Device File (DMF) Strecher

CHANDIGARH INDUSTRIES
DEVICE FILE
DOC NO CHD/DMF/001
EXECUTIVE SUMMARY
PLOT NO 725
INDUSTRIAL AREA CHANDIGARH
Manufacturing activities: CHANDIGARH INDUSTRIES
Design and Manufacturer of Hospital and Medical furniture such as Hospital
Strecher Trolley CHANDIGARH INDUSTRIES - Manufacturer of table, office
furniture’s & office chair in Jind, Haryana.
An executive summary shall be provided by the manufacturer and shall
contain:
Stretcher
Size 1950X630X820mm
Usages Hospital, Clinic
Material Iron
Load bearing 159kg

DEVICE FILE
DOC NO CHD/DMF/001
Gross weight 30kg
Head and foot Bow – SS Pipe 30 mm diameter 18 mm with filling tube of 15 mm

diameter SS
The Strecher Trolley Top is perforated, the sterecher is duly powder coated.
Product Details:
Size
2030 X 900 X 600 mm
Color White
Automation Grade Manual
Brand Anku
Type Standard Stecher with trolley optional

DEVICE FILE
DOC NO CHD/DMF/001
Adjustable Yes
Back Rest Yes
Frame Material Metal, MS Tube, Mild Steel
Material Metal
Dimensions 2030 mm(L) * 900 mm(W) * 600 mm(H)
Features:
 · Tubular head and foot bows of unequal height mounted on rubber stump.
 · Provision for saline location.
 · Pretreated and Epoxy Powder Coated.
A stretcher, gurney, litter, or pram is an apparatus used for moving patients who require
medical care. A basic type (cot or litter) must be carried by two or more people. A wheeled
stretcher (known as a gurney, trolley, Strecher Trolley or cart) is often equipped with variable
height frames, wheels, tracks, or skids.
1.2 Information regarding sterilization of the device (whether it is sterile or non-sterile; if

sterile, mode of sterilization).
This Strecher Trolley does not require any sterilization it is a Non-Sterile.
1.3 Risk Management Plan, Risk Analysis, evaluation and control documents.
CHANDIGARH INDUSTRIES have a risk management plan in Procedure of Risk Management
QSP/QSP-7.3.2
Procedure for Control of Document QSP/QSP-4.2.4
Procedure for Control of Record QSP/QSP-4.2.5
1.4 Clinical Evidence and evaluation (if applicable).

CHANDIGARH INDUSTRIES Does not have this requirement applicable
1.5 Regulatory status of the similar device in India
DEVICE FILE
DOC NO CHD/DMF/001
Yes, Stretcher Trolley Falls in Class A Category of CDSO as per regulation of Govt of India
MDR 2017
1.6 Declaration of Conformity
MANUFACTURER DECLARATION
Manufacturers’ declarations have two primary purposes. The first is to facilitate the movement of
goods in and out of a country, providing critical information about the goods so that imports can be
customs cleared with ease. Customs authorities are also able to simply review the manufacturer’s
declaration, rather than physically inspect goods (reducing costs and the potential inspection
charges). The second and more important purpose is to ensure the security of animal, human and
plant health when importing foreign goods into India. The document aims to manage the biosecurity
risk of importing products, as such declarations inform customs authorities if the goods are of animal
origin or contain materials that create a biosecurity risk.
Manufacturer’s Declaration
To whom it may concern:
We hereby declare that the goods we produced for invoice No. _____________ dated on
__________ is New, Unused & Non-Field Tested.
The date of manufacture of the product was __________.
Name: ______________________________________________________
The date of manufacture of the product was __________.
Name: ______________________________________________________
Company: __________________________________________________
Position: ___________________________________________________
Date: _______________________________________________________
Signature: __________________________________________________
1.7 Marketing history of the device from the date of introducing the device in the market
The semi fowler Strecher Trolley is an existing design and mostly commonly used in hospitals and
have been in usage regularly.
DEVICE FILE
DOC NO CHD/DMF/001
Since 2010 the company is dealing in manufacturing of Hospital furniture.
1.8 Domestic price of the device in the currency followed in the country of origin-
The current price listed in catalogue is inr 7500/plus taxes
1.9 List of regulatory approvals or marketing clearance obtained
Ministry of Health and Family Welfare Notification No. G.S.R, 78(E) dated 31st January 2017
notifies Medical Devices Rules 2017, has come into force with effect from 1st January 2018.
As of now the devices stated in the link are the regulated medical devices and in vitro diagnostic
devices along with its classification. New devices shall be added to this list by Ministry of Health and
Family Welfare from time to time.
1.10 Safety and performance related information on the device
Summary of reportable event and field safety corrective action from the date of introduction
Procedure : Regulatory Authorities reporting QSP/QSP-8 Dated 01/04/22

DEVICE FILE
DOC NO CHD/DMF/001
Procedure for Recall QSP/QSP-8.3.1
For Serious Adverse Event:
Procedure for Recall QSP/QSP-8.3.1
Accident Prevention QSP/QSP-6.5
For Field Safety Corrective Action (FSCA):
Monitoring and Measurement of products QSP/QSP-8.2.6
Procedure for Customer Feedback QSP/QSP-8.2.1
2. Device description and product specification, including variants and accessories
Generic Name Model Name Model No Material Of Intended Instruction of use

Construction usage
Stretcher CHD- 98 CHD-098 Pipe /CRS Transport and General instructions
trolley SHEET carrying
Strecher patients
Trolley
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS POTENTIAL ADVERSE

EFFECTS;
NA NA NA NA
GENERAL WARNINGS
• Before carrying out any kind of operation on the appliance, the operator must carefully read the
enclosed instructions, paying particular attention to the correct safety precautions and to the
procedures to be followed for installation and for correct use.
• In the case of any doubts as to the correct interpretation of the instructions, please contact Ankur
Steel for any necessary clarifications.
• Regularly check the appliance. Carry out the prescriStrecher Trolley maintenance in order to keep
the appliance in good condition and to guarantee correct functioning and a long life.
• In the case of any abnormalities or damage to the appliance, which could jeopardize the
functioning, and the safety, the appliance must be immediately removed from service.
• Do not alter or modify in any way the appliance; any such interference could cause malfunctions
and injury to the patient and/or rescuer.
DEVICE FILE
DOC NO CHD/DMF/001
• The appliance must not in any way be tampered with, in such cases all responsibility will be denied
for any malfunctions or eventual injuries caused by the appliance itself. • Who modifies or has
modified, prepares or has prepared medical appliances in such a way that they no longer serve the
purpose for which they were intended, or no longer supply the intended service, must satisfy the
valid conditions for the introduction onto the market.
• Ensure that all the necessary precautions are taken in order to avoid hazards that can arise as the
result of contact with blood or body fluids.
• Handle with care
SPECIFIC WARNINGS
• This product should be used only by adequately trained staff.
• Follow the approved EMS procedures for the restraint and transport of patients. Failure to do so
could cause serious harm to the patient.
• This device is designed for use by at least 2 operators in good physical condition.
• The patient must always be immobilised on the stretcher.
• Do not use if the weight of the patient is not evenly distributed.
• Do not exceed the maximum loading weight and follow the maintenance guide indicated in this
instruction manual.
• Do not leave the patient unassisted on the stretcher.
• The product should not be exposed or come into contact with sources of heat or inflammable
agents.
2.3 PHYSICAL REQUIREMENTS FOR OPERATORS
Strecher is a stretcher which should be used exclusively by trained professionals. Those operating
with it must have the following minimum requirements:
• Have the physical strength to use the stretcher
• Be able to tightly hold the stretcher with each hand
• Have a generally good muscular condition
INTENDED USE
The stretcher is a device designed for the rescue and transport of patients. It can be used in all
rescue operations in which it is impossible to intervene with the standard transport methods and
DEVICE FILE
DOC NO CHD/DMF/001
where the patient needs protection from possible side impact. This device can be used for
helicopter transport. It is not designed for any intervention on behalf of the patient.
DESIGN AND MANUFACTURING INFORMATION:

CHANDIGARH INDUSTRIES is following IS4037 standard for developing stretchers
ESSENTIAL PRINCIPLES CHECKLIST:
Schedule Essential Principle from the Regulations Applicable/ Not Medical Device Other standards Evidence of
1: applicable Standards or procedures compliance or
applied by applied by reason for no
manufacturer manufacturer applicability
Part 1. General principles
1 Use of medical devices not to yes ISO IS 4037

compromise health and safety A 13485:2016
medical device is to be designed and
produced in a way that ensures that:
(a) the device will not compromise
the clinical condition or safety of a
patient, or the safety and health of
the user of any other person, when
the device is used on a patient under
the conditions and for the purposes
for which the device was intended
and, if applicable, by a user with
appropriate technical knowledge,
experience, education or training;
and (b) any risks associated with the
use of the device are: (i) acceptable
risks when weighed against the
intended benefit to the patient; and
(ii) compatible with a high level of
protection of health and safety
Design and construction of yes ISO IS 4037
medical devices to conform with 13485:2016
safety principles (1) The solutions
adopted by the manufacturer for
the design and construction of a
medical device must conform
with safety principles, having
regard to the generally
acknowledged state of the art. (2)
Without limiting subclause (1), in
selecting appropriate solutions
DEVICE FILE
DOC NO CHD/DMF/001
for the design and construction of

a medical device so as to
minimise any risks associated
with the use of the device, the
manufacturer must: (a) first,
identify hazards and associated
risks arising from the use of the
device for its intended purpose,
and foreseeable misuse of the
device; and (b) second, eliminate,
or reduce, these risks as far as
possible by adopting a policy of
inherently safe design and
construction; and (c) third, if
appropriate, ensure that
adequate protection measures
are taken, including alarms if
necessary, in relation to any risks
that cannot be eliminated; and
2. (d) fourth, inform users of any yes ISO IS 4037
residual risks that may arise due 13485:2016
to any shortcomings of the
protection measures adopted. (3)
In paragraph (2) (d): residual risk,
for a medical device, means the
risk remaining after the measures
descriStrecher Trolley in
paragraphs (2) (a), (b) and (c)
have been applied.
3 Medical devices to be suitable for yes ISO IS 4037
intended purpose A medical 13485:2016
device must: (a) perform in the
way intended by the
manufacturer; and (b) be
designed, produced and
packaged in a way that ensures
that it is suitable for one or more
of the purposes mentioned in the
definition of medical device in
subsection 41BD (1) of the Act.
4. Long-term safety A medical yes ISO IS 4037
device must be designed and 13485:2016
produced in a way that ensures
that if: (a) the device is used
within the period, indicated by
DEVICE FILE
DOC NO CHD/DMF/001
the manufacturer, in which the

device can be safely used; and (b)
the device is not subjected to
stresses that are outside the
stresses that can occur during
normal conditions of use; and (c)
the device is regularly maintained
and calibrated in accordance with
the manufacturer’s instructions;
the characteristics and
performances mentioned in
clauses 1, 2 and 3 are not
adversely affected.
5. Medical devices not to be ISO IS 4037
adversely affected by transport or 13485:2016
storage A medical device must be
designed, produced and packed
in a way that ensures that the
characteristics and performance
of the device when it is being
used for its intended purpose will
not be adversely affected during
transport and storage that is
carried out taking account of the
instructions and information
provided by the manufacturer.
6. Benefits of medical devices to yes ISO IS 4037
outweigh any undesirable effects 13485:2016
The benefits to be gained from
the use of a medical device
for the performance intended by
the manufacturer must
outweigh any undesirable effects
arising from its use
7. Chemical, physical and biological No IS 4037
properties
7.1 Choice of materials NA IS 4037
In ensuring that the requirements
of Part 1 are met in
relation to a medical device,
particular attention must be
given to:
(a) the chemical and physical
properties of the materials
DEVICE FILE
DOC NO CHD/DMF/001
used in the device; and

(b) the compatibility between the
materials used and
biological tissues, cells, body
fluids and specimens;
having regard to the intended
purpose of the device.
7.2 Minimisation of risks associated NA IS 4037
with contaminants and residues
(1) A medical device must be
designed, produced and packed
in a way that ensures that any
risks associated with
contaminants and residues that
may affect a person who is
involved in transporting, storing
or using the device, or a patient,
are minimised, having regard to
the intended purpose of the
device.
(2) In minimising risks, particular NA
consideration must be given to
the likely duration and frequency
of any tissue exposure associated
with the transportation, storage
or use of the device.
7.3 Ability to be used safely with yes
materials etc (1) A medical device
must be designed and produced
device can be used safely with
any material, substance or gas
with which the device may come
into contact during normal use or
use in routine procedures. (2) If
the device is intended to be used
to administer medicine, it must
be designed and produced in a
way that ensures that the device:
(a) is compatible with the
provisions and restrictions
applying to the medicine to be
administered; and (b) allows the
medicine to perform as intended.
7.4 Verification of incorporated yes
DEVICE FILE
DOC NO CHD/DMF/001
substance (1) If a medical device

incorporates, or is intended to
incorporate, as an integral part, a
substance that, if used
separately, might be considered
to be a medicine that is intended
to act on a patient in a way that is
ancillary to the device: (a) the
safety and quality of the
substance must be verified in
accordance with the
requirements for medicines; and
(b) the ancillary action of the
substance must be verified having
regard to the intended purpose
of the device. (2) For the
purposes of this clause, any
stable derivative of human blood
or human plasma is considered to
be a medicine.
7.5 Minimisation of risks associated yes
with leaching substances A
medical device must be designed
and produced in a way that
ensures that any risks associated
with substances that may leach
from the device are minimised
Part 2. Principles about design and
construction
7.6 Minimisation of risks associated yes
with ingress or egress of
substances A medical device must
way that ensures that any risks
associated with unintentional
ingress of substances into, or
unintentional egress of
substances out of, the device are
minimised, having regard to the
nature of the environment in
which the device is intended to
be used.
8. Infection and microbial NO
contamination
DEVICE FILE
DOC NO CHD/DMF/001
8.1 Minimisation of risk of infection NA

and contamination (1) A medical
device must be designed and
that the risk of infection to a
patient, a user, or any other
person, is eliminated or
minimised. (2) The device must
be designed in a way that: (a)
allows it to be easily handled; and
(b) if appropriate, minimises
contamination of the device or
specimen by the patient, user or
other person; and (c) if
appropriate, minimises
contamination of the patient,
user or other person by the
device or specimen.
8.2 Control of animal, microbial or NA
recombinant tissues, tissue
derivatives, cells and other
substances (1) This clause applies
in relation to a medical device
that contains: (a) tissues, tissue
derivatives, cells or substances or
animal origin that have been
rendered non-viable; and (b)
tissues, tissue derivatives, cells or
substances of microbial or
recombinant origin.
(2) If the tissues, tissue NA
derivatives, cells or substances
originated from animals, the
animals must have been
subjected to appropriate
veterinary controls and
supervision, having regard to the
intended use of the tissues, tissue
derivatives, cells or substances.
(3) If the medical device contains
tissues, tissue derivatives, cells or
substances of animal origin, a
record must be kept of the
country of origin of each animal
from which the tissues, tissue
DEVICE FILE
DOC NO CHD/DMF/001
derivatives, cells or substances

originated. (4) The processing,
preservation, testing and
handling of tissues, tissue
derivatives, cells or substances of
animal, microbial or recombinant
origin must be carried out in a
way that ensures the highest
standards of safety for a patient,
the user of the device, and any
other person. (5) In particular,
the production process must
implement validated methods of
elimination, or inactivation, in
relation to viruses and other
transmissible agents. Note: This
may not apply to certain IVD
medical devices if the
characteristics mentioned in
subclause 8.2(5) are integral to
the intended purpose of the IVD
medical device.
8.3 Medical devices to be supplied in NA
a sterile state (1) This clause
applies in relation to a medical
device that is intended by the
manufacturer to be supplied in a
sterile state. (2) The device must
be designed, produced and
packed in a way that ensures that
the device is sterile when it is
supplied, and will remain sterile,
if stored and transported in
accordance with the directions of
the manufacturer, until the
protective packaging is opened or
damaged. (3) The device must be
produced and sterilised using an
appropriate validated method. (4)
The device must be produced in
appropriately controlled
conditions.
8.4 Medical devices to be supplied in NA
a non-sterile state (1) A medical
DEVICE FILE
DOC NO CHD/DMF/001
non-sterile state must be packed
device maintains the level of
cleanliness stipulated by the
manufacturer. (2) If the device is
intended to be sterilised before it
is used, the device must be
packed in a way that: (a) ensures
that the risk of microbial
contamination is minimised; and
(b) is suitable, having regard to
the method of sterilisation that
the manufacturer indicates is to
be used for the device. (3) The
device must be produced in
appropriately controlled
conditions
Distinction between medical NA
devices supplied in sterile
and non-sterile state
If a medical device is supplied in
both a sterile state and a
non-sterile state, the information
provided with the device
must clearly indicate whether the
device is in a sterile state
or a non-sterile state
9. Construction and environmental
properties
9.1 Medical devices intended to be Yes
used in combination with other
devices or equipment A medical
manufacturer to be used in
combination with another
medical device or other
equipment (including a
connection system) must be
designed and produced in a way
that ensures that: (a) the medical
device, and any other device or
equipment with which it is used,
operate in a safe way; and (b) the
intended performance of the
DEVICE FILE
DOC NO CHD/DMF/001
device, and any other device or

equipment with which it is used,
is not impaired.
9.2 Minimisation of risks associated Yes
with use of medical devices A
ensures that, as far as
practicable, the following risks
are removed or minimised: (a)
the risk of injury arising from the
physical features of the device;
(b) any risks associated with
reasonably foreseeable
environmental conditions; (c) the
risk of reciprocal interference
involving other devices that are
normally used in an investigation
or treatment of the kind for
which the device is intended to
be used; (d) any risks arising if
maintenance or calibration of the
device is not possible; (e) any
risks associated with the ageing
of materials used in the device; (f)
any risks associated with the loss
of accuracy of any measuring or
control mechanism of the device;
(g) the risk of fire or explosion
occurring during normal use of
the device, and in the event of a
single fault condition, especially if
the device is intended to be
exposed to flammable substances
or substances that can cause
combustion; (h) the risks
associated with disposal of any
waste substances.
10. Medical devices with a measuring NO
function
A medical device that has a NA

measuring function must be
DEVICE FILE
DOC NO CHD/DMF/001
that ensures that the device

provides accurate, precise and
stable measurements within the
limits indicated by the
manufacturer and having regard
to the intended purpose of the
device.
(2) The measurement, monitoring
and display scale of the device
in accordance with ergonomic
principles, having regard to the
intended purpose of the device
(3) The measurements made by
the device must be expressed: (a)
in Australian legal units of
measurement; or (b) if the device
measures a physical quantity for
which no Indian legal unit of
measurement has been
prescriStrecher Trolley under the
MDR 2017/CDSCO guidelines, in
units approved by the
CDSCO/GOI for the particular
device.
11. Protection against radiation NA
11.1 Minimisation of exposure to NA
radiation A medical device must
way that ensures that the
exposure of a patient, the user, or
any other person, to radiation is
minimised, having regard to the
levels of radiation required to
enable the device to perform its
therapeutic and diagnostic
functions and the intended
purpose of the device.
11.2 Medical devices intended to emit NA
radiation (1) This clause applies in
relation to a medical device that
is intended by a manufacturer to
emit hazardous levels of visible or
invisible radiation because the
DEVICE FILE
DOC NO CHD/DMF/001
emission is necessary for a

specific medical purpose, the
benefit of which is considered to
outweigh the risks inherent in the
emission. (2) The device must be
that ensures that the user can
control the level of the emission.
(3) The device must be designed
ensures the reproducibility and
tolerance of relevant variable
parameters. (4) If practicable, the
device must be fitted with a visual
indicator or an audible warning,
or both, that operates if
potentially hazardous levels of
radiation are emitted.
11.3 Minimisation of exposure to NA
unintended radiation A medical
that the exposure of a patient,
the user, or any other person, to
the emission of unintended, stray
or scattered radiation is
minimised.
11.4 Operating instructions The NA
operating instructions for a
medical device that emits
radiation must include detailed
information about the following
matters: (a) the nature of the
radiation emitted; (b) the means
by which patients and users can
be protected from the radiation;
(c) ways to avoid misusing the
device; (d) ways to eliminate any
risks inherent in the installation
of the device.
Medical devices intended to emit NA
ionising radiation – additional
requirements (1) This clause
applies, in addition to clauses
11.1 to 11.4, in relation to a
DEVICE FILE
DOC NO CHD/DMF/001
medical device that is intended

by the manufacturer to emit
ionising radiation. (2) The device
in a way that ensures that, if
practicable, the quantity,
geometry and energy distribution
(or quality) of radiation emitted
can be controlled and varied,
having regard to the intended
purpose of the device. (3) If the
device is intended to be used for
diagnostic radiology, the device
in a way that ensures that, when
used in relation to a patient for a
purpose intended by the
manufacturer; (a) the device
achieves an appropriate image or
output quality for that purpose;
and (b) the exposure of the
patient, or the user, to radiation
is minimised.
(4) if the device is intended to be
used for therapeutic radiology,
the device must be designed and
that the delivered dose of
radiation, the type and energy of
the radiation beam, and, if
appropriate, the energy
distribution of the radiation
beam, can be reliably controlled
and monitored.
12. Medical devices connected to or NA
equipped with an energy source
12.1 Programmed or programmable NA

medical device or software that is
a medical device (1) A
programmed or programmable
medical device, or software that
is a medical device, that is
intended to make use of either or
both of data and information
DEVICE FILE
DOC NO CHD/DMF/001

in a way that ensures that: (a) the
safety, performance, reliability,
accuracy, precision, useability,
security and repeatability of the
device are appropriate for the
intended purpose of the device;
and (b) any consequent risks, or
impairment of performance,
associated with one or more fault
conditions is eliminated or
appropriately reduced; and (c)
the device is resilient with
respect to interactions that could
occur during the use of the device
and that could result in unsafe
performance of the device;
and(d) if relevant to the safety of
a patient, or the safety and health
of the user or any other person,
the device provides suitable
warnings in a timely manner: (i)
following the disruption to
services upon which the device is
dependent for the device’s
operation; and (ii) following the
performance of the device being
adversely affected; and (e) if
relevant to the safety of a
patient, or the safety and health
the device provides a means by
which the user can verify correct
operation of the device; and (f) if
relevant to the safety of a
patient, or the safety and health
the integrity and quality of the
data or information is
maintained; and (g) if relevant,
the privacy of the data or
information is maintained. (2) A
programmed or programmable
medical device, or software that
is a medical device, must be
DEVICE FILE
DOC NO CHD/DMF/001
developed, produced and

maintained having regard to the
generally acknowledged state of
the art (including for design,
development life cycle,
development environment,
version control, quality and risk
management, security,
verification and validation,
change and configuration
management and problem
resolution). (3) A programmed or
programmable medical device, or
software that is a medical device,
that is intended to be used in
combination with computing
platforms must be designed and
developed taking into account
the capability, resources and
configuration of the platforms
and the external factors
(including information technology
environments) related to the use
of the platforms. (4) The
manufacturer of a programmed
or programmable medical device,
or software that is a medical
device, must provide instructions
or information with the device
that sets out requirements
(including requirements about
hardware, software, information
technology environments and
security measures) necessary to
operate the device as intended.
(5) A programmed or
programmable medical device, or
software that is a medical device,
must be designed, produced and
maintained with regard to best
practice in relation to software,
security and engineering to
provide cybersecurity of the
device, including where
appropriate the following: (a)
DEVICE FILE
DOC NO CHD/DMF/001
protection against unauthorised

access, unauthorised influence or
unauthorised manipulation; (b)
minimisation of risks associated
with known cybersecurity
vulnerabilities (including either or
both of remediation of known
vulnerabilities and application of
compensating controls); (c)
facilitation of the application of
updates, patches, compensating
controls and other
improvements; (d) disclosure of
known vulnerabilities in the
device or its components and
associated mitigations; (e) making
available sufficient information
for a user to make decisions with
respect to the safety of applying,
or not applying, updates, patches,
compensating controls and other
improvements (6) The
manufacturer of a programmed
or programmable medical device,
or software that is a medical
device, having regard to the
intended purpose of the device,
the generally acknowledged state
of the art and best practice, must
ensure that the data that
influences the performance of
the device is: (a) representative;
and (b) of sufficient quality; and
(c) maintained to ensure
integrity; and (d) managed to
reduce bias.
12.2 Safety dependent on internal NA
power supply (1) This clause
device if the safety of a patient
on whom the device is to be used
will depend on an internal power
supply for the device. (2) The
device must be fitted with a
means of determining the state
DEVICE FILE
DOC NO CHD/DMF/001
of the power supply

12.3 Safety dependent on external NA
power supply (1) This clause
device if the safety of a patient
on whom the device is to be used
will depend on an external power
supply for the device. (2) The
device must be fitted with an
alarm system that indicates
whether a power failure has
occurred
12.4 Medical devices intended to NA
monitor clinical parameters A
by the manufacturer to be used
to monitor one or more clinical
parameters of a patient must be
fitted with an appropriate alarm
system to warn the user if a
situation has developed that
could lead to the death of the
patient or a severe deterioration
in the state of the patient’s
health
12.5 Minimisation of risk of NA
electromagnetic fields A medical
that the risk of an
electromagnetic field being
created that could impair the
operation of other devices or
equipment being used in the
vicinity of the medical device is
minimised.
12.6 Protection against electrical risks NA
A medical device must be
that ensures that, as far as
possible, when the device is
installed correctly, and the device
is being used for an intended
purpose under normal conditions
of use and in the event of a single
DEVICE FILE
DOC NO CHD/DMF/001
fault condition, patients, users,

and any other persons, are
protected against the risk of
accidental electric shock.
12.7 Protection against mechanical NA
risks A medical device must be
that ensures that a patient, the
users and any other person, is
protected against any mechanical
risks associated with the use of
the device.
12.8 Protection against risks NA
associated with vibration (1) A
with vibrations generated by the
device are minimised. (2) If
vibrations are not part of the
intended performance of the
device, particular attention must
be given to relevant technical
progress, and the available
means, for limiting vibrations,
particularly at source.
12.9 Protection against risks
associated with noise (1) A
with noise emitted by the device
are minimised. (2) If noise is not
part of the intended performance
of the device, particular attention
must be given to relevant
technical progress, and the
available means, for reducing the
emission of noise, particularly at
source
associated with terminals and
connectors A medical device that
is intended by the manufacturer
to be connected to an electric,
DEVICE FILE
DOC NO CHD/DMF/001
gas, hydraulic, pneumatic or

other energy supply must be
that ensures that any risks to the
user associated with the handling
of a terminal or connector on the
device, in relation to the energy
supply are minimised.
associated with heat A medical
that, during normal use, any
accessible part of the device
(other than any part intended by
the manufacturer to supply heat
or reach a given temperature),
and any area surrounding an
accessible part of the device,
does not reach a potentially
dangerous temperature
associated with administration of
energy or substances (1) This
clause applies in relation to a
by the manufacturer to be used
to administer energy or a
substance to a patient. (2) The
that: (a) the delivered rate and
amount of energy or of the
substance can be set and
maintained accurately to ensure
the safety of the patient and the
user; and (b) as far as possible,
the accidental release of
dangerous levels of energy or of
the substance is prevented. (3)
the device must be fitted with a
means of indicating or, if
appropriate, preventing
inadequacies in the rate and
amount of energy or of the
DEVICE FILE
DOC NO CHD/DMF/001
substance administered that

might cause danger to the
patient, the user or any other
person. (4) The functions of each
control and indicator on the
device must be clearly specified
on the device. (5) If the
instructions for the operation of
the device, or the operating or
adjustment parameters for the
device, are displayed by means of
a visual system incorporated into
the device, the instructions or
parameters must be able to be
understood by the user and, if
appropriate, the patient.
12.13 Active implantable medical NA
devices (1) An active implantable
medical device must incorporate,
display, emit or exhibit a code or
unique characteristic that can be
used to identify: (a) the type of
device; and (b) the manufacturer
of the device; and (c) the year of
manufacture of the device. (2)
the code or unique characteristic
must be able to be read without
the need for surgery to the
person in whom the device is
implanted.
13. Information supplied by the Yes
manufacturer
13.1 Information to be provided with yes
medical devices – general (1) The
following information must be
provided with a medical device:
(a) information identifying the
device; (b) information
identifying the manufacturer of
the device; (c) information
explaining how to use the device
safely, having regard to the
training and knowledge of
potential users of the device. (2)
DEVICE FILE
DOC NO CHD/DMF/001
In particular: (a) the information

required by clause 13.3 must be
provided with a medical device;
and (b) if instructions for use of
the device are required under
subclause 13.4, the information
mentioned in subclause 13.4(3)
must be provided in those
instructions. (3) The information:
(a) must be provided in English;
and (b) may also be provided in
any other language. (4) The
format, content and location of
the information must be
appropriate for the device and its
intended purpose. (5) Any
number, letter, symbol, or letter
or number in a symbol, used in
the information must be legible
and at least 1 millimetre high. (6)
If a symbol or identification
colour that is not included in a
medical device standard is used
in the information provided with
the device, or in the instructions
for use of the device, the
meaning of the symbol or
identification colour must be
explained in the information
provided with the device or the
instructions for use of the device
13.2 Information to be provided with YES
medical devices – location (1)
Unless it is impracticable and
inappropriate to do so, the
information required to be
provided with a medical device
must be provided on the device
itself. (2) If it is not practicable to
comply with subclause (1) in
relation to the provision of the
information, the information
must be provided: (a) on the
packaging used for the device; or
(b) in the case of devices that are
DEVICE FILE
DOC NO CHD/DMF/001
packaged together because

individual packaging of the
devices is not practicable – on the
outer packaging used for the
devices. (3) If it is not practicable
to comply with subclause (1) or
(2) in relation to the provision of
the information required under
subregulation 10.2(1) or clause
13.3: (a) for a medical device that
is not software—the information
must be provided on a leaflet
supplied with the device; or (b)
for a medical device that is
software—the information must
be provided on a leaflet supplied
with the device or the
information must be provided
electronically. (4) If it is not
practicable to comply with
subclause (1) or (2) in relation to
the provision of the information
under clause 13.4, the
information must be provided in
printed documents or other
appropriate media
13.3 Information to be provided with YES
medical devices – particular
requirements The information
mentioned below must be
provided with a medical device.
(1) The manufacturer’s name, or
trade name, and address (2) The
intended purpose of the device,
the intended user of the device,
and the kind of patient on whom
the device is intended to be used
where these are not obvious(3)
Sufficient information to enable a
user to identify the device, or if
relevant, the contents of
packaging (4) Any particular
handling or storage requirements
applying to the device (5) Any
warnings, restrictions on use, or
DEVICE FILE
DOC NO CHD/DMF/001
precautions that should be taken,

in relation to the use of the
device (6) Any special operating
instructions for the use of the
device (7) If applicable, an
indication that the device is
intended for a single use only (8)
If applicable, an indication that
the device has been custom-
made for a particular individual or
health professional and is
intended for use only by that
individual or health professional
(9) If applicable, an indication
that: (a) if the device is a medical
device other than an IVD medical
device – the device is intended
for premarket clinical
investigation; or (b) if the device
is an IVD medical device – the
device is intended for
performance evaluation only (10)
For a sterile device, the word
“STERILE” and information about
the method that was used to
sterilise the device (11) The batch
code, lot number or serial
number of the device. (12) If
applicable, a statement of the
date (expressed in a way that
clearly identifies the month and
year) up to when the device can
be safely used (13) If the
information provided with the
device does not include the
information mentioned in item 12
– a statement of the date of
manufacture of the device (this
may be included in the batch
number of the device provided
the date is clearly identifiable)
(14) If applicable, the words “for
export only” Note: In addition to
the information mentioned
DEVICE FILE
DOC NO CHD/DMF/001
above, regulation 10.2 requires

certain information to be
provided with a medical device
Instructions for use (1) YES
Instructions for the use of a
medical device must be provided
with the device. (2) However,
instructions for use of a medical
device need not be provided with
the device, or may be
abbreviated, if: (a) the device is a
Class I medical device, a Class IIa
medical device or a Class 1 IVD
medical device; and (b) the
device can be used safely for its
intended purpose without
instructions. (3) Instructions for
the use of a medical device must
include information mentioned
below that is applicable to the
device. (1) The manufacturer’s
name, or trade name, and
address (2) The intended purpose
of the device, the intended user
of the device, and the kind of
patient on whom the device is
intended to be used (3)
Information about any risk arising
because of other equipment
likely to be present when the
device is being used for its
intended purpose (for example,
electrical interference from
electro-surgical devices or
magnetic field interference from
magnetic resonance images) (4)
Information about the intended
performance of the device and
any undesirable side effects
caused by use of the device (5)
Any contraindications, warnings,
restrictions on use, or
precautions that may apply in
relation to use of the device (6)
Sufficient information to enable a
DEVICE FILE
DOC NO CHD/DMF/001
user to identify the device, or if

relevant, the contents of the
packaging (7) Any particular
handling or storage requirements
applying to the device(8) If
applicable, an indication that the
device is intended for a single use
only (9) If applicable, an
indication that the device has
been custom-made for a
particular individual or health
professional and is intended for
use only by that individual or
health professional (10) If
applicable, an indication that: (a)
if the device is a medical device
other than an IVD medical device
– the device is intended for pre-
market clinical investigation; or
(b) if the device is an IVD medical
device – the device is intended
for performance evaluation only
(11) For a sterile device, the word
“STERILE” and information about
the method that was used to
sterilise the device (12) For a
sterile state: (a) an indication that
the device is sterile; and (b)
information about what to do if
sterile packaging is damaged and;
(c) if appropriate, instructions for
resterilisation of the device. (13)
For a medical device that is
intended by the manufacturer to
be sterilised before use –
instructions for cleaning and
sterilising the device which, if
followed, will ensure that the
device continues to comply with
the applicable provisions of the
essential principles (14) Any
special operating instructions for
the use of the device (15)
DEVICE FILE
DOC NO CHD/DMF/001
Information to enable the use to

verify whether the device is
properly installed and whether it
can be operated safely and
correctly, including details of
calibration (if any) needed to
ensure that the device operates
properly and safely during its
intended life. (16) Information
about the nature and frequency
of regular and preventative
maintenance of the device,
including information about the
replacement of consumable
components of the device during
its intended life (17) Information
about any treatment or handling
needed before the device can be
used (18) For a device that is
intended by the manufacturer to
be installed with, or connected
to, another medical device or
other equipment so that the
device can operate as required
for its intended purpose –
sufficient information about the
device to enable the user to
identify the appropriate other
medical device or equipment that
will ensure a safe combination.
(19) For an implantable device –
information about any risks
associated with its implantation
(20) For a reusable device: (a)
information about the
appropriate processes to allow
reuse of the device (including
information about cleaning,
disinfection, packaging, and, if
appropriate, resterilisation of the
device); and (b) an indication of
the number of times the device
may be safely reused. (21) For a
by the manufacturer to emit
DEVICE FILE
DOC NO CHD/DMF/001
radiation for medical purposes –

details of the nature, type,
intensity and distribution of the
radiation emitted (22)
Information about precautions
that should be taken by a patient
and the user if the performance
of the device changes (23)
Information about precautions
that should be taken by a patient
and the user if it is reasonably
foreseeable that use of the device
will result in the patient or user
being exposed to adverse
environmental conditions(24)
Adequate information about any
medicinal product that the device
is designed to administer,
including and limitations on the
substances that may be
administered using the device
(25) Information about any
medicine (including any stable
derivative of human blood or
blood plasma) that is
incorporated, or intended to be
incorporated, into the device as
an integral part of the device.
(25A) For a medical device, other
than an IVD medical device,
information about any tissues,
tissue derivatives, cells or
substances of animal origin that
have been rendered non-viable,
or tissues, cells or substances of
microbial or recombinant origin
that are included in the device
(26) Information about
precautions that should be taken
by a patient and the user if there
are special or unusual risks
associated with the disposal of
the device (27) Information about
the degree of accuracy claimed if
the device has a measuring
DEVICE FILE
DOC NO CHD/DMF/001
function (28) Information about

any particular facilities required
for use of the device or any
particular training or
qualifications required by the
user of the device. (29) For an IVD
medical device, information
(including, to the extent
practicable, drawings and
diagrams) about the following: (a)
the scientific principle (the ‘test
principle’) on which the
performance of the IVD medical
device relies; (b) specimen type,
collection, handling and
preparation(c) reagent
description and any limitations
(for example, use with a
dedicated instrument only); (d)
assay procedure including
calculations and interpretation of
results; (e) interfering substances
and their effect on the
performance of the assay; (f)
analytical performance
characteristics, such as sensitivity,
specificity, accuracy and
precision; (g) clinical performance
characteristics, such as sensitivity
and specificity; (h) reference
intervals, if appropriate; (i) any
precautions to be taken in
relation to substances or
materials that present a risk of
infection (30) For an adaptable
medical device, instructions for
assembling or adapting the
device which, if followed, will
ensure that the device continues
to comply with the applicable
provisions of the essential
principles (31) For a medical
device production system,
instructions for the process to be
followed in producing the
DEVICE FILE
DOC NO CHD/DMF/001
medical device the system is

intended to produce which, if
followed, will ensure that the
device so produced will comply
with the applicable provisions of
the essential principles
13A Patient implant cards and patient NO
information leaflets
13A.1 Scope of clauses 13A.2 to 13A.4 NO
Clauses 13A.2 to 13A.4 apply to a
medical device that is: (a) an
implantable medical device or an
active implantable medical
device; and (b) not a suture,
staple, dental filling, dental brace,
tooth crown, screw, wedge,
plate, wire, pin, clip or connector
13.A.2 Patient implant cards for NA
implantable devices (1) A card (a
patient implant card) that meets
the requirements of subclause (2)
and clause 13A.4 must be
provided with the medical device.
(2) The card must include the
information mentioned in the
following table (in the
Regulations). (1)(a) the name of
the device; and (1)(b) the model
of the device; and (1)(c) the batch
number of the device; and (1)(d)
the unique device identifier of
the device (if any) (2) The
manufacturer’s name, address
and website
13.A.3 Patient information leaflets for YES
implantable devices (1) A leaflet
(a patient information leaflet)
that meets the requirements of
subclauses (2) to (4) and clause
13A.4 must be provided with the
medical device. (2) The leaflet
must include the following
information: (a) information
identifying the device, or the kind
DEVICE FILE
DOC NO CHD/DMF/001
of device; (b) the intended

purpose of the device; (c)
information explaining how to
use the device safely; (d) other
information about the device that
the manufacturer considers
would be useful for patients. (3)
In particular, the leaflet must
include the information
mentioned in the following table
(in the Regulations). (1)(a) the
name of the device; and (1)(b)
the model of the device (2(a) the
intended purpose of the device;
and (2)(b) the kind of patient on
whom the device is intended to
be used (3)Any special operating
instructions for the use of the
device (4)(a) the intended
performance of the device; and
(4)(b) any undesirable side effects
that could be caused by use of
the device (5) Any residual risks
that could arise due to any
shortcomings of the protection
measures adopted as mentioned
in subclause 2(2) (6)(a) warnings
about risks that could arise from
the interaction of the device with
other equipment; and (6)(b)
precautions and other measures
that, because of those risks,
should be taken by the patient or
a health professional Example 1:
The risk of electrical interference
from electrosurgical devices.
Example 2: The risk of magnetic
field interference from magnetic
resonance imaging devices(7)(a)
the nature and frequency of
regular or preventative
examination, monitoring or
maintenance of the device that
should be undertaken; and (7)(b)
symptoms that could indicate
DEVICE FILE
DOC NO CHD/DMF/001
that the device is malfunctioning;

and (7)(c) precautions and other
measures that should be taken by
the patient if the performance of
the device changes or the patient
experiences any of the symptoms
mentioned in paragraph (b); and
(7)(d) the expected device
lifetime; and (7)(e) anything that
could shorten or lengthen the
device lifetime; and (7)(f)
precautions and other measures
that should be taken at, or near,
the end of the expected device
lifetime; and (7)(g) other
circumstances in which the
patient should contact a health
professional in relation to the
operation of the device (8)(a) the
materials and substances
included in the device; and (8)(b)
any manufacturing residuals that
could pose a risk to the patient
(9) (a) a notice that any serious
incident that occurs in relation to
the device should be reported to
the manufacturer and to the
Therapeutic Goods
Administration; and(9)(b) the
address of the Therapeutic Goods
Administration’s website (4) The
information in the leaflet must be
written in a way that is readily
understood by patients
13.A.4 Form of patient implant cards and NA
patient information leaflets (1)
The information required by
clause 13A.2 or 13A.3 to be
included in a patient implant card
or patient information leaflet: (a)
must be included in English; and
(b) may also be included in any
other language. Note: The
information may also include
diagrams or drawings. (2) Any
DEVICE FILE
DOC NO CHD/DMF/001
number, letter, symbol, or letter

or number in a symbol, used in a
patient implant card or patient
information leaflet must be: (a)
legible; and (b) at least 1
millimetre high
13.B Software – version numbers and NA
build numbers
(1) For a medical device that is

software, or that incorporates
software, the current version
number and current build
number of the software must be
accessible by, and identifiable to,
users of the device. (2) The
current version number and
current build number of the
software: (a) must be in English;
and (b) may also be in any other
language
14. Clinical evidence NA
14.1 Every medical device requires NA

clinical evidence, appropriate for
the use and classification of the
device, demonstrating that the
device complies with the
applicable provisions of the
essential principles. Note: See
regulation 3.11 and the clinical
evaluation procedures.
3. LABELLING:
Copy of original label of the device, including accessories if any, and its packaging
configuration; (enclosed )
Instructions for use (Prescriber’s manual);( enclosed)
Product brochure ( enclosed )
Promotional material. (NA
Manufacturing Processes:
DEVICE FILE
DOC NO CHD/DMF/001
The information may take the form of flow chart showing an overview of production,
manufacturing environment, facilities and controls used for manufacturing, assembly, any
final product testing, labelling and packaging and storage of the finished medical device. If
the manufacturing process is carried out at multiple sites, the manufacturing activities at
each site should be clearly specified.
Risk analysis and control summary:

This risk analysis should be based on prescriStrecher Trolley standards and be part of the
manufacturer’s risk management plan based on complexity and risk class of the device.
The technique used to analyse the risk must be specified, to ensure that it is appropriate
for the medical device and risk involved. The risks and benefits associated with the use of
the medical device should be descriStrecher Trolley. The risk analysis submitted shall have
periodic updation of the risks identified as per risk management plan.
Warranty
CHANDIGARH INDUSTRIES (“ASI”) Product Warranty
CHANDIGARH INDUSTRIES (“ASI”), warrants to the original user ("Customer") all products manufactured
by ASI to be free from defects in material and workmanship under normal use and service. If such a
defect appears and Customer has given immediate written notice of the same, ASI shall replace or repair
such part at ASI’s option. ASI will require the return of the defective part to establish the claim.
ASI’s obligation under this warranty shall be limited to said replacement and/or repair. Installation and
freight costs for replaced or repaired items remains the responsibility of the Customer. This warranty
does not cover failure due to negligence, accident, deliberate abuse, nor improper installation and/or
maintenance. Modifications made to products (including modifications without the expressed written
consent of ASI) shall void this warranty in its entirety.
NO FURTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO WARRANTIES OF

MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE NOT SPECIFIED HEREIN, ARE MADE BY
THE MANUFACTURER, and this warranty sets forth the full extent of the liability arising from the
manufacture, use, or sale of the products and materials sold hereunder. No allowances will be made for
delay or loss of profit, nor for any other special, indirect or consequential damages or injuries, whether
based on tort or contract.
Applicable warranty periods commencing from date of shipment from ASI are as follows:
 Welds -- Lifetime
 Electrical components -- 3 years
 Mechanical components -- 3 years

DEVICE FILE
DOC NO CHD/DMF/001
 Casegoods and wood products -- 1 year
For the Elite Riser:
 Welds -- Lifetime
 Electrical components -- 4 years
 Mechanical components -- 4 years
 Case goods and wood products -- 1 year
Verification and validation of the medical device

Procedure For Measuring and Monitoring
 During Manufacturing process the product quality is monitored at raw material stage, in-
process(pre paint)Stage and final stage (Pre Dispatch Stage) as descriStrecher Trolley bellow:
IN PROCESS (PRE PAINT) INSPECTION FOR STRECHER
ASSEMBLED BY: MODEL NO: Sr.NO: Date:

Fitting Inspection Date :
Physical Check Criteria Status Quality Remarks
Points
Measurements and Scale or
Dimensions of ICU measuring
Strecher Trolley as tape
per specifications
Sheet Thickness Vernier
Pipes Diameter and Vernier and
size scale
Any Dents or visual
scratches/rust on
Strecher Trolley
Welding quality Visual
( welding should be
proper in all
joints )
Grinding after Visual
welding (no rough
Mark should be
there)
Fitting of all parts Visual
and position on
floor(should rest
smooth on levelled
surface)
Screws and Nut Visual
DEVICE FILE
DOC NO CHD/DMF/001
bolts should be
proper quality and
make as per
specification (BOM)
There should not Visual
be any sharp edges
on any surface of
Strecher Trolley
Check movement Visual
after fitting of
wheels (wheels to
be removed before
paint)
Check all positions Visual
and movements
including
Hydraullic parts
( remove hydraullic
parts before
painting)
 Approved BY : _____________________ CHECKED BY______________
AFTER PAINT QUALITY CONTROL Stretcher

 Customer Name/Place ______________ Sr.No_______
 MODEL No: ______________________________ Date :_____________

Sr.N Visual and Functional Checks Status Remarks
o
Check Paint quality (there should be no
scratches on any surface and paint quality
should be smooth
2. Paint coating thickness must be checked for
consistency across the surface using
alcometer.
3. Paint Shade should be same in all surfaces
and parts
4. Check all motorized/hydraulic
movements/adjustments as per
specifications
5. Check fitment of all parts (attachments and
accessories) as per specifications
6. Check electrical parts its fittings and Fuse
as per ratings /specifications.
7. Check for any Noise/sound during
movement/adjusting Strecher Trolley
(there should be no noise)
8 Check all Material as PER BOM and all
Attachments/Accessories and their
specifications
DEVICE FILE
DOC NO CHD/DMF/001

 STRECHER TROLLEY CLEARED FOR DISPATCH (YES/ NO)
 INSPECTED BY: QUALITY INSPECTOR FINAL APPROVED BY:
 NAME : NAME:

 DESIGNATION: DESIGNATION:
PRODUCT VERIFICATION AND VALIDATION:
CHANDIGARH INDUSTRIES conducts following validation activities for process and product validations :
1.WELD INSPECTION AND TEST PLANNING

2. Quality Control for weld Joints Using Third party testing reports (NDT )
3. Surface Treatment Testing
4. Powder coating validation
5. Third party testing validation reports are also verified as per specifications
INSTALLATION
The Strecher Trolley will arrive in multiple packaging. Remove all loose packaging material before unpacking
the contents. Most Strecher Trolleys assemble the same and can be done quickly whether they are electric,
semi electric or just manual Strecher Trolleys. The Following Instructions are referenced from the Owner’s
Manual for your convenience:
Foot Section Package
 Include one-foot end section
If electronic, foot section package will also include
 Pendant
 power supply with power cord
 Head, foot and hi/lo motors with cables
 One emergency crank handle
Head Section Package
 Includes One head end section
Assembling the Strecher Trolley
 Place the head section on its side to your left so the center mounting latches are on the right.
 Open the head section to a 45 degree to a 90-degree angle for support.
DEVICE FILE
DOC NO CHD/DMF/001
 Place the foot section on its side to your right with the head pull tube at the top of the assembly.
 The center mounting rivets should be on the left side.
 Place the head and foot sections 90 degrees from each other.
 Hook the bottom head section center mounting latch to the bottom of the foot section center
mounting rivet.
 Hook the top head section center mounting latch to the bottom to the top foot section center
mounting rivet.
 Push the sections into a horizontal position while keeping the sections on their sides.
Casters Installation
 Lay the Strecher Trolley end flat on the floor.

 Insert the shaft of a locking caster assembly into the caster socket in the leg of one of the
Strecher Trolley ends.
 Lock the caster to prevent excess Strecher Trolley movement during assembly.
 Repeat these 3 steps for the remaining casters.
Strecher Trolley End Installation
 Stand one Strecher Trolley end as close to the head section as possible.
 Grasp the head section by the side and raise it until the rivets on the corner plates of the section
are high enough to place into the corner locks on the Strecher Trolley ends.
 Tilt the Strecher Trolley ends toward the head section and place the rivets into the corner locks.
 Return the Strecher Trolley end to its full upright position. The rivets will lock into place.
 Repeat the following procedure for the other Strecher Trolley end.
Drive Shaft Installation
 Remove the plastic caps from each end of the drive shaft
 Press spring button on the inner shaft and insert the inner shaft into the outer shaft.
 Engage the spring button into the positioning hole.
 Attach the inner shaft to the bottom gear box output shaft on the head end of the Strecher
Trolley.
 Push in on the spring-loaded end of the drive shaft and attach the foot end as follows:
1. Attach drive shaft to the hi/lo motor output shaft facing head end of the Strecher Trolley.
 Attach the hi/lo motor to the foot end gear box as follows:
1. Locate the hi/lo motor output shaft spring loader coupler.

2. Ensure the hi/lo motor output shaft spring-loaded coupler is properly aligned with the foot end
gear box.
DEVICE FILE
DOC NO CHD/DMF/001
3. Release the hi/lo motor output shaft spring-loaded coupler by pushing in against the hi/lo motor
output shaft spring-loaded coupler and turning clockwise.
4. The coupling will release and engage the foot end top gear output shaft cross pins.
 Install the mattress keepers by positioning it over the end slate and sliding it back until the tabs lock
onto side rail. Be sure to properly inspect the Strecher Trolley before patient use. Test all the
features and troubleshoot if necessary.
Packaging
WORK INSTRUCTION FOR PACKAGING AT CHANDIGARH INDUSTRIES
Material Considerations
The material and type of SBS should be considered at the beginning of any new development project.
Consider the approximate size and weight of the device or system, the sterilization method(s), and the
proposed quantity of sterile barriers (single barrier or double barrier) when designing the SBS. Determining
your requirements early will help reduce lead times typically associated with packaging design and will
allow for early feasibility studies.
Equipment Qualifications
IQ (Installation Qualification)
This testing provides documented evidence that the utilities, safety features and ancillary systems used in
the function of the equipment meet the user’s specified requirements.
OQ (Operation Qualification)
This testing provides documented evidence that the upper and lower limit sealing operating parameters of a
piece of equipment provide seals that meet predetermined acceptance criteria for a specific material
combination. Engineering studies should be completed prior to the OQ to determine these limits and
acceptance criteria.
PQ (Performance Qualification)
This testing provides documented evidence that the equipment used to apply a final seal will consistently
produce seals that meet predetermined specifications under specified operating conditions. This typically
consists of three production runs produced at nominal equipment settings using multiple material lots.
Three runs allow for the ability to evaluate variability due to material lots, machine equilibrium, personnel
changes, and day-to-day environment changes.
Package Testing
Packaging Distribution
DEVICE FILE
DOC NO CHD/DMF/001
Prior to receiving regulatory approvals, the SBS must prove that it is capable of withstanding the expected
transit life cycle. Package distribution test samples must contain product or representative product
(dunnage/simulant) that has been sealed at equipment worse case conditions and sterilized. Expected
transit life includes processing, handling, sterilization, transit and warehousing. Typical distribution
simulation for medical devices is defined in ASTM D4169 Standard Practice for Performance Testing of
Shipping Containers and Systems, DC-13. Testing intensity is determined based on the specific device and
system. Final testing after simulation proves strength and integrity of the SBS.
Aging Studies
Aging studies must be completed prior to receiving regulatory approvals to prove the SBS is still intact at the
end of the labeled shelf life. Testing must verify package strength and integrity after the desired time
point(s). Accelerated aging can be completed for regulatory submission, but real time aging samples must
run in parallel.
Types of Package Testing
Package Integrity Testing
Package Integrity Testing is important in determining the sterility and the shelf life of a medical device or
product. This is done by documenting that the SBS system has no detectable path through, channels or
punctures that may allow the introduction of microbes into the system. Examples of package integrity
testing include ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by
Dye Penetration or ASTM F2096 Standard Test Method of Detecting Gross Leaks in Packaging by Internal
Pressurization (Bubble Test). Visual inspection should also be used to confirm package integrity. The
standard for visual inspection is ASTM F1886/F1886M Standard Test Method for Determining Integrity of
Seals for Flexible Packaging by Visual Inspection.
Package Strength Testing
Package Strength Testing shows the force required to separate the two components of the sterile barrier
system. Packaging strength is important to show that the package protecting the product is strong enough
to contain the product system after distribution or aging. Seal strength also allows the medical device
manufacturer to confirm the reproducibility of their sealing process and adherence to design specifications.
Examples of package strength testing include ASTM F88/F88M Standard Test Method for Seal Strength of
Flexible Barrier Materials or ASTM F1140/F1140M Standard Test Methods for Internal Pressurization Failure
Resistance of Unrestrained Packages.
When performed together, integrity and strength testing provide documented evidence both qualitatively
and quantitatively that the SBS is robust and appropriate to maintain product integrity.
DEVICE FILE
DOC NO CHD/DMF/001
CHECKLIST FOR HOSPITAL STRECHER TROLLEY
Standard Hospital Strecher Trolley Maintenance Checklist
Components of a Hospital Strecher Trolley Inspection
 All moving parts, mattresses, and electronics should be included in the inspection.
General Visual Inspection
 The technician should start with a simple visual inspection of the Strecher Trolley for obvious
damage. The visual inspection offers insight into the overall condition of the Strecher Trolley and
identifies potential problem areas that may need additional attention or repair.
Hardware Inspection
 The technician should also carefully inspect the base, framework, Strecher Trolley ends, and side rails.
Checking the castors and brakes for visible signs of wear ensures the continued maneuverability and safety of
the Strecher Trolley.
Electrical Component Inspection
 The electrical inspection includes components that control the head, lifting, tilting, and foot mechanisms.
 Any component that moves the Strecher Trolley or changes its profile should be meticulously checked. In
addition, the control box and motors should be inspected for any signs of damage.
Strecher Trolley Alarm & Communication Device Inspection
 Most modern hospital Strecher Trolleys are equipped with alarms to alert caregivers to a potential fall or
other problem. And the r Strecher Trolley is equipped with an alarm, the alarm components must be
inspected and tested.
 In addition, the nurse and patient control panels must be inspected and tested to ensure proper function.
This also includes an inspection of the power lead and transformer for wear and tear.
Maintenance and Mechanical Component Checklist
❑ Inspect all hospital Strecher Trolley components for excessive wear and damage
DEVICE FILE
DOC NO CHD/DMF/001
❑ Visually check rail welds for damage and cracks.
❑ Inspect the foot and head sections for warping, bending, or damage.
❑ Inspect all rivets and bolts to make sure each is tightened securely and properly functioning
❑ Check surfaces where patients can sleep or lay to make sure every link is intact.
❑ Check casters to make sure they roll when they should and lock when they shouldn’t
Electrical Component Checklist
❑ Inspect all hospital Strecher Trolley electrical parts for excessive wear or damage such as broken housing,
cracked housing, and worn components.
❑ Check power, pendants, and motor cords for excessive wear, cuts, or signs of chafing.
❑ Ensure every plug is free of damage and fully attached.
❑ Ensure the junction box cable lock is properly positioned and locked.
❑ Inspect whether the head lowers and raises properly.
❑ Inspect whether the foot lowers and raises properly.
❑ Inspect whether the Strecher Trolley lowers and raises properly.
❑ Inspect all other mechanical functions.

DEVICE FILE
DOC NO CHD/DMF/001
DOCUMENTATION CHECKLIST FOR HOSPITAL STRECHER TROLLEYS AND

ACCESSORIES
Policy References: § Local Coverage Determination (L33820) § Policy Article (A52508)

Documentation References: Standard Documentation Requirements Policy Article (A55426)
The supplier must be able to provide all of these items on request:
o Standard Written Order (SWO) Beneficiary Authorization
o Proof of Delivery (POD)
o Continued Need Continued Use Medical records from treating practitioner as noted below
o Medical records should contain: Hospital Strecher Trolleys Fixed Height Hospital Strecher Trolleys (E0250,
E0251, E0290, E0291, E0328)
o Medical records document one or more of the following criteria are met:
o Beneficiary has a medical condition which requires positioning of the body in ways not feasible with an
ordinary Strecher Trolley. Elevation of the head/upper body less than 30 degrees does not usually require the
use of a hospital Strecher Trolley;
o or Beneficiary requires positioning of the body in ways not feasible with an ordinary Strecher Trolley in
order to alleviate pain; or Beneficiary requires the head of the Strecher Trolley to be elevated more than 30
degrees most of the time due to congestive heart failure, chronic pulmonary disease, or problems with
aspiration;
o or Beneficiary requires traction equipment, which can only be attached to a hospital Strecher Trolley.
o Variable Height Hospital Strecher Trolleys (E0255, E0256, E0292, E0293)
o Beneficiary meets criteria for a fixed height hospital Strecher Trolley; and
o Beneficiary requires a Strecher Trolley height different than a fixed height hospital Strecher Trolley to
permit transfers to chair, wheelchair or standing position.
o Semi-Electric Hospital Strecher Trolleys (E0260, E0261, E0294, E0295, E0329) Beneficiary meets criteria for
a fixed height hospital Strecher Trolley; and Beneficiary requires frequent changes in body position and/or has
an immediate need for a change in position.
o Heavy Duty Extra Wide Hospital Strecher Trolleys (E0301, E0303) Beneficiary meets criteria for a fixed
height hospital Strecher Trolley; and Beneficiary’s weight is more than 350 pounds but doesn’t exceed 600
pounds.
o Extra Heavy Duty Hospital Strecher Trolleys (E0302, E0304) Beneficiary meets criteria for a fixed height
hospital Strecher Trolley; and Beneficiary’s weight exceeds 600 pounds.
o Total Electric Hospital Strecher Trolleys (E0265, E0266, E0296, E0297) Denied as not reasonable and
necessary since height adjustment is a convenience feature. Accessories Trapeze Equipment (E0910, E0940)
Records support that the beneficiary needs the device to sit up because of a respiratory condition, to change
body position for other medical reasons, or to get in or out of Strecher Trolley.
o Heavy Duty Trapeze Equipment (E0911, E0912) Records support that the beneficiary meets the criteria for
regular trapeze equipment (see above) and the beneficiary's weight is more than 250 pounds.
DEVICE FILE
DOC NO CHD/DMF/001
o Strecher Trolley Cradle (E0280) Records support that a Strecher Trolley cradle is necessary in order to
prevent contact with the Strecher Trolley coverings. Side Rails (E0305 or E0310) or Safety Enclosures (E0316)
Covered when they are required by the beneficiary’s condition and they are an integral part of,
o or an accessory to, a covered Strecher Trolley. Replacement Innerspring Mattress (E0271) or Foam Rubber
Mattress (E0272) Beneficiary owns a hospital Strecher Trolley that requires a mattress replacement
Installation activities
o CHANDIGARH INDUSTRIES does not provide installation activities.
Servicing activities
Documented procedures or work instructions describe, as applicable the method and extend for
performing servicing activities. Service records are maintained through service reports(QF-7.5_4),or
customized reports.
Supporting Procedures: Individual Work Instructions
Sterilization of product
o CHANDIGARH INDUSTRIES does not provide sterile devices.
Quality Assurance:
Description of the quality assurance system and of the activities of the quality assurance department.
Procedures for the release of finished products
Following procedures are implemented under MDQMS At CHANDIGARH INDUSTRIES
Procedure for QMS Planning QSP/QSP-5.4.2
Procedure for Product Identification QSP/QSP-7.5.8
Procedure for Traceability QSP/QSP-7.5.8
Procedure for monitoring and measuring
Control of Non-Confirming Product QSP/QSP-8.3
Monitoring and Measurement of products QSP/QSP-8.2.6
Storage:
Policy on the storage of medical device is Made at CHANDIGARH INDUSTRIES
The policy aims to minimize related hazards, to ensure that employees are properly trained and competent in
the use of Medical Devices/Equipment, that devices are maintained in a safe and reliable condition, are quality
assured and subjected to asset management that is inclusive of device history and tracking.
DEVICE FILE
DOC NO CHD/DMF/001
Medical devices must also be stored in accordance with the labelled conditions, including potential relative
humidity conditions. The temperature always needs to be monitored to make sure that the appropriate
conditions are maintained.
DOCUMENTATION:
Arrangements for the preparation, revision and distribution of necessary documentation, including storage of
master documents
Master List of Documents AS/MDQ MS-LI-01 is being maintained for MDQMS
Medical Device Complaints and Field Safety Corrective Action:
CHANDIGARH INDUSTRIES have following procedure for handling customer complaints and field safety -
Arrangements for the handling of complaints: Complaint Handling procedure
Arrangements for the handling of field safety corrective action.
Internal Audit:
CHANDIGARH INDUSTRIES have a robust internal auditing procedure implemented Procedure for Internal
Audit QSP/QSP-8.2.4 and the frequency of Internal audit is six monthly.
Contract Activities:
Description of the way in which the compliance of the contract acceptor is assessed.
Ankur Steel Does a through contract review before accepting any order/contract – which includes risk review,
product descriptions, process validation requirements, product and process validation requirements
Procedure for Customer Related Processes QSP/QSP-7.2
Review of Customer requirements

Device File (DMF) Strecher

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Device File (DMF) Strecher

Uploaded by

Copyright:

Available Formats

CHANDIGARH INDUSTRIES

Usages Hospital, Clinic

Load bearing 159kg

Gross weight 30kg

Head and foot Bow – SS Pipe 30 mm diameter 18 mm with filling tube of 15 mm

Automation Grade Manual

Type Standard Stecher with trolley optional

Back Rest Yes

Frame Material Metal, MS Tube, Mild Steel

Dimensions 2030 mm(L) * 900 mm(W) * 600 mm(H)

1.2 Information regarding sterilization of the device (whether it is sterile or non-sterile; if

Procedure for Control of Document QSP/QSP-4.2.4

Procedure for Control of Record QSP/QSP-4.2.5

1.4 Clinical Evidence and evaluation (if applicable).

To whom it may concern:

The date of manufacture of the product was __________.

The date of manufacture of the product was __________.

Since 2010 the company is dealing in manufacturing of Hospital furniture.

The current price listed in catalogue is inr 7500/plus taxes

1.9 List of regulatory approvals or marketing clearance obtained

Procedure : Regulatory Authorities reporting QSP/QSP-8 Dated 01/04/22

Procedure for Recall QSP/QSP-8.3.1

For Serious Adverse Event:

Procedure for Recall QSP/QSP-8.3.1

Accident Prevention QSP/QSP-6.5

For Field Safety Corrective Action (FSCA):

Monitoring and Measurement of products QSP/QSP-8.2.6

Procedure for Customer Feedback QSP/QSP-8.2.1

2. Device description and product specification, including variants and accessories

Generic Name Model Name Model No Material Of Intended Instruction of use

CONTRAINDICATIONS, WARNINGS, PRECAUTIONS POTENTIAL ADVERSE

• Handle with care

• This product should be used only by adequately trained staff.

• The patient must always be immobilised on the stretcher.

• Do not use if the weight of the patient is not evenly distributed.

• Do not leave the patient unassisted on the stretcher.

2.3 PHYSICAL REQUIREMENTS FOR OPERATORS

• Have the physical strength to use the stretcher

• Be able to tightly hold the stretcher with each hand

• Have a generally good muscular condition

DESIGN AND MANUFACTURING INFORMATION:

Part 1. General principles

1 Use of medical devices not to yes ISO IS 4037

for the design and construction of

the manufacturer, in which the

used in the device; and

substance (1) If a medical device

8.1 Minimisation of risk of infection NA

derivatives, cells or substances

device, and any other device or

A medical device that has a NA

that ensures that the device

emission is necessary for a

medical device that is intended

12.1 Programmed or programmable NA

must be designed and produced

developed, produced and

protection against unauthorised

of the power supply

fault condition, patients, users,

gas, hydraulic, pneumatic or

substance administered that