Professional Documents
Culture Documents
for purchasing the new IMEC. Please read through this operating instructions carefully
and observe all safety instructions and requirements regarding the operation and care
of the device.
The IMEC operating instructions are only valid when combined with the operating ins-
tructions of the ceiling support systems. You will find all the information in the following
operating instructions:
• Ceiling support systems operating instructions.
• TruPort ceiling support systems operating instructions.
How to contact us
Germany TRUMPF Medizin Systeme GmbH + Co. KG
Benzstra?e 26
82178 Puchheim
Germany
Email service.med@de.trumpf.com
Trademarks
IMEC System® und IMEC Solo®, incarePORT® / klinoPORT® andTruPort® are regis-
tered trademark of Trumpf Medical.l.
• All trademarks mentioned in these operating instructions are the sole and
exclusive property of the corresponding manufacturer.
3.3.4 Transferring the transfer unit from the support head to the transport unit ........................................................30
3.3.5 Docking the transport unit with transfer unit onto the bed.................................................................................32
3.4 Before transport .............................................................................................................................. 33
3.5 During transport .............................................................................................................................. 34
3.5.1 Undocking the transport unit withtransfer unit from the bed .............................................................................35
3.5.2 Transferring the transfer unit from the transport unit to the support head ........................................................36
These Operating Instructions are intended solely for devices with the manufacturer's
rating plate bearing the following information:
Make sure you are using the latest version To ensure that you always have the latest version of these Operating Instructions, all
of these Operating Instructions pages bear a 7-digit identity number with a 2-digit version number and country codet:
This identification is binding for the validity of the Operating Instructions and must not
be removed, regardless of the type of publication (printed form, electronic form or
excerpts).
1.3.1 Operator
An operator (e.g. a medical practice or hospital) is any individual person or legal entity
which owns and operates the device or on whose behalf the device is operated.
• The operator shall undertake to provide a safe device and to instruct the user ade-
quately in the operation of the device and its intended use.
1.3.2 User
Users are persons who, due to their qualification or training by qualified staff, are
entitled to operate and work with the device.
• Users are entirely responsible for the safe operation of the device and for ensuring
that it is used for its intended purpose.
Procedural guidelines The device is designed according to state-of-the-art technology and is safe to operate.
However, use of this appliance may still constitute a hazard, in particular if it is used by
staff without sufficient training or if it is not used properly and in accordance with its
intended purpose.
• The device may only be operated, cleaned, disinfected and maintained by qualified
staff.
1.4.3 Warranty
Warranty Trumpf Medical guarantees the safety and functional reliability of the device only on
condition that:
• The device is used exclusively as prescribed and operated, maintained and
repaired as stipulated in these Operating Instructions.
• Only spare parts and accessories authorized by Trumpf Medical are used;
• No structural alterations are made on the device;
• Inspections and maintenance are carried out at the specified time intervals;
• Initial commissioning has been carried out and the device has been released for
operation by means of a declaration of acceptance.
• This ensures:
– top quality,
– convenient operation,
– functional design,
– optimization for the intended use.
1.5 Delivery
Prior to installation, inspect the delivered components for completeness and damage
that may have occurred in transit.
• To inspect the delivery, all components must be unpacked and subjected to visual
inspection.
• The components can be identified by means of the order number indicated on the
shipping note and /or the order-specific dimension sheet.
1.7.1 Marking
Conformity The manufacturer declares that this product complies with the basic requirements of
MDD Appendix I and shows conformity by means of the CE mark.
CE marking: This device is a Class I Medical Device in accordance with the European
Medical Device Directive (MDD 93/42/EEC, 2007).
UL mark UL marking: device tested by Underwriter Laboratories Inc. for use in the USA and
Canada with respect to electric shock, fire and mechanical hazards..
UL/cUL classification:
• UL 60601-1, 1st Edition, 2006-04-26
• CAN/CSA C22.2 Nr. 601.1 - M 90, 2005
state of charge of the batteries in syringe and infusion pumps, the level of gas in the
gas bottles) for the duration of transport.
• The device is not suitable for operation in potentially explosive atmospheres.
The device is not suitable for use in rooms or environments with atmospheres con-
taining combustible mixtures of anaesthetics with air, oxygen or laughing gas.
If high concentrations of inflammable mixtures of anesthetics with oxygen or nit-
rous oxide occur in the environment of the appliance, there is a risk of ignition
under certain conditions. In accordance with EN 11197, the hazardous zone inclu-
des an area of between 5 cm and 25 cm from the gas leak or exit point..
1.7.6 Contraindications
No contraindications have been found.
Different conditions are required for the operation and interim storage of the device.
Read the operating instructions for • The IMEC is fitted with equipment (e.g. syringe pumps, monitors etc) from other
combined medical products manufacturers. For the operation of these devices, please refer to the respective
operating instructions.
• Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1
may be attached to the system. If a medical device is installed afterwards, the ins-
tallation must be performed as specified in IEC 60601-1 and IEC 60601-1-1 or in
accordance with the specifications provided by the manufacturer. Compliance with
this standard must be ensured by the service technician responsible.
Maximum load • Observe the maximum load:
– of the IMEC System of 115 kg of which a maximum of 65 kg should be placed
on the transfer unit,
– of the IMEC Solo of 125 kg
1.10 Disposal
The device should be disposed of in accordance with the corresponding national regu-
lations and at a suitable waste disposal point for the recycling of electrical and elect-
ronic devices.
RoHS conformity • The device meets the requirements of Directive 2011/65/EU RoHS (restriction of
the use of certain hazardous substances in electrical and electronic equipment).
DANGER indicates an immediate hazard, which, if not avoided, will cause death or
DANGER
serious injury.
WARNING WARNING indicates a potential hazard, which, if not avoided, may cause death or
serious injury.
Caution indicates a potential hazard, which, if not avoided, may cause minor or slight
CAUTION
injury.
ATTENTION ATTENTION indicates a potential hazard, which, if not avoided, may cause damage to
property.
NOTE NOTE gives you additional information and helpful tips for the safe and efficient use of
the device
Gas explosion: warns of the danger of the explosive ignition of gas mixtures.
Electric shock: warns of an electric shock which may result in severe or even fatal
injury.
Risk of fire: warns of the risk of fire due to the improper handling of oxygen.
Collapse of the ceiling support system: warns of the ceiling support system suddenly
collapsing as a result of additional loads.
Damage to surfaces: warns of the risk of damage to the surfaces through the use of
incorrect cleaning agents or disinfectants.
Damage to surfaces: warns of the risk of damage to the surfaces through the use of
incorrect cleaning agents or disinfectants.
CE conformity mark: confirms conformity of the device with the guidelines of the Euro-
pean Medical Device Directive (MDD)
The UL mark confirms that the device has been tested by Underwriter Laboratories Inc.
for use in the USA and Canada. The UL/cUL classification with respect to electric
shock, fire and mechanical hazards is only in accordance with UL 60601-1, 2006 and
CAN/CSA C22.2 No. 601.1 - M 90, 2005.
Risk of explosion
DANGER
Gas explosion
--------------------------------------------------------------------------------------------------
Oxygen explosion
Oxygen may explode in contact with oils, greases and lubricants. There is
a risk of explosion due to the compressed oxygen:
• Keep the oxygen and gas outlet point free of substances containing oils,
greases and lubricants!
• When cleaning, do not use cleaning agents containing oils, greases or
lubricants.
• The oxygen bottle connections must be clean and free of dirt particles.
--------------------------------------------------------------------------------------------------
Risk of explosion
When docking and undocking the IMEC, the connections of the optional
gas bottles can become damaged and the gas bottles can explode:
• Only install gas bottles on the IMEC with a protective covering on the
connections.
• Avoid collisions and bumps with the connections of the optional gas
bottles.
Risk of fire
WARNING
Oxygen
--------------------------------------------------------------------------------------------------
WARNING
Electric shock
--------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------
The transfer unit of the IMEC System must begrounded with earth
conductors.
WARNING
Danger of pulling off supply lines when disconnecting the transport unit
from the bed:
• Switch off the height adjustment for the bed; deactivate it; do not
operate.
• During transport, the lever of the IMEC System must be in the upper-
most position.
--------------------------------------------------------------------------------------------------
• Check that all the locking screws on the fixing parts, e.g. the equipment
rails 25 x 10mm, etc. are secured tightly.
• During transport and when docking and undocking, do not drive over,
trap, pull off or disconnect the supply lines (e.g. respirator tubes) to the
patient.
• Arrange the supply lines so that they cannot get caught e.g. on door
handles etc.
--------------------------------------------------------------------------------------------------
• There must be a sufficient supply of gas and electricity (e.g. the state of
charge of the batteries in syringe and infusion pumps, the level of gas in
the gas bottles) for the duration of transport.
• Do not connect up any equipment which would endanger the patient in
the event of a power or gas failure.
--------------------------------------------------------------------------------------------------
• The sockets which supply the IMEC transfer unit must be individually
fused (separate circuits).
• Before undocking the transport unit, remove the supply lines between
the patient and the support head.
• The supply lines between the patient and the transfer unit do not have
to be removed.
• When docking and undocking, avoid collisions with the medical equip-
ment installed.
Additional loads
WARNING
Ceiling-mounted support system falling
--------------------------------------------------------------------------------------------------
During transport the lever of the IMEC System must be in the uppermost
position.
CAUTION
IMEC toppling over
• The maximum load of the IMEC System of 115kg (57.5kg per side) of
which a maximum of 65kg (32.5kg per side) should be placed on the
transfer unit must not be exceeded.
• Do not exceed the maximum load of 125kg (62.5kg on each side) on the
IMEC Solo.
• Mount the medical equipment on the infusions rods and equipment rails
so that it is equally distributed.
• Prevent the IMEC from moving accidentally by locking the front castors.
• Avoid collisions with door frames and objects by manoeuvring the IMEC
carefully.
• Do not drive over any objects lying on the ground.
WARNING
Switching off the power supply
Contact with live parts may result in an electric shock.
• Always disconnect the device from the main power supply prior to
cleaning and disinfecting.
• Do not insert objects into device openings.
WARNING
Improperly used cleaning or disinfecting agents can endanger patients or
damage products.
Failure to follow and comply with the instructions below could result in
damage to the paint finish or coating on the device. Particles could
become loose and fall into open wounds, which represents a risk of conta-
mination or infection for patients. It also completely voids the warranty.
• Only use a wipe-down disinfectant to disinfect the device.
• The cloth used to clean/disinfect the device should only be damp, not
wet.
• Dose the cleaning agent/disinfectant as such that no fluid flows into the
joints or openings of the pendant system.
• Only use surface disinfectants in the concentration specified by the ma-
nufacturer.
• Only use disinfectants approved by the manufacturer for use on the fol-
lowing materials:
Polycarbonate (PC), polyamide (PA), acrylonitrile-butadiene-styrene
copolymer (ABS), polystyrene (PS), polyurethane (PUR), polyphenyl
sulphone (PPSU), polyvinyl chloride (PVC), polybutylene terephthalate
(PBT), and silicones.
• In the event of increased build-up of surface disinfectant, conduct a tho-
rough basic clean.
• The operator's hygiene guidelines must be complied with.
ATTENTION
Damage to surfaces / lacquered surfaces
To avoid damage:
CAUTION
Risk of trapping fingers
--------------------------------------------------------------------------------------------------
When placing the heavy pressurised gas bottle on the holder, this may fall
or you could trap your fingers.
• Only grasp the pressurised gas bottle by the sides and place on the hol-
der.
• When lifting, make sure not to lift the pressurised gas bottle over your
feet.
Maintenance
CAUTION
Performing adjustment work
--------------------------------------------------------------------------------------------------
Warranty
The safety, reliability and performance of the device can only be guaran-
teed if genuine Trumpf Medical spare parts or parts approved as suitable
by Trumpf Medical are used exclusively.
Start-up
CAUTION
Initial commissioning prior to use
Prior to use for medical operation, the lighting system must be subjected
to initial commissioning, including all relevant tests, before being handed
over to the operator.
• Initial commissioning comprises the functional test and safety inspec-
tion of the complete lighting system.
• Handover must be documented by means of a declaration of accep-
tance
Optional accessories:
• The optional accessories are mounted on the IMEC Sys-
tem on delivery.
• Mount any accessories ordered at a later date in
accordance with the Installation Instructions for the
accessory.
Supply sockets:
• On each side of the body there is a supply socket 8 with
retaining clamp 9 for power supply to a maximum of eight
outlet sockets 7 .
• The medical equipment connected to the outlet sockets 7
are grounded with equipotential bondings B .
Before transport, lower the transfer unit onto the transport unit:
• The transfer unit 5 is on the transport unit 6 in the upper-
most position (blue arrow).
• To prevent the transfer unit 5 from falling out during trans-
portation, the lever 3 must be pushed upwards as far as it
will go in order to lower the transfer unit 5 onto the trans-
port unit 6 (black arrow).
WARNING
-------------------------------------------------------------------
-------------------------------------------------------------------
1. Check that all the locking screws on the fixing parts, e.g.
the equipment rails 25 x 10mm 2 etc. are secured tightly.
2. Mount the medical equipment 3 on the equipment rails
25 x 10mm 2 or optional infusion rods 1 so that it is
equally distributed.
WARNING
Pulling off the supply lines
WARNING
Failure of medical equipment
WARNING
Electricity leakage to patients
WARNING
Electricity leakage to patients
DANGER
Risk of explosion
CAUTION
KRisk of trapping fingers
ATTENTION
Damage to the shelf
WARNING
Electric shock
WARNING
Failure of medical equipment
WARNING
Transfer unit falling
Figure 16 3.3.5 Docking the transport unit with transfer unit onto
the bed
DANGER
Risk of explosion
WARNING
Transfer unit falling
-------------------------------------------------------------------
-------------------------------------------------------------------
CAUTION
Risk of trapping fingers
WARNING
-------------------------------------------------------------------
-------------------------------------------------------------------
-------------------------------------------------------------------
-------------------------------------------------------------------
DANGER
Risk of explosion
CAUTION
Risk of trapping fingers
WARNING
Failure of medical equipment
WARNING
Failure of medical equipment
Optional accessories:
• The optional accessories are mounted on the IMEC Solo
on delivery.
• Mount any accessories ordered at a later date in
accordance with the Installation Instructions for the acces-
sory.
Figure 24
During transport
• The IMEC Solo 1 is connected to the bed via two bed-
specific couplings 4 .
• The bed-specific spring couplings 4 compensate for diffe-
rent bed heights and uneven floors during transportation.
• During transport, the medical equipment (infusion pumps,
etc.) on the IMEC Solo 1 must be powered by integrated
batteries.
• The duration of powering by battery can be found in the
operating manual from the respective manufacturer.
• Medical equipment (respirators) on the optional shelf 3 is
supplied with compressed air and/or vacuum via the optio-
nal gas bottle (02) 2 .
WARNING
-------------------------------------------------------------------
1. Check that all the locking screws on the fixing parts, e.g.
the equipment rails 25 x 10mm 2 etc. are secured tightly.
2. .Mount the medical equipment 3 on the equipment rails
25 x 10mm 2 or optional infusion rods 1 so that it is
equally distributed.
WARNING
Trapping/pulling off the supply lines
WARNING
Electricity leakage to patients
DANGER
Risk of explosion
CAUTION
Risk of trapping fingers
ATTENTION
Damage to the shelf
DANGER
Risk of explosion
WARNING
Danger of pulling off supply lines when disconnec-
ting the IMEC from the bed:
-------------------------------------------------------------------
CAUTION
Risk of trapping fingers
WARNING
-------------------------------------------------------------------
-------------------------------------------------------------------
-------------------------------------------------------------------
DANGER
Risk of explosion
CAUTION
Risk of trapping fingers
WARNING
Failure of medical equipment
For cleaning and disinfecting the IMEC, refrain from any other method than wiping.
WARNING
Electric shock
The surface of the swivel-arms is coated with a high-quality powder stoved enamel
coating. Blank metal parts are made of anodized aluminium or stainless steel.
Cleaning
Cleaning agent and disinfectants The following cleaning agents may be used:
• for stainless steel parts
– all customary stainless steel cleaning agents or alkalescent multi-purpose
cleaners (active components: tensides and phosphates)
• for all other parts
– alkalescent multi-purpose cleaner (active components: tensides and phospha-
tes).
WARNING
Risk of contamination and infection of the patient
ATTENTION
Damage to surfaces
To avoid damage:
• Only use agents that do not contain chlorides or halides.
• Do not use benzine, paint thinner, alkaline / acidic agents or aldehyde-
based cleaning agents.
• Do not use abrasive cleaners
--------------------------------------------------------------------------------------------------
Exclusion of warranty
Since each device is subjected to wear and tear over time, the safety and proper func-
tioning of your device must be checked at regular inspection and maintenance inter-
vals. Carry out repeat inspections in accordance with your national regulations.
Service hotline
Customer service Phone: 0 180 / 2 25 41 35
Inquiries from Germany Chargeable phone call:
6 ct/call from German landline
42 ct/minute (max.) from mobile phones
Fax: +49 / (0) 36 71 / 586 - 41 175
E-mail service.med@de.trumpf.com
Weekly inspection Prior to any use of the device for medical operation, a functional test
and a visional inspection must be performed once a week.
WARNING
Functional test
--------------------------------------------------------------------------------------------------
Defective devices
ATTENTION
Observe the annual inspection intervals
Five year maintenance Maintenance by TRUMPF Customer Service every five years
The device must only be serviced by TRUMPF Customer Service or an authorized
partner.
ATTENTION
Observe the servicing schedule
6.3 Repairs
WARNING
Unauthorized repairs
Authorized service providers The device may only be opened and repaired
by TRUMPF Customer Service or authorized service providers.
Classification
This device is a Class I Medical Device in accordance with the European Medical Device Directive (MDD 93/42/EEC,
2007, Appendix IX).
Operating mode: Continuous operation
Protection level:Typ B
Protection type: Enclosed Design
Ordinary Appliance (enclosed unit with no protection against ingress of water).
The equipment is not suitable for operation in potentially explosive atmospheres..
Notes on EMC
The device has been designed for operation in one of the environments described below. The customer or user of the device
should ensure that it is operated in such an environment.
RF emissions in accordance with CISPR 11 Class A The ceiling support system is suitable for opera-
tion in facilities other than private homes provi-
Harmonic emissions in accordance with
Class A ded that these facilities are connected to the
IEC 61000-3-2
PUBLIC POWER SUPPLY NETWORK which
Voltage fluctuation/flicker emissions in accordance with also supplies buildings used for residential pur-
Complies poses.
IEC 61000-3-3
Interference Immunity Test IEC 60601 Imm. Test Level Compliance Level Environment/Guidelines
Floors should be made from
wood or concrete or covered
Electrostatic discharge in
±6 kV contact discharge ±6 kV contact discharge with ceramic tiles. If a floor is
accordance with
±8 kV air discharge ±8 kV air discharge covered with synthetic mate-
IEC 61000-4-2
rial, the relative humidity must
be at least 30 %.
The supply voltage quality
Electrical fast transient/burst ±2 kV for power lines ±2 kV for power lines
should correspond to that in a
in accordance with ±1 kV for input and output ±1 kV for input and output
typical business or hospital
IEC 61000-4-4 lines lines
environment.
100 % dip of UN for 1 period 100 % dip of UN for 1 period The supply voltage quality
60 % dip of UN 60 % dip of UN should correspond to that in a
for 5 periods for 5 periods typical business or hospital
30 % dip of UN 30 % dip of UN environment.
Voltage dips, short interrup- for 25 periods for 25 periods If the ceiling support system
tions and voltage variations in 100 % dip of UN for 250 peri- 100 % dip of UN user requires uninterrupted
accordance with ods for 250 periods functionality even in case of
IEC 61000-4-11 voltage interruptions, we
Note: Note: recommend you supply the
UN is the AC supply voltage UN is the AC supply voltage ceiling support system via the
prior to applying the test prior to applying the test uninterruptible power supply
levels. levels. (UPS) or a battery.
Guidelines and manufacturer's declaration - electromagnetic immunity / portable and mobile radio units
Portable and mobile radio units must not be used at a distance from the ceiling support system, including cables, less than the
recommended protection ratio calculated on the basis of the transmission frequency equation.
Recommended protection ratio:
Interference Immunity Test IEC 60601 Imm. Test Level Compliance Level Environment/Guidelines
Conducted RF in accordance
3 Veff 150 kHz to 80 MHz 3 Veff D = 1, 2 P
with IEC 61000-4-6
D = 1, 2 P at:
Conducted RF in accordance 80 MHz to 800 MHz *
3 V/m 80 MHz to 2.5 GHz 3 V/m
with IEC 61000-4-3 D = 2, 3 P at:
800 MHz to 2.5 GHz *
* P represents the nominal power of the transmitter in Watt (W) in accordance with the transmitter manufacturer's specifications,
and D indicates the recommended protection ratio in meters (m). In accordance with an on-site inspectiona, the field strength of sta-
tionary radio transmitters at all frequencies must be less than the compliance level.
b Interference is possible in the environment of devices marked with the following graphic symbol:
Explanation re a and b:
a The field strength of stationary transmitters including the base stations of mobile phones and mobile based radios, amateur radio
stations, AM and FM radio and TV broadcasting transmitters cannot be theoretically and precisely predetermined. In order to deter-
mine the electromagnetic environment with regard to stationary transmitters, a study of the location should be considered. If the
field strength measured at the location where the above-mentioned equipment is used exceeds the above-mentioned compliance
levels, the ceiling support system should be monitored because additional measures might be required such as modified orienta-
tion or a different location.
b The field strength in the 150 kHz to 80 MHz frequency range should be less than 3 V/m.
Notes:
For 80 MHz and 800 MHz the higher value applies.
These guidelines might not be applicable in all cases. The propagation of electromagnetic quantities is influenced by the absorption
and reflection of buildings, items and human beings..