1 Introduction.............................................5 6 Behaviour in the operating room. ................................. 17 2 Operating room sign in..................7 6.1 Rules for working in the operating room........... 17 6.2 Performing the OPD in the operating room.......19
3 Admittance into the operating room...........................9
6.3 Problems before and during an OPD................21 6.4 Concentration during an OPD..........................22
3.1 Admittance through the personnel lock..............9 3.2 Lock systems...................................................10
7 Inappropriate behaviour during an OPD. ..................................23
4 Hand disinfection. ............................ 11 4.1 Hygienic hand disinfection................................ 11 4.2 Surgical hand disinfection................................12
5 Preparation for the OPD.............15
8 Completing the OPD with the OR team.............................25
Disclaimer This document is intended for training purposes on the European and Asian market only. All pages are marked â€œconfidentialâ€? which means that it is prohibited to pass this information on to any external party. The comparison to competition has been written to the best of our knowledge at the date of publication. Please keep in mind that our competitors enhance their products as well, so their products might have changed in the mean time. Make sure you use competitor comparisons only carefully in your conversations with customers. This training material does not constitute medical or legal advice and should not be relied upon as such. This document should not be considered as a substitute for carefully reading all applicable labelling, including the Instructions for Use (IFU) supplied with the devices and published, peer-reviewed articles concerning the topics presented. Before using or selling any product, please thoroughly review the relevant user manual(s) for instructions, warnings and cautions.
OR Guide Introduction
Fig. 1: Setting in the ENDOALPHA
The daily routine in an operating room is defined by a code
visitors to behave correctly, however, it is also crucial to do
of conduct driven by hygienic and internal rules. Everything
so in order not to leave a bad impression. The purpose of
happens for a very special reason and according to the
this manual is to prepare Olympus employees for their â€œOn
routine which has been established and proved to be
Patient Demonstrationâ€? (OPD), so it will run as smoothly as
efficient. Any irregularity will at least disturb if not even lead
desired and lead to positive results.
to complications during surgery. It is not easy for external
Operating room sign in Correctly signing in to the operating room for an â€˜On Patient Demonstrationâ€™ (OPD) is part of a good daily routine as well as being an important component in a company's image cultivation. It is the signal to the OR team that the Olympus employee has arrived and therefore that the OPD may begin. While the employee is getting ready, preparations for the OPD, such as anaesthetisation, can take place in the operating room. The OR manager or doctor responsible for the OPD knows who, when and where everyone is. This is of particular importance to the OR manager as they have to organise everything that goes on in an operating room. The OR manager must ensure that the Olympus employee is available because mobile phones must be switched off in the operating room. In general, it is possible to correctly sign into the operating room via the OR manager/doctor, the responsible doctorâ€™s secretary or the hospital telephone exchange. Depending on whether it is a regular or a new customer, signing in procedures may have been established, particularly for the former. For new customers, it is advisable to arrange the sign in procedure in the initial meeting with the doctor responsible for the OPD. Should it turn out that the originally responsible Olympus employee has to be replaced, then their replacement, the doctor responsible for the OPD and the OR team have to be informed. In order to be correctly signed in to the operating room, the name, role, contact person and company must be stated. The correct signing in procedure can establish how to admit brought along equipment, instruments and sterilized materials into the operating room. Usually, every operating room has a sterilization area where clean objects can be admitted into the operating room. Rollable objects must have their castors cleaned. This includes cases for an OPD.
OR Guide Operating room sign in
OR Guide Admittance into the operating room
Admittance into the operating room
3.1 Admittance through the personnel lock Generally speaking, only things that are ‘essential’ should be taken into the operating room. It should be decided whether or not a laptop, shoulder bag, briefcase, etc. are needed for an OPD. Under no circumstances are any back packs, suitcases, etc. to be brought into the OR. Upon entering the personnel lock, you are in the socalled ‘unclean area’ of the lock. Here you undress down to your underwear. Sleeveless shirts may be kept on. Your personal clothing should then be either hung up on provided coat hooks or, ideally, locked away in specially designated wardrobes. In the latter, valuables can also be stored as all jewellery (rings, bracelets, watches) must be removed from the hands. If valuables cannot be securely stored in the personnel lock, then they should be taken
Fig. 2: Wearing the name badge but no jewellery
into the operating room and stored in the OR manager’s office. It is important that you keep your name badge for
1. appropriately sized OR scrubs
2. appropriately sized OR trousers 3. a scrub cap (different styles depending on hair style, there
Mobile phones must be switched off. The bathroom of each OR is generally found in the ‘unclean area’. You
must not be any hair protruding from under the cap) 4. potentially, a face mask (potentially because in most
should therefore consider going to the bathroom before
operating areas a face mask is not worn until entering
entering the ‘clean area’, as after entering the ‘clean area’,
the operating room itself; must be enquired)
every time you re-enter the ‘unclean area’ you have to change your clothes. Before leaving the ‘unclean area’, it is vital that you hygienically disinfect your hands.
5. OR shoes (ideally those intended for guests, be careful with shoes that have names written on them!) 6. put on your name badge for identification 7. pocket valuables
After entering the ‘clean area’, you must put on operating
8. hygienically disinfect your hands
room clothing. The colour of the scrubs (green or blue) is
9. enter the operating room department
different from the normal white clothing in the hospital, so the different areas can be clearly distinguished. Dressing
Face masks must generally be replaced after they have
must always be done in the following order:
been taken off (and when visibly soiled, of course).
OR Guide Admittance into the operating room
3.2 Lock systems
adjacent to one another. There is a separate entrance to
Lock systems vary depending on the structure of the
the OR department from the ‘clean side’ and an exit in the
OR department building. Normally, there are one, two or three chamber personnel locks in OR departments. All
The two chamber personnel lock differs from the one
systems are based on the same hygienic principle but vary
chamber personnel lock in that all areas are separated in
in the number of rooms. Following the hygienic principle,
self-contained rooms. The ‘clean side’ room again has a
lock systems are made up of an ‘unclean side’ with an
separate entrance into the operating room and can only
integrated sanitization area and a ‘clean side’ with access
be used in this direction. The exit from the operating room
to the OR department. Personal clothing is left and used
is situated on the ‘unclean side’ where used OR clothes,
OR clothing including shoes, scrub cap and face mask
scrub caps and face masks are also disposed of.
are disposed of on the ‘unclean side’. OR clothing, scrub cap, face mask (if applicable) and shoes are put on on the
From a hygienic point of the view, the three chamber
‘clean side’ before entering the OR department.
personnel lock is the ideal system. It differs from the previous two in that the ‘unclean side’ is situated in a self-
In a one chamber personnel lock, the areas named
contained room. The operating room clothes, shoes, scrub
above are situated in a single room, with only the
caps and face masks are disposed of here. Used OR
sanitization area specially confined. The ‘unclean side’ and
clothes are logically separated from ‘white’ and personal
‘clean side’ areas are separated by coloured lines and are
Fig. 3: Three different lock systems: one chamber lock, two chamber lock and three chamber lock (from left to right)
OR Guide Hand disinfection
The hands of hospital personnel and visitors are the
(approx. 10 ml = two or three strokes from a wall
most common cause of hospital infections. Therefore, it
dispenser) in your palm and work into both hands
is particularly important to know the two forms of hand
including between the fingers, fingertips, thumbs and
disinfection. There is hygienic hand disinfection and
wrists, allowing at least 30 seconds for it to take effect.
surgical hand disinfection. In order for it to be effective
2. Apply and rub disinfectant into your palms.
it is important that no jewellery is worn on hands and
3. Rub the back of your hands with your palms in rotation
for both hands. 4. Rub palm to palm with fingers entangled and spread apart.
4.1 Hygienic hand disinfection Hygienic hand disinfection is carried out in the OR area
5. Rub between the fingers of the opposite hand with entangled fingers. 6. Rub each thumb in a circular motion with the other hand wrapped right around it, rub each palm in a circular motion with fingers in a ball.
before and after entering hygienic areas such as the operating room itself, entrance area/anaesthetization,
Frequent users of hygienic and surgical hand disinfectant
waiting room, sterilized materials storage area, anaesthetic
should take note that hand care also plays an important
recovery room, entrance/exit room, etc. Hand disinfection
part. Your hands should therefore be regularly groomed with
takes place as follows:
a lotion/cream. Along with care of the hands and forearms, it is important that finger nails are cut and clean when visiting
1. With dry hands, put some alcoholic hand disinfectant
Fig. 4: Sequence of images: hygienic hand disinfection
an OR. Nail extensions and nail varnish must be removed.
OR Guide Hand disinfection
4.2 Surgical hand disinfection Surgical hand disinfection is carried out before every operation. It should be noted that these are carried out in accordance with the Robert Koch Institute guidelines. Surgical hand disinfection is carried out as follows:
Fig. 5: Set the clock to 3 minutes: one minute for every step.
1. Roll up the sleeves of the OR scrubs so that they do not get in the way. Then wash your hands with antibacterial gel (1 stroke) from the finger nails, via the hands, all the way up to the elbows. Rinse thoroughly so that no soap remains. Dry off with lint-free disposable towel/fleece. The brushing of finger nails and skin is largely forgone nowadays as this can lead to skin lesions and heighten the risk of infection for both personnel and patients.
Fig. 6: Step one: taking up the disinfectant and spreading it across your hands and forearms to just above the elbows
2. Begin the surgical hand disinfection by taking some disinfectant from the wall dispenser (1 stroke = 3 ml). Operate the handle of the disinfectant dispenser with your elbow. In the first phase of disinfection, evenly spread the disinfectant across your hands and forearms to just above the elbows once. When evenly spreading the disinfectant, it is important to remember only to rub in up to just before the elbows (so called safety area). Forearms, hands and finger nails are included in the first minute, as they are with hygienic hand disinfection. Fig. 7: Step two: taking up the disinfectant and spreading it across your hands and forearms to half-way up your forearms
OR Guide Hand disinfection
3. In the second phase of disinfection, the disinfectant is once again taken from the disinfectant dispenser using your elbows. This time the disinfectant is evenly spread out from your fingernails, via your hands to half way up your forearms. This also takes one minute. 4. The final phase of disinfection is also the same, from the taking of disinfectant to the spreading of the disinfectant. However, the difference is that now only the hands and fingernails are included. Fig. 8: Step three: taking up the disinfectant and spreading it across your hands and fingers
Fig. 9: Never touch anything with your hygienically clean hands!
OR Guide Preparation for the OPD
Preparation for the OPD
After passing through the lock into the OR department and
What should be considered?
after the hygienic hand disinfection, the Olympus employee
• e. g. generator settings
introduces himself/herself to the OR team. At this point they
• e. g. compatibility between instruments and generators
can establish where any material for the OPD that came through the lock separately is. If it has not already taken
place, there must be a briefing about instruments and
• These are recommended as they offer proof that
equipment to the personnel involved in the OPD. It is highly recommended to find a quiet room/place for this purpose.
aforementioned points/aspects were discussed. • This is verified by signature.
At least the operating doctor and the OR personnel (instrumental technician and relief person) must take part
Use the manual
in the briefing. The following aspects of the Olympus
• Everything is written in black and white. Plus, the
employee's instruments and equipment must be discussed:
diagrams/images can be referred to. • The manual is indispensible for OR and sterilization
Construction and deconstruction of the instruments
personnel, doctors and medical technicians.
and equipment • e. g. SonoSurgX: The blade is pulled tight with a special hook wrench. • e. g. HiQ instruments: Insert must be turned half-way in
Sterilization preparation and assessment • Construction and deconstruction are important. • The sterilization department requires a recommended
a clockwise direction before it can be attached to the
and validated preparation process. Please refer to the
handle with the operating sheath.
Olympus System Guide and advise the sterilization staff
• e. g. LESS surgery instruments cannot be
to get familiar with it.
deconstructed. It is very important that any questions about the OPD Functionality
are raised. Any answers are binding. Should this not be
• e. g. cutting forceps by Gyrus are a bipolar instrument,
possible, then it is advisable to contact another member
meaning a patient electrode is not necessary. • e. g. HD EndoEYE is only fully functional with Exera II (NBI).
of the Olympus team who can answer these questions bindingly.
OR Guide Behaviour in the operating room
Behaviour in the operating room 6.1 Rules for working in the operating room
Do not walk through the sterilized zone. A typical situation that arises when preparing a patient for the operating room: The as yet unsterilized OR team are resting a patient and behind them the sterilized OR
Should any participants in the OPD not have been
personnel are preparing the sterilized instruments/tables.
introduced to the Olympus employee, then upon first
It is not uncommon for people to walk through this zone
entering the operating room would be the ideal opportunity.
and desterilize something. In order to get from A to B in
However, take note of the particular situation. There are
an operating room, it is best to choose a route via the
often occasions when a situation is hectic and therefore
anaesthetic team, around the head side of the patient.
introductions would be inappropriate. It is important, with
This way you are closer to the wall in order to keep an
time, to develop a sense for what is appropriate in which
appropriate distance from the sterilized area. If you are
situation. The following rules on behaviour have been set
unsure whether or not you can take a certain route, ask
out for communication, movement and behaviour in an
the presiding OR team.
operating room: Sterilized zone
Approach the sterilized zone slowly and deliberately. Avoid approaching the sterilized zone briskly and hectically. The danger of such behaviour leading to
sterilized materials becoming desterilized is very high. The sterilized OR personnel are particularly attentive of this Medical tower
and verbally ‘defend’ the sterilized zone. Should anything become desterilized, it can sometimes be very difficult to find a sterilized replacement. In the worst case scenario, the OPD would have to be called off.
Fig. 10: Sterilized zone before the start of the operation
Hint: Should you need to approach the sterilized zone, then it helps to let the sterilized team know that you are coming. Always approach the sterilized zone ‘forwards’, never ‘backwards’. As we cannot see what is happening behind us, the danger
Scrub nurse Sterilized zone
scenario is the OPD being called off because no sterilized
of desterilizing something when moving backwards towards the sterilized zone is very high. Again, the worst case
Surgeon Medical tower
replacement is available. When moving forwards, you have all the areas that are to be protected in your line of sight.
Fig. 11: Sterilized zone during an operation
OR Guide Behaviour in the operating room
Report the desterilization of any instruments
concentration. Walking around in the operating room also
causes unwanted air circulation with negative effects on
If you should desterilize anything in the sterilized zone, then
hygiene in the operating room. Unnecessary walking around
inform the OR team immediately, so that the situation can
is therefore also to be avoided. Even if other participants in
be rectified. Even if a member of the OR team desterilizes
the OPD are walking around constantly, this is not a reason
something without realising and you are the only one to
for you to do so, too.
notice, you should report this immediately. It is important to ensure that groups of visitors are not Keep at least an armâ€™s length distance from the
too large. Four or five visitors is a normal size. An entirely
deciding factor is the size of the operating room and what
As a rule it is good to remember to keep at least an armâ€™s
operation is currently being carried out.
length away from the sterilized zone in order to be on the safe side. Should anyone come any closer than that, then
Avoid noise and hectic.
you should notify them immediately.
Noise and hectic of any sort are to be avoided in an operating room. This includes any conversations with other participants of the OPD about past holidays or weekend activities. Such behaviour disturbs the concentration of the OR team and therefore the OPD. Hectic behaviour owing to a lack of preparation is also to be avoided, as the damage to the company image would be impossible to repair. It is sensible to follow the OPD in order to gather information about the procedure or further possible OPDs. Respect the patient's privacy. This is a very important point that is often ignored. This includes not entering the operating room when the patient is lying naked on the OR table and is being prepared for
Fig. 12: Keeping a safe distance
the operation or if the patient is receiving a catheter. The golden rule is: Only enter the operating room if the patient is covered by sheets for the operation.
Keep OR doors closed as far as is possible and avoid walking around.
If you are unsure, then ask the OR personnel before
The circulation of the air conditioning and the laminar airflow
entering the operating room. Generally, you leave the
ceiling over the operating area are disturbed whenever
operating room whilst anaesthesia is being removed.
an OR door is opened. This has an effect on the hygienic
Equally, patient data records are to be handled with
conditions during an operation. Constant and, in particular,
utmost care, so as not to lead to the patient's personal
unnecessary walking in and out during an operation should
rights being violated. If you take endoscopic pictures, for
therefore be avoided. Moreover, the opening and closing
example (for any of your purposes), the patientâ€™s name,
of the OR door causes noises that disturb the OR team's
date of birth, etc. must not be visible!
OR Guide Behaviour in the operating room
6.2 Performing the OPD in the operating room
point can help you point to specific parts of the sterilized
A vital part of success is a thorough preparation for an
instrument/piece of equipment might fall down. In the
OPD. In order for an OPD to proceed successfully during
worst case scenario, this would lead to the OPD being
an operation, the following behaviour is suitable:
abandoned. In order to prevent this, you can advise that
instrument. Take a sterilized replacement instrument with you. During any operation, it is possible that a sterilized
the instrument should be constructed over the sterilized Take a second instrument with you for
instrumentation and side table. Furthermore, prevent
the instrument/piece of equipment from being rested
Sometimes, despite being well prepared, problems can
on a patient. Ideally, when preparing for the OPD, you
arise during the OPD. For example, the construction of
should plan to take a second instrument with you to be
instruments or their use in a sterilized operating area can
prepared in sterilization. That ensures that a replacement
fail. It is, therefore, a good idea to take an unsterilized
is available and you are safeguarded. Numerous so-called
instrument of the same model with you, to show the
'disposable' items should also be taken with you.
sterilized OR team how it is constructed or how it works from the unsterilized zone. Please remember to approach
Give correct answers to questions about the product.
the sterilized zone with care and from a safe distance.
Under no circumstances are â€˜half-truthsâ€™ or false information to be given about a product. In these situations, it is better to be honest and state that you will follow up on their question as soon as possible. If this information cannot be given immediately, offer to research it and let them know the answer at a later date. Intervene 'verbally' if there is a threat of misuse in the sterilized zone. If you notice during or after an OPD that a misuse of the representative product is likely to happen, intervene immediately and, if necessary, give an urgent warning. You cannot do anything wrong in this situation. There is more likely to be a problem if you say nothing. After the situation
Fig. 13: Demonstration on a second instrument
has been rectified, give the customer another briefing about correct use.
Use a laser pointer for demonstration. A further possibility is to point with a laser pointer from the unsterilized into the sterilized zone. Always announce your intention to use a laser pointer beforehand! The laser
OR Guide Behaviour in the operating room
If you are not getting anywhere: â€˜sterilized scrub inâ€™
his/her arms, which are held out, into the sleeves of the
ď‚¨ sterilized help.
lab coat. It is important to keep a large enough distance
If there are problems with the use of the product that
from the sterilized OR personnel so as not to desterilize
cannot be solved by the sterilized OR team and even
them. After this, the unsterilized OR colleague closes
helping from the unsterilized zone is unsuccessful, then
the lab coat.
scrub in in order to get to the bottom of the problem. The
3. The OR nurse holds up the OR gloves, which you then put
Olympus employee should, however, be certain they can
on. Then, take hold of the lab coat fastener fixed in front
solve the problem from within the sterilized zone. Sterilized
of your stomach, give it to the sterilized OR personnel and
scrubbing in is explained above. The process of getting
turn clockwise until the lab coat is done up.
dressed in sterilization proceeds as follows:
4. It is important that you hold your hands by your stomach or chest so that they do not become
1. After the surgical hand disinfection, as described above, enter the operating room with your arms held up slightly. 2. Approach the sterilized side table of the sterilized OR
desterilized. 5. At this point it is important to realise that habits such as touching your head, scratching your nose, adjusting
personnel and politely ask them to help you get dressed
your glasses or letting your arms hang at your sides are
in sterilization. The sterilized OR personnel then unfolds
prohibited, as you will become desterilized and will need
the sterilized lab coat and the Olympus employee puts
to leave the vicinity of the operating table.
Fig. 14: Getting dressed in sterilization
OR Guide Behaviour in the operating room
6.3 Problems before and during an OPD The instrument which is necessary for the OPD is
OPD cannot begin as the operator does not know
how to use the instrument.
Solution: Ring the OR manager one or two days before
Solution: good preparation of the OR team before the OPD.
the OPD to make sure the delivery was successful and has already been returned from sterilization. Always check
Equipment does not work.
internally and with the customer.
Solution: Carry out equipment check. Ensure you have given yourself enough time to do this. Have a second
Instrument cannot be traced.
Solution: Ring the OR manager one or two days before the OPD to make sure the delivery was successful and
Operator wants to abandon the OPD.
has already been returned from sterilization. Always check
e. g. because they have run out of patience with the new
internally and with the customer.
instruments/equipment and are not confident. Solution: Calmly and professionally explain the
Sterilized construction is not successful.
advantages and functionality. Motivate them to continue.
Solution: Take a second unsterilized instrument and/or laser pointer for demonstration with you. Instrument falls down during the OPD. Solution: Have a second sterilized instrument. There are no personnel in the operating room for handing over sterilized instruments. Solution: Get/advise personnel for the operating room or ask someone from anaesthetics. Only intervene yourself in an emergency when the patient could be in danger.
OPD Guide Behaviour in the operating room
6.4 Concentration during an OPD Concentration, from the beginning to the end of the OPD, is expected by the customer. This is the only way the customer can be convinced of the advantages of the product. Furthermore, this is the way to demonstrate true professional customer service, which is a requirement for all employees. Recording of important information can be ensured this way and it serves to further build on customer contact. For example, during the OPD, there are often comments on the need for further products. A vigilant employee registers these wishes and takes further action. Attentively following an OPD ensures quick intervention if there should be a problem, e.â€‰g. if there is the threat of misuse.
Fig. 15: Quiet and focused discussion in an OR
OR Guide Inappropriate behaviour during an OPD
Inappropriate behaviour during an OPD
The following inappropriate behaviour during an OPD is to
be avoided at all costs in order to prevent damage to the
The patient has a medical treatment contract with the
company image and unprofessional behaviour:
hospital or the doctor. This states that the doctor named in the contract is to carry out the treatment or by a colleague
designated by him who has a state-certified specialist
Arriving late for an OPD must be avoided at all costs.
qualification (medical specialist). An external employee of
You must ensure you have allowed enough time. Should
a medical technology company is not normally a medical
there be circumstances out of your control (e.â€‰g. bad
expert. And even if they are, they have not signed a
weather conditions) then the OR manager/doctor must be
medical treatment contract with the patient.
informed as soon as possible. The problem is that not only is the image being damaged, but the entire OPD is put under pressure of time. This increases the likelihood that something will go wrong.
It is clear that no treatment is to be carried out by employees of a medical technology company. This includes using a pair of SonoSurg scissors in/on the
Beginning an OPD without being properly prepared
patient, for example.
As a rule, this leads to important elements of the operation failing: for example, the sterilized construction of the demonstrated product does not work or questions about
Not following general and specific OR department rules
the product cannot be answered. This gives the customer
This includes specific hygiene rules which are valid
good reason to be dissatisfied. A successful relationship
particularly in the clinic where the OPD is being carried
with the customer then becomes very difficult to build.
out, such as the wearing of a face mask in the corridor, presence of visitors in the operating room etc. Disregard
for such rules involves immense potential for conflict and
In the worst-case scenario, inappropriate behaviour in
is therefore to be avoided. Rules should be asked about in
the sterilization zone can, as already mentioned on the
the initial meeting or upon being introduced.
previous page, lead to the OPD being abandoned. The damage to the company image is also difficult to repair if
Making agreements that do not conform to
grossly negligent behaviour in the sterilized zone leads to
desterilization. Attentive and cautious behaviour is of the
As a company working in the healthcare and public
sectors, we are subject to a number of legal restrictions (e.â€‰g. local criminal code and tax regulation, EU and
Disturbing those at work during an operation
international anti-corruption law, service law), particularly
This includes, for example, unsterilized behaviour and if
when collaborating with external parties. Invitations to
you are standing in the way, e.g. in the operating room
business lunches and small gifts are part of everyday
corridor. A good tip is to always walk along or stand by the
business practice, however, problems do arise when gifts,
walls. You can also ask the OR personnel where best to
entertainment and other business courtesies are used
stand to follow the OPD.
improperly or appear to be used to influence business
OPD Guide Inappropriate behaviour during an OPD
decisions/obtain a business advantage, especially when the public sector is involved. With this background, a â€œCompliance Framework: Working with Healthcare & Public Sector Organisationsâ€? was issued where you find all details for the daily practice which needed to be followed strictly. This applies to all companies of the Olympus Europa Group.
OR Guide Completing the OPD with the OR team
Completing the OPD with the OR team To complete the OPD, there must be a feedback meeting without fail. Everyone involved with the OPD should be questioned for this. Questions should include the overall impression, handling, therapeutic outcome etc. The opinion of the operator trying out the product is of particular interest. This also provides an opportunity to discuss a loan for a test period, the conditions for an offer or further customer wishes. Taking leave of all those involved in the OPD and thanking them for the successful OPD and the support closes the OPD.
W7.070.240 1.2_03/10 Printed in Germany