Dräger Prana S User manual

1
Instructions for U
se
PranaSandPranaV
WARNING
For a full understanding of the
performance characteristics
of this device, the user shall
carefully read these
Instructions before use of the
device.
Bed Head Units for medical
applications

2
1 Consecutive numbers indicate steps of
action, with the numbering restarting with "1"
for each new sequence of actions.
•Bullet points indicate individual
actions or different options for action.
–Dashes indicate the listing of data, options,
or objects.
(A) Letters in parentheses refer to elements in
the related illustration.
A Letters in illustrations denote elements
referred to in the text.
Trademarks
Trademark
Trademark owner
DrägerService
®
Dräger
Microzid
®
Schülke & Mayr
Acryl-des
®
Schülke & Mayr
T erralin
®
Schülke & Mayr

3
Safety information definitions
WARNING
A WARNING statement provides important
information about a potentially hazardous
situation which, if not avoided, could result
in death or serious injury.
CAUTION
A CAUTION statement provides important
information about a potentially hazardous
situation which, if notavoided,mayresult in
minor or moderate injury to the user or patient
or in damage to the medical device or other
property.
NOTE
A NOTE provides additional information
intended to avoid inconvenience during
operation.
Abbreviations and symbols
For explanations refer to sections
"Abbreviations" and "Symbols" in chapter
"Overview".

4
Definition of target groups
Users, service personnel and
experts must have received
instruction in the use of the product
and must have the necessary
training and knowledge to use,
install, reprocess, maintain, or repair
the product.
Users
Users are persons who utilize the
product in accordance with its
intended use.
Service personnel
Service personnel, responsible for
the installation, reprocessing and
maintenance must be trained in the
applicable processes.
Experts
Experts, responsible for repair and
complex maintenance must have
the necessary knowledge and
experience on the product.
Patients
This product can be considered for all patient population.

5
Contents
For your safety and that of your patients . . . 7
General safety information . . . . . . . . . . . . . . . . 7
Product-specific safety instructions . . . . . . . . . 9
Application and Overview . . . . . . . . . . . . . . 11
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Variants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Putting the device into operation . . . . . . . . . 15
Putting into operation for the first time . . . . . . . 15
Acceptance and handover . . . . . . . . . . . . . . . . 16
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 16
Fault –Cause –Remedy . . . . . . . . . . . . . . . . . 16
Cleaning and disinfection . . . . . . . . . . . . . . . 17
Safety information . . . . . . . . . . . . . . . . . . . . . . 17
Manual Cleaning & Disinfection . . . . . . . . . . . 17
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Preventive main te nance. . . . . . . . . . . . . . . . . . 19
Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Disposal of the medical device. . . . . . . . . . . . . 20
Technical
da ta. . . . . . . . . . . . . . . . . . . . . . . . . 22
Declaration of Hazardous Substance…………23
OrderList . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

6
This page was intentionally left blank.

7
Not for use in areas of explosion hazard
WARNING
Increased fire risk.
Gas terminal units must not come into
contact with oil, grease or flammable
liquids.
General safety information
The following WARNING and CAUTION
statements apply to general operation of the
medical device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
instructions for use or in the instructions for use of
another product being used with this medical
device.
Please follow Instructions for Use
carefully
WARNING
Risk of incorrect operation and of incorrect
use
Any use of the medical device requires full
understanding and strict observation of all
sections of these instructions for use. The
medical device must only be used for the
purpose specified under "Intended use" on
page 11.
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device
labels. Failure to observe these safety
information statements constitutes a use of
the medical device that is inconsistent with its
intended use.
Accessories
WARNING
The given maximal loads and moment are to be
observed when using accessories on the
standard rails.
Maintenance
WARNING
Risk of medical device failure and of patient
injury
A regular inspection of gas –electrical
components is to be carried out through the
operator.
For the respective systems, the inspections
will include the various components of the
medical gas supply system (terminal units),
electrical supply (outlets) and data
technology (low-voltage supply). The medical
device must be serviced regularly by service
personnel. Repair and complex maintenance
carried out on the medical device must be
performed by experts.
The wall duct does not require regular
inspection or maintenance.
Dräger recommends that a service contract is
obtained with DrägerService and that all
repairs are performed by DrägerService. For
maintenance Dräger recommends the use of
authentic Dräger repair parts.

8
NOTE
The medical electrical equipment used
with this device should comply with
EMI/EMC requirements of the standard
IEC 60601-1-2.
Connected devices
WARNING
Risk of electric shock and of device
malfunction
Any connected devices or device
combinations not complying with the
requirements mentioned in these
instructions for use can compromise the
correct functioning of the medical device
and lead to an electric shock. Before
operating the medical device, strictly
comply with the instructions for use of all
connected devices or device combinations.
WARNING
Risk of electric shock
The device housing must not be opened.
WARNING
Components that have been subsequently
installed on the medical device must
correspond to all regulatory or technical
requirements and approvals.
The operator of the healthcare facility is
responsible for choosing the appropriate
components.
Dräger assumes no warranty and no
liability for parts from third-party
manufacturers or the functionality of third-
party manufacturers' products.
Only experts may carry out subsequent
installation.
If the above are not complied with, the
correct functioning of the medical device
may be compromised.

9
Product-specific safety instructions
Note:
Any serious incident that has occurred to the
medical device shall be reported to the
manufacturer.
Patient safety
The design of the medical device, the accompanying
documentation, and the labeling on the medical
device are based on the assumption that the
purchase and the use of the medical device are
restricted to persons familiar with the most important
inherent characteristics of the medical device.
Instructions and WARNING and CAUTION
statements are therefore largely limited to the
specifics of the Dräger medical device.
The instructions for use do not contain any
information on the following points:
–Risks that are evident to the medical expert
–Consequences of obvious improper use of the
medical device
–Potentially negative effects on patients with
different underlying diseases
Alterations to the medical device or incorrect use of
the medical device can be dangerous.
Note:
The patient can only be considered as a user
for this device to switch on and switch off the
lights present in the device.
Liability for Proper Function or Damage
The liability for the proper function of the device is
irrevocably transferred to the owner or operator to the
extent that the device is not installed correctly by
professional experts.
Draeger India Pvt. Ltd. cannot be held responsible for
damage caused by non-compliance with the
recommendations given above. The warranty and
liability provisions of the terms of sale and delivery of
Draeger India Pvt. Ltd. are likewise not modified by the
recommendations given above.

10
WARNING!
The electrical connections from the hospital
wiring to the terminal strip must be made by a
qualified electrician.
Putting into operation for the first time
WARNING
Risk of injury to the patient or user due to
malfunction of the bed head unit
Before putting the bed head unit into operation
for the first time, in case of terminal units
installedinside, the following checks have to be
performed in accordance with ISO 7396-1:
–Leakage test
–Clogging test
–Test for solid impurity
–Gas type check
Along with above tests to ensure safety from
electrical hazards, ground continuity test and
leakage current test should be performed.
If the above tests are not successfully
completed, the bed head unit cannot be put
into operation.
Risk of electric shock
WARNING!
Risk of electrical shock!
To avoid the risk of electric shock, this
equipment must only be connected
to a supply mains with protective earth.
Risk of fire
WARNING!
Risk of fire
The terminal units and probes for oxygen and
nitrous oxide used in the bed head unit must not
come into contactwith oil, grease or flammable
liquids.
WARNING!
Do not use this device in oxygenated areas.