity with the 93/42/CEE
directive
Chapter 5 – Maintenance
The battery group does not need any specific maintenance because all the batteries used are lead-sealed
and are based upon the modern technology of oxygen recombination.
This makes the lamp completely safe thanks to the loss of the electrolyte. The lamp can be used in any
position and does not need any further maintenance.
Charge/discharge cycles depend on the depth of discharge; however it is possible to calculate roughly
1000 charge/discharge cycles at 20-30% of discharge depth. The average lamp life of the battery group is
usually 4 years in stand-by.
If the storage takes place in a dry place and not in extreme conditions the battery maintains its charge for
approximately one year.
If you do not know the status of the battery and want to check its general conditions, it is necessary to
charge it at least 12 hours and to run it down at 50% of the highest luminous intensity, verifying that it
lasts at least 4 hours.
For extraordinary maintenance of the lamp the following points need checking:
luminous intensity reduced by more than 30%: check that an opaque mist has not formed on the
internal surface of the glass protection with the evaporation of detergents penetrated inside the
head and evaporated due to the heat of the bulb.
detachment of parts of the paint from the apparatus due to accidental collision with other objects:
these fragments can fall onto the patient zone during the use of the device.
For the cases mentioned above, contact the Manufacturer or the assistance centre nearest the Client
authorised by the Manufacturer.
n Problem Solution
Check the horizontally of the plate floor and the
1 The lamp does not hold its position adjustment of the frictional force
The lamp does not work Check the presence of the fuses inside the terminal
board and their condition.
2
The luminous band on the operating Check the correct position of sterilizable handle.
5 field is not in focus
The lamp working thanks to the The charger does not work. The interior green light
6 battery runs down after one hour. does not switch on.
Batteries are exhausted.
Led 3W Z100113
Chapter 6 – Diagrams
6.1 General electrical diagram