Home Healthcare, IEC 60601-1-11

Home HealthcareIEC 60601-1-11

October 24, 2013

Michael Brousseau Safety ManagerMichael Brousseau, Safety Manager

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Part 1Background

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Background: Size & Scope

F t F tFast Facts12 Million Americans Receive Home Care

75 Million Americans by 203075 Million Americans by 2030$74.3 Billion Annual Expenditure 2011 (CMS)

3% Annual Health Care Expenditure 201175% Receive Skilled Nursing Care in part by a caretaker or self

Majority are >65 years44 Million are caregivers of someone >1844 Million are caregivers of someone >18

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Background: The Drivers

Overall SpendingOverall Spending

2011: $2.7 Trillion2011: $2.7 Trillion

(projected growth)

2020: $4.6 Trillion2020: $4.6 Trillion

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Per Capita Expenditure Per PersonPer Capita Expenditure Per Person

2011: $8,6802011: $8,680

(projected growth)

2020: $13 7082020: $13 7082020: $13,7082020: $13,708

The US spends $2,800+ more per person than the second highest spender among developed countries

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U.S. Spends More Money on Health Care Per Capita as a %GDP than Any Country in the World

Obesity 400M

Chronic Disease Non -

Aging 600M

860M Non

Compliance 300B

U.S. Healthcare System Ranks 37th out of 191 Countries

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Chronic DiseaseAging Population Hospital R d i i$2.025 Trillion 2011

$3 out of every $4 health d ll

Aging Population65 & Older

Will increase from

Readmissions$26 B in 2011

($17 B Preventable)care dollars

1 out of every 2 Americans

Will increase from40 million in 2010

to88 million in 2050

Nearly 1 in 5 patients readmitted within 30 days

Medical Technology Remote Monitoring & Telemedicine

Seeking cost-effective delivery of care

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Background: FDA Definition

Device intended for users in a non-clinical or transitory environmentManaged partl or holl b the serManaged partly or wholly by the user

May require training for the user by a healthcare professional in order to be used safely and effectively.

I l d tl d t il i l t d d iIncludes permanently and temporarily implanted devices Any type of equipment that a person may use to recover and rehabilitate

Must be capable of safely accommodating the many needs of the person using it.

“Home Use Extends Beyond the Home”Home Use Extends Beyond the HomeEncompass all environments in which a person plans to

use his or her medical device in day-to-day life.Delivers Medical Care Anywhere and Everywhere

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Delivers Medical Care Anywhere and Everywhere

Background: US vs. EU

M j iMajor variances exist betweenUnited StatesUnited States and Europe

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Background: US vs. EU

S• U.S. Nursing Homes are considered professional environments and products are classified as Class 1USA

• Europe Nursing Homes are considered a EU p ghome environment and products are classified as Class 2

EU

Class One Rely on a Ground, Class Two Do not rely on a ground

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y g

Part 2Challenge & Opportunity

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From 1997 through 2009, FDA received over 19,000 reports of adverse events in which the reporter listed the

location where the incident took place as “home.”

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Hospital vs. Home

The Home environment is fundamentally different from the clinical environment. These unique challenges have the potential to impact patient safety:

• Caretaker Knowledge

• Device Usability

• Environmental Predictability

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Challenges: Environmental Issues

ChildrenLocation

Power Sources

SanitationEMI

Temperature & Humidity

Pets & Vermin

Public Emergencies Noise

Air Quality

Water

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Presence of Ho sehold PetsCase Example: A patient was put on peritoneal dialysis because of her failing kidneys. She lived in a one bedroom apartment with

Presence of Household Pets:

g y pher cat. Although the patient kept the cat out of her bedroom while she was undergoing dialysis, there was cat fur and dander throughout the room. Cat fur got into the patient’s dialysis tubing and entered her peritoneum and she contracted peritonitisand entered her peritoneum, and she contracted peritonitis.

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Electromagnetic InterferenceCase Example: An individual with an implantable cardioverterdefibrillator (ICD) was playing electric guitar at home. As he was

Electromagnetic Interference:

( ) p y g gunplugging the guitar from the amplifier, feedback from the amplifier caused the individual to feel a painful vibration at the site of his ICD. His left arm became immobile for almost two minutes. The painful sensation stopped when his wife unplugged theThe painful sensation stopped when his wife unplugged the amplifier.

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Noise Le els

Case Example: A pediatric patient was receiving ventilator therapy in the home, and the ventilator tubing became

Noise Levels:

py , gdisconnected. The patient’s mother was asleep and did not hear the ventilator alarm. There were other ambient noises in the home (e.g., television), and they may have interfered with the mother’s ability to hear the alarm The patient diedability to hear the alarm. The patient died.

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Challenges: User Issues

Off-Label

LifestyleDurability

Use

Physical Capabilities

Education

Ease of Use Availability

Education Level

of Instructions Emotional

Stability

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Challenges: User Issues

Ph sical CapabilitiesCase Example: A patient doing home nocturnal dialysis was found by her husband, unresponsive. She was disconnected from

Physical Capabilities:

y , pthe dialysis machine and her tubing was in a closed circuit filled with saline. There was a syringe attached to one of her lines, but the other line was open, and the patient had lost a significant amount of blood It appeared that she had been unable to clampamount of blood. It appeared that she had been unable to clamp her catheter by herself. The patient died due to blood loss.

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Part 3The Standard

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The Standard: National Deviations

“Medical Electrical Equipment – Part 1: General Requirements forMedical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance – Collateral Standard:

Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment”Electrical Systems Used in the Home Healthcare Environment

ANSI/AAMI HA60601-1-11: 2011 – US Deviations

CAN/CSA-C22.2 No. 60601-1-11: 2011

CENELEC EN 60601-1-11: 2010

IEC 60601-1-11: 2010

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Clause 4.1 – Mains Supply for ME Equipment and ME Systems

Non-life-supporting Medical Electrical Equipment or Medical Electrical Systems

- Testing completed at 110% and 85% of rating voltage or voltage range

Life-supporting Medical Electrical Equipment or Medical Electrical Systems

- Testing completed at 110% and 80% of rating voltage or voltage rangeg p g g g g

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Clause 4.2.1 – Environmental Conditions of Transport and Storage between Uses

Unless otherwise indicated in the IFU or if the Medical Electrical Equipment is t ti th i t h ll l t th f ll i t t d tstationary, the equipment shall comply to the following transport and storage

conditions

-25°C without relative humidity control; and

70°C at a relative humidity up to 93% non-condensing

If the IFU states a more restricted range j stification is pro ided as part of theIf the IFU states a more restricted range, justification is provided as part of the Usability Engineering File which appears in the Risk Management File; and

The range is marked on the product and the product’s carrying case

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Clause 4.2.1 Test Conditions

a) Prepare equipment for transport or storage per the IFU

b) Expose equipment at lowest environmental conditions for 24 hrs or till thermal stability is reached (minimum 2 hrs)thermal stability is reached (minimum 2 hrs)

c) Expose equipment at highest environmental conditions for 24 hrs or till thermal stability is reached (minimum 2 hrs)

d) Allo eq ipment to stabili e back to operating conditions of normal sed) Allow equipment to stabilize back to operating conditions of normal use

e) Evaluate equipment against its specifications, Basic Safety, and Essential Performance characteristics

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Clause 4.2.1 – Environmental Operating Conditions

Unless otherwise indicated in the IFU or if the Medical Electrical Equipment is t ti th i t h ll l t th f ll i t t d tstationary, the equipment shall comply to the following transport and storage

conditions

A t t f 5°C t 40°CA temperature range of 5°C to 40°C;

A relative humidity range of 15% to 93%, non-condensing; and

An atmospheric pressure range of 700 hPa to 1060 hPap p g

If the IFU states a more restricted range, justification is provided as part of the Usability Engineering File which appears in the Risk Management File; andy g g pp g

The range is marked on the product and the product’s carrying case

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Clause 4.2.2 – Test Conditions

a) Expose equipment to ambient conditions for 6 hrs or till thermal stability (minimum 2 hrs)

b) Evaluate equipment against its specifications, Basic Safety, and Essentialb) Evaluate equipment against its specifications, Basic Safety, and Essential Performance characteristics

c) Evaluate equipment against its specifications, Basic Safety, and Essential Performance characteristics at lowest specified atmospheric pressurep p p

d) Evaluate equipment against its specifications, Basic Safety, and Essential Performance characteristics at highest specified atmospheric pressure

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Clause 4.2.2 – Test Conditions, cont’d

e) Cool equipment to lowest specified environmental operating conditions for 6 hrs or till thermal stability (minimum 2 hrs)

f) Evaluate equipment against its specifications, Basic Safety, and Essentialf) Evaluate equipment against its specifications, Basic Safety, and Essential Performance characteristics

g) Warm equipment to highest specified environmental operating conditions for 6 hrs or thermal stability (minimum 2 hrs)y ( )

h) Evaluate equipment against its specifications, Basic Safety, and Essential Performance characteristics

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Clause 4.2.3 – Environmental Shock to Transit-Operable ME Equipment

a) Set up equipment for operation according to intended use

b) Expose equipment to lowest specified environmental operating conditions for 6 hrs or thermal stability (2 hrs)

c) Within 5 minutes, expose equipment to highest specified operatingc) Within 5 minutes, expose equipment to highest specified operating conditions

d) While maintaining step c) evaluate equipment against its specifications, Basic Safety, and Essential Performance characteristics until thermal y,stability or for 2 hrs

Repeat test new sample allowed by reversing steps b) and c)Repeat test, new sample allowed, by reversing steps b) and c)

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Clause 5 – General Requirements for Testing ME Equipment

In addition to the requirements of clause 5.9.2.1 of the general standard, accessibility also determined by:

Small Finger Probe – in a bent or straight position

a) For all positions of equipment when operated in normal use) p q p p

b) After opening access covers and removal of parts

i) Opened without use of tool

ii) IFU states Lay Operator is to open access cover

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Clause 6 – Classification of ME Equipment and ME Systems

Unless equipment in the Home Healthcare Environment is to be permanently installed, the equipment shall be:

Class II or Internally Powered;

Shall not have a Functional Earth Terminal; and

Applied Parts, shall be Type BF or Type CF

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Clause 7.1 – Usability of Accompanying Documents

Usability of the identification, marking, and accompanying documents intended f L O t L R ibl O i ti h ll b l t d i tfor Lay Operator or Lay Responsible Organization shall be evaluated against the Operator Profile assuming a maximum of eight years education.

Equipment in the Home Healthcare Environment should be designed to be simple to use and not require reference to complex Accompanying Documents.

Equipment in the Home Healthcare Environment should be designed to be q p gsimple to use and to minimize, reference to Accompanying Documents.

Verified by inspection of the Usability Engineering Process/FileVerified by inspection of the Usability Engineering Process/File

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Clause 7.2 – Additional Requirements for Marking IP Classification

For the following types of products, an IP rating is required:

a) Body-worn b) Hand-held

If a carrying case provides the protection against ingress of liquids, then it shall be marked but

c) Mobile d) Portable

be marked, but…

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Clause 7.2 – Additional Requirements for Marking IP Classification

If the enclosure does not provide the minimum protection against ingress of t it h ll b k dwater, it shall be marked:

“KEEP DRY”KEEP DRY

Or

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Clause 7.3.1 – Contact Information

The IFU shall include the following:

) f i t if d d i tti i i t i i th d ta) for assistance, if needed, in setting up, using, or maintaining the product

b) to report unexpected operation or events

A postal address and either a phone number or web address to contact the Manufacturer or Manufacturer’s Representative

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Clause 7.3.2 – Lay Operator Briefing Information

IFU shall include information for the Healthcare Professional to brief Lay Operator or Lay Responsible Organization on any known contraindications to the equipment and precautions to be taken including the following:be taken including the following:

• Changes in performance of equipment

• Exposure to reasonably foreseeable environmental conditions

• Information on medicinal substances or human blood derivatives

• Measuring function accuracies

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Clause 7.4.1 – Additional Requirements for Warning and Safety Notices

For each warning and safety sign, the IFU shall:

D ib th t f th h d- Describe the nature of the hazard;

- Consequences that could occur from not following advice; and

- Precautions for reducing riskg

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The IFU shall, at least, address the following:

St l ti d t bl d h- Strangulation due to cables and hoses

- Small parts being inhaled or swallowed

- Allergic reactions to accessible materialsg

- Contact injuries

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The IFU shall include warnings that it is unsafe to:

U i t d ib d i th IFU- Use accessories not described in the IFU

- Interconnect equipment to other equipment not described in the IFU

- Modify the equipmenty q p

- Use equipment outside of the carrying case, if the case provides a degree of protection

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Clause 7.4.2 – Additional Requirements for an Electrical Power Source

If Basic Safety and Essential Performance is dependent on an Internal Electrical Power Source, the IFU shall describe the following:

- Typical operation time or number of procedures

- Typical service life

- For a Rechargeable Internal Electrical Power Source, the behavior of the equipment while charging

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Clause 7.4.3 – Additional Requirements for ME Equipment Description

The IFU shall include easily understood (effective):

• diagrams,

• illustrations, or

h t h• photographs

of a fully assembled, ready to operate equipment including:

• controls,

• visual information signals, and

• indicators• indicators

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Clause 7.4.4 – Additional Requirements for ME Equipment Start-up Procedure

The IFU shall include easily understood (effective):

• diagrams,diagrams,

• illustrations, or

• photographs

of the proper connection of the Patient to the equipment, accessories or other equipment.

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Clause 7.4.4 – Additional Requirements for ME Equipment Start-up Procedure

The IFU shall include the time from switching “ON” until the equipment is ready for Normal Use, if the time is greater than 15 seconds

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Clause 7.4.5 – Additional Requirements for Operating Instructions

The IFU shall include information on conditions in the Home Healthcare E i t th t ff t B i S f t d E ti l P f i l diEnvironment that can affect Basic Safety and Essential Performance including:

- Effects of lint, dust, or lightEffects of lint, dust, or light

- Devices or sources that could cause interference problems

- Effects of degraded sensors and electrodes

- Effects of pets, pests, and children

Information shall include steps the Lay Operator can take to identify andInformation shall include steps the Lay Operator can take to identify and resolves these issues.

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Clause 7.4.5 – Additional Requirements for Operating Instructions

The IFU shall explain the meaning of the IP rating that appears on either:

Th i t- The equipment, or

- The equipment’s carrying case

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Clause 7.4.6 – Additional Requirements for ME Equipment Messages

The IFU shall include a troubleshooting guide for malfunctions during start-up and operation.

The troubleshooting guide shall disclose the necessary steps to be taken for an alarm condition.

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Clause 7.4.7 – Additional Requirements for Cleaning, Disinfection and Sterilization

The IFU shall indicate, for equipment, parts, or accessories, the frequency of:

- cleaning,

- cleaning and disinfection, or

l i d t ili ti- cleaning and sterilization

The IFU shall also include the following methods for:

- drying,y g,

- handling, and

- storage between uses

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Clause 7.4.7 – Additional Requirements for Cleaning, Disinfection and Sterilization

These instructions shall cover either:

- single patient,

lti l ti t- multiple patients, or

- indicate that professional hygienic maintenance prior to re-use is required (including contact information for the service)

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Clause 7.4.8 – Additional Requirements for Maintenance

The IFU shall include the following information:

- Expected Service Life of the Medical Electrical Equipment

E t d S i Lif f i hi d ith M di l El t i l- Expected Service Life of accessories, shipped with Medical Electrical Equipment

- If the Shelf Life is less than the Expected Service Life, the Shelf Life of accessories shipped ith the Medical Electrical Eq ipmentof accessories, shipped with the Medical Electrical Equipment

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Clause 7.4.9 – Additional Requirements for Environmental Protection

The IFU shall include information on:

di l f th M di l El t i l E i t t- proper disposal of the Medical Electrical Equipment, parts, or accessories and

- a statement that the Lay Responsible Organization shall contact local a thorities for the disposal of potentiall bio ha ardo s parts andauthorities for the disposal of potentially bio-hazardous parts and accessories

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Clause 7.4.10 – Additional Requirements for ME Equipment and ME Systems

For equipment that incorporates the use of a Distributed Alarm System, the IFU shall state the recommended placement of the remote part of the Distributed Alarm System to ensure the operator is notified at all times.

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Clause 7.5.1 – Permanently Installed Class I Equipment

For Permanently Installed Class I Equipment, the Technical Description shall i l dinclude:

- Warning that connection of Protection Earth is completed by aWarning that connection of Protection Earth is completed by a qualified Service Personnel

- Specifications for the Protective Earth Conductor

Warning to erif the integrit of the e ternal protecti e earthing- Warning to verify the integrity of the external protective earthing system

- Warning to connect and verify the Protective Earth Terminal is connected to the external protective earth systemconnected to the external protective earth system

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Clause 7.5.2 – Additional Requirements for Professional Hygienic Maintenance

If equipment requires profession hygienic maintenance prior to re-use

Th T h i l D i ti i l d l i d di i f ti l i dThe Technical Description include cleaning and disinfection or cleaning and sterilization:

- before and after any servicing

- when equipment is transferred to another patient

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Clause 7.5.2 – Additional Requirements for Cleaning & Disinfection of ME Equipment and ME Systems

Cleaning and disinfection procedures for equipment in the Home Healthcare E i t h ll b bl f b i f d b L O tEnvironment shall be capable of being preformed by a Lay Operator.

The Usability of these processes shall be documented in the UsabilityThe Usability of these processes shall be documented in the Usability Engineering File

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Clause 8.2 – Additional Requirements for Sterilization of ME Equipment and ME Systems

Sterilization procedures for equipment in the Home Healthcare Environment h ll b bl f b i f d b L O tshall be capable of being preformed by a Lay Operator.

The Usability of this process shall be documented in the Usability EngineeringThe Usability of this process shall be documented in the Usability Engineering File

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Clause 8.3.1 – Ingress of Water or Particulate Matter into ME Equipment

An IP Rating of IP22 shall be provided for the following equipment:

) T it bl H d h ld i ta) Transit-operable, Hand-held equipment

b) Body-worn equipment

All other Transportable Equipment shall be provided with an IP Rating of IP21

If carrying case provides the protection, then the case shall be marked.

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Clause 8.3.2 – Ingress of Water or Particulate Matter into ME Equipment

Enclosures of non-ME Equipment shall also provide a degree of protection against harmful ingress of water or particulate matter in accordance with there relevant end of product standards

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Clause 8.4 – Additional Requirements for Interruption of the Power Supply / Supply Mains to ME Equipment and ME Systems

Life-supporting ME Equipment or ME Systems shall maintain Essential P f f ffi i t ti b f d t ll f lt tPerformance for a sufficient time or number of procedures, to allow for alternate methods to be employed, after failure of the supply mains.

The following types of devices can be utilized for maintaining Essential Performance:

- Internal Electrical Power Source or

- An independent means

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The IFU shall disclose the time or number of procedures available following the failure of electrical power system

The IFU shall describe the alternate means of life support employed

The Technical Description shall describe methods that can employed for a longer period of time

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If a Internal Electrical Power Source is not used, the equipment shall be id d ith l t i l di di i it l fprovided with an alarm system including an medium priority alarm for power

supply failure.

If the equipment incorporates an Internal Electrical Power Source automatic switch over shall occur in the case of power supply failure.

The equipment shall be provided with an alarm system including an low priority alarm for the automatic switchover.

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The equipment shall be provided with an alarm system including a medium i it t h i l l i di ti th I t l El t i l P S i ipriority technical alarm indicating the Internal Electrical Power Source is nearing

insufficient remaining power to keep the equipment functional.

The technical alarm shall provide the Lay Operator sufficient time or number of procedures to act.

A low priority technical alarm shall remain on until the Internal Electrical Power Source is returned above the alarm limit.

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Clause 9 – Accuracy of Controls & Instruments and Protection against Hazardous Outputs

The following, at a minimum, shall be considered as part of the Usability E i i P d FilEngineering Process and File:

Changes of Controls

Confusion in Operation Modes

Unexpected Movement

Transfer of Energy /

Substances

Potential of Disconnection

Exposure to Biological Improper / Unsafe

OperationParts Inhaled /

SwallowedDisconnection Materials Operation Swallowed

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Clause 10.1.1 – General Requirements for Mechanical Strength – Table 1

• Push, Drop, Molding Stress Relief, Shock, and Vibration

Non-Transit-operable and Hand-Held

• Push, Impact, Drop, Molding Stress Relief, Shock, and Vibration

Non-Transit-operable and Body-worn

• Push, Impact, Drop, Molding Stress Relief, Shock, and Vibration

Non-Transit-operable and Portable

• Push, Impact, Drop, Rough Handling, Molding Stress Relief, Shock, and

Non-Transit-operable and Mobile

Vibration

Fixed or Stationary

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• Push, Impact, and Molding Stress Relief

Clause 10.1.1 – General Requirements for Mechanical Strength – Table 2

P h D M ldi S R li f Sh k d Vib i

Transit-operable and Hand-Held• Push, Drop, Molding Stress Relief, Shock, and Vibration

Transit-operable and Body-worn• Push, Impact, Drop, Molding Stress Relief, Shock, and Vibration

Transit-operable and Portable• Push, Molding Stress Relief, Free Fall, Shock, and Vibration

Transit-operable and Portable

• Push, Impact, Rough Handling, Molding Stress Relief, Free Fall, Shock and Vibration

Transit-operable and Mobile

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Shock, and Vibration

Clause 10.1.2 – Requirements for Mechanical Strength for Non-Transit-Operable ME Equipment

a) Shock Test in accordance IEC 60068-2-27: 2008

- Three shocks per direction per axis (18 total)

b) Broad-band Random Vibration Test in accordance with IEC 60068-2-64: 2008

- 30 minutes per perpendicular axis

c) Verify that Basic Safety and Essential Performance are maintainedc) Verify that Basic Safety and Essential Performance are maintained

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Clause 10.1.3 – Requirements for Mechanical Strength for Transit-Operable ME Equipment

For Body-worn Equipment

a) Shock Test in accordance with IEC 60068-2-27: 2008

- Either Type 1 or Type 2 three shocks per direction per axisEither Type 1 or Type 2, three shocks per direction per axis


- 30 min per perpendicular axis (three total)

c) Verify that Basic Safety and Essential Performance are maintained

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For Hand-Held Equipment


Eith T 1 T 2 th h k di ti i- Either Type 1 or Type 2, three shocks per direction per axis

b) Broad-band Random Vibration Test in accordance with IEC 60068-2-64: )2008

- 30 min per perpendicular axis (three total)

c) Verify that Basic Safety and Essential Performance are maintained

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For Portable and Mobile Equipment


- Either Type 1 or Type 2, three shocks per direction per axisEither Type 1 or Type 2, three shocks per direction per axis


30 min per perpendic lar a is (three total)- 30 min per perpendicular axis (three total)

c) Free Fall Test in accordance with IEC 60068-2-31: 2008

- Procedure 1, two falls in each specified altitudep

d) Verify that Basic Safety and Essential Performance are maintained

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Clause 10.2 – Additional Requirements for Internal Electrical Power Sources

If a Internal Electrical Power Source is essential to maintain Basic Safety, E ti l P f t l i k f l f E ti l P f itEssential Performance, or control risks from loss of Essential Performance it shall be provided with one of the following means of indication:

- Number of procedures remaining

- Remaining operating time

- Percentage of remaining operating time or energy

a “f el” ga ge- a “fuel” gauge

This means may be indicated continuously or by operator action.

The IFU shall state how to determine the state of the Internal Electrical Power Source

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Clause 10.3 – Additional Requirements for Actuating Parts of ME Equipment

Control of Medical Electrical Equipment that can affect Basic Safety or Essential P f h ll b t t d f id t l th i d dj t tPerformance shall be protected from accidental or unauthorized adjustment

- Access controlled by tool

- Access controlled by Responsible Organization passwordAccess controlled by Responsible Organization password

- Access controlled by Operator password

- Access controlled by fingerprints

Operator-adjustable controls for calibration shall include means to prevent unintentional changesg

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Clause 11 – Protection Against Strangulation or Asphyxiation

Means shall be provided to control the risk of strangulation or asphyxiation of the ti t d thpatient and others

- By routing of wirings/tubing

- By retention devicesBy retention devices

- Multiple length accessories

- Not providing removable small pieces

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Clause 12.1 – Emissions Classification

Medical Electrical Equipment and Medical Electrical Systems in the Home Healthcare Environment shall be classified as Class B according to CISPR 11: 2009

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Clause 12.2 – Protection of the Public Mains Network

For Home Healthcare Equipment the Public Mains Network requirements of Clause 6.1.3 of IEC 60601-1-2: 2007 apply

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Clause 12.3 – Additional Technical Description Requirements Applicable to ME Equipment & ME Systems

The IFU shall have a statement that the equipment is to be installed and put into i di t th i f ti i th i d tservice according to the information in the accompanying documents

The IFU shall have a statement that wireless communication equipment canThe IFU shall have a statement that wireless communication equipment can affect the equipment and should be kept at least a distance of “d” away from the equipment.

“d” is calculated by the manufacturer from 800 MHz to 2.5 GHz using Tables 5 y gand 6 of IEC 60601-1-2: 2007

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Clause 12.5 – Additional Requirements for Electrostatic Discharge (ESD) Tests

The standard test finger of the general standard (Figure 6) is used to determine ibl t d i th ESD t taccessible parts during the ESD test

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Clause 13.1 – Additional Requirements for Generation of Alarm Signals

Each High and Medium Priority Alarm provided in the Home Healthcare E i t h ll th ti f di lEquipment shall cause the generation of an audio alarm

Exception – Unless connected to a Distributed Alarm System that includesException Unless connected to a Distributed Alarm System that includes the generation of auditory alarm signals

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Clause 13.2 – Additional Requirements for of Alarm Signal Volume

If the Home Healthcare Equipment is capable of setting the volume below audio l l th i t h lllevels the equipment shall:

- Activate the indication of “ALARM OFF” or “AUDIO OFF” per IECActivate the indication of ALARM OFF or AUDIO OFF per IEC 60601-1-8

- For Life-supporting Medical Electrical Equipment not be possible unless connected to a Distributed Alarm System capable of generating y p g gAuditory Alarm Signals

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Part 4Why do products fail?

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Why do products fail?

Manuals

MarkingsMarkings

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Want More?

Download the audio recording to accompany these slides

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If you have questions about a specific device that you areIf you have questions about a specific device that you arelooking to bring to new markets, contact us directly.

[email protected] 1-800-WORLDLAB

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