OR Table Packet 2.pdf

Equipment*Packet:*Operating*Tables*UMDNS*#:*13961*Date*of*Creation:*November*12,*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*operating*room*tables.**Part*I:*External*From*the*Packet:** 1. An*Introduction*to*Operating*Tables:**PowerPoint**Part*II:*Included*in*this*Packet:** 1. Operation*and*Use:*a. Brief*Overview*of*Operating*Tables*(p.*3)*b. Introduction*to*Operating*Tables*(p.*4O6)*c. Operation*and*Use*of*Operating*Tables*(p.*7O10)*d. Considerations*for*Choosing*an*Operating*Table*(p.*11O12)*2. Diagrams*and*Schematics:*a. Figure*1:*Diagram*of*a*Hydraulic*Operating*Table*(p.*14)*b. Figure*2:**Positioning*Operating*Tables*(p.*15)*c. Figure*3:*WHO*Specification*for*Hydraulic*Operating*Table*(p.*16O18)*3. Preventative*Maintenance*and*Safety:*a. Operating*Table*Preventative*Maintenance*Schedule*(p.*20O21)*b. Operating*Table*Preventative*Maintenance*Table*(p.*22)*4. Troubleshooting*and*Repair:**a. Operating*Table*Preventative*Maintenance*Table*(p.*24)*b. Operating*Table*User*Checklist*(p.*25)*5. Resources*for*More*Information*a. Resources*for*More*Information**(p.*27)*b. Bibliography*(p.*28)** *** *
2




**1.*Operation*and*Use*of*Operating*Tables****Featured*in*this*Section:*****Burnett,*Joanne,*Clift,*Laurence,*Clift,*Maxine.*“Buyers’*Guide:*Operating*Tables.*CEP09016.”*NHS:(Centre(for(Evidence>Based(Medicine,*August*2009.*Retrieved*from:*https://dspace.lboro.ac.uk/dspace]jspui/bitstream/2134/7390/1/AR2614%20Buyers%20Guide%20Operating%20Tables.pdf** *Skeet,*Muriel*and*David*Fear.*“Theatre*Equipment:*Operating*Table.”*Care(and(Safe(Use(of(Medical(Equipment.*VSO*Books,*1995,*p.*118]125.* *Strengthening*Specialised*Clinical*Services*in*the*Pacific.*User(Care(of(Medical(Equipment:(A(first(line(maintenance(guide(for(end(users.*(2015).* *Wikipedia.*“Operating*Table.”*Wikipedia.*Retrieved*from:*https://en.wikipedia.org/wiki/Operating_table*** *** ** *
2




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


66


Chapter 4.20 Tables – (Operating Theatre and Delivery)


Function
Tables are required to hold the patient in a position comfortable both for themselves and for medical


staff during procedures. They can include dedicated supports for head, arms and legs and often have movable
sections to position the patient appropriately. They are made both with wheels and on static platforms and can
have movements powered by electric motors, hydraulics or simply manual effort. They can be found in
emergency departments, operating theatres and delivery suites.


How it works
Where the table has movement, this will be enabled by unlocking a catch or brake to allow positioning.


Wheels have brakes on the rim or axle of the wheel, while locks for moving sections will normally be levers on
the main table frame. Care should be taken that the user knows which lever applies to the movement required, as
injury to the patient or user may otherwise result. The table will be set at the correct height for patient transfer
from a trolley then adjusted for best access for the procedure.

















Brief Overview of Operating Tables


Strengthening Specialised Clinical Services in the Pacific. User Care of


Medical Equipment: A first line maintenance guide for end users. (2015).


3




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1 Definition


1.1 Two main classifications: system and
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2 Properties and requirements
made of an operating table


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Introduction to Operating Tables


Wikipedia. “Operating Table.” Wikipedia. Retrieved from: https://en.wikipedia.org/wiki/


Operating_table


4




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3 Comparison: Operating table
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6 Literature
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7 References
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Wikipedia. “Operating Table.” Wikipedia. Retrieved from: https://en.wikipedia.org/wiki/


Operating_table


5




8 Text and image sources, contributors, and licenses


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Wikipedia. “Operating Table.” Wikipedia. Retrieved from: https://en.wikipedia.org/wiki/


Operating_table


6




THEATRE EQ U IPM EN T


OPERATING TABLES


1. Purpose of Equipment


To support the patient undergoing surgery in an appropriate position for the
particular operation being carried out.


2. How the Equipment Works


An operating table has several features which allow the surgical team to position
the patient as required (Figure 35).


As there are many models, the following information is presented as a general guide
only.


i. Height 0* and D)


The table is raised by slowly pumping the pump pedal (P) and lowered by using
the release pedal (D) until the required height is reached.


ii. Brake (B)


The table runs on small wheels or castors. They must be securely locked while the
operation is being carried out.


To lock the wheels or castors:


turn the small brake lever (B) through 90° (a right-angle)
check that the table does not move when pushed-----------------------------------


To unlock the wheels or castors:


reverse the action, turning the brake lever (B) back, to its original position


iii. Lateral rotation (L and R)


To rotate the table:
release the locking lever (L) by turning it anticlockwise
turn the rotation arm (R) clockwise
return the locking lever to original position


To return the table to the normal position:
release the locking lever (L)
turn the rotation arm (R) anticlockwise
return the locking lever to original position


iv. Back rest (E)


To put up the back rest:
slowly turn the elevation arm (E) clockwise until it reaches the required
position


To lower the back rest:
slowly turn the elevation arm (E) anticlockwise


Operation and Use of Operating Tables


Skeet, Muriel and David Fear. “Theatre Equipment: Operating Table.” Care and Safe Use of Medical


Equipment. VSO Books, 1995, p. 118-125.


7




To lower the leg rest:
release the retention catch and the hinged leg rest position of the table will
drop


To raise the leg rest:
lift hinged portion of table back to normal position. It should lock
automatically


vi. Accessories


Other accessories such as arm rests, leg and chest supports either screw or clip
into position, according to the manufacturer’s design.


3. Routines and safety


Looked after carefully, an operating table may be used for many years without any
maintenance problem.


IT MUST BE CAREFULLY CLEANED AND WELL DRIED AFTER USE.


If it is not dried properly, the facilities described above in Section 2 will corrode and
it will not be possible to position the patient correctly. It may even mean that some
operations cannot be performed.


a. After each operation:


thoroughly clean the table with a mixture of water, detergent and
disinfectant, removing all traces of blood and debris to prevent cross
infection
dry quickly and thoroughly


b. Daily:


clean and dry the whole table
- inspect mattress for tears or other damage (repairs may be done locally


but only antistatic, waterproof material should be used)
check that all facilities are working easily and safely
check that the wheel brake works well and that the table moves easily
when the brake is released
check that accessories (arm rest and leg supports) fit correctly and are
undamaged


c. Weekly:


check the hydraulic fluid level (Figure 35) and fill if necessary. The filler
point is usually beneath the base cover. Remove the four corner screws,
lift the table support column, unscrew the filler cap and check that the oil
level is near the top. If not, fill up with the specified hydraulic oil or (if not
available) car brake fluid.
DO NOT use any other oil. Other oils will destroy the pump seals and the
height facility


- with a colleague acting as the ‘patient’, check that the hydraulic lift and
other facilities are functioning. Wear theatre dress for this


Skeet, Muriel and David Fear. “Theatre Equipment: Operating Table.” Care and Safe Use of Medical


Equipment. VSO Books, 1995, p. 118-125.


8




extend worm gears and main support shaft (Figure 35) .
apply a light smear of grease to the worm gears and also to the main
support shaft
check wheels and castors for signs of damage or wear
check all accessories for damage or wear


Back rest elevat ion arm (E)


Leg rest h inge (H)


Leg rest dow n posit ion


Back rest h inge point


Base cover
ret ain ing screw s


Brake lever (B ) ----- —> - ! n -
It ^


H yd rau lic o il f i l ler po int /
locat ed under b ase co ver


Base co ver raised for
access to hyd rau lic
f i ller point


Release p ed al Pump p ed al
(lower) (D) (raise) (P)


W h eel / cast o r


Figure 35: Hydraulic operating table


d. Safety:


The following safety points are of vital importance:
check that the table functions well daily, weekly and BEFORE EACH
OPERATION
check daily that all accessories are available and in good working order
clean and dry table thoroughly AFTER EACH OPERATION


4. How to use the equipment


Correct use of the equipment is described above. Always refer to the
manufacturer’s instructions for specific advice on the equipment you are using. The
guidelines given here are general only.


Skeet, Muriel and David Fear. “Theatre Equipment: Operating Table.” Care and Safe Use of Medical


Equipment. VSO Books, 1995, p. 118-125.


9




5. Simple fault f inding and maintenance
Example a:


Table cannot be raised:
- check hydraulic oil level


if oil level is satisfactory:
- call a qualified technician


Example b:


Table will not rotate:
check worm gears are greased


if table still does not rotate:
call a qualified technician


Example c:


Back rest cannot be raised:
- check worm gears are greased


if back rest still cannot be raised:
call a qualified technician


All other poor functioning or faults will need the skills of a qualified technician.


6. Spares


Always have a second table available for emergency use.


Hydraulic oil
Lubricating grease or vaseline
Set of pump seals


Skeet, Muriel and David Fear. “Theatre Equipment: Operating Table.” Care and Safe Use of Medical


Equipment. VSO Books, 1995, p. 118-125.


10




Operational considerations 16


CEP09016: August 2009


Device selection / features
The operating table chosen should be matched to the users’ needs. Table 7 provides
a detailed explanation of the product characteristics which would be useful for
clinicians to consider when choosing a particular device.


Table 7. Operational characteristics of operating tables



Model range /


Operation type
Manufacturers usually provide a range of models to cover all aspects of surgery.
Accessories are also available to further adapt the tables to specific needs. Trauma
surgery in particular requires a large number of different accessories – different modules
fixed on and taken off depending on the operation.


Tabletop
design


Most tables are now modular in design; usually three or four segments per tabletop –
head, leg and one or two body/back sections. On some tables the segments can be
manoeuvred independently of the base to allow better positioning and these sections can
be attachable to or detachable from the tabletop.
The different sections can be heavy and sometimes difficult to attach or position
correctly. Some tables have powered or hydraulic mechanisms to manoeuvre the
sections into position.
The more sections that are available the more adaptable the table is.
Some tabletops are just one piece – these are usually the imaging tables.


Base The tables are available with fixed (operating table systems) or movable (mobile
operating tables) bases.
The base should be as small as possible so that it does not obstruct the surgeon.
The bases are usually attached with either an end or centre pedestal to the table top. In
many cases end pedestals are preferred by staff as these ensure maximum c-arm
coverage. Some tables have the facility to move off centre if there is a longitudinal slide
facility on the table.


Tabletop
dimensions


Patients have now, on average, increased in breadth and stature since the standard
width and length operating tables were designed [36]. The regular size tables may not fit
some patients. Patients’ heels can now rub against the edge of the bed which can cause
pressure ulcers. Accessories (extenders) to broaden either/both the length and width
may be required.
However, the table must still permit surgeons to operate safely. The extenders are very
unpopular with surgeons as they press into their abdomen when they reach over.


Weight Patient: A higher percentage of bariatric patients are now treated [36]. The tables should
have a maximum patient weight clearly stated to ensure safety standards are met and
there is no possibility of table failure.
The maximum patient weight on a table is different when the table is flat (level) than
when it is placed in to different positions. For example, one particular table can operate
safely with a patient weighing up to 500kg when level but this reduces to a maximum of
260kg when the table is in the Trendelenburg position.
Table: A heavy table can be difficult to manoeuvre, particularly with a patient in situ.
Powered tables may be easier to move.


Considerations for Choosing an Operating Table


Burnett, Joanne, Clift, Laurence, Clift, Maxine. “Buyers’ Guide: Operating Tables. CEP09016.” NHS: Centre for


Evidence-Based Medicine, August 2009. Retrieved from: https://dspace.lboro.ac.uk/dspace-jspui/bitstream/


2134/7390/1/AR2614%20Buyers%20Guide%20Operating%20Tables.pdf


11




Operational considerations 17


CEP09016: August 2009



Table


adjustments /
positions


The different table positions have been demonstrated in figure 1.
The height adjustability is very important due to potential medical problems arising for
the surgeons if tables are positioned incorrectly, as discussed in the Introduction. This
has become more relevant with the growth of laparoscopic type surgery due to the
increased length of the surgical instruments that are used.
Longitudinal slide is very important for two reasons: it allows the imaging field to be
extended (sometimes patients are turned round in the operation to get the required
access to the C-arm equipment) and pressure ulcer formation can be prevented if the
table can be moved rather than the patient having to be re-positioned.
Tables are often available with a normal (one piece) leg section and a split leg section to
enable surgical procedure flexibility.
Tabletop rotation allows the surgeon closer access to the patient.


Manoeuvrability During stakeholder consultation with NHS theatre staff, the brakes and manoeuvrability
of operating tables were mentioned as being two of the most important considerations
when choosing a table model. This has become a particular issue due to the increase of
bariatric patients and associated manual handling problems. All staff agreed that
electrical adjustment was very important and is much preferred than manual adjustment.
Manual overdrive systems are available if the electrical system should fail.
Brakes need to be secure and not allow movement of the tables.
The wheel designs on some tables make them very difficult to manoeuvre, particularly if
the table is heavy and unwieldy. Large wheels or castors ensure easier manoeuvrability.
Some tables have powered drive units, which allow the table to be moved using a control
system, rather than manually by staff. Integral track stabilisation enables the table to
follow a straight line when it is being moved.


Mattress The evidence presented in the Introduction suggests that patients would benefit from a
pressure-redistributing mattress on an operating table.
The width and length of the mattress are relevant to ensure the products will fit operating
tables. The weight of the mattress and accessories should be considered in addressing
manual handling issues for the clinicians who use them.
The mattress should be x-ray translucent to allow imaging of the patient to be performed.


Preset
positions


Preset positions include flex, urology (extension), chair and return to level (not available
on all tables). A button on a control panel manoeuvres the table into these positions. It is
a quick method of adjusting the tables, very useful for staff that may have had to position
the table manually otherwise; making manual handing of the table easier as a result.


Imaging
capabilities


The tabletop construction is important as it has to be an X-ray translucent material to
allow imaging to take place. The joints of a table may not be X-ray translucent so this will
limit the coverage. It is important to know the exact imaging coverage a table is capable
of since the patient may have to be repositioned during surgery if the table is not able to
provide the required coverage.
X-ray cassettes were previously an essential requirement for operating tables but digital
imaging has now replaced this method so cassette channels are no longer required.


Hand controls /
power


According to staff, images used on the controls can be confusing and not always obvious
what feature the image is intended for. The table can be adjusted / operated either
manually by staff, or using electrically operated controls. The controls can either be a
hand control that is attached to the table or a wall mounted unit. Other control features
include back up column control (if the hand control fails) and a serial interface port.


Purchasing A product can be bought, rented or provided as part of a contracted service. See
Purchasing for details.
Suppliers will usually provide demonstrations of their products for training purposes. This
should include the accessories that have been bought as part of the system.


Burnett, Joanne, Clift, Laurence, Clift, Maxine. “Buyers’ Guide: Operating Tables. CEP09016.” NHS: Centre for


Evidence-Based Medicine, August 2009. Retrieved from: https://dspace.lboro.ac.uk/dspace-jspui/bitstream/


2134/7390/1/AR2614%20Buyers%20Guide%20Operating%20Tables.pdf


12




2.*Diagrams*and*Schematics*of*Operating*Tables*****Featured*in*this*Section:****Burnett,*Joanne,*Clift,*Laurence,*Clift,*Maxine.*“Buyers’*Guide:*Operating*Tables.*CEP09016.”*NHS:(Centre(for(Evidence>Based(Medicine,*August*2009.*Retrieved*from:*https://dspace.lboro.ac.uk/dspace]jspui/bitstream/2134/7390/1/AR2614%20Buyers%20Guide%20Operating%20Tables.pdf***Skeet,*Muriel*and*David*Fear.*“Theatre*Equipment:*Operating*Table.”*Care(and(Safe(Use(of(Medical(Equipment.*VSO*Books,*1995,*p.*118]125.** *WHO.*“Obstetrical*Table*(Manual).”*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.*“Obstetrical*Table*(Line]Powered).”*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/*** *


13




Figure 1: Diagram of a Hydraulic Operating Table


Skeet, Muriel and David Fear. “Theatre Equipment: Operating Table.” Care and Safe Use of Medical


Equipment. VSO Books, 1995, p. 118-125.


14




Operational considerations 15


CEP09016: August 2009


Operating table positions
An operating table can be adjusted to different positions; the most common are listed
in figure 1. The starting position is usually when the tabletop is level. Patients would
be lying in a supine (on back) or prone (on front) position and the table is positioned
horizontal to the ground. The pedestal is centred, but end pedestals are available.


Figure 1. Different operating table positions
Starting position
(supine/prone) Name of position Diagram of position Position use examples


Trendelenburg
(head lowered, feet


elevated)








ƒ Used to reduce risk of shock.
ƒ Improves access to pelvis as


bowel moves proximally.


Reverse
Trendelenburg


(head elevated, feet
lowered)








ƒ Can be used to prevent or
relieve patient choking.
ƒ Reduces venous oozing
during head and neck
surgery.


Lateral tilt


ƒ Allows surgeons better
access to anatomy.


ƒ Used in obstetrics to prevent
the baby from pressing on
the mother’s abdomen,
causing her to faint.


Flexion





ƒ Flexion and extension can
be of individual segments.


ƒ Back surgery.
ƒ Kidney surgery.
ƒ Gall bladder surgery.
ƒ Abdominal surgery. Extension







Chair








ƒ Opthalmic surgery.
ƒ Neurosurgery.
ƒ Shoulder surgery.


Lithotomy
(split leg)













ƒ Obstetrics.
ƒ Gynacological surgery.
ƒ Perineal surgery.
ƒ Urology.


Figure 2: Positioning Operating Tables


Burnett, Joanne, Clift, Laurence, Clift, Maxine. “Buyers’ Guide: Operating Tables. CEP09016.” NHS: Centre for


Evidence-Based Medicine, August 2009. Retrieved from: https://dspace.lboro.ac.uk/dspace-jspui/bitstream/


2134/7390/1/AR2614%20Buyers%20Guide%20Operating%20Tables.pdf


15




WHO_TS_61_MDs_web.xlsx 59


1


i Version No. 1ii Date of initial version 8/13/12iii Date of last modification 6/18/14iv Date of publicationv Completed / submitted by WHO working group
1 WHO Category / Code (under development)2 Generic name Operating table3 Specific type or variation (optional) hydraulic4 GMDN name Universal operating table, hydraulic5 GMDN code 580346 GMDN category 04 Electro mechanical medical devices7 UMDNS name Tables, Operating 8 UMDNS code 139619 UNSPS code (optional)10 Alternative name/s (optional) Table, operation mobile11 Alternative code/s (optional) MS 3133312 Keywords (optional) Operating theater, theatre, theater, Operating room


13 GMDN/UMDNS definition (optional) As in GMDN (http://www.gmdnagency.com ) A mobile, manually-operated hydraulic table designed to be adjusted to support a patient during many types of surgical interventions. The table surface consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface) to satisfy the requirements of many clinical specialties. It is typically operated via an integral foot-pedal(s) that adjust the table top position.14 Clinical or other purpose be adjusted to support a patient during many types of surgical interventions.15 Level of use (if relevant) health centre, district hospital, provincial hospital, specialized hospital16 Clinical department/ward(if relevant) operating theater, emergencies


17
Overview of functional requirements All movements must be controlled individually and together for the following movementsVertical height movement range to include 0.75 to 1.1 m from floor levelControllable global movements to include up/down, forward/back, left/right and Trendelenburg at least ±30 degIndividual movements to allow at least head +20 deg, leg raise/lower +20 / -90 degAll movements must be motorized and controlled individually and together for the following movementsVertical height movement range to include 0.75 to 1.1 m from floor levelControllable global movements to include up/down, forward/back, left/right and Trendelenburg at least ±30 degIndividual movements to allow at least head +20 deg, leg raise/lower +20 / -90 degMust accommodate patients up to at least 150 kg


18
Detailed requirements All movements must be hydraulically operated and controls clearly labelled to allow the following movements:a)Vertical height movement range to include 0.75 to 1.1 m from floor levelb)Global movements to include up/down, forward/back, left/right and Trendelenburg and reverse trendelenburg range from at least +25º to -10º.c)Individual movements to allow at least head +20 deg, leg raise/lower +20 / -90 deg d) Longitudinal displacement regulation range of at least of 200 mm.Minimum overall table dimensions: 1.8m long x 0.6m wideBase to be fitted with castors, minimum diameter 12cm, with braking / stationary facility At least 4 articulated sections: back, pelvis and 2 separate legs sections


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 3: WHO Specification for Hydraulic Operating Tables


WHO. “Operating Table (hydraulic) 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 59


2


19 Displayed parameters20 User adjustable settings


21
Components(if relevant) Base to be solid and stable when braked and must not obstruct operator access to patientSupplied with two armrests at least 0.4m long, that fit adjustable positions on each side of tableSupplied with removable or foldable side restraints on each side of tableSupplied with two leg slings and two vertical supports for leg slingsLeg section of table to be removable to allow lithotomy position Supplied with padded mattress, in sections that match layout of table sectionsAll exposed metal parts to be constructed of stainless steelAll non-metal parts to be constructed of durable, waterproof, washable and antistatic materialNo sharp edges or points to be presentEasy access to filters and oil sumps required for on-site maintenance Mattresses covering in fire extinguish material, resistant to corrosion, water, detergent soap, 70% ethylic alcohol solution with or without nitrite and to the hypochlorite of sodium.22 Mobility, portability(if relevant) Mobile, on castors with brakes23 Raw Materials(if relevant) N/A


24 Electrical, water and/or gas supply (if relevant) None


25
Accessories (if relevant) Two each of armrests, side restraints and leg slings / supports Supplier to provide details of all other available fittings with specifications and costs*The following basic accessories will be provided together with the equipment:a) 2 stainless steel foot support;b) 2 stainless steel hands support;c) 2 stainless steel feet supports separable with cushion;d) 1 stainless steel head support;e) 1 stainless steel shoulder support; f) 2 stainless steel wrist support o support for extended arm;g) 2 feet belts;h) 1 stainless steel support for hand operation;i) 1 autoclave sterilizable basin;j) 1 cushion for back support;k) 1 telescopic stainless steel dismountable intravenous support system.26 Sterilization process for accessories (if relevant)27 Consumables / reagents (if relevant) Oil and replacement filters sufficient for two years’ daily use28 Spare parts (if relevant)29 Other components (if relevant)


30 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/A
34 Context-dependent requirements Capable of being stored continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%.Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%.
35 Pre-installation requirements(if relevant) Supplier to provide details of all other available fittings with specifications and costs.Supplier to perform installation, safety and operation checks before handover36 Requirements for commissioning (if relevant) Local clinical staff to affirm completion of installation37 Training of user/s (if relevant) Training of users in operation and basic maintenance shall be provided


UTILITY REQUIREMENTSACCESSORIES, CONSUMABLES, SPARE PARTS, OTHER COMPONENTS


PACKAGING
ENVIRONMENTAL REQUIREMENTS
TRAINING, INSTALLATION AND UTILISATION


PHYSICAL/CHEMICAL CHARACTERISTICS


WHO. “Operating Table (hydraulic) 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




WHO_TS_61_MDs_web.xlsx 59


3


38 User care(if relevant) Table layout to enable easy cleaning and sterilization of all surfaces, with no fluid traps39 Warranty40 Maintenance tasks41 Type of service contract 42 Spare parts availability post-warranty43 Software / Hardware upgrade availability
44 Documentation requirements User, technical and maintenance manuals to be supplied in ************** language.Certificate of inspection to be provided.List to be provided of equipment and procedures required for local calibration and routine maintenanceList to be provided of important spares and accessories, with their part numbers and cost.45 Estimated Life Span 15 years46 Risk Classification Class I (GHTF Rule 1);Class I (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 devices49 Reginal / Local Standards
50


Regulations US regulations 21 CFR part 820 21 CFR section 878.4950 table and attachments, operating-room21 CFR section 878.4950 table, operating-room, non-electrical21 CFR section 878.4960 table, examination, medical, powered21 CFR section 890.3760 table, powered JP regulations MHLW Ordinance No.169 36867010 General-purpose manually-operated operation table


DOCUMENTATION
DECOMMISSIONINGSAFETY AND STANDARDS


WARRANTY AND MAINTENANCE


WHO. “Operating Table (hydraulic) 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




3.*Preventative*Maintenance*of*Operating*Tables*****Featured*in*this*Section:****Engineering*World*Health.*“Preventative*Maintenance*Schedule*for*Operating*Tables.*EWH.*2012.***Strengthening*Specialised*Clinical*Services*in*the*Pacific.*User(Care(of(Medical(Equipment:(A(first(line(maintenance(guide(for(end(users.*(2015).*


19




Preventative)Maintenance)Schedule)for)Operating)Tables))Table,)Operating)Room) Inspect(exterior(of(equipment(for(damage(or(missing(hardware.(( Inspect(the(power(cord,(strain(relief(and(plug/s(for(any(signs(of(damage.(( Turn(unit(off,(open(user(accessible(covers(and(inspect(unit(for(damage.( Clean(unit(interior(components(and(exterior(with(vacuum(or(compressed(air.( Inspect(interior(for(signs(of(corrosion(or(missing(hardware.(Repair(as(required.( Inspect(electrical(components(for(signs(of(excessive(heat(or(deterioration.((( Verify(mechanical(integrity(including(all(controls.((( Inspect(condition(of(mattress(and(replace(as(necessary.(( Lubricate(motor(and(gear(assemblies(as(needed.(( Run(bed(to(all(heights(and(positions(verifying(smooth(operation.(( Verify(correct(operation(of(alarms(and(remote(signaling(systems(if(present.((( Verify(correct(operation(of(all(buttons,(controls,(displays(and/or(indicators.((( Verify(correct(operation(of(unit(in(all(functional(modalities.((Bed,)Hydraulic) Inspect(exterior(of(equipment(for(damage(or(missing(hardware.(( Inspect(interior(for(signs(of(fluid(leaking.(Clean(interior.((( Clean(unit(interior(components(and(exterior(with(vacuum(or(compressed(air.( Inspect(interior(for(signs(of(corrosion(or(missing(hardware.(Repair(as(required.(


Operating Table Preventative Maintenance Schedule


T


e


x


t


Engineering World Health. “Preventative Maintenance Schedule for Operating Tables. EWH. 2012.


20




Inspect(unit(for(mechanical(integrity(noting(any(evidence(of(abuse.(( Inspect(condition(of(mattress(and(replace(as(necessary.(( Inspect(all(hydraulic(assemblies(for(leaks(and(verify(correct(reservoir(levels.(( Run(bed(to(all(heights(and(positions(verifying(smooth(operation.(( Inspect(condition(of(maximum(and(minimum(stops.( Verify(correct(operation(of(all(buttons,(controls,(displays(and/or(indicators.((( Verify(correct(operation(of(unit(in(all(functional(modalities.((


Engineering World Health. “Preventative Maintenance Schedule for Operating Tables. EWH. 2012.


21




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


68


User Care Checklist – Operating Theatre and Delivery Tables


Daily

Cleaning



9 Clean, dry and disinfect all parts

9 Remove all paper, tape and foreign matter




Visual checks



9 Check all parts are present and tightly fitted

9 Replace mattress if worn or damaged

9 Check no oil is leaking from hydraulics




Function
checks



9 Check essential movements before use




Weekly

Cleaning



9 Clean and dry table, base and underneath table and base

9 Wipe off any escaped oil or grease from joints




Visual checks



9 Fully inspect mattress and table for signs of wear

9 Replace any worn items and send for repair




Function
checks



9 Check wheel brakes function and wheels rotate

9 Ensure all moving parts can move, applying grease if needed





Every six months
Technician check required




Operating Table Preventative Maintenance Table


Strengthening Specialised Clinical Services in the Pacific. User Care of


Medical Equipment: A first line maintenance guide for end users. (2015).


22




4.*Troubleshooting*and*Repair*of*Operating*Tables** ***Featured*in*this*Section:*****Skeet,*Muriel*and*David*Fear.*“Theatre*Equipment:*Operating*Table.”*Care(and(Safe(Use(of(Medical(Equipment.*VSO*Books,*1995,*p.*118]125.** *Strengthening*Specialised*Clinical*Services*in*the*Pacific.*User(Care(of(Medical(Equipment:(A(first(line(maintenance(guide(for(end(users.*(2015).* ************** ******
23




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


67


Troubleshooting – Operating Theatre and Delivery Tables




Fault Possible Cause Solution


1.



Table cannot be relocated



Wheels jammed

Electric motor not operational
(electrically driven table)



Clean wheels, remove obstruction

Check power to table
Replace fuse if blown
If problem persists, refer to
technician



2.



Table section or body cannot be
moved



Lock or lever is jammed


No power to electric table


No oil in hydraulic table



Clean jammed part, remove rust
and dirt, lightly oil and replace

Check correct switch is used
Check power and fuses

Refill hydraulic oil if needed
Check no leakage occurs



3.



Oil leakage from hydraulic table



Oil leakage



Locate leak and block it.
Clear spillage.
Refer to technician.



4.



Electric shocks



Wiring fault



Refer to technician immediately




Operating Table Troubleshooting Table


Strengthening Specialised Clinical Services in the Pacific. User Care of


Medical Equipment: A first line maintenance guide for end users. (2015).


24




7. User Checklist (to be displayed near the equipment)
Always refer to the manufacturer’s instructions


To keep this equipment in good working order for as long as possible:


Before using the table check:


- it has been thoroughly cleaned and dried since the last operation
- height control pedals
- brake and mobility of the table


lateral rotation function
- back raising function


leg rest is free and can be locked in position
all accessories, such as arm rests, and leg and chest supports, are
available and in good working order


Report to the Maintenance Officer:


any visible damage to table or mattress
any fault in the functioning of the table


Follow these SAFETY points:


Do check that all functions are working well - weekly, daily and
immediately before use.
Do check that all accessories are available in good condition and fit
securely.
Do clean and dry the table after each operation.
Do ensure that the pumping mechanism is regularly exercised if the
table is not going to be used daily.


109


Operating Table User Checklist


Skeet, Muriel and David Fear. “Theatre Equipment: Operating Table.” Care


and Safe Use of Medical Equipment. VSO Books, 1995, p. 118-125.


25




***5.*Resources*for*More*Information*about*Operating*Tables*and*Operating*Theatres****Featured*in*this*Section:*****Stanco,*Cassandra*ed.*for*EWH.*“Operating*Room*Lights*Packet.”*Engineering(World(Health,*2015.****WHO.*“Operating*Table:*Basic*Principles.”*From(the(Publication:(Maintenance(and(Repair(of(Laboratory,(Diagnostic(Imaging,(and(Hospital(Equipment.*WHO:*1996.***** ******** ***
26




***Resources*for*More*Information:****Internal*Resources*at*library.ewh.org:*For*More*Information*about*Infusion*pumps,*please*see*this*resource*in*the*BMET*Library!** 1. Malkin,*Robert.*“Microscopes:*Use*and*Operation.”*Medical(Instrumentation(in(the(Developing(World.*Engineering*World*Health,*2006.*** 2. Stanco,*Cassandra*ed.*for*EWH.*“Operating*Room*Lights*Packet.”*Engineering(World(Health,*2015.** ***


27




Operating*Tables*Bibliography:*****Burnett,*Joanne,*Clift,*Laurence,*Clift,*Maxine.*“National*Health*Service*Buyers’*Guide:*Operating*Tables.*CEP09016.”*NHS:(Centre(for(Evidence>Based(Medicine,*August*2009.*Retrieved*from:*https://dspace.lboro.ac.uk/dspace]jspui/bitstream/2134/7390/1/AR2614%20Buyers%20Guide%20Operating%20Tables.pdf***Engineering*World*Health.*“Preventative*Maintenance*Schedule*for*Operating*Tables.*EWH.*2012.(** Skeet,*Muriel*and*David*Fear.*“Theatre*Equipment:*Operating*Table.”*Care(and(Safe(Use(of(Medical(Equipment.*VSO*Books,*1995,*p.*118]125.***Stanco,*Cassandra*ed.*for*EWH.*“Operating*Room*Lights*Packet.”*Engineering(World(Health,*2015.*** Strengthening*Specialised*Clinical*Services*in*the*Pacific.*User(Care(of(Medical(Equipment:(A(first(line(maintenance(guide(for(end(users.*(2015).***WHO.*“Operating*Table:*Basic*Principles.”*From(the(Publication:(Maintenance(and(Repair(of(Laboratory,(Diagnostic(Imaging,(and(Hospital(Equipment.*WHO:*1996.***WHO.*“Operating*Table*(hydraulic)*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.*“Operating*Table.”*Wikipedia.*Retrieved*from:*https://en.wikipedia.org/wiki/Operating_table******
28




Copyright 2016, Engineering World Health