8 DEVICE MASTER RECORDS
INTRODUCTION
Document For Intended Employees
Adequate Information
Preparation and Signatures
Location of Records
Record Retention
DEVICE MASTER RECORD CONTENTS
Device Specification
Specific Documents
Records for In Vitro Diagnostic
Products
QUALITY SYSTEM RECORD DOCUMENTS
WRITTEN PROCEDURES
Developing Procedures
Content of Procedures
CHANGE CONTROL
EXHIBITS
Documents That May Appear in a Device
Master Record
Device Master Record Index
Product Specification for a Portable
Defibrillator
Zener Diode Specification
Label Example
Handle Assembly and Parts List
Cable Assembly and Parts List
Device Master Record Index for Amylase
Product Description
Amylase Diluent Solution
Filling Record - Liquid, Non Freeze
Dried
Finished Product Release Form
Production Sample Card
Shop Order Traveler
Device master record (DMR) is the term used in the Quality System
(QS) regulation for all of the routine documentation required
to manufacture devices that will consistently meet company requirements.
Section 820.3(j) of the QS regulation defines device master record
as a compilation of records containing the procedures and specifications
for a finished device. The detailed requirements for device master
records are contained in section 820.181, as well as throughout
the regulation.
The definition for design output in 820.3(g) gives the basis and/or
origin of the device master record for all Class II and III devices
as follows:
Design output means the results of a design effort at each design
phase and at the end of the total design effort. The finished
design output is the basis for the device master record. The total
finished design output consists of the device, its packaging and
labeling, and the device master record.
For some devices, many of the design output documents are the
same as the device master record documents. Other device output
information is used to create a DMR drawing such as for a test
or an inspection procedure. Figure 6.1 shows the close relationship
between design output and the device master record.
Section 820.181, Device Master Record, lists some typical documents
in a DMR as follows:
The DMR for each type of device shall include, or refer to the
location of, the following information:
(a) Device specifications including appropriate drawings, composition,
formulation, component specifications, and software specifications;
(b) Production process specifications including the appropriate
equipment specifications, production methods, production procedures,
and production environment specifications;
(c) Quality assurance procedures and specifications including
acceptance criteria and the quality assurance equipment to be
used;
(d) Packaging and labeling specifications, including methods and
processes used; and
(e) Installation, maintenance, and servicing procedures and methods.
The definition for Design Output 820.3(g) and requirements for
Design Output 820.30(d) do not apply to most Class I devices.
Therefore, the requirements for the DMR for most Class I devices
are in 820.181 Device Master Record. Of course, a manufacturer
of Class I devices may use the design output sections of the GMP
as guidance.
However, almost all sections of the QS regulation have requirements
related to the device master record. The device master record
contains specifications for the device, accessories, labeling,
and packaging, and contains a full description of how to procure
the components and manufacture the device including specifications
for facilities, environment, and production equipment. In addition
to the device specifications, a device master record contains
documents that cover typical manufacturing activities such as:
Note that the listed activities and records or documents are required to produce any product –– medical, industrial, or consumer. There is nothing special about device master records except the name!
Also, note that in common usage, the term "device master record" refers to the total record or any of its individual records. Therefore, the term is singular for the total record, singular for a single document, and plural for a group of single documents. The term also may refer to an original record or a copy of a record.
Device master records should be technically correct, contain and/or
reflect the approved device and process designs, be under change
control, contain the release or other control date, contain an
approval signature, and be directed toward the intended user.
These requirements are in the QS regulation because the device
master record is the "beginning and end" of a product
–– errors in the device master record will have a serious
impact on the stateofcontrol of the manufacturing
operation and may have a serious impact on the safety and performance
of the device. The device master record should be accurate and
complete because the essence of the QS regulation is a quality
system based on designing a device to meet user needs, documenting
the design and production procedures in the device master record
and then producing a finished device that meets the device master
record requirements. Thus, the device master record shall accurately
reflect the device intended to be produced by a manufacturer.
The content, style, language, graphics, etc., of device master
records should be directed toward the needs of the intended employees
and, if the record is a specification or text for labeling, it
should be directed toward users. A failure to consider the intended
user leads to confusion and means that the company has not achieved
the stateofcontrol intended by the QS regulation.
Therefore, applicable records should be directed toward the needs
of procurement, processing, and test/inspection personnel, rather
than the needs of drafting, technical services, or product development
departments. Likewise, installation instructions should be directed
to installers. Labeling is often prepared by the same employees
that draft device master records; and, these employees should
also be aware that labeling shall meet the needs of the user as
directed by 21 CFR 809.10, 801.6 and 820.30.
In any manufacturing activity such as assembly, labeling, processing,
testing, etc., achieving and maintaining a stateofcontrol
is enhanced by appropriate personnel knowing:
In order for employees to perform a job correctly, they should
know exactly what is to be done and exactly how to do the work.
Section 820.181 requires that what is done be documented in the
device master record. The device master record also contains test
and inspection procedures and data forms that are used to help
determine and record what was done.
Documents that instruct people how to fabricate, assemble, mix,
label, test, inspect, etc., or how to operate equipment should:
If a component is changed, the representations on pictorial/photographic
type drawings are no longer correct and may be very confusing
to employees, particularly new employees.
The howtomanufacture instructions should be adequate
for use by the intended employees and correct for the intended
operation. In the mediumtolarge company, the instructions
tend to be extensive technical (engineering) drawings and written
procedures. In any company, particularly small manufacturers,
the work instructions may take several forms as discussed below.
Documentation may be supported by production aids such as labeled
photographs, video tapes, slide shows, sample assemblies, or sample
finished devices. All of these perform device master record functions
and should be identified, and be current, correct, and approved
for the intended operation.
The most commonly used aids are models or samples. There are two
conditions that should be satisfied in order to use these aids.
First, a written specification for the sample shall be contained
in the device master record. This specification, of course, may
be the same as the specification for the assembly or finished
device to be manufactured. This specification shall be subject
to a formal changecontrol procedure. Even though a model
is available, the specification is needed for present and future
product development, and for production control purposes. Second,
the sample should:
A card or tag as shown in the exhibits or an equivalent card may
be used to identify and help control the use of samples of assemblies
or finished devices. Such tags are usually covered by a clear
plastic pouch and attached to the model or sample.
Samples and other aids such as photographs are subject to normal
wear and tear in a production environment. Therefore, such aids
should be adequately protected by a suitable means such as being
located in a protected area, or covered by a protective pouch
or container. Production aids should be periodically audited to
make sure they continue to be suitable for the intended use. Section
820.100 contains requirements for corrective action. Corrective
action may involve the use of samples, changes to the samples,
or changes in the control of the samples.
Although a manufacturer tries to document for the intended employees,
there is a need to audit periodically to see how well the goal
is being met. There are various means of determining if information
in the device master record, production tools, and other production
elements are adequate for a given operation and associated employees.
These include analyzing the:
If any of these factors persist and are out of line with industry
norms or with the previous production experience, then the manufacturer
should take corrective action. Management shall review the quality
system as directed by 820.20 and, thus, be aware of device quality
problems or quality system problems such as listed above. The
corrective action may include changes in supervision or documentation,
adding new documentation, modifying the design, using different
tools, modifying the environment, etc.
A separate device master record is required for each type or family
of devices. Also, a separate device master record may be needed
for accessories to devices when these are distributed separately
for health care purposes. Such accessories are considered to be
finished devices. In practice, if the device and accessories are
made by the same manufacturer, the device master record for the
accessory may be incorporated into the device master record for
the primary device.
Within a family of devices, variations in the family may be handled
by dash number extensions on drawing and procedure numbers. Usually,
a top assembly or other major drawing contains a table/list of
the devices in the family and lists the variable parameters for
each member of the family.
Section 820.40 of the QS regulation requires that an individual(s)
be designated to: review, date, and approve all documents required
by the QS regulation including the device master record and authorize
changes. An individual(s) with the necessary technical training
and experience shall be designated to prepare and control device
master records. In addition to requiring approval signatures on
device master records, the QS regulation requires individual identification
for a few other activities. For convenience, these activities
along with the section numbers that require them are listed in
Table 8.1.
Table 8.1 GMP ACTIVITIES REQUIRING INDIVIDUAL IDENTIFICATION
820.30(b) | Approval of Design Plans |
820.30(c) | Approval of Design Input |
820.30(d) | Approval of Design Output |
820.30(e) | Results of Design Review |
820.30(f) | Results of Design Verification |
820.30(g) | Results of Design Validation |
820.40 | Approval of in Device Master Record or Changes |
820.70(g) | Equipment Maintenance and Inspection Activities Performed |
820.72(b) | Calibration Performed |
820.75(a) | Approval of Process Validation |
820.75(1)(2) | Performance of Validated Process |
820.80(d) | Release of Finished Devices |
820.80(e) | Acceptance of Activities Conducted |
820.90(b) | Authorization to Use Non-Conforming Product |
820.120(b) | Labeling Inspection |
820.180(c) | Audit Certification |
820.198(b) | Decisions Not to Investigate Complaints |
The list is selfexplanatory except for audit certification.
When a manufacturer certifies in writing to FDA that quality system
audits have been performed, the certification letter is signed
by management having responsibility for the matters audited. Also
note that the records in 820.70, 820.72, 820.80, 820.90(b), 820.120(b)
and 820.160 are not part of the device master record but, instead,
are part of the device history record (DHR). Records in 820.198(b)
are part of the complaint files.
If a record that requires a signature is maintained on a computer,
it is best if the designated individual(s) maintains an uptodate
signed printout of the record. Where it is impracticable to maintain
current printouts, computercompatible identifiers may be
used in lieu of signatures as long as there are adequate controls
to prevent improper use, proper employee identification, inaccurate
data input, or other inappropriate activity. If identifiers such
as coded badges and equipment keys are not controlled (i.e., not
restricted to designated employees), then these will not meet
applicable GMP "signature" requirements.
Device master records shall be stored at the manufacturing establishment
or at other locations (820.180) that are reasonably accessible
to company employees responsible for the manufacturing activities
and accessible to FDA investigators. Appropriate records may be
maintained in computer data banks if the records are protected,
change controlled, and readily accessible for use by responsibleemployees at all relevant facilities. It is acceptable for a manufacturer
to maintain records on microfilm and discard the original hard
copies. Microfiche and/or microfilm reductions may be used in
lieu of original record retention if the following conditions
are met.
If the reproduction process results in a copy that does not reveal
changes or additions to the original record, the original should
be retained. In this situation, the reproduced copy and any image
shown on a viewing screen should note any alteration from the
original and indicate that the original record is available.
By maintaining the device master record, complaints and other
records required by the QS regulation at the manufacturing establishment
or other reasonably accessible location, responsible officials
of a company can exercise control and accountability over the
entire design, manufacturing, and postmarketing activities and,
thereby, maximize the probability that the finished device conforms
to its design specifications. This GMP requirement helps assure
that responsible officials at the manufacturing establishment
have ready access to those documents essential for producing devices
and for conducting selfinspections, complaint investigations,
failure analyses, audits, and corrective action.
The device master record is a single source document or file.
Portions of this file may be kept in various locations. A device
master record may exist as:
These documents shall contain the latest DMR revisions, be signed,
and be dated to show they have been checked for adequacy and approved
for use (820.30, 820.40 and 820.181).
The QS regulation allows use of reference lists as a means to
reduce the duplication of records, particularly duplication of
general documents such as standard operating procedures (SOP's).
General SOP's (not directly related to a product or process) however
should be made a part of the quality system record (QSR) (820.186).
Use of a reference list also allows filing of device master record
documents at several convenient locations. If the device master
record contains a list of documentation, the actual documents
shall be available for employee use and FDA inspection at the
manufacturing site or other reasonably accessible locations. As
noted above, this is a key and important GMP requirement. Typical
locations of various device master records are shown in Table
8.2.
When performing an inspection of a company, FDA investigators
shall have access to actual records for review and copying during
reasonable business hours. FDA investigators review these records
to determine if a manufacturer is complying with the QS regulation
and with the Food, Drug, and Cosmetic Act.
Records deemed confidential by a manufacturer should be marked
to aid FDA in determining whether or not specific information
may be disclosed under the Freedom of Information Act. However,
routinely stamping every document as "Confidential"
defeats the purpose of requesting extra care be taken to protect
a specific document or set of documents.
Table 8.2 LOCATION OF DEVICE MASTER RECORDS
Typical Locations of Documents
TYPE OF DMR ELEMENT | ORIGINALS | WORKING COPIES |
Reference list(s) | Engr. master file | |
Component drawings | Engr. or Manuf. Engr. master file | Manuf. or Procurement |
Component acceptance procedures | SOP master file | Receiving department |
Device Input specifications (final version) | Engr. master file | Marketing or Engineering |
Manufacturing procedures | Engr. or Manuf. Engr. master file | Manufacturing |
Test specifications | Engr. master file | Engr. or Manuf. Engr. |
Test procedures | Engr. or Manuf. Engr. master file | Manuf., QA, QC or Final Test |
Inspection procedures | Manuf., QC, or SOP master file | Manufacturing or QC |
Label drawings | Engr. master file | Engr., QA, or Manuf. |
Label artwork | Artwork master file | Engr., Procurement |
Label control procedures | Manuf., QC, or SOP master file | Manufacturing |
Specific cleaning procedures | SOP master file | Manufacturing |
General cleaning procedures | QSR master file | |
System audit procedures | QSR master file | |
Employee training procedures | QSR master file |
SOP = Standard Operating Procedure
QSR = Quality System Record
QA = Quality Assurance
QC = Quality Control
The QS regulation in section 820.180(b) requires that all records pertaining to a device shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer. Manufacturers of longlife products should make prudent decisions as to how long to keep records. For example, there
may be no value in keeping records for longlife devices
such as stretchers, surgical tools, containers, etc., forever
if the probability is low that any postdistribution remedial
activity will occur. For devices that require repair or capital
equipment devices that probably will be updated, appropriate records
should be retained to support these repairs or modifications.
Device master record requirements apply to devices modified in
the field by the manufacturer's representatives after the devices
are commercially distributed. Modification of a device is manufacturing
and the QS regulation covers all manufacturing of devices where
the result is placed into commercial distribution. In any case,
a manufacturer should be prepared to provide a rationale for its
decision to discontinue record-keeping.
As discussed above, the device master record shows and/or tells
employees how to perform specific functions related to the production
of a device. The QS regulation does not dictate how this information
is to be arranged or filed in the device master record and quality
system record except that it shall be readily accessible. Because
each device master record and quality system record contain many
documents, an index of each is usually needed.
There may be many specifications in the device master record.
One of these is the device specification. A device or product
specification is a specific document in the device master record
that briefly describes and gives all important details of the
external characteristics of a device. The product specification
may also contain some internal characteristics of the device that
are important to the manufacturer and/or the users. The finished
device specification is derived from the design input specifications
in 820.30. For some devices, many of the external characteristics
such as temperature tolerance are related to the environment in
which the devices will function properly. For some in vitro products,
the package insert is used by some manufacturers as the product
specification for marketing purposes.
Generally a product specification will contain the device's:
Table 8.3 contains a list of characteristics that often appear
in product specifications; however, note that not all of the listed
items will appear in the product specification for a given device.
In addition to defining and describing a device, a product specification
is a communication tool which, if used in a timely manner, can
help achieve some important results. First, it helps assure that
everyone is talking about the same device and working toward the
same objectives with respect to safety, effectiveness, human factors,
configuration, labeling, packaging, processing, finished device
acceptance, etc.
Ultimately, the device specification or a condensed version of
it should be used in catalogs, or other product documentation,
to aid communication between salespersons and customers. If the
marketing department uses the product specifications when preparing
advertisements and catalog sheets, public relations with users
will be enhanced because the marketing documents are based on
proven scientific safety and performance claims for the actual
device. The user has an opportunity to read the technical specifications
of the item actually being offered for sale.
Thus the use of device product specifications will result in:
A sample product specification for a portable defibrillator is
in the exhibits at the end of this chapter. This specification
is long and detailed because it is a combined product and test
specification, and because it is for a complex device.
Specific documents are drawings, procedures, labels, data forms,
etc., for a specific product or family of products. Product specific
documents are almost always part of the device master record.
The originals of specific documents are usually located in files
in engineering or technical service departments. In most manufacturers,
specific documents contain no general information; however, they
often refer to general documents. (A list of specific and general
documents is exhibited later in this chapter.) The number of specific
documents for a given product line may range from about 10 to
several hundred. If large numbers of documents are needed, an
index is usually needed to help locate them, particularly forpersonnel that do not work in the drafting department or in technical
services.
The main differences between device master records for chemicalbased
in vitro products and for electromechanical products, such as
instruments and artificial kidneys, is terminology and the relatively
extensive use of written processing procedures and status reports
for in vitro diagnostic products rather than a few assembly drawings
and test/inspection reports. For example, device master records
for chemicalbased devices would contain a manufacturing
section dealing with areas such as solution preparation and filling,
whereas manufacturing sections for electromechanical products
would cover operations such as assembly. Status records for weighing,
mixing, filling, etc., are used for general control of in vitro
products. Status reports are also used because it is often difficult
to determine the status of inprocess in vitro products by
looking at them the opposite is usually true for
most hardware devices. Records for in vitro devices also shall
contain control data that allows components and kits to be traced
[809.10(a)(9), etc.].
Quality system record (QSR) (820.186) or general documents are
used for many activities that are essential to operating a manufacturing
establishment these are not specific to any given
product even if the company produces only one product. Thus, the
quality system record includes general documents such as standard
operating procedures (SOP's) and standard quality assurance procedures
(QAP's). If the company added another product line, the basic
content of these documents would undergo none or only minor changes.
In a typical manufacturing operation, general QSR, SOP, and QAP
documents may include the following:
Employee training procedures | Supplier assessment policy |
Cleaning procedures | General design control procedures |
Insecticide useremoval procedures | Component inspection procedures |
Air conditioning/heating procedures | Workmanship standards |
Tool kit policy | Design review policy/procedure |
Safety procedures | Label review policy/procedure |
Procurement procedures | Sterile water system maintenance |
Returned goods policies | Calibration policy |
Drawing numbering system | Complaint handling procedure |
Change control procedure | Recall procedure |
Service policy | Deviation review policy/procedure |
The above list is not all inclusive. Mediumtolarge
companies tend to have many of these general documents to guide
management in maintaining consistent operations. A very small
company may have only the most essential and appropriate of these
documents such as procedures for design controls, drawing numbering
system, change control, employee training, use of hazardous materials,
etc.
The original copy of each general procedure is filed in the department
specified by management as having responsibility for maintaining
that procedure, or it is filed in an automated system with access
by the designated departments. The working copies of the above
procedures are usually located in SOP manuals and QA manuals.
The procedures are usually numbered and arranged in a logical
order by topic. The QS regulation does not require manufacturers
to keep quality system record documents in SOP or QA manuals;
however, the experience of many industries has demonstrated that
such manuals are worthwhile if they are kept current and contain
only the real working procedures.
Many sections of the QS regulation require written procedures
for instructions in performing various quality system, design
product acceptance, QA, and manufacturing tasks. Certain devices
such as in vitro products, because of the nature of the manufacturing
operations, tend to have a relatively large number of written
procedures.
Written procedures are used for quality system audits, product
development, manufacturing, postmarketing activities, etc.,
to:
In large manufacturing facilities involving many operations and
people of various skill levels, many written procedures are usually
necessary. In a small manufacturer, communication lines are usually
short, few people are involved, and management is readily available
to provide guidance, so that the need for written procedures is
usually less than for a larger manufacturer.
A manufacturer, particularly a small manufacturer, may conclude
that GMP requirements for written procedures are not applicable
for a particular operation. Although the number of written procedures
may vary, all manufacturers are required to maintain a device
master record (820.181) for each type or family of devices they
produce.
Often training and work experience alone or combined with drawings,
photographs, and models are valid substitutes for written procedures.
For example, machinists are typically skilled personnel who fabricate
components and finished devices using dimensional drawings for
guidance instead of written procedures. The company and FDA investigator
will evaluate each situation based on the training and knowledge
of the operators and the control needed to meet device specifications.
Typically, a written procedure is not necessary when:
Written procedures and associated history or status records, however,
are often needed for activities where there is no change, such
as color, texture, or form, to indicate that the activity has
been performed correctly.
Manufacturers should determine that they meet all GMP requirements
and, if necessary, exceed them in order to produce finished devices
that meet device master record specifications because FDA insists
that manufacturers meet their quality claims [FD&C Act, section
501(c)]. Achieving this required stateofcontrol may
require fewer or more written procedures than specifically required
by the QS regulation. FDA does not insist that a manufacturer
generate records that do not contribute to assuring conformance
to specifications.
Developing written procedures is relatively labor intensive and
time consuming, which may lead to use of "backoftheenvelope"
notes instead of formal procedures. Likewise, changing these procedures
is time consuming, which may lead to delays or forgetting to make
the changes. Drafting or changing written procedures is also prone
to errors. Therefore, manufacturers are encouraged to use computers
and lowcost printers as word processors to aid in writing
and changing procedures. With the use of computers, these tasks
become easier thereby increasing the probability that they will
be performed correctly and when needed. Computers can also be
used for generating and maintaining device master record indices
and complaint files, and performing a host of other GMP related
activities.
There is a method for developing procedures that will result in
short, clear procedures that help
solve real problems. The first two steps are:
Events that point to a problem are excessive rework, employee
confusion, customer complaints, recalls, etc. These "pointers,"
however, may not be the real problem. The real problem may be
inadequate design, components, equipment, maintenance, operational
techniques, documentation, environment, etc. The real problem
should be identified before it can be solved. A written procedure
may or may not be needed to help solve the problem.
The real problem can be identified by careful analysis of:
Operational analysis is aided by flow-charting which is a stepbystep
chart of the minute details of the operation. Thus, a flow chart
is much more detailed than a QA audit report and is very helpful
in determining what is actually happening in a particular manufacturing
operation. This knowledge may lead to a solution of manufacturing
and quality problems. An example of a flow chart appears in the
exhibit section of chapter 10.
From a company quality system, interface, and personnel management
viewpoint, the problem, the reason for flowcharting the
given activity, etc., should be discussed with affected personnel.
Their input should be requested with respect to identifying and
solving the real problem. By using the information presented by
the flowchart and the experience gained while producing the chart,
the QA auditor is better able to:
Written procedures are widely used and industry experience has
shown that these should contain the following items:
The effective date may be the same as the approval date. Also,
the effective date may appear on a separate document such as an
engineering change order (ECO) form. The main body of the procedure
should cover, as appropriate:
Particularly for the new employee, it is important for the procedure
to state the reason for performing a function and the reason it
is to be performed in a certain way. Background information such
as this helps the employee to understand an assignment and remember
how to perform it. For example, when working on static sensitive
integrated circuits that are easily damaged by electrostatic potentials,
unskilled employees need to understand why they have to be grounded,
work on grounded mats and, especially, why they are not allowed
to wear certain fabrics while at work. Likewise, employees working
in environmentally controlled, clean manufacturing areas need
to be told about invisible microbes and particulates, and that
humans are the major source of these unwelcome contaminates. If
so informed, employees are more likely to follow the operational
procedures for working in controlled areas.
The task description in each procedure should cover appropriate
details such as:
If the procedure being developed, for example, covers change control,
the procedure should also cover related activities such as changes
to labeling. Consider a change to a device where an analog meter
is replaced with a digital meter obviously the instruction
manual (labeling) and service manual also need to be modified.
Otherwise the finished device:
After the procedure is drafted, if appropriate, it should be reviewed
with the affected personnel before it is approved and implemented.
During the initial implementation, the use of the procedure should
be monitored. Then, based on actual experience in using the procedure,
if necessary, it should be modified to more exactly meet the need
of the operation or process.
The QS regulation in section 820.181 by reference to 820.40 requires that any changes to the
device master record be authorized by the signature of a designated
individual(s). Change control requirements also appear throughout
the QS regulation. The control of changes to devices, processes,
and the associated device master records is one of the most important
elements of a quality assurance system. The requirements for a
successful change control system are so extensive that the entire
next chapter of this manual is devoted to changes and associated
procedures.
Reprinted on the next pages are typical documents (records) that
appear in device master records. Manufacturers may use these as
guides in developing their device master records.
The first exhibit is a list of documents that might appear in
device master records. Each device master record would contain
only those documents that are applicable for a specific device.
Some of the listed documents are general rather than product specific.
General documents are usually called standard operating procedures
(SOP's) and, if necessary, are referenced in the device master
record rather than actually being included. The general documents
are usually part of the quality system record (QSR).
This exhibit is a policy/procedure for drafting a device master
record index. An index is also known as a document plan, table
of contents, etc. An example of a device master record index follows
immediately after the policy/procedure. Note that this particular
policy/procedure contains definitions. It is important that procedures
contain definitions, in a case like a complex device master record
index where employees may not be familiar with the terminology.
Finished device or product specifications are the backbone of
any device master record. The one illustrated as the third exhibit
is for a complicated piece of equipment and is, therefore, extensive.
For long documents it is recommended that a table of contents
be incorporated as was done in this specification. Appendix A
and B of this specification are not exhibited.
This specification for a noncomplicated part contains the
necessary information to describe the item in sufficient detail
for the correct part to be procured per the 820.50 Purchasing
Controls.
A sample label is exhibited. Labels and labeling are components
and their specifications, art work, etc., are part of the device
master record. As for any component, labeling shall be specified
(documented). The resulting device master record document shall
be reviewed, approved, change controlled, and stored such that
it may be readily accessed. Such records are used to meet requirements
such as those in 820.50, 820.80(b), 820.80(d), 820.120(b), 820.120(e),
etc.
This exhibit is an engineering drawing and parts list for a handle assembly. Engineering drawings, parts lists, or formulations are a vital part of many device master records. In this case, the engineering drawing not only details how this assembly is to be made, but there is also important information in the notes on the drawing. If properly trained and with sufficient experience, employees are able to use this drawing as the instructions for assembly of this handle. A written assembly procedure is not necessary.
This exhibit is similar to the handle assembly mentioned above.
The type of drawing used and information on a drawing can aid
a manufacturer in reducing paperwork needed to manufacture a specific
product.
This document is a device master record index for an invitro
diagnostic product. Proprietary information in this index is replaced
by X's. The company that prepared this index uses purchase specifications
and raw material specifications. Some manufacturers, particularly
small companies, specify and purchase standard, routine items
such as bottles and caps by using catalog numbers. Component specification
drawings are not always used for routine items such as standard
bottles.
This exhibit is a product description for an in vitro diagnostic
product. The standard operating procedures, quality control procedures,
manufacturing flow sheets, and notes mentioned in this product
description are not reprinted herein.
This exhibit is the procedure for making a batch of amylase solution.
In this procedure, note that for each step the company requires
the initials or signature of the person actually performing the
operation and of the individual who checked that person's performance
of the operation.
This is an exhibit of a filling record used for liquid products
to document the steps in a filling operation. The completed filling
record becomes a part of the device history record (DHR) for the
batch being filled.
This form is used to record that the device history record is
complete for a lot of product, the product meets specifications,
and the lot may be approved for release.
This exhibit shows both sides of a card or tag used to identify
and help control the use of manufacturing aids such as samples
of assemblies or finished devices. The use of a sample identification
card is described in the main text of this chapter.
The last exhibit is two job travelers or job followers. These
cards, forms, tags, etc., are used to identify a batch or subbatch
of inprocess assemblies as they are passed from one department
to another. Where needed, travelers are used to reduce mixups
and confusion and, in general increase the stateofcontrol
of an overall manufacturing operation. Travelers help meet the
general requirements of 820.60, Identification, and the specific
requirements of 820.86, Acceptance Status.
1.0 Device Master Record Index
The device master record Index is a table of contents which is
used for convenience. It may be known as a:
Device Master Record Index
Documentation or Device Master Record Unit;
Documentation Plan;
Product Tree;
Documentation Index;
Product Structure; or
Bill of Materials (if it also lists the device master record documents).
2.0 Device Specifications
(Device specifications are described in the chapter text.)
3.0 Manufacturing Information
3.1 Index
(Optional. See 1.0 above for total table of contents.)
3.2 Formulation or top assembly drawing
3.3 List of components
1. List of ingredients (including grade or type)
2. Bill of materials (i.e., component list usually arranged by subassembly or other subproduct level or by process steps)
3. Formula
3.4 Procurement documentation
1. Specifications
2. Drawings
3. Certificate of compliance requirements
4. Supplier Assessment procedures
3.5 Device documentation
1. Fabrication drawings
2. Surface finish procedures
3. Subassembly drawings
4. Wiring and piping diagrams
5. Assembly procedures
6. Assembly drawings
7. Reference documentation
a. Wiring and piping schematics
b. Test specifications
8. Subbatch procedures
9. Blending or mixing procedures
10. Solution procedures
11. Final formulation procedures
12. Software packages
3.6 Precautions and special notations
1. Apparel
2. Cleaning
3. Storage conditions
4. Filling, mixing conditions
5. Hazards and safety precautions
3.7 Equipment, lines, and procedures
1. Process lines
2. Assembly lines
3. Vessels
4. Mixers, tools
5. Molds
6. Machine maintenance procedures
7. Calibration procedures
8. Setup procedures
9. Operating procedures
10. Process flow charts
3.8 Sterilization procedures
1. Procedures for ethylene oxide, radiation, filtration, steam, etc.
2. Handling and flow procedures
3. Cycle parameter specifications
4. Diagrams for loading products in the chamber
3.9 Production control documentation
1. Inspection procedures
2. Test procedures
3. Blank job travelers
4. Blank inspection/test forms
5. Instrument charts
6. Reporting forms
7. Approved deviations
4.0 Labeling and Packaging
4.1 Index (Optional. see 1.0 above.)
4.2 Labeling
1. Label drawings
2. Labeling drawings
3. Label/labeling review procedures and forms
4. Production control procedures and history record forms
5. Instruction manuals
6. Service manuals
7. Customer software
8. Customer feedback forms
4.3 Packaging
1. Package drawings (usually includes labeling information)
2. Closure drawings
3. Filling and/or packaging procedures
4. Packing procedures
5. Special shipment procedures
4.4 Storage requirements
1. Temperature
2. Humidity
3. Shelflife
5.0 Control Procedures and Activities
5.1 Index (optional. see 1.0 above.)
5.2 Inspection procedures
1. Incoming
2. Inprocess
3. Finished devices
4. Process control charts
5. Blank data reporting forms
5.3 Test procedures
1. Incoming
2. Inprocess
3. Pretest conditioning
4. Finished device
5. Process control charts
6. Blank device history record forms
7. Automated test programs and/or software
6.0 Final Release
6.1 Release document review list
6.2 Distribution procedures
6.3 Blank device history record forms
Title: DEVICE MASTER RECORD INDEX
Policy No.______________ Rev. ______________ Date _______________
Approval ___________
1.0 Purpose and Scope: To prescribe the responsibilities for preparing
device master record (DMR) Indices and content of DMR Indices
(lists).
2.0 Policy: A DMR Index shall be prepared and maintained for all
devices being developed or manufactured.
3.0 Definition: A DMR Index is a table of contents for the device
master record of a device. It also contains information on the
breakdown of the device into assemblies and/or manufacturing steps.
It is called a document plan during planning and early development
of a new product. A DMR is:
3.1 An aid in proposing, planning, tasking, and reviewing projects;
3.2 A framework for preparing drawings, parts lists, and test
equipment lists;
3.3 A means of familiarizing personnel with the device configuration;
3.4 A current record and status of the physical configuration
of the device and a list of all reference documentation required;
and
3.5 An index to the productspecific documentation required
for procurement of components, manufacture, and evaluation of
a device.
4.0 Procedure:
4.1 Preliminary document plans may be generated for the convenience
of Engineering. Upon completion of the design when formal records
are needed, a formal document plan will be initiated.
4.2 The configuration and structure of the document plan is set
by the Engineering, Manufacturing Engineering, and Drafting Supervisors.
4.3 After agreements, the plan will be drawn, document numbers
assigned, status of drawings indicated, and the plan approved
by Engineering and Manufacturing. All nonproduct specific
documents such as standard operating procedures that are used
during production of the device will be listed on the plan. (Because
the plan is now complete, it is a DMR Index.)
5.0 Example: Part of an index in "tree" form is on the
following pages. A "tree" form allows a large amount
of information to be displayed in a small area. Each column covers
a major section of the documentation such as the battery charger.
The index contains codes to convey additional information such
as a rectangle with a dark triangle in a top corner or a mark
such as "#" to indicate a parts list is included with
a particular drawing.
(Sample for training purposes only. Do not use for technical parameters.)
PRODUCT SPECIFICATION PORTABLE DEFIBRILLATORS
CONTENTS
PRODUCT SPECIFICATION
1.0 Reference Documents
2.0 Overall Description
3.0 Configurations
4.0 Functional Characteristics
5.0 Performance Characteristics
APPENDIX A (not reprinted in this manual)
TEST RECOMMENDATIONS
APPENDIX B (not reprinted in this manual)
TEST POINT AND BOARD INTERCONNECT SIGNAL
DEFINITIONS
Throughout this Product Specification * indicates need for test.
NOTE: Values not in parentheses refer to Models D320 and D320W.
Values in parentheses refer to Models D400 and D400W.
LTR | DESCRIPTION | DATE | APPROVED |
1 | Pilot released per ER - 3556 | 04/23/75 | |
2 | Revised and Retyped per ECO - 3968 | 01/27/76 | |
3 | Revised and Retyped per ECO - 4225 | 05/28/76 | |
4 | Revised per ECO - 4636 | 12/28/76 | |
A | Released to Production per ERN - 4645 | 03/10/77 | |
Title: PRODUCT SPECIFICATION PORTABLE DEFIBRILLATORS | |||
DR BY: A J Lucas | DATE: 4/15/75 | DWG NO. 04300538 | Sheet 1 of 14 |
REVISION: A | Date: 3/10/77 | ||
APP'D: | DATE: |
PRODUCT SPECIFICATION PORTABLE DEFIBRILLATORS
D320, D320W, D400, & D400W
1.0 REFERENCE DOCUMENTS
1.1 Portable Defibrillators D320/400 and D320W/400W 23990081XX
1.2 Adult Anterior Paddles 2499008201 450 AA
1.3 Adult AnteriorPosterior Paddles 2499011301 450
APA
1.4 Adult Anterior Paddles 2499011403 450 AI
1.5 Pediatric Anterior Paddles 2499008202 450 PA
1.6 Pediatric Internal Paddles 2499011402 450 PI
1.7 Infant Internal Paddles 2499011401 450 II
1.8 Adult Anterior Paddles with Remote Charge 2499008203
450 AAR
1.9 Patient Cable Assay. 3 Electrode 21 D2499011801
1.10 Tube XXXXXX (712) 1042507001
1.11 D320/400 Shipping List
1.12 D320/400 Operators Manual
1.13 D320/400 Maintenance Manual
2.0 OVERALL DESCRIPTION
The D320/400 (Ref. 1.1) is a portable defibrillator with integral
isolated input, solid trace, ECG monitor scope. The D320/400W
contains in addition a 40 mm strip chart recorder. They may be
used for nonsynchronous ventricular defibrillation or synchronous
conversion of arrhythmias. Power is derived from internal rechargeable
batteries or from the AC power line whenever the unit is connected
to the AC power line via the internal charger.
Standard accessories included in the D320 Shipping List (Ref.
1.11) are:
1 Adult Anterior Paddle Set (Ref. 1.2)
1 Patient Cable21(Ref. 1.8)
1 Tube XXXXXX Electrode Paste (Ref. 1.9)
1 Operator's Manual (Ref. 1.11)
1 Shipping Carton
Optional Accessories are alternate paddles described in section
4.
2399008101 Battery Operated Defibrillator D320 (120V)
2399008102 Battery Operated Defibrillator D320 (220V)
2399008103 Battery Operated Defibrillator with Writer D320W (120V)
2399008104 Battery Operated Defibrillator with Writer D320W (220V)
2399 Battery Operated Defibrillator D400 (120V)
2399 Battery Operated Defibrillator D400 (220V)
2399 Battery Operated Defibrillator with Writer D400 (120V)
2399 Battery Operated Defibrillator with Writer D400W (220V)
4.0 FUNCTIONAL CHARACTERISTICS
4.1 DEFIBRILLATOR FUNCTIONAL CHARACTERISTICS
The defibrillator becomes operational in the nonsynchronous
mode when the power switch is turned ON and the paddle connector
is attached. A charge cycle is initiated by depressing and holding
the MANUAL CHARGE button until the desired charge is reached.
Automatic charge to 160 (200) or 320 (400) joules is accomplished
by depressing the AUTO CHARGE 160 (200) or AUTO CHARGE 320 (400)
buttons respectively. An audible tone and a DELIVERED ENERGY bar
display on the scope indicate when a charge is in process. When
the charge cycle is complete, the audible tone stops and the DELIVERED
ENERGY meter indicates the amount of energy to be delivered. The
stored energy is delivered in the form of an Edmark waveform by
pressing the buttons located on the anterior paddles or, if interior
paddles are used, pressing the INTERNAL PADDLE switch located
on the control panel.
For safety and equipment protection, a charge cycle is followed
by an automatic time out that dumps the stored energy (disarms)
after 45 seconds if energy is not delivered or the charge button
pressed again within the time out period. The stored energy is
also automatically dumped when the power switch is turned OFF.
The operator may disarm the unit by depressing the DISARM button.
4.1.1 Delivered Energy Indicator
The DELIVERED ENERGY INDICATOR displays the energy to be delivered
into a 50 ohm load as a horizontal line at the top of the CRT
screen. When a charge is initiated, the end of a solid bar will
follow the amount of energy to be delivered.
4.1.2 Paddle and Accessory Storage
A molded paddle holder is in the defibrillator front panel cover
for one set of anterioranterior adult defibrillator paddles.
One (D320W/400W) or two (D320/400) accessory holders are located
below the front panel to hold cables, electrodes, and paste. Under
normal usage, the defibrillator is stored or transported with
defibrillator cables connected. This approach minimizes the number
of steps needed to bring the defibrillator from an idle state
to the emergency nonsynchronous mode.
4.1.3 AnteriorAnterior paddles
Anterioranterior paddle assemblies are available with two
electrode sizes: adult 8.5 cm (Ref. 1.2) and pediatric 5.0 cm
(Ref. 1.7). Each assembly consists of a connector, two paddles
with discharge buttons, and a dual coiled cord extendable to 10
feet.
Ethylene oxide sterilization is the only permissible sterilization
technique for all of these paddles.
4.1.4 AnteriorAnterior Paddles with Remote Charge (Optional)
Same as 4.1.3 except one paddle will have a charge button that
functions identically to MANUAL CHARGE button on the front panel
(Ref. 1.8).
4.1.5 AnteriorPosterior Paddles
An anteriorposterior paddle assembly (Ref. 1.4) is available
for use only on adults. It consists of an anterior paddle identical
to the 8.5 cm paddle in a 4.1.3, a posterior 12 cm paddle, a dual
10ft. coiled cord, and connector.
4.1.6 Internal Paddles
Internal paddle assemblies are available with three electrode
sizes: adult 8.5 cm (Ref. 1.4), pediatric 5.0 cm (Ref. 1.5), and
infant 2.5 cm (Ref. 1.6). Each assembly consists of a connector,
2 paddles, and a dual coiled cord extendable to 10 ft.
4.2 ECG AMPLIFIER AND SOLID TRACE SCOPE FUNCTIONAL CHARACTERISTICS
4.2.1 ECG Amplifier
The ECG amplifier is an isolated, variable gain amplifier which
feeds the display, QRS detector, and output jack. Input to the
amplifier is through the defibrillator paddle connector or through
the patient cable. A lead selector switch selects the paddles,
or leads I, II, or III for input. The amplifier incorporates the
following features:
1. Slew Rate Limit Limits the slew rate and, therefore,
the amplitude of the pacer pulses so that they can be seen on
the display and will not trigger the QRS detector in most lead
configurations.
2. Fast Recovery Circuit Returns the signal to on screen
limits within 0.5 seconds after defibrillation or other overload.
4.2.2 Solid Trace Display
The solid trace display shows the last 4 seconds of ECG waveform
on the screen. The waveform appears as if a strip chart recorder
were writing the ECG at the right hand edge of the screen and
the paper was being pulled from right to left. Current information
is displayed at the right of the screen with information becoming
increasingly older towards the left. When operating the defibrillator
in the synchronous mode, sync pulses appear showing where the
energy would have been delivered had the discharge buttons been
pushed. The waveform may be stopped or "frozen" for
review by pushing the latching FREEZE button.
4.3 HEART RATE METER FUNCTIONAL CHARACTERISTICS
The heart rate meter displays heart rate as a bar at the screen
bottom. The heart rate is also compared to alarm limits that are
displayed on the same bar. When a limit is exceeded for longer
than three seconds, the red alarm led blinks, an audible alarm
sounds, and the hard copy writer runs (D320W/400W only). Alarms
are disabled or reset by putting the LOW LIMIT knob fully counterclockwise
and the HIGH LIMIT fully clockwise. In this position the limit
indications are not displayed on the screen.
The threshold for QRS detection is automatically adjusted depending
on the amplitude of the QRS complex. The minimum threshold is
equivalent to 0.6 cm on the scope display. At maximum gain, a
0.3 mv QRS complex will be detected. Detection of a complex will
cause an audible beep if the BEEP push-button is depressed. Proper
adjustment of the gain control will result in an Rwave amplitude
on the screen of one to two cm.
*4.4 SYNCHRONIZED CARDIOVERTER FUNCTIONAL CHARACTERISTICS
The synchronizer detects the peak of the R wave and, after the
discharge buttons on both defibrillator paddles have been pushed,
delivers the stored energy. The QRS amplitude must be set to at
least 0.6 cm on the scope display using the SIZE control. QRS
detection is verified by an audible QRS beep and by a SYNC pulse
displayed on the scope at the time relative to each QRS complex
that the energy would have been delivered.
4.5 WRITER FUNCTIONAL CHARACTERISTICS ( D320W/400W only)
The D320/400W is equipped with a 40 mm direct hard copy writer.
The writer is started manually by the RECORD push-button on the
front panel or automatically on alarm. No other controls are provided.
Gain of the writer is equal to the gain of the scope. Therefore,
setting the QRS size control to a convenient point for the scope
will produce a reasonable gain for the writer. Centering of the
writer is automatic to within approximately .25 cm. An internal
stylus heat adjustment is provided. An external control is not
needed due to the regulation of the stylus power supply.
4.6 MODES OF OPERATION
The defibrillator has two modes of operation: nonsynchronous
defibrillation and synchronous defibrillation. The defibrillator
is always in the nonsynchronous defibrillation mode when
power is turned on. It can be switched from the nonsynchronous
mode to the synchronous mode by pressing the SYNC ON push-button.
It can be returned to the nonsynchronous mode by pressing
the SYNC OFF push-button. Synchronous mode is indicated by a SYNC
light on the front panel and by sync pulses appearing on the scope
coincident with QRS detection.
*4.7 OPERATOR CONTROLS
4.7.1 ON/OFF
A two push-button switch turns on the ECG amplifier and Solid
TraceScope and puts the unit in the nonsynchronous mode
when ON is depressed.
When OFF is depressed it dumps (disarms) the defibrillator capacitor
and switches off all power to the unit. Closing the front cover
automatically depresses OFF.
4.7.2 MANUAL CHARGE
A momentary push-button that causes the capacitor to be charged
while depressed.
4.7.3 AUTO CHARGE 160 (AUTO CHARGE 200)
A momentary push-button which initiates an automatic charge to
160 joules delivered.
4.7.4 AUTO CHARGE 320 (AUTO CHARGE 400)
A momentary push-button which initiates an automatic charge to
320 joules delivered.
4.7.5 PADDLE CHARGE (Optional)
A momentary push-button located on the right paddle which functions
identically to the MANUAL CHARGE push-button.
4.7.6 SYNC ON/SYNC OFF (Labeled SYNC/DEFIB ON D400/400W)
Two momentary push-buttons used to select synchronous or nonsynchronous
mode of operation. Pressing SYNC ON after the power is turned
on puts the unit in the synchronous mode and illuminates the SYNC
light. The unit is put in the nonsynchronous mode when power
is turned on or by pressing SYNC OFF when operating in the synchronous
mode.
4.7.7 DISARM
A momentary push-button that is used to dump the internal stored
charge. It is used if a lower energy than the one already selected
is desired, or if no more countershocks are to be delivered.
4.7.8 QRS SIZE
A potentiometer used for setting the gain of the ECG amplifier.
Gain may be varied from X300 at fully CCW to X3000 at fully CW.
At center position, the gain is X1000.
4.7.9 FREEZE
A latching push-button that causes the scope to cease updating.
4.7.10 1MV
A momentary push-button that injects a 1 mv +/ 2.5% signal.
4.7.11 BEEP
A latching push-button that activates the QRS beep when depressed.
4.7.12 HIGH LIMIT
A potentiometer used for setting the alarm high rate limit over
a range of at least 100 to 250 BPM. It is set to 120 BPM with
knob pointer is straight up.
4.7.13 LOW LIMIT
A potentiometer used for setting the alarm low rate limit over
a range of at least 0 to 150 BPM. It is set to 60 BPM with knob
pointer is straight up.
4.7.14 RECORD
A latching push-button that starts the writer when depressed.
The writer is always started on alarm.
4.7.15 LEAD SELECT
Four interlocking push-buttons labeled PADDLES, I, II, III that
select paddles or standard leads I, II, III respectively as input
to the ECG amplifier. A threelead cable with RA, LA, and
LL (which may be labeled R) can be used.
*4.8 INDICATORS
4.8.1 BATTERY LOW
A red lamp that begins flashing when the battery has a minimum
of ½ hour of continuous monitoring capacity left or 2 charges
to 320 joules (1 charge to 400 joules). The lamp flashes to indicate
circuit operation when power is turned on.
4.8.2 SYNC
An amber LED that illuminates when the unit is operating in the
synchronous mode.
4.8.3 DELIVERED ENERGY, JOULES
An illuminated bar that indicates the energy in joules to be delivered
into a 50 ohm load.
4.8.4 TEST
A light located on the defibrillator paddle holder that illuminates
when a counter shock of at least 300 joules is discharged into
the paddle holders.
4.8.5 ALARM
A red light that flashes during an alarm.
4.8.6 LINE
Two red lights that illuminate when AC power is being received
by the unit.
4.8.7 QRS Beep
An audible tone that is produced every time a QRS complex is detected
when the BEEP push-button is depressed.
4.8.8 Charging
A audible tone that increases in pitch as the capacitor charges.
4.8.9 Sync Pulse
A negative pulse displayed on the ECG trace with its center within
20 ms of where the energy should have been delivered if the DISCHARGE
BUTTON(S) had been pushed.
4.8.10 Heart Rate Bar
An illuminated bar graph showing Heart Rate and alarm limit settings.
*4.9 CONNECTORS
4.9.1 Defibrillator Paddle Connector
G pin High Voltage Connector
Pin D High Voltage Paddle Lead
Pin A +High Voltage Paddle Lead
Pin F Ground
Pin C INTPDL (Internal Paddle Jumper)
Pin B FDLSW (Paddle Switch)
Pin E RMTCHG (Remote Charge Switch)
4.9.2 Isolated Input Connector
5 pins MS series Connector Located on front panel.
Pin A Right Arm
Pin B Left Arm
Pin C Left Leg
Pin D Left Leg
Pin E Left Leg
4.9.3 ECG/Output Connector
3wire phone jack on front panel
Tip ECG Output
Ring Signal Ground
Sleeve Chassis Ground
Sheet 1 of 1
TITLE: IN4278 ZENER DIODE SPECIFICATION NUMBER
Drafted by App. Date
REV. ECN History Notes Date
1. SCOPE: This specification describes a onewatt zener diode
used for voltage reference in the XYZ Stimulator.
2. ELECTRONIC CHARACTERISTICS
2.1 Zener Voltage: 3.1 vdc @ 76 madc
2.2 Maximum Zener Impedance: 10 ohms @ 76 madc
2.3 Reverse Leakage Current: (25%) 100 microamps (max) @ l vdc
3. TESTING: All diodes shall meet the requirements of JANTX IN4278
as specified in MILS19500/127G.
4. PHYSICAL CHARACTERISTICS
4.1 Diodes shall be packaged in a voidfree silicone case.
4.2 Leads shall be readily solderable.
5. MARKING
5.1 The cathode shall be identified by a color band.
5.2 An identification number and lot number or date code shall
represent a specific manufacturing period.
5.3 All markings shall be permanent such that cleaning solutions
will not remove the markings.
6. CERTIFICATION
6.1 A certification of compliance with this specification and
a test data sheet must accompany each lot shipped.
6.2 Certification must include a statement that no changes have
been made in materials or physical or electrical characteristics.
7. APPROVED SUPPLIERS
7.1 XXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXX
OPEN HERE HAND-SWITCHING PENCIL STERILE REUSABLE
Catalog No. E2502B
STERILITY GUARANTEED UNLESS PACKAGE HAS BEEN DAMAGED OR OPENED: CONTENTS:
One sterile reusable Hand-switching Pencil with 10 follt cord and plug and disposable blade electrode. Accepts all standard 3/32" shaft electrodes. DIRECTIONS: 1) Open package by peeling apart at arrow. 2) Remove LectroSwitch®Pencil from sterile package using aseptic technique. Do not perrmit LectroSwitch®Pencil to contact unsterile end of package or any object outside the sterile field. 3) Check blade electrode connection for secure fit prior to use 4) Insert plug connection into active hand-switching receptacle on generator. An adapter may be required for generators not manufactured by Valleylab, Inc.
5) Remove protective sleeve from blade electrode.
CAUTION:AFTER USE THE LECTROSWITCH®PENCIL MUST BE STERILIZED. DISCARD THE DISPOSABLE BLADE ELECTRODE BEFORE REPROCESSING. RECOMMENDED STERILIZATION TECHNIQUE IS SHOWN ON PACKAGE INSERT IN BOX CONTAINING LECTROSWITCH®PENCILS.
NOTE:GOOD OPEATING ROOM PRACTICE SUGGESTS THAT ACTIVE ACCESSORIES BE PLACED AWAY FROM THE PATIENT WHEN NOT IN USE. |
COMPANY LOGO | ||||
USED ON 29330080 | TITLE Handle Assemby | SHEET
1 OF 1 | ||
DRAWN DATE | CHECKED DATE | APPROVED DATE |
NOTES:
|
COMPANY LOGO | ||||
USED ON Port Scope | TITLE Cable Interconnecting &
Point to Point Wiring | SHEET
1 OF 1 | ||
DRAWN DATE | CHECKED DATE | APPROVED DATE |
Notes: |
Device Master Record For Amaylase | Dwg No | Sheet 2 Of 2 |
Sheet 1 of 3
1. PRODUCT SPECIFICATION FOR AMYLASE, CATALOG NO. 3200
1.1 Product name: Amylase Set
1.2 Description of product
This Amylase Set is used for the quantitative determination of
amylase in biological fluids.
The principle of the procedure is as follows:
Starch + H20 amylase > colorless starch fragments
Unhydrolyzed Starch + I2 >
colored starchiodine complex
The color produced by the starchiodine complex after 7.5
minutes incubation of substrate with specimen and 15 minutes color
development is compared with a reagent blank. The decrease in
absorbanceoptical density (OD) at 660 nm is proportional to amylase
activity in the specimen because the enzyme hydrolyzes starch
to fragments that do not react with the iodine reagent.
1.3 Product availability
Catalog No.: 320001
Catalog No.: 320010
1.4 Components of product
Catalog No. 320001
15 Tubes of lyophilized substrate
1 Bottle (10 ml) Iodine (.OIN)
1 Instruction sheet
Catalog No. 320010
100 tubes lyophilized substrate
2 Bottles (30 ml ea.) Iodine (.OIN)
1 Instruction sheet
1.5 Storage of reagent
Store at room temperature. Do not refrigerate.
Minimum shelf life is one year.
Do not use any substrate tube in which moisture is observed.
1.6 Stability of specimen
Amylase activity in serum is stable up to one week at room temperature
and for one to two months if refrigerated at 2 to 8°C.
Caution: Some urine specimens may contain reducing substances
which could exhaust the iodine reagent.
1.8 Units
One amylase unit is defined as that amount of enzyme activity
which, under the conditions of this procedure, will hydrolyze
10 mg of starch in 30 minutes to a stage at which no color is
generated with iodine.
1.9 Normal Range
Normal range for serum is 50 to 200 units at 37°C.
Infants below two months have no measurable serum amylase. Adult
level is reached by the age of one year. The above normal range
includes an average serum blank of 25 amylase units. Normal values
for urine is less than 375 units per hour at 37°C.
Amylase Description | DWG NO: XX-3200 | Sheet 3 of 3 |
1.10 Precision
Coefficient of variation of 5 to 6 percent at a level of 120 units
and 3 to 5 percent at a level of 250 units are obtained with good
laboratory technique.
1.11 Performance characteristics
This assay measures amylase levels up to 500 units per 100ml specimen
in a linear manner. Specimens with higher activity must be diluted
by the procedure given in Note 2 [not reprinted in this manual].
The calculated value includes a serum blank, which averages about
25 units in human sera. Control sera may have larger serum blanks,
often up to 100 units. Values obtained on patient sera when corrected
for the serum blank activity of approximately 25 units are very
close to the values obtained by the Somogyi Saccharogenic method.
1.12 Cautions
This product must be protected from contamination by amylase.
Saliva is a very potent source of amylase. Perspiration contains
some amylase as do other body fluids. Insensible droplets of saliva
are projected during speech, sneezing, etc.
Face masks and hair covering must be worn during solution and
diluent preparation, solution filling, tube racking and capping,
and when handling any raw material defined for use with this diagnostic
test.
Equipment used in the procedure should be designed "For Amylase
Only". Glassware and other equipment suspected of amylase
contamination must be rinsed with XXXXXXX. Avoid contamination
with detergents or soap. (See SOP #G021). Observe safety precautions
when handling acids (SOP #G022).
1.13 Manufacturing Flow Sheet.
See Form No. 9926. [Not reprinted in this Manual].
Page 1 of 2
FOR USE IN CATALOG Numbers: XXXX01 15 tests and XXXX10
100 tests
Batch No. __________________ Code No. ___________________
Date _____________________
Prepared by ___________________________Checked by __________________________________
>
MASKS MUST BE WORN THROUGHOUT THIS PROCEDURE TO PREVENT SALIVA
CONTAMINATION.
FOR 50 LITERS OF AMYLASE DILUENT SOLUTION:
1. Weigh the following chemicals and place them in 43 liters of
deionized water in a calibrated clean container.
DEIONIZED WATER: Source _______ Vol. _______ ml Done By _______________________
Conductivity Light: On ________ Off ________ Checked
By _____________________________
VENDER LOT AMOUNT WEIGHED
CODE NO. REQ'D WEIGHT BY BY
RM. NO. CHEMICAL
__________________________________________________________________________________
010004 Sodium Chloride _____ _____ 425.0 g G ____ _____ _____
±0.1 T ____
N ____
01000X XXXXXX _____ _____ 523.25 G ____ _____ _____
Basic _____ _____ ±0.1 T ____ _____ _____
N ____
01000X XXXXXX _____ _____ 1275.0 g G ____ _____ _____
Basic _____ _____ ±0.1 T ____ _____ _____
N ____
Note: Slowly add the sodium XXXXXXXX to prevent caking.
__________________________________________________________________________________
Procedure Amylase Diluent Solution No. __________________ Rev. __________________
Completed by _____________________ Date __________________ Date Eff. _______________
Checked by _______________________ Date __________________
App'd _________________
Batch no._________________ Page 2 of 2
2. Stir the diluent until all of the salts go into solution.
Done by ____________________
3. Check the pH of the solution against 7.00 pH reference buffer.
Initial pH ____________________ Checked by ____________________
4. Adjust the solution to a pH of 7.00 + 0.05 @ 25°C using 2N NaOH
mls of _____ --_ used. Lot No. _______ pH ______ @ 25°C
Checked by ____________________
5. Add 125 mls of 1% XXXXXX solution & mix well. Done
by ____________________
No. of mls added _______________ Supplier____________________
Lot No. _________________
6. Bring the volume to 50 liters with deionized water and mix
well. Recheck the pH. It should still be 7.00 + 0.05 @ 25°.
Adjust, if necessary, with 2N NaOH or 6N HCl.
DEIONIZED WATER:
Source ____________________ Final Vol. _________
mls. Done by __________________
Conductivity Light: On ________ Off ______________ Checked
by ____________________
mls of ______ used to adjust. Lot No. ______ Done by ____________________
Final pH @ 25°C ____________________
Checked by ____________________
7. Solution must be approved by the Solutions Supervisor(s) or
their designee before it can be used. Approved by: __________________
Date ____________________
8. The Solution is now ready to be used in the preparation of Amylase.
It will be filtered as it is during that preparation.
9. Label the Diluent Solution with the Product Name, Batch
Number, and Date of Manufacturing.
__________________________________________________________________________________
PROCEDURE Amylase Diluent Solution No. _________________
Rev. __________________
Form No. 1084 Sheet 1 of 1
Product Name ____________________________________ Kit Cat. # _______________________
Distributor ____________________________________ Kit Lot # _______________________
Theoretical Tube & Vial Yield _______________________
Kit Exp. Date ____________________
SPECIAL INFORMATION _________________________________________________________
__________________________________________________________________________________
IODINE
Batch # __________________________ Date Manuf. ______________________________
Date Received _______________ Time Received _______________________________
TUBE AND VIAL Code # ________________________ # Racked
INFORMATION # Lost _________________________ Total # Used
FILLING DATA
Machine(s) Before Filling Signed __________________ Date _________________
Cleaned:
After Filling Signed ____________________ Date _________________
Fill Vol. ________ ml Limits ± _____ ml Filling ___________________________
Batch Vol. ______ ml Leftover ________ ml Method __________________________
# Tubes or Vials Filled _______ #Bad Fills _______ [ ] Refilled
[ ] Not Refilled
APU _______________ ml TPU ml _______________ TPR ml _______________
Filling Operators 1) _____________ 2) _____________ 3) _____________ 4) _____________
Volumetric Fill Checks: 1) _____________ 2) _____________ 3) _____________
4) _____________ 5) _____________ 6) _____________ 7) _____________
8) _____________
Checks done by _______________________________________ Date ____________________
CAP AND LABEL INFORMATION
1. Cap Code # ___________ # Used ___________ # Lost ___________
2. Cap Code # ___________ # Used ___________ # Lost ___________
Label Code # ___________ # Used ___________ # Lost ___________
Signed _______________________________________ Date _____________________
Checked by ___________________________________________________ Date _________________
ATTACH SAMPLES OF LABELS
FINISHED PRODUCT RELEASE | Form No. | Rev. | Sheet 1 of 1 | |||
Form Approved by: | Date | |||||
ECN notes: | ||||||
Title: AMYLASE SET | ||||||
Packaging lot number | Circle one CATALOG Number ® AM-389-01
AM-389-02 | |||||
The device history documents below were reviewed by ®
Circle one form number in 2, 5 & 7 below. | MFG
ü | QC
ü | ||||
1. Form # 9926 | Product flow sheet | |||||
2. Form # 1077 or 1078 | Iodine solution | |||||
3. Form # 1082 | Substrate solution | |||||
4. Form # 1083 | Substrate tube filling sheet | |||||
5. Form # 1084 or 1085 | Iodine filling sheet | |||||
6. Form # 1086 | Packaging record | |||||
7. Form # QC-PP-07 or QC-PP-01 | Finished device specification | |||||
Comments | ||||||
Sign. MFG Designee APP. Yes or No® | xxxxxxxxx | |||||
Comments | ||||||
Signature QC Designee Approved Yes or No |
Production Workmanship and Configuration Sample Tag
PRODUCTION SAMPLE NAME | ||
INSTRUMENT/PART NUMBER | REV | OPTION CODES |
SAMPLE NUMBER | ECN HISTORY ON BACK | |
NOTES: | ||
APPROVED FOR USE BY: | Form Number 6-53 | |
PROJECT ENGINEER | Signature Master Sample Only | DATE |
LEAD ASSEMBLER | Signature all samples | DATE |
LEAD TECHNICIAN | signature all samples | DATE |
PRODUCTION MANAGER | signature master sample only | DATE |
Back of Sample Control Tag (the above tag)
SAMPLE MODIFICATION HISTORY | ||||||
Modification Number | ENG (MASTER ONLY) | LEAD ASSEMBLER | LEAD TECHNICIAN | |||
SIGNATURE | DATE | SIGNATURE | DATE | SIGNATURE | DATE | |
SHOP ORDER TRAVELER Form 058-SOT | S.O.T. NUMBER |
DATE | |
Description | Part No. |
FROM Department | TO Department |
Quantity Delivered | Quantity Accepted |
Supervisor | Supervisor |
Remarks | Lot No. Complete Thru OPN |
FOLLOWER TAG | Form 092-FT | |
Instrument Name | S/N | |
Line Voltage | Model No. | |
Record discrepancies & nature of rework on back | ||
PROCESS | BY EMPLOYEE | DATE |
Assembled | ||
In-process Check | ||
Chassis Check | ||
Test & Calibration | ||
Burn-in | ||
Audio Calibration | ||
Final In-process Inspect. | ||
Seal Card Cage | ||
Pre-Cover Inspection | ||
Final Assembly | ||
Final Test | ||
Final Inspection | ||
Packing/Shiping Inspect. |
Updated January 1, 1997
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