Dräger Prana S Bedienungsanleitung

Instructions for U

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

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

erralin

Schülke & Mayr

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".

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.

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

nance. . . . . . . . . . . . . . . . . . 19

Repair. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Disposal of the medical device. . . . . . . . . . . . . 20

Technical

ta. . . . . . . . . . . . . . . . . . . . . . . . . 22

Declaration of Hazardous Substance…………23

OrderList . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

This page was intentionally left blank.

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.

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.

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.

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.

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