Lights Packet V3.pdf

Equipment*Package:*Lamps&and&Lights*UDMS*#:&12282&Date*of*Creation:&November&10,&2015&Creator:&Complied&by&Cassandra&Stanco&for*Engineering&World&Health&(EWH)***Equipment*Packet*Contents:*This&packet&contains&information&about&the&operation,&maintenance,&and&repair&of&laboratory&lamps&and&lights.&&Part*I:*External*From*the*Packet:** 1. An*Introduction*to*Operating*Room*Lights:*&PowerPoint&*Part*II:*Included*in*this*Packet:** 1. Operation*and*Use:*a. Brief&Introduction&to&Lamps&(p.&3)&b. Introduction&to&Surgical&Lighting&(p.&4N6)&c. Operation&and&Use&of&Lamps&(p.&7N9)&2. Diagrams*and*Schematics:*a. Figure&1:&Mobile&Theatre&Lamp&(p.&11)&b. Figure&2:&&Fixed&Theatre&Lamp&(p.&12)*c. Figure&3:&Parts&of&an&Incandescent&Bulb&(p.&13)*d. Figure&4:&Parts&of&an&LED&(p.&14)*e. Figure&5:&Bulb&Replacement&(p.&15)&f. Figure&6:&WHO&Specification&Operating&Light&(p.&16N17)&g. Figure&7:&WHO&Specification&Examination&Light&(p.&18N20)&3. Preventative*Maintenance*and*Safety:*a. Operating&Room&Light&Preventative&Maintenance&(p.&22)*b. Lights&Preventative&Maintenance&Table&(p.&23)*4. Troubleshooting*and*Repair:**a. Operating&Room&Light&Repair&and&Troubleshooting&Flowchart&(p.&25N28)*b. Lights&Troubleshooting&Table&(p.&29)*5. Resources*for*More*Information*a. Resources&for&More&Information&(p.&31)*b. Bibliography&(p.&32N33)** *
1




1.*Operation*and*Use*of*Lamps*and*Lights****Featured*in*this*Section:****Malkin,&Robert.&“Theatre&Lamps&and&Other&Lights.”&Medical%Instrumentation%in%the%Developing%World.&Engineering&World&Health,&2006.&&*WHO.&“Operating&Light.”&From&the&publication:&“WHO&Technical&Specifications&for&61&Medical&Devices.&WHO.&Retrieved&from:&http://www.who.int/medical_devices/management_use/mde_tech_spec/en/&* *Wikipedia.&“Surgical&Lighting.”&Wikipedia.&Retrieved&from:&https://en.wikipedia.org/wiki/Surgical_lighting&&* ** *


2




User Care of Medical Equipment – First line maintenance for end users


36


Chapter 4.10 Lamps


Function
There are many kinds of sources of light used in medicine. This chapter deals with large lights for


operating theatres or delivery suites, ultraviolet or infrared phototherapy units, ophthalmic slit lamps, handheld
and head worn lamps for ENT clinics, dental curing lights and domestic torches. However, the principles here
will help in the user care of any kind of light source. Endoscopes are dealt with separately in chapter 4.7.


How it works
Each type of lamp will have a power source with switch and a bulb. Some will also have controls for the


brightness or focus of the light, while others will also have lenses to direct the light where required. Some lights
operate off mains electricity, while others use batteries instead. Some lights have both, using the batteries for
back-up power in case of mains supply failure. Electric bulbs and batteries have limited life and will need
regular checking. Bulbs can last from hundreds of hours operation to thousands of hours. Some equipment, e.g.
UV phototherapy units, will indicate when bulbs need replacing. Turning bulbs on and off frequently can reduce
the bulb life. A stock of spares should be kept of all the correct voltages and wattages (ratings) of parts.

















Strengthening Specialised Clinical Services in the Pacific. User Care of Medical Equipment: A first line


maintenance guide for end users. (2015).


Brief Introduction to


Bilirubinometer


Brief Introduction to Lamps


3




Surgical lighting 1


Surgical lighting
A surgical light – also referred to as an operating light or surgical lighthead – is to assist medical personnel during a
surgical procedure by illuminating a local area or cavity of the patient. A combination of several surgical lights is
often referred to as a “surgical light system”.


History
Technology development For lighting a surgical operation in the middle of 1850s, the room itself was built towards
the south-east with windows in the ceiling to benefit from the natural sunlight as much as possible. The greatest
problem with this was that the possibility to perform a procedure relied on the time of the day and weather
conditions, but also the problem of the doctor, nurse or medical equipment easily blocking the illuminated area. A
development of this was the use of mirrors on the four corners of the ceiling to reflect the sunlight towards the
operating table but the problems where only slightly reduced.


Optical condenser in an indirect light was also tried to reduce the heating but without success. When the electric
lights made their entrance into the operating room in the 1880s it also quickly showed problems. At this early stage
of electricity the ability to control the light emitted was very low. The light created was still moving and diffuse with
great heat radiation.


With the introduction of light-emitting diodes as light sources, the problem of heat radiation is removed, while
energy requirement is reduced.


Terminology and measurements
• Lux (lx)
Unit for the amount of visible light measured by a luxmeter at a certain point.


• Central illuminance (Ec)
Illuminance (lx) at 1m distance from the light emitting surface in the light field centre.


• Light field centre
Point in the light field (lighted area) where illuminance reaches maximum lux intensity. It is the reference point for
most measurements.


• Depth of illumination
The distance under the light emitting area where the illumination reaches 20% of the central illuminance


• Shadow dilution
The lights ability to minimise the effect of obstructions.


• Light field diameter (D10)
Diameter of light field around the light field centre, ending where the illuminance reaches 10% of Ec. The average of
four different cross sections through the light field centre.


• D50
Diameter of light field around the light field centre, ending where the illuminance reaches 50% of Ec. The average of
four different cross sections through the light field centre


Introduction to Surgical Lighting


Wikipedia. “Surgical Lighting.” Wikipedia. Retrieved from: https://en.wikipedia.org/wiki/


Surgical_lighting


4




Surgical lighting 2


Norms and requirements for surgical light
The International Electrotechnical Commission (IEC) has created the document IEC 60601-2-41 – Particular
requirements for the safety of surgical luminaries and luminaries for diagnosis, 2000 to establish norms and
guidelines for the characteristics of a surgical and examination light to secure safety for the patient as well as lower
the risk to a reasonable level when the light is used according to the user manual. Some of the standards for surgical
lightheads are the following.


Homogenous light The light should offer a good illumination on a flat, narrow or deep surface in a cavity, despite
obstacles such as surgeons' heads or hands.


Lux The central illuminance can not exceed 160 000 lux and should not be lower than 40 000 lux
Light field diameter The D50 should not exceed 50% of d10 diameter
Colour rendition For the purpose of distinguishing true tissue colour in a cavity, the colour rendering index (Ra)
should be between 85 and 100.


Backup possibility In case of interruption of the power supply, the light should be restored within 5 seconds with at
least 50% of the previous lux intensity, but not less than 40 000 lux. Within 40 seconds the light should be
completely restored to the original amount of lux.


Announcement The IEC document also mentions what needs to be notified to the user. For example, should the
voltage and power consumption be marked on or near the lampholder as well as on the lighthead. In the instructions
for use the following info should be announced.


• Cleaning and decontamination of the surgical light
• Safety aspects of optical filter (purpose and warning to prevent removal)
• Central illuminance
• Light field diameter
• Depth of illumination
• Shadow dilution
• Correlated colour and colour rendering index
• Total irradiance
• Cleaning, disinfecting
• Handling of the lighthead in case of failure
• How the user should respect the national rules for hygiene and disinfecting


References
1. Extrait de la revue Techniques Hospitalières noo 400 Janvier/1979 "L’éclairage en salle d’opération" by M.
Hainault p. 47


2. IEC International 60601 – Particular requirements for the safety of surgical luminaries and luminaries for
diagnosis – Part 2-42.


Wikipedia. “Surgical Lighting.” Wikipedia. Retrieved from: https://en.wikipedia.org/wiki/


Surgical_lighting


5




Article Sources and Contributors 3


Article Sources and Contributors
Surgical lighting  Source: http://en.wikipedia.org/w/index.php?oldid=434703128  Contributors: A5b, Chris the speller, Fabrictramp, Kjkolb, MarmotteNZ, Mild Bill Hiccup, Paalappoo,
Respirator, RockfangSemi, Thorseth, Wperdue, 9 anonymous edits


License
Creative Commons Attribution-Share Alike 3.0 Unported
http:/ / creativecommons. org/ licenses/ by-sa/ 3. 0/


Wikipedia. “Surgical Lighting.” Wikipedia. Retrieved from: https://en.wikipedia.org/wiki/


Surgical_lighting


6




Medical Instruments in the Developing World Malkin


Page 59




2.16 Theatre Lamps and Other Lights


2.16.1 Clinical Use and Principles of Operation

All lights in all parts of the hospital operate on the same principals. However, the operating
theatre has the most variety of lights.

Operating rooms in the developing world have several separate lighting sources. The first is the
general room lighting found in the ceiling. This is used during the set up of the rooms, cleaning
and as background lighting for the staff who are not working in the sterile field.

The second source of light is the overhead operating room lights. These can be large reflectors
with one or more bulbs in them, mounted on a counter balanced arm that can be positioned over
the site of the operation. These units have a sterile positioning handle that is often adjusted over
the period of the operation. Many of the problems associated with these lights are mechanical in
that they do not stay in the position selected and the counter weights have to be adjusted. A
secondary problem is that one or more of the lights will burn out giving dark spots in the surgical
field. These lights have control boxes on or in the wall where the intensity control is found along
with the on off controls. This control box usually contains an SCR control board, or transformer
that powers the lights at some voltage under 115 volts.




In some rooms there may be a portable operating room light. These are large reflector lights
that roll from room to room. They simply plug in to a 115 pr 220 volt outlet and are positioned
as needed by the surgeons.

The third source of light is the “personal head light” that a surgeon will wear. This is a lens that
focuses light transmitted to it by a fiber optic cable from a remote light source. This light source
may have a multitude of bulbs in it that can be switched into use via a knob on the top of the


A typical OR in Africa showing two
principal lighting sources: The
overhead light and the window.
Against the far wall is an X-ray
viewing light source.


Malkin, Robert. “Theatre Lamps and Other Lights.” Medical Instrumentation in the


Developing World. Engineering World Health, 2006.


Operation and Use of Theatre Lamps and Lights


7




Equipment found in the OR, ICU and ER


Page 60


unit, or by moving the fiber optic cable from one side to another and turning on that light. These
units are often the personal property of the surgeon.

Some lights will utilize cooler light systems by filtering out infrared portions of the light. The
different mirrors and reflective surfaces on the inside of the light will allow for maximum light
transfer to the operating area. Also, the lights may have a plastic coating and thermal guard on
the outside housing to ensure a cooler surface when adjusting the light.



For overhead lights, the distance from the lower edge of the light to the operating table should
be approximately one meter. Initial positioning is accomplished by using the rail on the lamp
housing to move it into place. The surgeon has the option of adjusting the light using the center
hand grip, which is provided with a replaceable, sterilized sleeve.



Most operating lamps work directly from the outlet power through a switch. However, some
lights may provide dimming circuits. Older dimmers found in the developing world often work
with a rectifier or a variable transformer (variac) gradually varying the voltage applied to the
lamp and therefore the intensity of the light delivered. Some dimmers operate using solid-state
electronics (SCR’s). These are rarely seen in the developing world and are typically impossible to
repair.

Some operating room lights use fluorescent bulbs. Fluorescent bulbs generally operate through a
transformer and use a starting circuit (sometimes called a ballast). In some cases, the bulb is
heated before the starter is engaged. The heat causes both a change in the internal tube
pressure and an increased electronic flow between the electrodes. A high voltage (25,000 V)
spike from the starter establishes an arc in the atmosphere between the electrodes. After the
initial spike, the bulb will operate at a low current and temperature,




A surgeon’s headlamp


Older theatre lamps used
simple circuits, such as those
shown here to vary the
intensity of the light. Similar
circuits are used for 220 volts.


Malkin, Robert. “Theatre Lamps and Other Lights.” Medical Instrumentation in the


Developing World. Engineering World Health, 2006.


8




Medical Instruments in the Developing World Malkin


Page 61


2.16.2 Common Problems

Take special precautions when working with medical lights. The highest intensity lights can
cause blindness if you look directly into the light. For the same reason, the light should not be
used if the cover glass or filter system is damage or destroyed. In placing the light to begin
work, your eyes should be greater than two feet or approximately sixty centimeters away from
the source.

The lamps can be xenon, quartz-halogen, mercury-vapor or metal halide. These bulb types are
not interchangeable because of the voltage supplying the bulb, the connector for the bulb and
the heat generated by the bulb. The bulbs have a life expectancy of about 250 hours and need
to be monitored for replacement. When replacing bulbs care must be taken to avoid touching
the reflector part of the bulb as that can affect the brightness at the surgical site. Also, avoid
touching the bulb itself. Your fingerprints can cause excessive heating of the glass, dramatically
shortening the life of the bulb. If the glass of the bulb has been touched, clean the fingerprints
off with alcohol.

It can be very difficult to find replacement light bulbs in the developing world and impossible to
ship replacements into the county. While it may be possible to wire a replacement socket for a
more readily available bulb, the engineer must be sure to consider size, voltage, temperature and
materials. It maybe more prudent to start with a readily available bulb and socket and design a
completely new fixture.


2.16.3 Suggested Minimal Testing

There is no calibration needed for operating room lights. If the light turns on, changes intensity
(if equipped) and stays in place after adjustment, it is ready to use.




Malkin, Robert. “Theatre Lamps and Other Lights.” Medical Instrumentation in the


Developing World. Engineering World Health, 2006.


9




2.*Diagrams*and*Schematics*of*Lamps*and*Lights****Featured*in*this*Section:*****Skeet,&Muriel&and&David&Fear.&“Shadowless&Theatre&Lamps.”&Care%and%Safe%Use%of%Medical%Equipment.&VSO&Books,&1995,&p.&118N125.&**WHO.&“Operating&Light.”&From&the&publication:&“WHO&Technical&Specifications&for&61&Medical&Devices.&WHO.&Retrieved&from:&http://www.who.int/medical_devices/management_use/mde_tech_spec/en/&&&WHO.&“Examination&Light.”&From&the&publication:&“WHO&Technical&Specifications&for&61&Medical&Devices.&WHO.&Retrieved&from:&http://www.who.int/medical_devices/management_use/mde_tech_spec/en/&*Wikimedia&Commons.&“Incandescent&light&bulb&(with&labels).”&Posted&November&8,&2009.&Retrieved&from:&https://commons.wikimedia.org/wiki/File:Incandescent_light_bulb_(no_labels).svg&*Wikipedia.&“LightNemitting&diode.”&Wikipedia.&Retrieved&from:&https://en.wikipedia.org/wiki/LightNemitting_diode&* *


10




Figure 1: Mobile Theatre Lamp


Skeet, Muriel and David Fear. “Shadowless Theatre Lamps.” Care and Safe Use of Medical Equipment.


VSO Books, 1995, p. 118-125.


11




Figure 2: Fixed Theatre Lamp


Skeet, Muriel and David Fear. “Shadowless Theatre Lamps.” Care and Safe Use of Medical Equipment.


VSO Books, 1995, p. 118-125.


12




Figure 3: Parts of an Incandescent Bulb


Wikipedia Commons. “Incandescent light bulb (with labels).” Posted November 8, 2009. Retrieved from: https://


commons.wikimedia.org/wiki/File:Incandescent_light_bulb_(no_labels).svg


13




Figure 4: Parts of an LED (Light-Emitting Diode)


Wikipedia. “Light-emitting diode.” Wikipedia. Retrieved from: https://en.wikipedia.org/wiki/Light-


emitting_diode


14




Figure 5: Bulb Replacement


Skeet, Muriel and David Fear. “Shadowless Theatre Lamps.” Care and Safe Use of Medical Equipment.


VSO Books, 1995, p. 118-125.


15




WHO_TS_61_MDs_web.xlsx 38


1


i Version No. 1ii Date of initial version 6/13/12iii Date of last modification 7/4/14iv Date of publicationv Completed / submitted by WHO working group1 WHO Category / Code (under development)2 Generic name Operating light3 Specific type or variation (optional) fixed4 GMDN name Operating light5 GMDN code 122826 GMDN category 04 Electro mechanical medical devices 7 UMDNS name Lights, Surgical 8 UMDNS code 12-2829 UNSPS code (optional)10 Alternative name/s (optional) Lamp/light for medical use; Lamp, operating-room; Lamp, surgical; Lamp, surgical, incandescent; Light, surgical, ceiling-mounted; Light, surgical, connector; Light, surgical, instrument; Operation light; Operating shadowless light; OR light; Surgical lamp11 Alternative code/s (optional) MS 34634; S 39345; S 32248; S 39385; S 32244; S 32243; S 32238; S 36539; S 34635; S 32216; S 3232612 Keywords (optional) operating theater, operating room, overhead, theatre, theater, lamp
13 GMDN/UMDNS definition (optional)


A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.
14 Clinical or other purpose Designed to provide a specialized source of light for illumination of a site of medical intervention. 15 Level of use (if relevant) district hospital, provincial hospital, specialized hospital16 Clinical department/ward(if relevant) operating room, orthopaedics, emergency room17 Overview of functional requirements Provides clear and cool light to operating area.Minimizes shadows and distortion of colour.Mounted on wall or ceiling of operating theatre.Single head must be easily moved by operator to direct light to required area.


18


Detailed requirements Colour temperature to be between 3,000 and 5,000 K.Maximum illumination level at 1m distance to be at least 150,000 lux.Minimum bulb life required 1,000 hours (incandescent type) or 20,000 hrs (LED type). Field diameter required >=20cm (at 1 meter distance from the light source), field depth required>= 50cm. Focal length required>= 65 cm. Heat to light ratio to be ≤ 6 mW/m2.lx. Vertical height adjustment greater than 0.8 m range and rotational radius greater than 1.5 m. Brightness control to allow full adjustment from zero to maximum illumination. Illumination backup to be provided through, e.g. multiple bulb use or spare bulb auto-activation, if a bulb fails (safety system of an additional bulb in each head with automatic switch in case of first bulb failure)Bulb lamp tension no greater than 24V.24) For xenon lamp infrared filtration of at least 90% of the emitted power.25) Color Rendering index of the illumination at least 92%.26) Manual mobilization of each lamp through removable autoclave sterilizable handler.
19 Displayed parameters


MEDICAL DEVICE SPECIFICATION(Including information on the following where relevant/appropriate, but not limited to)
NAME, CATEGORY AND CODING


PURPOSE OF USE


TECHNICAL CHARACTERISTICS


Figure 6: WHO Specification: Operating Light


WHO. “Operating Light.” From the publication: “WHO Technical Specifications for 61 Medical Devices. WHO. Retrieved from: http://


www.who.int/medical_devices/management_use/mde_tech_spec/en/


16




WHO_TS_61_MDs_web.xlsx 38


2


20 User adjustable settings
21


Components(if relevant) *Case is to be hard and splashproof. *Exposed surface characteristics:a) free of sharp edges and washable;b) resistant to corrosion, water, detergent soap, 70% ethylic alcohol solution with or without nitrite and to the hypochlorite of sodium. *Handle for movement must be easy to grasp and clean. *Light must remain steady on position once moved. *Layout and heat production must not interfere with laminar air flow system.
22 Mobility, portability(if relevant)*Allowed movements and ranges:a) arm vertical displacement of at least 75cm;b) horizontal independent rotation of each head of at least 340°;c) independent inclination of each head of at least 90º. Movement must be easily achieved by operator of height 1.5 m. 23 Raw Materials(if relevant)38 User care(if relevant) Unit layout to enable easy cleaning and sterilization of all surfaces.39 Warranty40 Maintenance tasks41 Type of service contract 42 Spare parts availability post-warranty43 Software / Hardware upgrade availability
44 Documentation requirements Advanced maintenance tasks required shall be documentedUser, technical and maintenance manuals to be supplied in ************** language.List to be provided of equipment and procedures required for local calibration and routine maintenance, List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration and inspection to be provided. Contact details of manufacturer, supplier and local service agent to be provided45 Estimated Life Span 10 years46 Risk Classification Class A (GHTF Rule 4);Class II (USA); Class I (EU, Japan, Canada and Australia)47 Regulatory Approval / Certification Must be FDA, CE or UL approved product.


48
International standards ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes (Australia, Canada and EU)ISO 14971:2007 Medical devices -- Application of risk management to medical devices IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systemsIEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests 49 Reginal / Local Standards


50 Regulations US regulations 21 CFR part 820 21 CFR section 878.4580 Light, surgical, ceiling-mounted JP regulations MHLW Ordinance No.169 12282000 Surgical light


DOCUMENTATION
DECOMMISSIONINGSAFETY AND STANDARDS


WARRANTY AND MAINTENANCE


PHYSICAL/CHEMICAL CHARACTERISTICS


WHO. “Operating Light.” From the publication: “WHO Technical Specifications for 61 Medical Devices. WHO. Retrieved from: http://


www.who.int/medical_devices/management_use/mde_tech_spec/en/


17




11/4/15 WHO_TS_61_MDs_web.xlsx 12


Page 1


i Version No. 1ii Date of initial version 6/13/12iii Date of last modification 6/18/14iv Date of publicationv Completed / submitted byWHO working group1 WHO Category / Code (under development)2 Generic name Examination light3 Specific type or variation (optional) Halogen light, LED light 4 GMDN name Fixed examination/treatment light 5 GMDN code 122766 GMDN category 04 Electro mechanical medical devices7 UMDNS name Lights, Examination 8 UMDNS code 12-2769 UNSPS code (optional)10 Alternative name/s (optional) Lamp/light for medical use; Examination light; Light, examination, ceiling-mounted; Light, examination11 Alternative code/s (optional) MS 34634; S 34636; S 15866; S 4546012 Keywords (optional) operating theatre, operating room, portable, physician offices13 GMDN/UMDNS definition (optional)
A device that provides light to illuminate the site of examination and/or treatment of the patient. It typically consists of one or more light bulb(s), which reflect the light via reflectors or mirrors depending upon the construction and will often be mounted on a pantograph counterbalance assembly that is attached to the mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another.14 Clinical or other purpose Provides light to illuminate the site of examination and/or treatment of the patient15 Level of use (if relevant) Health centre, district hospital, provincial hospital, specialized hospital, general hospital16 Clinical department/ward(if relevant) External consult, physician offices17 Overview of functional requirements 1. Clear and cool light to operating area, with minimal shadows and distortion of colour. 2. Mounted on mobile base. 3. Single head must be easily moved by operator to direct light to required area. 4. Integral rechargeable battery for operation without mains electricity. 5. Halogen light or LED light.18 Detailed requirements A star base with at least four anti-static castors wheels. Height adjustable stand or articulated (or flexible) arm with step-less vertical displacement. At least radial and angular movements of the lamp. Led or halogen light source. Maximum intensity not less than 20 000 lux / 1 m (+/-10%). Illumination control. Color Temperature not less than 3200 °K. Lifetime of halogen bulbs not less than 1500 hours; if LED light is provided not less than 20.000 hours. Integrated ON/OFF switch button.19 Displayed parameters N/A20 User adjustable settings N/A21 Components(if relevant) mobile base, single head, integral rechargeable battery, halogen or LED light. 22 Mobility, portability(if relevant) Mobile


MEDICAL DEVICE SPECIFICATION(Including information on the following where relevant/appropriate, but not limited to)
NAME, CATEGORY AND CODING


PURPOSE OF USE


TECHNICAL CHARACTERISTICS


PHYSICAL/CHEMICAL CHARACTERISTICS


Figure 7: WHO Specification: Examination Light


WHO. “Examination Light.” From the publication: “WHO Technical Specifications for 61 Medical Devices. WHO. Retrieved from: http://


www.who.int/medical_devices/management_use/mde_tech_spec/en/


18




11/4/15 WHO_TS_61_MDs_web.xlsx 12


Page 2


23 Raw Materials(if relevant) N/A24 Electrical, water and/or gas supply (if relevant) Electrical source requirements: Amperage: ______; Voltage: ______. 1. Internal, replaceable, rechargeable battery allows operation for at least (*****) hours in the event of power failure.2. Battery charger to be integral to mains power supply, and to charge battery during mains power operation of unit. Compliance with ______ electrical standards and regulations25 Accessories (if relevant) N/A26 Sterilization process for accessories (if relevant) N/A27 Consumables / reagents (if relevant) N/A28 Spare parts (if relevant) Two sets of spare fuses (if replaceable fuses used).Ten sets of replacement bulbs (if incandescent).29 Other components (if relevant) N/A30 Sterility status on delivery (if relevant) N/A31 Shelf life (if relevant) N/A32 Transportation and storage (if relevant) N/A33 Labelling (if relevant) N/A34 Context-dependent requirements N/A35 Pre-installation requirements(if relevant) N/A36 Requirements for commissioning (if relevant) Supplier to perform installation, safety and operation checks before handover. Local clinical staff to affirm completion of installation.37 Training of user/s (if relevant) Training of users in operation and basic maintenance shall be provided.Advanced maintenance tasks required shall be documented.38 User care(if relevant) Unit layout to enable easy cleaning and sterilization of all surfaces39 Warranty 2 years warranty40 Maintenance tasks Preventive/periodic maintenance requirements to be listed. 41 Type of service contract None42 Spare parts availability post-warranty N/A43 Software / Hardware upgrade availability N/A44 Documentation requirements 1. User, technical and maintenance manuals to be supplied in English language.2. Certificate of calibration and inspection to be provided.3. List to be provided of equipment and procedures required for local calibration and routine maintenance.4. List to be provided of important spares and accessories, with their part numbers and cost.5. Contact details of manufacturer, supplier and local service agent to be provided.


UTILITY REQUIREMENTS


DECOMMISSIONING


ACCESSORIES, CONSUMABLES, SPARE PARTS, OTHER COMPONENTS


PACKAGING
ENVIRONMENTAL REQUIREMENTSTRAINING, INSTALLATION AND UTILISATION


WARRANTY AND MAINTENANCE
DOCUMENTATION


WHO. “Examination Light.” From the publication: “WHO Technical Specifications for 61 Medical Devices. WHO. Retrieved from: http://


www.who.int/medical_devices/management_use/mde_tech_spec/en/


19




11/4/15 WHO_TS_61_MDs_web.xlsx 12


Page 3


45 Estimated Life Span 10 years46 Risk Classification Class A (GHTF Rule 4); Class I (USA, EU, Japan, Canada and Australia)47 Regulatory Approval / Certification FDA approval (USA); CE mark (EU)48 International standards ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes (Australia, Canada and EU)ISO 14971:2007 Medical devices -- Application of risk management to medical devicesIEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systemsIEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests49 Reginal / Local Standards N/A50 Regulations US regulations21 CFR part 82021 CFR section 880.6320 device, medical examination, ac poweredEU regulationsCouncil Directive 93/42/EEC of 14 June 1993 concerning medical devicesDirective 93/68/EEC (CE Marking)Directive 98/79/ECDirective 2001/104/EC Directive 2007/47/ECJapan regulationsMHLW Ordinance No.16912276000 Examination light


SAFETY AND STANDARDS


WHO. “Examination Light.” From the publication: “WHO Technical Specifications for 61 Medical Devices. WHO. Retrieved from: http://


www.who.int/medical_devices/management_use/mde_tech_spec/en/


20




3.*Lamps*and*Lights*Preventative*Maintenance*****Featured*in*this*Section:****&Cooper,&Justin&and&Alex&Dahinten&for&EWH.&“Operating&Room&Light&Preventative&Maintenance.”&From&the&publication:&&Medical%Equipment%Troubleshooting%Flowchart%Handbook.&Durham,&NC:&Engineering&World&Health,&2013.&*&Strengthening&Specialised&Clinical&Services&in&the&Pacific.&User%Care%of%Medical%Equipment:%A%first%line%maintenance%guide%for%end%users.&(2015).&*


21




EQUIPMENT))OR)Light)Preventative)Maintenance)
Preventative!Maintenance:!


• Checking)mechanical)functionality)(grease,)tightening,)etc.),))o Check)supporting)framework)for)mobility))o If)framework)is)high)resistive)to)movement,)grease)resistive)parts)and/or)loosen)braking)screws)o If)framework)moves)too)easily)(does)not)stay)in)place)after)adjustment),)tighten)braking)screws)• Cleaning)bulb)housings)o Clean)the)bulb)housings)periodically)so)lengthen)bulb)life)and)improve)light)quality)o Do)not)touch)IR)filters)with)bare)hands)o Fingerprints)left)on)bulbs/filters)will)cause)overheating)and)could)damage)lamp)• Keep)any)bulbs)that)could)be)viable)replacements)available)o Salvage)functional)light)bulbs)from)nonFfunctional)OR)lamps)and)keep)for)future)use)as)replacements)in)other)lamps)o Keep)any)bulbs)that)are)viable)replacements)for)those)in)lamp)to)use)as)replacements)when)needed))


Operating Room Light Preventative Maintenance


Cooper, Justin and Alex Dahinten for EWH. “Operating Room Light Preventative Maintenance.” From the publication: Medical Equipment


Troubleshooting Flowchart Handbook. Durham, NC: Engineering World Health, 2013.


22




User Care of Medical Equipment – First line maintenance for end users


38


User Care Checklist – Lamps


Daily

Cleaning



9 Wipe dust off exterior and cover equipment after checks




Visual checks



9 Check all fittings and accessories are mounted correctly

9 Check there are no cracks in glass / covers or liquid spillages




Function
checks



9 If in use that day, run a brief function check before clinic





Weekly

Cleaning



9 Unplug, clean outside with damp cloth and dry off

9 Clean any filters, covers and battery compartment



9 Remove dirt from wheels/any moving part




Visual checks



9 Check all screws and parts are fitted tightly

9 Check mains plug screws are tight

9 Check mains cable has no bare wire and is not damaged



Function
checks



9 Check all switches operate correctly

9 Remove or charge batteries if out of use






Every six months
Biomedical Technician check required


Lamp Preventative Maintenance Table


Strengthening Specialised Clinical Services in the Pacific. User Care of Medical Equipment: A first line


maintenance guide for end users. (2015).


23




4.*Troubleshooting*and*Repair*of*Lamps*and*Lights** **Featured*in*this*Section:*****&Cooper,&Justin&and&Alex&Dahinten&for&EWH.&“Operating&Room&Light&Troubleshooting&Flowchart&From&the&publication:&&Medical%Equipment%Troubleshooting%Flowchart%Handbook.&Durham,&NC:&Engineering&World&Health,&2013.&*&Strengthening&Specialised&Clinical&Services&in&the&Pacific.&User%Care%of%Medical%Equipment:%A%first%line%maintenance%guide%for%end%users.&(2015).&&&&&&&&&&&&** ******
24




112!*


OR*LIGHT*Flowchart* *
Operating Room Light Troubleshooting Flowchart


Cooper, Justin and Alex Dahinten for EWH. “Operating Room Light Troubleshooting Flowchart.” From the publication: Medical Equipment


Troubleshooting Flowchart Handbook. Durham, NC: Engineering World Health, 2013.


25




113!*


Description*#* Text*box* Explanation*or*Comment*1! Begin:!Troubleshoot!OR!Light! Start!the!diagnostic!process!for!a!work!order!on!an!OR!Light.!
2! Do!all!bulbs!illuminate?! Provide!the!light!with!power!and!observe!whether!or!not!all!of!the!bulbs!produce!light.!
3! Is!voltage!delivered!to!nondfunctional!bulbs?! If!some!of!the!bulbs!do!not!illuminate,!it!could!be!due!to!issues!with!the!bulb!or!the!power!supply.!Use!a!multimeter!to!check!that!appropriate!voltage!is!being!delivered!to!the!bulb!housings.!!See!BTA!skills!on!Electrical!Lighting/Indicators.!
4! Troubleshoot!bulb!connections!!


If!bulbs!do!not!illuminate!and!are!not!receiving!power,!then!there!may!be!something!wrong!with!the!connections!from!the!bulb!housing!to!the!bulb!itself.!Inspect!the!housing,!clean!any!residue!on!connections!and!mend!poor!connections.!
5! Check!continuity!of!power!supply!wires!to!bulb!housings! Ensure!that!the!bulb!housings!are!connected!to!the!power!supply.!Use!a!multimeter!to!check!the!continuity!of!the!wires!running!from!the!power!supply!to!the!bulbs.!!
6! Troubleshoot!power!supply! If!the!device!is!connected!to!power!but!does!not!turn!on,!there!is!a!problem!with!the!power!supply.!This!could!be!a!problem!with!the!wiring!or!connections!within!the!device.!See!BTA!skills!on!Power!Supply.!
7! Are!bulbs!incandescent?! Incandescent!light!bulbs!use!a!tungsten!filament!encased!inside!a!glass!housing.!
8! Are!bulbs!halogen?! Halogen!bulbs!have!a!tungsten!filament!encased!inside!a!quartz!housing.!The!housing!is!much!closer!to!the!filament!than!in!incandescent!light!bulbs.!
9! Are!bulbs!fluorescent?! Fluorescent!bulbs!have!a!sealed!glass!tube!filled!with!mercury!and!an!inert!gas.!!
10! If!bulb!type!is!unknown,!use!only!the!voltage!capacity!to!determine!the!replacement! Reference!BTA!skills:!Unit:!Lighting/Indicators,!Skill:!Fixtures.!
11! Use!replacement!bulb!from!manufacturer!if!available! Acquire!the!bulb!designed!for!the!OR!lamp!unit!by!the!same!manufacturer!as!the!unit.!Use!this!replacement!bulb!to!replace!any!


Cooper, Justin and Alex Dahinten for EWH. “Operating Room Light Troubleshooting Flowchart.” From the publication: Medical Equipment


Troubleshooting Flowchart Handbook. Durham, NC: Engineering World Health, 2013.


26




114!*


broken!bulbs!in!the!lamp.!
12! Find!incandescent!bulb!replacement! Match!the!voltage!capacity!and!wattage!of!replacement!bulb!to!original.!
13! Use!CFL,!LED,!or!halogen!replacement!bulb! If!a!CFL!or!LED!bulb!can!be!found!that!matches!the!voltage!of!the!original!incandescent!bulb,!then!it!may!be!used!to!replace!the!original!bulb.!
14! If!using!CFL!or!LED,!match!lumens!of!replacement!to!original!bulb! If!using!a!CFL!or!LED!as!a!replacement,!ensure!that!the!lumens!value!of!the!replacement!bulb!matches!that!of!the!original.!
15! Find!halogen!bulb!replacement! Match!the!voltage!capacity!and!wattage!of!replacement!bulb!to!original.!
16! Use!CFL!or!LED!replacement!bulb! If!a!CFL!or!LED!bulb!can!be!found!that!matches!the!voltage!of!the!original!incandescent!bulb,!then!it!may!be!used!to!replace!the!original!bulb.!
17! Check!ballasts!and!replace!if!necessary! Reference!instruction!document.!
18! Find!fluorescent!bulb!replacement! Match!the!voltage!capacity!and!wattage!of!replacement!bulb!to!original.!
19! Check!ballasts!and!replace!if!necessary! Reference!instruction!document.!
20! Use!incandescent!bulb!replacement! If!an!incandescent!bulb!can!be!found!that!matches!the!voltage!of!the!original!incandescent!bulb,!then!it!may!be!used!to!replace!the!original!bulb.!
21! Match!voltage!capacity!of!replacement!bulb!to!original! If!the!bulb!type!of!the!original!is!unknown,!then!the!voltage!capacity!alone!may!be!used!to!find!a!replacement.!Match!this!value!of!the!replacement!bulb!to!that!of!the!original.!
22! If!necessary!retrofit!light!socket!to!fit!replacement!bulb! Reference!BTA!skills:!Unit:!Lighting/Indicators,!Skill:!Fixtures.!23! Go!to:!Begin! Go!back!to!step!1!to!restart!the!troubleshooting!process.!
24! Do!all!bulb!have!an!IR!filter!in!front!of!them?! Check!that!all!of!the!functional!bulbs!have!infrared!filters!between!the!bulb!and!the!operating!field.!This!filter!usually!looks!like!a!plastic!sheet!


Cooper, Justin and Alex Dahinten for EWH. “Operating Room Light Troubleshooting Flowchart.” From the publication: Medical Equipment


Troubleshooting Flowchart Handbook. Durham, NC: Engineering World Health, 2013.


27




115!*


sitting!in!front!of!the!bulb!in!its!housing.!
25! Do!not!use!bulbs!without!filter! DO!NOT!use!the!lamp!if!any!illuminating!bulbs!do!not!have!a!filter.!This!filter!is!necessary!to!ensure!the!safety!of!patients.!
26! Replace!missing!filters! Insert!infrared!filters!wherever!missing.!These!filters!can!be!taken!from!bulb!housings!containing!nondfunctional!bulbs!or!from!other!OR!lamp!units.!!DO!NOT!handle!filters!with!bare!hands.!27! Go!to:! !28! Do!all!parts!of!light!and!support!move!freely?! Manipulate!the!lamp!to!ensure!that!all!moving!parts!can!be!easily!adjusted.!
29! Add!grease!to!resistive!parts! If!any!moving!parts!of!the!lamp!resist!adjustment,!lubricate!these!parts!using!grease!or!oil.!
30! Loosen!braking!screws! Locate!the!braking!screws!on!the!lamp!unit.!Loosen!these!screws!to!allow!for!more!fluid!movement.!
31! Adjust!spring!force!screws! Locate!and!adjust!the!tightness!of!spring!force!screws!on!the!lamp!unit!to!change!the!amount!of!tension!in!the!lamp!supports.!32! Go!to:! !
33! Does!light!stay!in!place!after!adjustment?! Ensure!that!the!lamp!stays!in!place!after!it!has!been!adjusted.!Try!several!manipulations!of!the!lamp!and!let!lamp!stand!in!each!for!a!few!minutes.!Observe!any!deviations!from!the!original!adjustment.!
34! Tighten!braking!screws! If!lamp!moves!after!adjustment,!tighten!the!braking!screws!to!prevent!this!movement.!35! Go!to:! !36! Light!is!functioning!properly! !!Preventative*Maintenance:*


• Checking!mechanical!functionality!(grease,!tightening,!etc.),!!o Check!supporting!framework!for!mobility!!o If!framework!is!high!resistive!to!movement,!grease!resistive!parts!and/or!loosen!braking!screws!
Cooper, Justin and Alex Dahinten for EWH. “Operating Room Light Troubleshooting Flowchart.” From the publication: Medical Equipment


Troubleshooting Flowchart Handbook. Durham, NC: Engineering World Health, 2013.


Cooper, Justin and Alex Dahinten for EWH. “Operating Room Light Troubleshooting Flowchart.” From the publication: Medical Equipment


Troubleshooting Flowchart Handbook. Durham, NC: Engineering World Health, 2013.


28




User Care of Medical Equipment – First line maintenance for end users


37


Troubleshooting – Lamps




Fault Possible Cause Solution

1.



No light or „power on‟ visible



No power at mains socket







Dead battery

Blown bulb


Battery leakage



Electrical cable fault



Internal wiring fault



Check power switch is on.
Replace fuse with correct rating
of voltage and current if blown.
Check mains power is present at
socket using equipment known to
be working. Contact electrician
for rewiring if power not present.

Charge or replace batteries

Replace bulb with correct voltage
and wattage

Remove batteries (if accessible),
clean battery terminals and
replace with new battery

Try cable on another piece of
equipment. Contact electrician
for repair if required.

Refer to electrician



2.



Fuse / bulb keeps blowing



Fuse or bulb is wrong rating

Power supply or cable fault



Replace with correct rating

Refer to electrician



3.



Light cannot be made bright
enough



Dirt on lens or tube

Poor power supply


Wrong bulb rating

Control malfunction



Clean area with dry, clean cotton

Check power line or replace
batteries

Check bulb rating is correct

Refer to electrician



4.



Electrical shocks



Wiring fault



Refer to electrician




Lamps Troubleshooting Table


Strengthening Specialised Clinical Services in the Pacific. User Care of Medical Equipment: A first line


maintenance guide for end users. (2015).


29




5.*Resources*for*More*Information*about*Lamps*and*Lights****Featured*in*this*Section:*****Skeet,&Muriel&and&David&Fear.&“Shadowless&Theatre&Lamps.”&Care%and%Safe%Use%of%Medical%Equipment.&VSO&Books,&1995,&p.&118N125.&&&Cooper,&Justin&and&Alex&Dahinten&for&EWH.&“Bililight&Preventative&Maintenance.”&From&the&publication:&&Medical%Equipment%Troubleshooting%Flowchart%Handbook.&Durham,&NC:&Engineering&World&Health,&2013.&&&Cooper,&Justin&and&Alex&Dahinten&for&EWH.&“Bililight&Troubleshooting&Flowchart.”&From&the&publication:&Medical%Equipment%Troubleshooting%Flowchart%Handbook.&Durham,&NC:&Engineering&World&Health,&2013.&&&&& &**&&&&*&&&&&
30




*Resources*for*More*Information:&*&&Internal*Resources*at*library.ewh.org:*For*More*Information*about,*please*see*these*resources*in*the*BMET*Library!*& 1. Skeet,&Muriel&and&David&Fear.&“Shadowless&Theatre&Lamps.”&Care%and%Safe%Use%of%Medical%Equipment.&VSO&Books,&1995,&p.&118N125.&& 2. Cooper,&Justin&and&Alex&Dahinten&for&EWH.&“Bililight&Preventative&Maintenance.”&From&the&publication:&&Medical%Equipment%Troubleshooting%Flowchart%Handbook.&Durham,&NC:&Engineering&World&Health,&2013.&& 3. Cooper,&Justin&and&Alex&Dahinten&for&EWH.&“Bililight&Troubleshooting&Flowchart.”&From&the&publication:&Medical%Equipment%Troubleshooting%Flowchart%Handbook.&Durham,&NC:&Engineering&World&Health,&2013.&&& *&&


31




Lamps*and*Lights*Bibliography:&&&&Cooper,&Justin&and&Alex&Dahinten&for&EWH.&“Operating&Room&Light&Preventative&Maintenance.”&From&the&publication:&&Medical%Equipment%Troubleshooting%Flowchart%Handbook.&Durham,&NC:&Engineering&World&Health,&2013.&&&Cooper,&Justin&and&Alex&Dahinten&for&EWH.&“Operating&Room&Light.”&From&the&publication:&Medical%Equipment%Troubleshooting%Flowchart%Handbook.&Durham,&NC:&Engineering&World&Health,&2013.& *Malkin,&Robert.&“Theatre&Lamps&and&Other&Lights.”&Medical%Instrumentation%in%the%Developing%World.&Engineering&World&Health,&2006.&&&&Skeet,&Muriel&and&David&Fear.&“Shadowless&Theatre&Lamps.”&Care%and%Safe%Use%of%Medical%Equipment.&VSO&Books,&1995,&p.&118N125.&&&Strengthening&Specialised&Clinical&Services&in&the&Pacific.&User%Care%of%Medical%Equipment:%A%first%line%maintenance%guide%for%end%users.&(2015).&&&WHO.&“Operating&Light.”&From&the&publication:&“WHO&Technical&Specifications&for&61&Medical&Devices.&WHO.&Retrieved&from:&http://www.who.int/medical_devices/management_use/mde_tech_spec/en/&&&WHO.&“Examination&Light.”&From&the&publication:&“WHO&Technical&Specifications&for&61&Medical&Devices.&WHO.&Retrieved&from:&http://www.who.int/medical_devices/management_use/mde_tech_spec/en/&&&Wikimedia&Commons.&“Incandescent&light&bulb&(with&labels).”&Posted&November&8,&2009.&Retrieved&from:&https://commons.wikimedia.org/wiki/File:Incandescent_light_bulb_(no_labels).svg&*Wikipedia.&“LightNemitting&diode.”&Wikipedia.&Retrieved&from:&https://en.wikipedia.org/wiki/LightNemitting_diode&&&Wikipedia.&“Surgical&Lighting.”&Wikipedia.&Retrieved&from:&https://en.wikipedia.org/wiki/Surgical_lighting* &
32




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