Report Reference No

20000710

Compiled by (+ signature)

Markus Weber

Reviewed by (+ signature)

Approved by (+ signature)

Date of issue

Verification laboratory

System Safety, Inc.

Address

10849 Penara Street

San Diego, CA 92126-5936

Verification location

Applicant

Address

Standard

EN 60601‑1‑4:1996 + A1: 2000

Test Report Form No

03092000

Test procedure

MDD Compliance

Procedure deviation

None

Non‑standard test method

None

Type of end product

End product Trademark

End product Model and/or type reference

End product Manufacturer

End product Address

See above

End product Rating(s)

PEMS/PESS Configuration Information:

No special hardware configuration necessary.

Software Designer (if different than end Product manufacturer).

NA

Address

NA

NA

Method of Identification of Software:

Revision

Particular Risks Addressed by Software:

As contained in hazard analyses

GENERAL INFORMATION

Particulars: verification item vs. verification requirements

As EN 60601‑1-4 is a collateral standard to EN 60601‑1, this report is to be used in conjunction with Test Report Reference No.: N.N.

Possible verification case verdicts

Verification case does not apply to the verification item---------------------------------------------------------- : N(ot)/A(pplicable)

Verification item is available------------------------------------------------------------------------------------------------- : N(oted)

Verification item does meet the requirement-------------------------------------------------------------------------- : P(ass)

Verification item does meet the requirement under the limited scope of this assessment----------- : P(ass) L(imited Scope)

Verification item does not meet the requirement-------------------------------------------------------------------- : F(ail)

Verification item does not meet the requirement under the limited scope of this assessment----- : F(ail) L(imited Scope)

Minor non-compliances are noted in regular case and font

Major non-compliances are note in ALL CAPS and / or BOLD

General remarks

‘’(See enclosure #)" refers to an enclosure appended to this report.

"(See appended table)" refers to a table appended to the report.

Throughout this report a period is used as the decimal separator.

The verification results presented in this report relate only to the item being verified.

This verification report shall not be reproduced except in full without the written approval of the verification laboratory.

SUMMARY OF CONTENTS:

The equipment has been evaluated according to standard EN 60601‑1-4 (1996) First Edition including Amendment 1 (2000)

All applicable verifications according to the above-specified standard(s) have been carried out, however the scope was limited to sub-system evaluation.

These verifications fulfil the requirements of standard EN 45001.

COTS

Commercial of the shelf software

DFU

Directions for Use

H&RA

Hazard and Risk Analysis

MDD

European Medical Device Directive

PEMS

Programmable Electronic Medical Devices

RMP

Risk Management Plan

SOP

Standard Operating Procedure

V&V

Verification and Validation

6                      IDENTIFICATION, MARKING AND DOCUMENTS

6.8                   ACCOMPANYING DOCUMENTS

6.8.201

All relevant information regarding significant residual risk including descriptions of the hazards and any actions by the operator or the user necessary to avoid/mitigate them shall be placed in both the instructions for use and the risk management file.

6.8.202

Accompanying documents for the pems shall identify, as a minimum, the manufacturer and a unique identifier such as revision level and date of release/issue.

NOTE – Information pertaining to any specific equipment that software is intended to be used in conjunction with, and a means by which the manufacturer can be contacted, can be located on the package or in the instructions for use so that it is available to the user independently of the software operation.

52                    ABNORMAL OPERATION AND FAULT CONDITIONS

52.201              Documentation

52.201.1

Documents produced from application of this standard are maintained and are part of the quality records; see figure 201. This should be done in accordance with 6.3 of ISO 9000­-3

(See appended table)

52.201.3

A RISK MANAGEMENT SUMMARY is developed throughout the DEVELOPMENT LIFE‑CYCLE as part of the RISK MANAGEMENT FILE. It contains:

Identified HAZARDS and their initiating causes;

(See 52.204.3.1.10)

Estimation of RISK

(See 52.204.3.2.5)

Reference to the safety measures, used to eliminate or control the risk of the hazard

(See 52.204.4.5)

Evaluation of effectiveness of RISK control;

(See 52.204.4.6)

Reference to VERIFICATION

(See 52.209.3)

52.202              RISK management plan

52.202.1

The manufacturer has prepared a RISK management plan.

52.202.2

The plan includes the following:

52.202.3

If the plan changes during the course of development, a record of the changes is kept.

52.203              DEVELOPMENT LIFE‑CYCLE

52.203.1

A DEVELOPMENT LIFE‑CYCLE is defined for the design and development of the PEMS

52.203.2

The DEVELOPMENT LIFE‑CYCLE is divided into phases and tasks, with a well‑defined input, output and activity for each.

52.203.3

The DEVELOPMENT LIFE‑CYCLE includes integral processes for RISK management.

52.203.4

The DEVELOPMENT LIFE‑CYCLE includes documentation requirements.

52.203.6

Where appropriate, a defined system for problem resolution within and between all phases and tasks of the development life cycle shall be developed and maintained as a part of the risk management file. Depending upon the problem, the system may have the following characteristics:

a)       Be defined as a part of the development life- cycle

b)       Allow the reporting of potential or existing safety problems

c)       Include an assessment of each problem for associated risks

d)       Identify the criteria (safety and/or performance) that have to be met for the issue to be closed

e)       Identify the action to be taken to resolve each problem

f)         Identify validation methods for each action

g)       Identify the steps taken for verification of continuing compliance

52.204              RISK management process

52.204.2

The process is applied throughout the DEVELOPMENT LIFE‑CYCLE

52.204.3           RISK analysis

52.204.3.1         HAZARD analysis

52.204.3.1.1

HAZARD identification is carried out as defined in the RISK management plan: see 52.202.

52.204.3.1.2

HAZARDS are identified for all reasonably foreseeable circumstances including: NORMAL USE; incorrect use.

52.204.3.1.4

Reasonably foreseeable sequences of events, which may result in a HAZARD, are considered.

52.204.3.1.5

Initiating causes considered include, as appropriate:

a)      Human factors including ergonomic limitations

b)      Hardware faults

c)      Software faults

d)      Integration errors

e)      Environmental conditions

52.204.3.1.6

Matters considered include, as appropriate:

a)      Compatibility of system components, including hardware and software

b)      User interface, including command language, Warning and error messages

c)      Accuracy of translation of text used in the user interface and INSTRUCTIONS FOR USE

d)      Data protection from human intentional or unintentional causes

e)      RISK /benefit criteria

f)        Third party software

52.204.3.1.7

HAZARD identification methods appropriate to the DEVELOPMENT LIFE‑CYCLE phase are used.

52.204.3.1.9

The results of the application of the methods are documented in the RISK MANAGEMENT FILE.

52.204.3.1.10

Each identified HAZARD and its initiating causes are recorded in the RISK MANAGEMENT SUMMARY

52.204.3.2         RISK estimation

52.204.3.2.1

For each identified HAZARD the RISK is estimated.

52.204.3.2.2

The estimation of the RISK is based on an estimation of the likelihood of each HAZARD and/or the SEVERITY of the consequences of each HAZARD.

52.204.3.2.5

The estimated RISK is recorded against each HAZARD in the RISK MANAGEMENT SUMMARY.

52.204.4           RISK control

52.204.4.1

RISK is controlled so that the estimated RISK of each identified HAZARD is made acceptable.

52.204.4.4

Risk control methods are directed at the cause of the hazard (e.g. by reducing its likelihood) or by introducing protective measures which operate when the cause of the hazard is present, or both, using the following priority:

a)      Inherent safe design

b)      Protective measures including alarms

c)      Adequate user information on the residual risk