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.

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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.

11
Application and Overview
Intended use
Prana S and Prana V–Bed Head Unit for medical
Applications
- For supplying medical devices with medical gases.
- For supplying medical devices with electrical power.
- For provision of reading light, indirect light and night light.
- For communication and data transmission.
- For ergonomic positioning of medical equipment onto the rail system.
Description
Medical treatment rooms supplied with medical gases, lighting, and electrical connections. They are the
basis for ergonomic workplace layout in intensive care units and ward units. It is permanently installed
and always ready to use.
Prana S (Single Duct)

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Versions
The Prana S, Prana V wall supply is available in the following versions:
- Prana S (Single Duct)
- Prana S (Double Duct)
- Prana V (Single Duct)
- Prana V (Double Duct)
These variants are customizable units wherein the number of Gas outlets, electrical sockets, data
(network) points and telephone sockets can be selected. There is feasibility to install reading light,
indirect light and night light within these variants. Two options of standard medical rail lengths are
available –300mm and 600mm. The variants are available in 4 standard RAL colors - RAL 1003,
RAL 9006, RAL 9016, RAL 5024. Prana can also have colors other than these on request.
Prana V (Single Duct)
Prana V (Double Duct)
Prana S (Double Duct)

13
Vent holes:
The side covers have holes
that provide sufficient
venting to atmosphere.
WARNING!
Do not cover or clog the vent openings e.g.
with clothes, towels, newspapers etc.
Load Capacity
The maximal load onto each standard rail is 5 Kg.
WARNING!
Danger of personal and material damage when
exceeding the load capacity!
The system maximal load must not be
exceeded.
Pay careful attention to maximal load!
Luminaires:
The luminaires used in the device are:
1. Philips 4ft T5 Astra line LED batten.
2. Philips 2ft T5 Astra line LED batten.
3. Philips 1ft T5 Astra line LED batten.
WARNING!
Electronic components and luminaires that
comply with the requirements of IEC 60601-
1-2 should be used to avoid any
electromagnetic interference with other
devices.
Draeger further recommends the use of
above enlisted luminaires only.
WARNING!
Do not place objects on the device or on the
light cover.
Objects placed on the wall duct can fall off
(e.g. cups containing liquid; writing
materials, clothing, etc.).
Risk of injury!
Risk of scalding with spillage of hot liquids!
Risk of short circuits!
The wall supply rail is not allowed to be used
for placing objects on.

14
Abbreviations
Abbreviation Explanation Abbreviations for the EMC declaration
O2 Oxygen CISPR Comité International Spécial des
N2O Nitrous Oxide Perturbations Radioélectriques
AIR Medical compressed air EMC Electromagnetic compatibility
VAC Vacuum HF High frequency
BHU Bed Head Unit ISO International Organization for
DIN Deutsches Institut für Normung Standardization
(German Institute for Standardization) UMDNS Universal Medical Device
EEC European Economic Community Nomenclature System
EN European standard
I(FL) Full load current
Symbols
Symbol Description
Date of Manufacture
Warning! Strictly follow these
Instructions for use
General warning sign
Warning, Electricity
Alternating Current
Symbol Description
Degree of protection -
Protected against solid
foreign objects of
Ø 12.5 mm and greater.
Type B Applied Part
Manufacture
Observe the maximum load
Contains Hazardous
substance (CMR)
Medical Device
IP2X
Maximum load
XX kg

15
Putting the device into operation
WARNING!
O2 and nitrous oxide are easily flammable
gases.
Increased fire hazard!
Do not bring terminal units and connectors for
O2 and nitrous oxide in contact with oil, grease
or flammable liquids.
Gas supply
•Ensure that the probe identification matches
the release bushing of the terminal unit.
•Ensure that the gas supply tube of the probe is
connected tightly to the medical device.
Probe in Park position Gas supply
• Insert probe into terminal unit to • Press probe into second
first click-lock position. click-lock position.
Interruption of Gas Flow Disconnection
• Press release bushing lightly: the • Press release bushing and
probe returns to the first click-lock simultaneouslypull probe out
position (park position). of the terminal unit.
WARNING!
Each use of the Terminal unit
requires full understanding and strict
observation of all sections of
instructions for use –terminal units.

16
Acceptanceandhandover
Troubleshooting
Fault –Cause –Remedy
WARNING
Repair and maintenance of the medical device
must be carried out by trained technical personnel.
Dräger recommends that a service contract is
obtained with DrägerService and that all
repairs are performed by DrägerService.
Dräger further recommends that only authentic
Dräger repair parts are used for maintenance.
Otherwise, the correct functioning of the medical
device may be compromised.
See "Maintenance" chapter.
Fault Cause Remedy
Insufficient gas supply, Pressurized gas is escaping from Notify the hospital maintenance
hissing sound. inside the supply unit. or DrägerService to check the
gas supply. Take care of patients
and connected consuming
devices.
Delivery
Inspect delivery
Check the shipping crate for
damage Ensure that the delivery
is complete: Instructions for Use /
Installation Instructions
Caution!
Prior to initial operation of terminal units and after exchange of compressed gas tubes in medical
supply units, the following tests are to be carried out in accordance with DIN EN ISO 7396-1
- Leakage test;
- Blockage test;
- Particle pollution test;
- Testing the gas-type.
If these tests do not pass inspection, the medical devices are not allowed to be put into Operation.
Final Test
(acc. to acceptance protocol)
The acceptance test includes:
Gas-type inspection
Inspection of electrical circuits (also for
emergency power outlets, if applicable)
Ground continuity test
Leakage current test

17
Cleaning/ Disinfection
Safety Information:
WARNING!
Electrical mains!
Risk of electric shock.
Do not open the housing during cleaning
process.
WARNING!
Penetration of liquids can influence the
functionality of the device or can cause
damage to the device.
Danger for patients! Risk of short circuits!
Wipe-disinfect the parts with moist cloth
only and ensure that no liquids can
penetrate.
Avoid usage of sprays on vent openings.
Ensure that no liquid enters the vent
openings.
CAUTION
Risk of fire
Do not use any flammable cleaning agents in
the vicinity of the terminal units or power
sockets.
WARNING
Damage to objects and injuries to people
Fluids that get into the device or into
terminals can impair the function of the
device and endanger the patient!
Only clean parts with a damp cloth and
disinfect the surface.
Do not allow any fluids to get in.
Manual cleaning & disinfection
Perform manual cleaning and
disinfection by following below steps:
1. Remove soiling immediately by using a cloth.
2. Clean vent openings with moist cloth.
3. Perform wipe disinfection with a cloth
damped with disinfectant.
4. After the product has been exposed to the
disinfectant for the specified contact time,
remove residual disinfectant.
5. Wipe with a cloth dampened with water.
Allow the product to dry.
Disinfectants
Due to the risk of causing damage to
materials, preparations based on the following
active ingredients are not suitable:
–Halogen-releasing compounds
–Strong organic acids
–Oxygen-releasing compounds
–Alcohols
Perform manual disinfection preferably with
disinfectants based on aldehydes or
quaternary ammonium compounds.

18
The manual disinfection of device surfaces was
tested with various agents. At the time of testing,
the following disinfectants showed good material
compatibility and effectiveness:
1. Quaternary ammonium compounds
1.1 Mikrozid® sensitive liquid 1)
1.2 Mikrozid® alcohol free liquid 1)
1.3 Mikrozid® sensitive wipes 1)
1.4 Mikrozid® alcohol free wipes 1)
1.5 acryl-des® 1)
1) limited virucidal
The composition of the disinfectant is the
responsibility of the manufacturer and can
change over time.
NOTE
The user must make sure to observe the
manufacturer's information on the disinfectant
exactly.
• Wipe the surfaces of the profiles of BHU as
well as its components with a cloth moistened
with disinfectant.
Do not allow any fluid to penetrate the terminal
units and electrical components.
DRAEGER does not take on a responsibility
for the use of other disinfectants.
Visual inspection
•Check all items for damage and external
signs of wear, such as cracking,
embrittlement, or pronounced hardening, and
residual dirt.

19
Maintenance
WARNING
The medical device must be inspected and
serviced regularly by trained technical
personnel. The medical device must also be
put into operation by trained technical
personnel.
Dräger recommends that a service contract
is obtained with DrägerService and that all
repairs are performed by DrägerService.
Dräger further recommends that only
authentic. Dräger repair parts are used for
maintenance.
If the above are not complied with, the
correct functioning of the medical device
may be compromised.
This chapter describes the maintenance
measures required to maintain the proper
functioning of the medical device. Maintenance
measures must be performed by the personnel
responsible.
Expected Service Life
Expected service life is 20 years assuming
service and maintenance has been performed
according manufacturers requirements.
Checks
Interval
Personnel responsible
Functionality test and visual
inspection of the whole supply unit
Every 6 Months.
Trained personnel must inspect
the device.
Experts
Visual inspection of all cables and
check of electrical safety.
Every 2 years.
Trained personnel must inspect
the device.
Experts
For the gas terminal units, the
instructions for use from the
respective manufacturer must be
observed.
For Dräger terminal units,
exchange of the O-ring and flat
sealing ring wear parts.
Every 6 years by trained
personnel.
Experts
General Overhaul of electrical
wires
Every 12 years
Experts
Repair
Dräger recommends that all repairs are carried out by
DrägerService and that only authentic Dräger repair
parts are used.

20
Disposal
Disposal of the medical device
When disposing of the medical device:
•Consult the relevant waste disposal company
for appropriate disposal.
•Observe the applicable laws and regulations.
For countries subject to the EU Directive
2002/96/EC
This device is subject to EU Directive 2002/96/EC
(WEEE). In order to comply with its registration
according to this directive, this device may not be
disposed of at municipal collection points for waste
electrical and electronic equipment. Dräger has
authorized a company to collect and dispose of this
device. To initiate collection or for further information,
visit Dräger on the Internet at www.draeger.
com. Use the Search function with the keyword
"WEEE" to find the relevant information. If access
to Dräger's website is not possible, contact the local
Dräger organization.