HT70 Drop Test Certificate RPT18012B-Covidien-signed

Environment Associates, Inc.
Test Report Number OC25286-1018012B
ENVIRONMENTAL TEST REPORT
FOR THE
HT70 PLUS EMERGENCY AND TRANSPORT VENTILATOR
PART NUMBER
GR-NMIH70PM
MANUFACTURED BY
COVIDIEN
6135 GUNBARREL AVENUE
BOULDER, CO 80301
PREPARED BY
ENVIRONMENT ASSOCIATES, INC.

2300 WEST CAPE COD WAY
SANTA ANA, CALIFORNIA 92703
The results of the testing reported herein relate only to the actual items tested.
This report shall not be reproduced except in full, without the written approval of
Environment Associates, Inc.
Maintains Laboratory Accreditation to ISO/IEC 17025 and ISO 9001
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Environment Associates, Inc. Test Report Number OC25286-1018012B
A P P R O V A L S H E E T
Environment Associates hereby certifies that the information presented in this report is,
to the best of our knowledge, true and correct in all respects.
Martin J. Povall Jr.

_________________________________
ENVIRONMENT ASSOCIATES, INC.
Martin J. Povall Jr., Laboratory Manager
March 30, 2015

_________________________________
Date
Report Written by Gerald Flippen on December 14, 2014
___________________________________
Proof Read
Page 2 of 52
R E V I S I O N S H E E T
REVISION LETTER DESCRIPTION OF REVISION DATE APPROVAL
None Original Issue 12/14/14 On File
A Corrected Typos 03/11/15 On File

Added Section 5 and 6
B Replaced bump data sheets 03/30/15
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A D M I N I S T R A T I V E D A T A
PURPOSE OF TEST: To demonstrate compliance to the applicable

requirements of the specifications cited below.
ITEM SUBJECTED TO TEST: HT70 Plus Emergency and Transport Ventilator

Part Number: GR-NMIH70PM
TEST SPECIFICATIONS: Covidien Protocol 10141555-EN 794-3 Clause 21
IEC 60068
SUBMITTED BY: Covidien

6135 Gunbarrel Avenue
Boulder, CO 80301
TESTING AGENCY: Environment Associates, Inc.

2300 West Cape Cod Way
Santa Ana, California 92703
DATES TESTING CONDUCTED: November 20, 2014 through February 25, 2015
AUTHORIZATION TO TEST: Covidien Purchase Order Number 298392
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T A B L E O F C O N T E N T S
Cover Page 1
Approval Sheet 2
Revision Sheet 3
Administrative Data 4
Table of Contents 5
Summary of Test Results 6
General Information 8
1.0 Sine Vibration 10

1.1 Reference 10
1.2 Procedure 10
1.3 Results 12
1.4 Date and Location of Test 12
Test Data 13
Notice of Test Deviation 19
Equipment List/test photograph 20
2.0 Random Vibration 21

2.1 Reference 21
2.2 Procedure 21
2.3 Results 23
Test Data 24
3.0 Bump 30
3.1 Reference 30
3.2 Procedure 30
3.3 Results 31
Test Data 32
4.0 Shock (Drop) 37

4.1 Reference 37
4.2 Procedure 37
4.3 Results 38
Test Data 39
Notice of Test Deviation 40
Equipment List 41
Test Photographs 42
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T A B L E O F C O N T E N T S ( C o n t i n u e d )
5.0 Shock (Drop) Retest 43

5.1 Reference 43
5.2 Procedure 43
5.3 Results 44
Test Data 45
Equipment List 46
Test Photograph 47
6.0 Shock (Drop) Retest 48

6.1 Reference 48
6.2 Procedure 48
6.3 Results 49
Test Data 50
Equipment List 51
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S U M M A R Y O F T E S T R E S U L T S
TEST SERIAL NO. STATUS
1.0 Sine Vibration GRHT7PM-0914-350 Fail1

GRHT7PM-0914-351 Complete
2.0 Random Vibration GRHT7PM-0914-351 Complete
3.0 Bump GRHT7PM-0914-351 Complete
4.0 Shock (Drop) GRHT7PM-0914-351 Complete2
5.0 Shock (Drop) Retest GRHT7PM-0914-351 Complete
6.0 Shock (Drop) Retest GRHT7PM-0914-351 Complete
1
Refer to Vibration Notice of Test Deviation number 001.
2
Refer to Vibration Notice of Test Deviation number 1.
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G E N E R A L I N F O R M A T I O N
GENERAL
TEST ITEM DESCRIPTION
HT70 Plus Emergency and Transport Ventilator

Serial Number: GRHT7PM-0914-350; GRHT7PM-0914-351
REFERENCE DOCUMENTS
Covidien
Doc. No. 10141555, Rev. A HT70 Plus Emergency and Transport Ventilator
Standard Compliance Evidence Protocol
International Electrotechnical Commission
IEC60068-2-27 Bump
IEC60068-2-36 Random Vibration
IEC60068-2-6 Sine Vibration
IEC60068-2-31 Shock (Drop)
TOLERANCES
Test Equipment
Test equipment utilized received ‘Accredited Calibrations’ to: International

Standard ANS/ISO/IEC17025-2005. General Requirements for the Competence of
Testing and Calibration Laboratories.
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TOLERANCES (Continued)
Unless otherwise described in this report, the environmental test equipment was
capable of controlling the test equipment within the following tolerances:
Random Vibration Amplitude: ± 3dB 10 Hz to 2000 Hz

Sinusoidal Vibration ± 10%
Vibration Frequency: 1% or ± 1/2 Hz below 25 Hz
Shock Amplitude: ± 15%

Shock Frequency: ± 10%
Time: ± 5%
Laboratory Ambient Conditions
All laboratory ambient conditions were maintained as follows:
Temperature: 25 ± 10 degrees C
Pressure: 30 ± 2 inches Hg
Relative Humidity: 90% maximum
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1.0 SINUSOIDAL VIBRATION
1.1 REFERENCE
Covidien Document Number 1014555, Revision A

IEC60068-2-6, Test Fc
1.2 PROCEDURE
1.2.1 Test Parameters
The vibration control system was programmed for the following sinusoidal conditions:
Frequency Level
10 – 59.4 Hz 0.35 mm 0-peak
59.4 – 1000 Hz 49m/s2
(logarithmic sweep, 10 Hz to 1000 Hz to 10 Hz, 1 octave/minute)
1.2.2 Axis Designation
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1.2.3
The test sample listed below was mounted on the vibration exciter in the Z axis. The
test fixture was instrumented with one (1) control accelerometer. The test sample was
operating and monitored by Covidien personnel during the vibration test.
Serial Number: GRHT7PM-0914-350
1.2.4
The test sample was subjected to one (1) sweep of sinusoidal vibration as specified in
paragraph 1.2.1. Plot #1 shows the input vibration levels recorded during the test. The
test was stopped at the request of Covidien personnel due to a problem with the test
sample. Refer to Notice of Test Deviation number 001.
1.2.5
The test sample was removed from the vibration exciter and returned to Covidien
personnel for evaluation.
1.2.6
The test sample listed below was mounted on the vibration exciter in the Z axis. The
1.2.7
The test sample was subjected to four (4) sweep cycles of sinusoidal vibration as
specified in paragraph 1.2.1. Plot #2 shows the input vibration levels recorded during
the test. No functional or visual anomalies were noted.
1.2.8
The test sample was reoriented on the vibration exciter in the X axis. The test fixture
was instrumented with one (1) control accelerometer. The test sample was operating
and monitored by Covidien personnel during the vibration test.
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1.2.8
1.2.9
The test sample was reoriented on the vibration exciter in the Y axis. The test fixture
1.2.10
1.2.11
The test sample was removed from the vibration exciter.
1.3 RESULTS
No visual or functional anomalies were noted.
1.4 DATE AND LOCATION OF TEST
1.4.1
The sinusoidal vibration test was performed at the facility of Environment Associates,
Inc., Santa Ana, California on November 20, 2014.
1.4.2
All inspection and operation of the test sample were by Covidien personnel.
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2.0 RANDOM VIBRATION
2.1 REFERENCE

IEC60068-2-36, Test db
2.2 PROCEDURE
The vibration control system was programmed for the following random conditions:
Frequency Level
10 - 200 Hz 0.01 g2/Hz
200 - 500 Hz 0.003 g2/Hz
(1.7 Grms overall)
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2.2.3
The test sample listed below was mounted on the vibration exciter in the Y axis. The
2.2.4
The test sample was subjected to thirty (30) minutes of random vibration as specified in
paragraph 2.2.1. Plot #1 shows the input vibration level recorded during the test. No
functional or visual anomalies were noted.
2.2.5
The test sample was reoriented on the vibration exciter in the X axis. The test fixture
2.2.6
2.2.7
The test sample was reoriented on the vibration exciter in the Z axis. The test fixture
2.2.8
2.2.9
Page 22 of 52
2.3 RESULTS
No visual or functional anomalies were noted.
2.4.1
The random vibration test was performed at the facility of Environment Associates, Inc.,
Santa Ana, California during the period of November 20 and November 21, 2014.
2.4.2
All inspection and operation of the test samples were by Covidien personnel.
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3.0 SHOCK (BUMP)
3.1 REFERENCE

IEC60068-2-27, Test Eb
3.2 PROCEDURE
The computer shock system was programmed for 16 g’s peak, 6 millisecond duration,
halfsine shock pulse.
3.2.3
The test sample listed below was mounted on the vibration exciter in the vertical axis.
The test fixture was instrumented with one (1) control accelerometer. The test
sample was operating during the shock test.

3.2.4
The test sample was subjected to four thousand (4000) shock pulses in the vertical axis
at the conditions specified in paragraph 3.2.1. Plot #1A & 1B show representative shock
pulses. No anomalies were noted.
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3.2.5
3.3 RESULTS
No visual anomalies were noted.
3.4.1
The shock (bump) test was performed at the facility of Environment Associates, Inc.,
Santa Ana, California on November 21, 2014.
3.4.2
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4.0 SHOCK DROP
4.1 REFERENCE

IEC60068-2-31
4.2 PROCEDURE
4.2.1
The test sample listed below was subjected to the following drop test. The test sample
was allowed to fall freely onto a smooth, hard, rigid surface of steel from a height of
0.75M (30 inches).

4.2.2
The test sample was dropped on its bottom from a height of 0.75M. Scuff marks were
noted. No functional anomalies were noted.
4.2.3
The test sample was dropped on its right side from a height of 0.75M. Scuff marks were
4.2.4
The test sample was dropped on its left side from a height of 0.75M. Scuff marks were
noted. A bolt on the cover was bent. No functional anomalies were noted.
4.2.5
The test sample was dropped on its back from a height of 0.75M. Scuff marks were
noted. The test sample powered off. Refer to Notice of Test Deviation Number 1.
4.2.9
Test was continued at the request of Covidien personnel.
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4.2.10
The test sample was dropped on its front from a height of 0.75M. Scuff marks were
noted. The test sample was not functioning.
4.2.11
The test sample was dropped on its top from a height of 0.75M. Scuff marks were
noted. The test sample was not functioning.
4.2.12
The test sample was returned to Covidien personnel for functional evaluation and visual
examination.
4.3 RESULTS
Visual and functional anomalies were noted. Internal examination of the test sample by
Covidien personnel and it was determined that the “No Power” condition was due to a
faulty circuit board and not a broken power switch. Refer to Notice of Test Deviation
number 1.
4.4.1
The shock (drop) test was performed at the facility of Environment Associates, Inc.,
Santa Ana, California on November 21, 2014.
4.4.2
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5.0 SHOCK (DROP) Retest
5.1 REFERENCE
Covidien Document Number 1014555, Revision A, Paragraph TS 8
5.2 PROCEDURE
5.2.1
0.75M (30 inches). The test sample was operating during the impacts with hoses
connected.

5.2.2
The test sample was dropped on its bottom from a height of 0.75M. No visual damage
was noted. No functional anomalies were noted.
5.2.3
The test sample was dropped on its right side from a height of 0.75M. No visual damage
5.2.4
The test sample was dropped on its left side from a height of 0.75M. No visual damage
5.2.5
The test sample was dropped on its back from a height of 0.75M. No visual damage was
5.2.6
The test sample was dropped on its front from a height of 0.75M. No visual damage was
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5.2.7
The test sample was dropped on its top from a height of 0.75M. The plastic label cover
on the test sample came off and the display reported a “pint failure”. The operation of
the test sample was not affected.
5.2.12
examination. Refer to data sheet for results of Covidien examination of the test sample.
5.3 RESULTS
Visual anomalies were noted. No functional anomalies were noted.
5.4.1
Santa Ana, California on February 23, 2015.
5.4.2
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6.0 SHOCK (DROP) Retest
6.1 REFERENCE
Covidien Document Number 1014555, Revision A, Paragraph TS 8
6.2 PROCEDURE
6.2.1
0.75M (30 inches). The test sample was operating during the impacts with hoses
connected.

6.2.2
The test sample was dropped on its bottom from a height of 0.75M. No visual damage
6.2.3
The test sample was dropped on its right side from a height of 0.75M. No visual damage
6.2.4
The test sample was dropped on its left side from a height of 0.75M. No visual damage
6.2.5
The test sample was dropped on its back from a height of 0.75M. No visual damage was
6.2.6
The test sample was dropped on its top from a height of 0.75M. No visual damage was
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6.2.7
The test sample was dropped on its front from a height of 0.75M. No visual damage was
6.2.12
examination.
6.3 RESULTS
No visual anomalies were noted. No functional anomalies were noted.
6.4.1
Santa Ana, California on February 25, 2015.
6.4.2
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END OF REPORT
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HT70 Drop Test Certificate RPT18012B-Covidien-signed

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HT70 Drop Test Certificate RPT18012B-Covidien-signed

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Environment Associates, Inc.

Test Report Number OC25286-1018012B

ENVIRONMENTAL TEST REPORT

HT70 PLUS EMERGENCY AND TRANSPORT VENTILATOR

ENVIRONMENT ASSOCIATES, INC.

Maintains Laboratory Accreditation to ISO/IEC 17025 and ISO 9001

Martin J. Povall Jr.

March 30, 2015

Report Written by Gerald Flippen on December 14, 2014

REVISION LETTER DESCRIPTION OF REVISION DATE APPROVAL

None Original Issue 12/14/14 On File

A Corrected Typos 03/11/15 On File

B Replaced bump data sheets 03/30/15

PURPOSE OF TEST: To demonstrate compliance to the applicable

ITEM SUBJECTED TO TEST: HT70 Plus Emergency and Transport Ventilator

TEST SPECIFICATIONS: Covidien Protocol 10141555-EN 794-3 Clause 21

SUBMITTED BY: Covidien

TESTING AGENCY: Environment Associates, Inc.

AUTHORIZATION TO TEST: Covidien Purchase Order Number 298392

1.0 Sine Vibration 10

2.0 Random Vibration 21

4.0 Shock (Drop) 37

5.0 Shock (Drop) Retest 43

6.0 Shock (Drop) Retest 48

TEST SERIAL NO. STATUS

1.0 Sine Vibration GRHT7PM-0914-350 Fail1

2.0 Random Vibration GRHT7PM-0914-351 Complete

3.0 Bump GRHT7PM-0914-351 Complete

4.0 Shock (Drop) GRHT7PM-0914-351 Complete2

5.0 Shock (Drop) Retest GRHT7PM-0914-351 Complete

6.0 Shock (Drop) Retest GRHT7PM-0914-351 Complete

TEST ITEM DESCRIPTION

HT70 Plus Emergency and Transport Ventilator

Part Number: GR-NMIH70PM

International Electrotechnical Commission

Test equipment utilized received ‘Accredited Calibrations’ to: International

Random Vibration Amplitude: ± 3dB 10 Hz to 2000 Hz

Shock Amplitude: ± 15%

Laboratory Ambient Conditions

All laboratory ambient conditions were maintained as follows:

Relative Humidity: 90% maximum

1.0 SINUSOIDAL VIBRATION

Covidien Document Number 1014555, Revision A

1.2.1 Test Parameters

(logarithmic sweep, 10 Hz to 1000 Hz to 10 Hz, 1 octave/minute)

1.2.2 Axis Designation

The test sample was removed from the vibration exciter.

No visual or functional anomalies were noted.

1.4 DATE AND LOCATION OF TEST

2.0 RANDOM VIBRATION

Covidien Document Number 1014555, Revision A

2.2.1 Test Parameters

(1.7 Grms overall)

2.2.2 Axis Designation

The test sample was removed from the vibration exciter.

No visual or functional anomalies were noted.

2.4 DATE AND LOCATION OF TEST

3.0 SHOCK (BUMP)

Covidien Document Number 1014555, Revision A

3.2.1 Test Parameters

3.2.2 Axis Designation

HT70 Plus Emergency and Transport Ventilator

The test sample was removed from the vibration exciter.

No visual anomalies were noted.