Sapphire Biomedical Functional Test Booklet

Contents Under no circumstances does the enclosed Biomedical Functional Test replace the Annual Certification Kit as per the Sapphire™ Infusion Pump Technical Services Manual. The Sapphire Infusion Pump is tested to IEC 60601-2-24 for Medical Electrical Equipment.

Touchscreen Test for Sapphire™ Infusion Pump …….…….…….…….…….…….…… 1 Purpose, Background, Goal, Scope…….…….…….…….…….…….…….…….…….…….…….…….… 1 Applicable Documents …….…….…….…….…….…….…….…….…….…….…….…….…….…….… 1 Required Test and Rationale …….…….…….…….…….…….…….…….…….…….…….…….…….… 1 Touchscreen Test …….…….…….…….…….…….…….…….…….…….…….…….…….…….…….…… 2 Results and Analysis…….…….…….…….…….…….…….…….…….…….…….…….…….…….…….… 2

Visual Electrical Safety Inspection for Sapphire™ Infusion Pump …….…….…….… 3 Purpose, Rationale …….…….…….…….…….…….…….…….…….…….…….…….…….…….…….… 3 Equipment …….…….…….…….…….…….…….…….…….…….…….…….…….…….…….…….…… 3 Inspection …….…….…….…….…….…….…….…….…….…….…….…….…….…….…….…….…… 3

Field Air Detector Test for Sapphire™ Infusion Pump …….…….…….…….…….… 4 Purpose, Background, Goal, Scope…….…….…….…….…….…….…….…….…….…….…….…….… 4 Applicable Documents …….…….…….…….…….…….…….…….…….…….…….…….…….…….… 4 Required Test and Rationale …….…….…….…….…….…….…….…….…….…….…….…….…….… 4 Sapphire™ Air Detector Test …….…….…….…….…….…….…….…….…….…….…….…….…….…… 5 Results and Analysis…….…….…….…….…….…….…….…….…….…….…….…….…….…….…….… 5

Field Occlusion Test for Sapphire™ Multi-therapy, Epidural and PCA …….…….… 6 Purpose, Background, Goal, Scope…….…….…….…….…….…….…….…….…….…….…….…….… 6 Applicable Documents …….…….…….…….…….…….…….…….…….…….…….…….…….…….… 6 Sapphire™ Multi-therapy Occlusion Assurance Test …….…….…….…….…….…….…….…….…….… 6 Sapphire™ Epidural Occlusion Assurance Test …….…….…….…….…….…….…….…….…….…….… 10 List of Figures and Tables…….…….…….…….…….…….…….…….…….…….…….…….…….…….… 13

Field Delivery Test for Sapphire™ Multi-therapy, Epidural and PCA Pump ……. 14 Purpose, Background, Goal, Scope…….…….…….…….…….…….…….…….…….…….…….…….… 14 Applicable Documents …….…….…….…….…….…….…….…….…….…….…….…….…….…….… 14 Sapphire™ Multi-therapy Accuracy Test …….…….…….…….…….…….…….…….…….…….…….… 14 Epidural Accuracy Test…….…….…….…….…….…….…….…….…….…….…….…….…….…….…… 18 List of Figures …….…….…….…….…….…….…….…….…….…….…….…….…….…….…….…….… 20

Touchscreen Test for Sapphire™ Infusion Pump 1.

Purpose The purpose of this document is to provide a protocol for validating the Sapphire™ infusion pump touchscreen in the field.

2.

Background Hospitals and specifically hospital biomedical engineering departments require a protocol for testing touchscreen prior to installing infusion pumps on patients.

3.

Goal Introducing a protocol for validating the Sapphire™ infusion pump touchscreen in the field.

4.

Scope The scope of this protocol is limited to validation of the pump touchscreen by a user.

5.

Applicable Documents N.A.

6.

Required Test and Rationale 6.1

Touchscreen Validation The goal of this test is: •

1

Validating the touchscreen

6.1.1

Equipment and Materials The accuracy evaluation will be done using the following equipment: • Q Core Sapphire™ pump (17000-028-00XX, 17000-031-00XX)

6.1.2

Control Article N.A.

6.1.3

Test Acceptance Criteria The test acceptance criterion is passing the screen calibration process.

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Touchscreen Test for Sapphire™ Infusion Pump 7.

Touchscreen Test 7.1

8.

Test Set up 7.1.1

Under technician authorisation level, on the startup screen press on “Options” button, press “Technician options”, press “Screen calibration”.

7.1.2

Click on the middle of the “+” as required.

7.1.3

Click in the green box to complete calibration and press “EXIT”.

7.1.4

Start a new infusion.

7.1.5

Enter VTBI of “12345”.

7.1.6

Press “Clear”.

7.1.7

Enter VTBI of “67890” and press “OK”.

7.1.8

Enter rate of “1.1”. (Note: Steps, to get to “Rate”, will depend on the current delivery mode).

7.1.9

Exit infusion mode.

Results and Analysis A passed screen calibration results in a calibrated screen and automatically returns to the “Technician Options” menu. In addition, all numbers should be displayed on screen when entered, and green dots should appear on each selected number.

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Visual Electrical Safety Inspection for Sapphire™ Infusion Pump 1.

Purpose The purpose of this document is to provide a procedure for checking the electrical safety of the Sapphire™ infusion pump.

2.

Rationale The Sapphire™ infusion pump meets all electrical safety requirements per IEC 60601-1 ed. 3.

3.

4.

3

Equipment •

Q Core Sapphire™ pump (17000-028-00XX, 17000-031-00XX)

•

Sapphire™ power supply (05020-150-0160-00)

•

Mini Cradle (if applicable 05040-300-0011)

•

Bolus Cable (if applicable 05022-410-0001)

Inspection 4.1

Perform a visual inspection of the pump, Mini Cradle, power supply, and Bolus Cable (if applicable) checking for loose/cracked enclosures, bent/loose pins, and frayed or exposed wires.

4.2

Connect the wall mount power supply to the power port on the pump and plug the wall mount main connector to the AC mains (mains power supply to be tested to International/ national standards for Class II BF) After a few seconds, the pump display should light up, the yellow charging LED will blink in case the battery isn’t full and indicate that the unit is charging.

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Field Air Detector Test for Sapphire™ Infusion Pump 1.

Purpose The purpose of this document is to provide a protocol for validating the Sapphire™ infusion pump air detector in the field.

2.

Background Hospitals and specifically hospital biomedical engineering departments require a protocol for testing the air detector prior to installing infusion pumps on patients.

3.

Goal Introducing a protocol for validating the Sapphire™ infusion pump air detector in the field.

4.

Scope The scope of this protocol is limited to validation of the pump air detector using the specified equipment (6.1.1).

5.

Applicable Documents N.A.

6.

Required Test and Rationale 6.1

Air detector Validation The goal of this test is: •

Validating the pump air detector

The rationale of this test is to validate that the pump did not undergo any unusual event and is able to detect air in the infusion set. 6.1.1

Equipment and Materials The air detector evaluation will be done using the following equipment: • Q Core Sapphire™ Pump (17000-028-00XX, 17000-031-00XX) • Q Core Mini Cradle (05040-300-0011) • Pole • AP 406/ AP 407 IV set (Q Core P/N 12000-000-0007/ 12000-000-0008)

6.1.2

Test Conditions New AP 406/ AP407 IV set.

6.1.3

Control Article N.A.

6.1.4

Test Acceptance Criteria The test acceptance criterion is an “Air in Line” alarm.

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Field Air Detector Test for Sapphire™ Infusion Pump 7.

Sapphire™ Air Detector Test 7.1

8.

7.1.1

Connect a Mini Cradle to the pole and mount a pump to the Mini Cradle.

7.1.2

Load the set (without an infusion bag)

7.1.3

Infusion Settings The following conditions will be set to the pump: • Set a new infusion with the following parameters: - Rate 90 mL/h - VTBI 50 mL Start the infusion after setting up the above parameters.

Results and Analysis 8.1

5

Test Set up

Air detector Test “Air in line” alarm sounds.

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Field Occlusion Test for Sapphire™ Multi-therapy, Epidural and PCA 1.

Purpose The purpose of this document is to describe a simple protocol for validating the Sapphire™ infusion pump occlusion detection and warning properties in the field.

2.

Background Occlusion can occur upstream of the pump (between the pump and the infusion bag) or downstream (patient end). The Sapphire™ infusion pump is designed to detect, pause and sound an alarm once either of these occlusions occurs.

3.

Goal Introducing a protocol for validating the Sapphire™ infusion pump occlusion detection in the field.

4.

Scope The scope of this protocol is limited to validation of the pump occlusion detection using the specified equipment (6.1.1, 7.1.1).

5.

Applicable Documents N.A.

6.

Sapphire™ Multi-therapy Occlusion Assurance Test 6.1

Sapphire™ Multi-therapy Occlusion Detection Validation The goal of this test is: •

Validating that the pump can detect, pause and sound an alarm once an upstream or downstream occlusion is detected

The rationale of this test is to validate that the used pump did not undergo any unusual event and can detect occlusion. 6.1.1

Equipment and Materials The occlusion detection evaluation will be done using the following equipment: • Q Core Sapphire™ pump (17000-028-00XX) • Q Core Mini Cradle (REF 05040-300-0011) • Pole • AP 406/ AP 407 IV set (Q Core P/N 12000-000-0007/ P/N 12000-000-0008) • 50 mL infusion bag or larger • Calibrated Digital Pressure Meter (DPM) • Three way valve • 5 mL (or equivalent) syringe

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Field Occlusion Test for Sapphire™ Multi-therapy, Epidural and PCA 6.1.2

Test Conditions • All testing and evaluations shall require fluid and air temperature of 20±2°C (68±4°F) • New AP 406/ AP 407 IV set

6.1.3

Control Article N.A.

6.1.4

Test Acceptance Criteria 6.1.4.1

Upstream Occlusion Once an upstream occlusion is generated, the pump will pause and sound an alarm (“Upstream occlusion” appears on the Sapphire™ screen).

6.1.4.2

Downstream Occlusion Once a downstream occlusion is generated, the pump will pause and sound an alarm (“Downstream occlusion” appears on the Sapphire™ screen). The pressure value depends on the threshold setting and may vary within ±0.3 bar (±4.4 psi).

6.2

Test Scheme The following scheme illustrates the test set up. Figure 1 - Multi-therapy Test Scheme

7

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Field Occlusion Test for Sapphire™ Multi-therapy, Epidural and PCA Figure 2 - Multi-therapy Test, Three Way Valve Open/Closed Positions

6.3

6.4

Test Set up • Connect the Mini Cradle to the pole and mount a pump to the Mini Cradle. Place an infusion bag (50 mL of water or more) •

Connect an AP 406/ AP 407 IV set to the infusion bag and to the pump

•

Connect the DPM to the end of the IV set using the three way valve (as illustrated in Figure 1) in an open position (as illustrated in Figure 2)

•

Place the open end in a collection container

•

Conduct priming in order to remove all the air from the IV set

•

Adjust the bag height so the water level in the bag will be 50 cm above the pump

Infusion Settings The following conditions will be set to the pump: •

Mode: Continuous

•

On the startup screen press on the “Options” button

•

Press “View”

•

Press “View System”

•

Press “Occlusion”

•

Define 0.4 or 0.8 bar (5.8 and 11.6 psi)

•

Press “OK”

•

Press “Next”

•

Press “Next”

•

Press “OK”

•

Press “Exit”

•

Set a new infusion with the following parameters: - Rate 40 mL/h - VTBI 50 mL

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Field Occlusion Test for Sapphire™ Multi-therapy, Epidural and PCA 6.5

Test Process 6.5.1

Upstream Occlusion Upstream occlusion is set to a fixed value of 0.4 bar (5.8 psi) in the pump, hence no occlusion parameters settings are needed for this part (see table 1). Start the infusion and allow the pump to run uninterrupted for at least 2 minutes. Clamp the IV tube 30 cm (11.8”) upstream of the pump, wait for the pump to pause and sound the alarm (less than a minute). Table 1 - Multi-therapy Upstream Occlusion Test Acceptance Criteria

Pass/Fail

Sounds an alarm

6.5.2

Downstream Occlusion Start the infusion and allow the pump to run uninterrupted for at least 2 minutes. Reset the pressure meter; resulting in zero pressure reading. Connect the 5 mL fully extended syringe (filled with air) to the free end of the opened valve (see figure 3). Gradually push the syringe piston, causing a build in pressure. Keep the pressure in the value ranges described in “Syringe induced pressure” of table 2 until the pump pauses and sounds the alarm (up to 40 seconds) and record it. In case an alarm does not initiate, increase the pressure (stay within the acceptance criteria values) and wait another 40 seconds. Table 2 – Multi-therapy Downstream Occlusion Settings Pump pressure setting

Syringe induced pressure

Acceptance criteria

0.4 bar (5.8 psi)

0.4-0.7 bar (5.8-10.2 psi)

0.1-0.7 bar (1.4-10.2 psi)

0.8 bar (11.6 psi)

0.8-1.1 bar (11.6-16 psi)

0.5-1.1 bar (7.2-16 psi)

Pass/Fail

Figure 3 – Multi-therapy test, Syringe connection

6.6

9

Results A pump passing the acceptance criteria is able to detect occlusion according to this protocol.

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Field Occlusion Test for Sapphire™ Multi-therapy, Epidural and PCA 7.

Sapphire™ Epidural Occlusion Assurance Test 7.1

Sapphire™ Epidural Occlusion Detection Validation The goal of this test is: •

Validating that the Epidural pump can detect, pause and sound an alarm once an upstream or downstream occlusion is detected

The rationale of this test is to validate that the used pump did not undergo any unusual event and can detect occlusion. 7.1.1

Equipment and Materials The occlusion detection evaluation will be done using the following equipment: • Q Core Sapphire™ pump (17000-031-00XX) • Q Core Mini Cradle (REF 05040-300-0011) • Pole • AP 402 IV set (Q Core P/N 12004-000-0001) • 50 mL infusion bag or larger • Calibrated Digital Pressure Meter (DPM) • Three way valve • 5 mL (or equivalent) syringe

7.1.2

Test Conditions • All testing and evaluations shall require fluid and air temperature of 20±2°C (68±4°F) • New AP 402 IV set

7.1.3

Control Article N.A.

7.1.4

Test Acceptance Criteria 7.1.4.1

Upstream Occlusion Once an upstream occlusion is generated, the pump will pause and sound an alarm (“Upstream occlusion” appears on the Sapphire™ screen).

7.1.4.2

Downstream Occlusion Once a downstream occlusion is generated, the pump will pause and sound an alarm (“Downstream occlusion” appears on the Sapphire™ screen). The pressure value depends on the threshold setting and may vary within ±0.3 bar (±4.4 psi).

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Field Occlusion Test for Sapphire™ Multi-therapy, Epidural and PCA 7.2

Test Scheme The following scheme illustrates the test set up. Figure 4- Epidural Test Scheme

Figure 5 – Epidural Test, Three Way Valve Open/Closed Positions

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Field Occlusion Test for Sapphire™ Multi-therapy, Epidural and PCA 7.3

7.4

Test Set up • Connect a Mini Cradle to the pole and mount a pump to the Mini Cradle. Place an infusion bag (50 mL of water or more) •

Connect the AP 402 IV set to the infusion bag and to the pump

•

Connect the DPM to the end of the IV set using the three way valve (as illustrated in Figure 4) in an open position (as illustrated in Figure 5)

•

Place the open end in a collection container

•

Conduct priming in order to remove all the air from the IV set

•

Adjust the bag height so the water level in the bag will be 50 cm above the pump

Infusion Settings The following conditions will be set to the pump: •

Mode: PCEA

•

On the startup screen press on the “Options” button

•

Press “View”

•

Press “View System”

•

Press “Occlusion”

•

Define 0.4 or 0.8 bar (5.8 and 11.6 psi)

•

Press “OK”

•

Press “Next”

•

Press “Next”

•

Press “OK”

•

Press “Exit”

•

Set a new infusion with the following parameters: - VTBI 20 mL - Press “mL” - Rate 20 mL/h - Demand Bolus 0 mL - Add Loading Dose No

7.5

Test Process 7.5.1

Upstream Occlusion Upstream occlusion is set to a fixed value of 0.4 bar (5.8 psi) in the pump, hence no occlusion parameters settings are needed for this part (see table 3). Start the infusion and allow the pump to run uninterrupted for at least 2 minutes. Clamp the IV tube 30 cm (11.8”) upstream of the pump, wait for the pump to pause and sound the alarm (less than a minute). Table 3 – Epidural Upstream Occlusion Test Acceptance Criteria

Pass/Fail

Sounds an alarm

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Field Occlusion Test for Sapphire™ Multi-therapy, Epidural and PCA 7.5.2

Downstream Occlusion Start the infusion and allow the pump to run uninterrupted for at least 2 minutes. Reset the pressure meter; resulting in zero pressure reading. Connect the 5 mL fully extended syringe (filled with air) to the free end of the opened valve (see figure 6). Gradually push the syringe piston, causing a build in pressure in pressure. Keep the pressure in the value ranges described in “Syringe induced pressure“ of table 4 until the pump pauses and sounds the alarm (up to 40 seconds) and record the value . In case an alarm does not initiate, increase the pressure (stay within the acceptance criteria values) and wait another 40 seconds. Table 4 – Epidural Downstream Occlusion Settings Pump pressure setting

Syringe induced pressure

Acceptance criteria

0.4 bar (5.8 psi)

0.4-0.7 bar (5.8-10.2 psi)

0.1-0.7 bar (1.4-10.2 psi)

0.8 bar (11.6 psi)

0.8-1.1 bar (11.6-16 psi)

0.5-1.1 bar (7.2-16 psi)

Pass/Fail

Figure 6 – Epidural Test, Syringe connection

7.6

8.

Results A pump passing the acceptance criteria is able to detect occlusion according to this protocol.

List of Figures and Tables Figure 1- Multi-therapy Test Scheme...7 Figure 2 – Multi-therapy Test, Three Way Valve Open/Closed Positions ...8 Figure 3 – Multi-therapy test, Syringe connection... 9 Figure 4- Epidural Test Scheme... 11 Figure 5 – Epidural Test, Three Way Valve Open/Closed Positions... 11 Figure 6 – Epidural Test, Syringe connection ...13 Table 1 – Multi-therapy Upstream Occlusion Test ...9 Table 2 – Multi-therapy Downstream Occlusion Settings ... 9 Table 3 – Epidural Upstream Occlusion Test ...12 Table 4 – Epidural Downstream Occlusion Settings...13

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Sapphire™ Infusion Pump Biomedical Protocols Document No 15020-042-0006-UNT Revision No 07

Field Delivery Test for Sapphire™ Multi-therapy, Epidural and PCA Pump 1.

Purpose The purpose of this document is to provide a protocol for validating the Sapphire™ infusion pump accuracy in the field.

2.

Background Hospitals and specifically hospital biomedical engineering departments require a protocol for testing accuracy prior to installing infusion pumps on patients.

3.

Goal Introducing a tool for validating the Sapphire™ infusion pump accuracy in the field, using a volume measurement protocol.

4.

Scope The scope of this protocol is limited to validation of the pump accuracy using the specified equipment (6.1.1, 7.1.1). Volume evaluation is done by an observer (not using additional measuring instrumentation).

5.

Applicable Documents N.A.

6.

Sapphire™ Multi-therapy Accuracy Test 6.1

Multi-therapy Volume Accuracy Validation The goal of this test is: •

Validation of pump accuracy

The rationale of this test is to validate that the pump did not undergo any unusual event and is accurate. 6.1.1

Equipment and Materials The accuracy evaluation will be done using the following equipment: • Q Core Sapphire™ pump (17000-028-00XX) • Q Core Mini Cradle (REF 05040-300-0011) • Pole • AP 406/ AP 407 IV set (Q Core P/N 12000-000-0007/ 12000-000-0008 ) • 50 mL infusion bag or larger • 150 mm 18 gauge metal needle • 25 mL graduated cylinder (minimal accuracy ±.25 mL) Class A • Metal clamp attached to the pole

6.1.2

Test Conditions • All testing and evaluations shall require fluid and air temperature of 20±2°C (68±4°F) • New AP 406/ AP 407 IV set

6.1.3

Control Article N.A.

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Field Delivery Test for Sapphire™ Multi-therapy, Epidural and PCA Pump 6.1.4

6.2

Test Acceptance Criteria The test acceptance criterion is deviation of ±1 mL. This value is a result of the error margins of the pump ±2.5% (0.5 mL), and the additional ±0.5 mL is a factor of the: • ±0.25 mL of accuracy of the graduated cylinder • The effect of the temperature • The user reading inaccuracy due to meniscus effect • Evaporation effect • Trumpet effect as the test duration is 15 minutes instead of the IEC standard requiring 2 hours

Test Scheme The following scheme illustrates the test set up. Figure 1 – Multi-therapy Test Set up

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Field Delivery Test for Sapphire™ Multi-therapy, Epidural and PCA Pump 6.3

6.4

Test Set up 6.3.1

A 25 mL graduated cylinder will be placed on a leveled surface.

6.3.2

Connect a Mini Cradle to the pole and mount a pump to the Mini Cradle. Adjust the pump to the level of the graduated cylinder (bottom of the pump will be on the same level as the bottom of the graduated cylinder).

6.3.3

Place an infusion bag (50 mL of water or more).

6.3.4

Connect an AP 406/ AP 407 IV set to the infusion bag and to the pump.

6.3.5

Connect the metal needle to the end of the administration set.

6.3.6

Conduct priming in order to remove all the air from the IV set.

6.3.7

Adjust the bag height so the water level in the bag will be 50 cm above the pump.

6.3.8

Place the metal needle as close as possible to the bottom of the graduated cylinder without allowing the metal needle to touch the bottom of the graduated cylinder (it can touch the side of the graduated cylinder).

6.3.9

Attach the set to the clamp to hold the metal needle in position.

Infusion Settings The following conditions will be set to the pump: •

Mode: Continuous

•

On the startup screen press on the “Options” button

•

Press “ Pump Configuration”

•

Press “General Settings”

•

Change authorisation level to ”Tech” using technician password

•

In “Tech Options” press “Pump Settings”

•

Press “Set KVO”

•

Set pump KVO on continuous mode to 0 mL/h

•

Set a new infusion with the following parameters: - Rate 125 mL/h - VTBI 20 mL

Start the infusion after setting up the above parameters. 6.5

Volume Measurement Once infusion is complete, take out the metal needle and evaluate the water volume in the column with the following emphases: •

When evaluating the water level – keep eyes and water on the same level.

•

Evaluate the water level from the lower part of the meniscus (Fig 2 position 2) and not the upper part (Fig 2 position 1).

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Field Delivery Test for Sapphire™ Multi-therapy, Epidural and PCA Pump Figure 2 – Proper column reading

6.6

7.

Results Read the water height at the bottom of the meniscus. If it is between 19 and 21 mL the device passes the delivery accuracy test.

Epidural Accuracy Test 7.1

Epidural Volume Accuracy Validation The goal of this test is: •

Validation of Epidural pump accuracy

The rationale of this test is to validate that the Epidural pump did not undergo any unusual event and is accurate.

17

7.1.1

Equipment and Materials The accuracy evaluation will be done using the following equipment: • Q Core Sapphire™ Epidural pump (17000-031-00XX) • Q Core Mini Cradle (REF 05040-300-0011) • Pole • AP 402 IV set (Q Core P/N 12004-000-0001) • 18 gauge epidural Catheter • 50 mL infusion bag or larger • 25 mL graduated cylinder (minimal accuracy ±.2 mL) Class A • Metal clamp attached to the pole

7.1.2

Test Conditions • All testing and evaluations shall require fluid and air temperature of 20±2°C (68±4°F) • New AP 402 IV set

7.1.3

Control Article N.A.

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Field Delivery Test for Sapphire™ Multi-therapy, Epidural and PCA Pump 7.1.4

7.2

Test Acceptance Criteria The test acceptance criterion is deviation of ±1 mL. This value is a result of the error margins of the pump ±2.5% (0.5 mL), and the additional ±0.5 mL is a factor of the: • ±0.25 mL of accuracy of the graduated cylinder • The effect of the temperature • The user reading inaccuracy due to meniscus effect • Evaporation effect • Trumpet effect as the test duration is 15 minutes instead of the IEC standard requiring 2 hours

Test Scheme The following scheme illustrates the test set up Figure 3 – Epidural Test Set up

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