CADD-Solis Technical Manual sw ver 4.2 Nov 2019

The issue date of this Technical Manual is included on the back cover. In the event one year has elapsed between the issue date and product use, contact Smiths Medical to see if an updated revision of this manual is available.

Technical Assistance For detailed instructions, specifications, warnings, warranties, and additional information on operating the CADD®-Solis ambulatory infusion pump, refer to the Operator’s Manual and the Administrator Settings Guide supplied with the product. Smiths Medical is available to help with the programming and operation of the CADD®-Solis ambulatory infusion pump. If you have comments or questions, call the number given below. When calling, specify the pump’s software version number. This information is located in the Device Information Report (see the Reports section in the CADD®-Solis Operator’s Manual for more information). U.S. Distribution: Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 USA Tel: 1 800 258 5361 (US/CA) Tel: +1 614 210 7300 European Distribution: Smiths Medical Czech Republic a.s. Olomoucká 306, Hranice 1 - Město, 753 01 Hranice, Czech Republic Tel: +44 (0) 1233 722100 www.smiths-medical.com

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Table of Contents Technical Assistance... 2 Introduction... 4 Contraindications... 4 Warnings... 4 Cautions... 5 Pump Overview... 6 Delivery Methods... 6 Pump Diagram... 8 Scroll Ranges... 9 Specifications (Nominal)... 11 General Pump Specifications... 11 Delivery Specifications... 15 Administrator Settings Specifications. . 16 Compatible Cassettes, Extension Sets, and Administration Sets... 17 Remote Dose Cord... 17 Pump Software Upgradeability using SureLink® Remote Support Software... 17

Cleaning and Disinfecting the Pump and Accessories... 26 Annual Inspection and Testing Procedures. 27 Inspection Recommendation... 27 I. Visual Inspection...27 II. Mechanical Inspection...27 III. Functional Testing... 28 IV. Occlusion Pressure Range Tests... 33 V. Accuracy Tests... 35 Pump Cleaning and Functional Testing Checklist... 38

Batteries... 18 CADD®-Solis Rechargeable Battery Pack... 18 CADD®-Solis Communication Module (Internal Battery)... 18 Battery Storage... 18 Battery Life... 18 Battery Status... 20 Collect Separately... 20 Construction... 21 Pumping Operation... 22 Battery Backed RAM...22 LCD Circuitry... 22 LED Status Indicators... 22 Audible Alarm Circuitry... 22 Power Circuitry... 22 Pumping Mechanism... 23 Pumping Characteristics... 24 Cassette “Type” Sensor Circuit... 24 Latch/Lock Sensor Circuit... 24 Hardware and Software Fault Detection.25 System Fault Alarm... 25 Order of System Fault Alarm Events... 25

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Introduction

Introduction

This Technical Manual is applicable only to the model 2110 CADD®‑Solis ambulatory infusion pump. It is intended to provide a basic but limited understanding of the mechanical and electrical operation of the CADD®‑Solis ambulatory infusion pump to people familiar with the device. It also outlines cleaning and functional testing procedures that can be performed on the pump. The CADD®‑Solis Operator’s Manual and Administrator Settings Guide should be used in conjunction with this manual for complete information. IMPORTANT NOTICE: CADD®‑Solis ambulatory infusion pump operations and safety features are based on a microcomputer design. Inadequate servicing or tampering with the safety features of the pump may seriously affect performance and safety. For that reason, ALL SERVICING AND REPAIR OF THE CADD®-SOLIS AMBULATORY INFUSION PUMP MUST BE PERFORMED BY SMITHS MEDICAL OR ITS AUTHORIZED AGENTS. The manufacturer’s warranty agreement shall become null and void if the pump is not used in accordance with the Operator’s Manual and Instructions for Use provided with the pump accessories; or if the pump is serviced by anyone other than Smiths Medical or those authorized by Smiths Medical.

Warnings • The user should ensure that the performance offered by the pump is fit for the intended use and that the pump is not used in any way or for any purpose other than its intended use. • If the pump is dropped or hit, inspect it for damage. Do not use a pump that is damaged or not functioning properly. Contact Smiths Medical Customer Service to return a pump for service. • Do not use rechargeable NiCd or nickel metal hydride (NiMH) batteries. Do not use carbon zinc (“heavy duty”) batteries. They do not provide sufficient power for the pump to operate properly. • Always check the battery compartment for fluid or debris before inserting the batteries, and do not allow any fluid or debris to fall into the battery compartment. Fluid or debris in the battery compartment may damage the battery contacts, and could result in loss of power and nondelivery of drug. • Residential/facility wiring must comply with all applicable electrical codes. Do not bypass power cord connections. Do not remove a prong from the power cord. • Ensure that the ± 6% system delivery accuracy specification is taken into account when programming the pump and/or filling the reservoir. Failure to do so may result in medication in the reservoir becoming depleted sooner than expected. • System delivery inaccuracies beyond ± 6% may occur as a result of back pressure or fluid resistance, which depends upon temperature, drug viscosity, catheter size, extension set tubing (for example, microbore), in-line components (such as filters and needleless access connectors), and placing the infusion reservoir and/or pump above or below the level of the patient. System delivery inaccuracy may result in under or overdelivery of medication. • There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) reservoirs and extension sets. Dispose of used batteries, reservoirs, extension sets, and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply. • The pump and reusable accessories should be cleaned and disinfected after each patient use and in accordance with this manual and your organization’s policies and procedures for reusable, solid surface, non-critical medical devices. • Ensure that debris is not allowed to build up on the pressure plate surface of the pumping mechanism. Inspect the air detector sensor slot and remove any debris. A blocked air detector sensor may not detect air present in the fluid path.

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Introduction

Cautions • Do not operate the pump at temperatures below 2°C (36°F) or above 40°C (104°F) to avoid damaging the electronic circuitry. • Do not store the pump at temperatures below –20°C (–4°F) or above 60°C (140°F) to avoid damaging the electronic circuitry. Do not store the pump with a CADD™ medication cassette reservoir or CADD® administration set attached. • Do not expose the pump to humidity levels below 20% or above 90% relative humidity to avoid damaging the electronic circuitry. • Do not store the pump for prolonged periods with the batteries installed. Battery leakage could damage the pump. • Do not twist or turn the remote dose cord connector, or use any instrument to remove it from the pump. • Inspect the AA batteries for damage or wear to the metal or plastic insulation prior to use, or after the pump has been dropped or hit. Replace the batteries if any damage is noted. • If the power up results in an error message indicating that the protocol library was lost, do not proceed with using the pump. Follow your facility’s procedures for downloading protocol libraries. • Do not immerse the pump in cleaning fluid or water. Do not allow solution to soak into the pump, accumulate on the keypad, or enter the battery compartment, USB port, remote dose cord jack, or power jack areas. Moisture buildup inside the pump may damage the pump. • Do not oversaturate the chassis area on the bottom of the pump with cleaning or disinfecting solutions. Oversaturating this area can cause damage to the pump sensors over time. • Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners, as damage to the pump may occur. Also refer to the instructions for use for each accessory before proceeding with cleaning and disinfecting. Some accessories may have their own list of acceptable cleaning and disinfecting solutions. • CADD® pumps are sealed units. A broken or damaged seal will therefore be considered conclusive evidence that the pump has been misused and/or altered, which voids any and all warranties. All service and repair of CADD® pumps must be performed by Smiths Medical or its authorized agents. • At the completion of the Downstream Occlusion Pressure Range Test 2, the pressure must be reduced to zero before detaching the cassette from the pump; otherwise, the cassette may rupture. Safety glasses should be worn while conducting or observing this test.

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Pump Overview

Pump Overview The CADD®-Solis Ambulatory Infusion System provides measured drug therapy to patients in hospital or outpatient settings. Therapy should always be overseen by a physician or a certified, licensed healthcare professional. As appropriate, the patient should be instructed in using the pump. The CADD®-Solis Ambulatory Infusion Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses.

Delivery Methods The pump provides the following methods of delivery: • Continuous rate: infusion of drug at a constant, programmed rate • Intermittent bolus (IB): a series of doses automatically delivered at regular, programmed intervals • PCA (PCEA) dose: a demand dose activated by the patient • Clinician bolus: a dose activated by the clinician Each of the methods may be programmed individually or in combination with each other. The figures below illustrate examples of combined delivery methods. Ranges, programming increments, rates, and volumes are listed in “Specifications (Nominal)” on page 11. Example 1: Continuous Rate, PCA Doses, and Clinician Bolus

Dosage

Clinician Bolus (used here as a loading dose) PCA Lockout

PCA dose

PCA dose denied

PCA dose

PCA dose

Continuous Rate

Time Example 2: Intermittent Boluses (IB) and PCA Doses, with Bolus Interval Type set as PCA Lockout

Dosage

Delivery of PCA dose moves out the delivery of the next IB.

IB

IB

IB

IB PCA dose

Next Bolus delay

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Intermittent Bolus (IB) Interval

Bolus Interval Type (set as PCA Lockout)

PCA Lockout

PCA dose denied

Time

Pump Overview Example 3: Intermittent Boluses (IB) and PCA doses with Bolus Interval Type set as Bolus Interval

Dosage

Delivery of PCA dose moves out the delivery of the next IB.

IB

IB

IB

IB PCA dose

Next Bolus delay

Intermittent Bolus (IB) Interval

Bolus Interval Type (set as Bolus Interval)

PCA dose denied

Time

Intermittent Bolus (IB) Interval

Programming Flexibility With the CADD®-Solis system, you have the flexibility to delay a PIB following a PCEA dose based on the PIB interval or PCEA dose lock out interval.

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Pump Overview

Pump Diagram Front View Battery Compartment Display Indicator Lights Amber Green

USB Port

Blue AC Power Light AC Power Jack

Remote Dose Cord Jack

Keypad

Rear View

Power Switch

Cassette/Keypad Lock (Unlock/Lock)

Cassette Latch

Cassette (The part of the CADD™ medication cassette reservoir or CADD® administration set that attaches to the pump)

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Serial number

Pump Overview

Scroll Ranges Continuous Rate Scroll Ranges Units

Starting Value

Increment

Maximum

Milliliters

0

0.10

100.00

Milligrams only

10% of concentration

Values between 0.01 and 0.5:

0.01 Concentration x 100

Micrograms only

10% of concentration

Values between 0.1 and 0.5:

0.1

Concentration x 100

Milligrams and Micrograms

10% of concentration

Values between 0.5 and 100:

0.1

Concentration x 100

Values between 100 and 1000:

1.0

Values greater than 1000:

10.0

PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges Units

Starting Value

Increment

Max.

Milliliters

0

0.05

50

PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges: Milligrams Concentration (mg/mL) 0.1

Increment (mg) 0.01

Max. (mg) 5

Concentration Increment (mg/mL) (mg) 20 1.00

Max. (mg) 1000

0.2

0.02

10

25

1.25

1250

0.3

0.03

15

30

1.50

1500

0.4

0.04

20

35

1.75

1750

0.5

0.05

25

40

2.00

2000

1

0.05

50

45

2.25

2250

2

0.10

100

50

2.50

2500

3

0.15

150

55

2.75

2750

4

0.20

200

60

3.00

3000

5

0.25

250

65

3.25

3250

6

0.30

300

70

3.50

3500

7

0.35

350

75

3.75

3750

8

0.40

400

80

4.00

4000

9

0.45

450

85

4.25

4250

10

0.50

500

90

4.50

4500

11

0.55

550

95

4.75

4750

12

0.60

600

100

5.00

5000

13

0.65

650

14

0.70

700

15

0.75

750

9

Pump Overview PCA Dose, Clinician Bolus, and Intermittent Bolus Scroll Ranges: Micrograms Concentration Increment (mcg/mL) (mcg) 1 0.05

10

Max. (mcg) 50

Concentration Increment (mcg/mL) (mcg) 35 1.75

Max. (mcg) 1750

2

0.10

100

40

2.00

2000

3

0.15

150

45

2.25

2250

4

0.20

200

50

2.50

2500

5

0.25

250

55

2.75

2750

6

0.30

300

60

3.00

3000

7

0.35

350

65

3.25

3250

8

0.40

400

70

3.50

3500

9

0.45

450

75

3.75

3750

10

0.50

500

80

4.00

4000

11

0.55

550

85

4.25

4250

12

0.60

600

90

4.50

4500

13

0.65

650

95

4.75

4750

14

0.70

700

100

5.00

5000

15

0.75

750

200

10.00

10,000

20

1.00

1000

300

15.00

15,000

25

1.25

1250

400

20.00

20,000

30

1.50

1500

500

25.00

25,000

Pump Overview

Specifications (Nominal) General Pump Specifications System definition

CADD®-Solis pump with 1 of the following attached: • Medication cassette reservoir and CADD® extension set • Medication cassette reservoir with Flow Stop feature and CADD® extension set • CADD® administration set • CADD® administration set with Flow Stop feature

Classification

CF J Class II K • CADD™ medication cassette reservoirs, < 21-7002 and < 21-7309 • CADD® extension sets, < 21-7047 and < 21-7046 • CADD® administration sets, < 21-7091 and < 21-7321 • CADD® high volume administration sets, < 21-7355 and < 21-7357

Used to test the pump

Resolution

• CADD™ medication cassette reservoir: 0.050 mL per pump stroke nominal • CADD® administration set: 0.050 mL per pump stroke nominal • CADD® high volume administration set: 0.1 mL per pump stroke nominal

Size

Excluding cassette and accessories: 4.1 cm × 10.2 cm × 12.7 cm 1.6 in × 4 in × 5 in

Weight

Including 4 AA alkaline batteries, excluding other accessories: 595 g 21 oz

System operating temperature

2°C to 40°C 36°F to 104°F

System storage and transportation temperature

–20°C to 60°C –4°F to 140°F

Maximum surface 48°C (118°F) Maximum Temperature (pump, while operating) Ingress protection

IP24 per IEC 60529

Relative humidity

20% to 90% relative humidity, non-condensing

Atmospheric pressure

70 kPa to 106 kPa 10.2 psi to 15.4 psi

Expected Service Life

5 years

Power sources

• AC adapter • CADD®-Solis rechargeable battery pack • CADD®-Solis Communication Module • Four AA alkaline batteries (for example, Duracell® PC1500 / MN1500, IEC LR6)

Charging system for internal memory backup battery

The internal memory backup battery uses lithium manganese dioxide technology. It charges whenever the pump is powered on and has a 10-month memory capacity once it has been charged for 250 hours at 20°C (68°F).

Battery fallout alarm

Alarm sounds for 2 minutes if the pump has been powered up for a minimum of 4 minutes. Note: Alarm enabled while pump is in run mode only.

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Pump Overview Pump alarms

• High priority alarms: Air in line detected, Battery depleted while delivering,

Delivery rate during priming

• Standard volume cassette tubing: approx. 250 mL/hr • High flow volume cassette tubing: 500 mL/hr

Alarm disabled during priming

Air-In Line

Maximum infusion pressure

1.86 bar 27.0 psi

High pressure alarm threshold

1.24 bar ± 0.62 bar 18 ± 9 psi

Air detector alarm

High Sensitivity: • Single bubble > 150 μL •A  ccumulated air > 2mL over 15 minutes Low Sensitivity: • Single bubble > 2mL (2000 μL) •A  ccumulated air > 4mL over 15 minutes

Battery removed while delivering, Battery unusable while delivering, Disposable attached improperly, Disposable damaged, Disposable detached while delivering, Disposable locked but not latched, Disposable type high flow administration set not allowed, Disposable type high flow administration set required, Disposable type invalid, Downstream occlusion, Key stuck, Pressure sensor faulty, Pump automatically stopped, Rechargeable battery end of life, Remote dose cord key stuck, Reservoir volume empty, Stop mode reminder, Upstream occlusion • Medium priority alarms: 19 • Low priority alarms: 8 • Informational messages/alerts 23

Note: Bubbles smaller than 50 μL are not included in the accumulated air measurement. Statistical tolerance limits calculated at 95/99 level.

Maximum volume infused under single-fault conditions

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• CADD® administration set: 0.15 mL • CADD® high volume administration set: 0.30 mL

Pump Overview Maximum time to occlusion alarm and

The pressure build-up that occurs after an occlusion may cause fluid to accumulate or be stored in the line. This extra fluid may be delivered as a bolus when the occlusion is released.

Maximum bolus volume at occlusion alarm

Flow Rate

Note: Values are representative and based on actual test data. Tubing Set

(mL/ hr)

0.1

Flow Rate

CADD™ medication cassette reservoir < 21-7002 with CADD® extension set < 21-7047 CADD® administration set < 21-7091 CADD® high volume administration set < 21-7055 Tubing Set

(mL/ hr)

10

System delivery accuracy

CADD™ medication cassette reservoir < 21-7002 with CADD® extension set < 21-7047 CADD® administration set < 21-7091 CADD® high volume administration set < 21-7055

Max. Time to Occlusion

Max. Bolus at Occlusion

Raw Test Data (min)

Spec. (min)

Raw Test Data (mL)

Spec. (mL)

90

≤ 160

0.107

≤ 0.25

122

≤ 190

0.139

≤ 0.30

1140

≤ 1200

1.250

≤ 1.40

Max. Time to Occlusion Raw Spec. Test (sec) Data (sec)

Max. Bolus at Occlusion Raw Spec. Test (mL) Data (mL)

50

≤ 60

0.121

≤ 0.25

58

≤ 150

0.124

≤ 0.30

545

≤ 580

0.1322

≤ 1.40

± 6% at nominal (at 90/90 tolerance level). At low infusion rates, stated accuracy may not be achieved for short periods. During the total infusion time, the accuracy averages out. System delivery accuracy is determined under the following nominal conditions: • Infusion rate of 10mL/hr • Ambient temperature of 22 degree C • Fluid viscosity of 0.89 cP (i.e., water) • 0.2 mmHg (0.004 PSI) back pressure (i.e., 2 inch 18Ga needle) • Pump is placed at the same height as the infusion site • Reservoir placed at the same height as the infusion site • CADD Administration Set with Flow Stop Free Flow Protection (i.e., 21-7322-24) Accuracy testing was performed using 22 CADD®-Solis Ambulatory Infusion Pumps and 22 CADD® Administration Sets with Flow Stop Free Flow Protection. Intermediate Rates Accuracy testing methods defined in industry standard IEC 60601-2-24 is performed using an `intermediate rate’ representative of typical rates for various therapies. The intermediate rate of 10 mL/hr is representative for use with standard volume administration sets.

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Pump Overview WARNING: • Ensure that the ± 6% system delivery accuracy specification is taken into account when programming the pump and/or filling the reservoir. Failure to do so may result in medication in the reservoir becoming depleted sooner than expected. If the pump is being used to deliver critical or life sustaining medication, the interruption in the delivery of medication could result in patient injury or death. • System delivery inaccuracies beyond ± 6% may occur as a result of back pressure or fluid resistance, which depends upon temperature, drug viscosity, catheter size, extension set tubing (for example, microbore), in-line components (such as filters and needleless access connectors), and placing the infusion reservoir and/or pump above or below the level of the patient. System delivery inaccuracy may result in under or over delivery of medication, which could result in patient injury or death. Patient Selection It is important to consider the following clinical factors for the route of administration, the prescribed medication, and system configuration chosen for the infusion to ensure acceptable delivery accuracy is achieved. Consideration of Continuous Flow at Low Rates Delivery accuracy is not tested below 10 mL/hr. When intending to deliver therapies that require a low continuous flow rate, consider using another type of infusion pump, such as a syringe pump. Challenge Conditions The adjusted flow rate accuracy for non-nominal environmental conditions when using a CADD® Administration Set with Flow Stop Free Flow Protection is summarized below as determined per testing methods defined in industry standard IEC 60601-2-24.

Challenge Conditions Pump & reservoir height approximately four feet below the infusion site (backpressure increase of 100mmHg) Backpressure increase of 300mmHg Pump & reservoir height approximately four feet above the infusion site (backpressure decrease of 100mmHg) Reservoir height 0.3 m below pump & infusion site Temperature at 2°C, 20% RH Temperature at 40°C, 90% RH 21 Gauge Epidural Catheter

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System Delivery Accuracy -10% to 5% -17% to -7% -6% to 11% -12% to 7% -12% to -1% -10% to 10% -20% to -1%

Pump Overview

Delivery Specifications Programming units

• Milliliters (mL) • Milligrams (mg) • Micrograms (mcg)

Concentration

mg/mL: • 0.1 to 0.5 mg/mL in increments of 0.1 mg/mL • 0.5 to 1 mg/mL in increments of 0.5 mg/mL • 1 to 15 mg/mL in increments of 1 mg/mL • 15 to 100 mg/mL in increments of 5 mg/mL mcg/mL: • 1 to 15 mcg/mL in increments of 1 mcg/mL • 15 to 100 mcg/mL in increments of 5 mcg/mL • 100 to 500 mcg/mL in increments of 100 mcg/mL 0 to 9999 Programmable in 1 mL increments. Displayed in 0.1 mL increments. 0 to 99,999.99 in 0.01 unit increments 0.1 to 1,900 mL (or the mg or mcg equivalent) in increments of: • 0.01 mL from 0.1 to 0.5 mL • 0.1 mL from 0.5 to 100 mL • 1 mL from 100 to 1,000 mL • 10 mL from 1,000 to 1,900 mL 0 to 100 mL/hr (or the mg or mcg equivalent) • 0 mL to 50 mL (or mg or mcg equivalent) • Delivery rate: 40 mL/hr to the maximum delivery rate in 1 mL increments. 0 mL to 50 mL (or the mg or mcg equivalent) Delivery rate: 40 mL/hr to the maximum delivery rate in 1 mL increments. 1 minute to 24 hours in the following increments: • 1 minute for values between 1 and 20 minutes • 5 minutes between 20 minutes and 24 hours • 0 mL to 50 mL (or the mg or mcg equivalent) 0 to 4 hours

Reservoir volume Given Delivery limit amount

Continuous rate Clinician bolus PCA dose PCA dose lockout

Intermittent bolus Intermittent bolus interval Next bolus Maximum doses per hour

0 to 4 hours 1 to 60

CADD® Ambulatory Tubing Set Testing One representative medication for each of the following routes of delivery was tested for drug interaction with pump disposables. Use any selected drug in accordance with the indications included in the drug package insert. Administration of any drug by the CADD®-Solis ambulatory infusion pump is limited by any warnings, precautions, or contraindications in the drug labeling. Route of Delivery Drug Tested Intravenous, subarachnoid space (intrathecal) Morphine Sulfate Injection Intra-arterial Floxuridine for Injection, USP Intraperitoneal Dianeal with dextrose Epidural space, local infiltration(subcutaneous, perineural, surgical site) Ropivacaine HCl Injection

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Pump Overview

Administrator Settings Specifications KVO rate Bolus interval type Maximum delivery rate (PCA dose, clinician bolus, intermittent bolus)

• 0 mL/hr if continuous rate is 0 mL/hr • 0.1 mL/hr if continuous rate > 0 mL/hr, with standard administration set • 0.2 mL/hr if continuous rate > 0 mL/hr, with high volume administration set • Bolus interval • PCA lockout • Model 2110 with standard administration set: 250 mL/hr • Model 2110 with high volume administration set: 500 mL/hr • Max. delivery rate = continuous rate + bolus rate (PCA dose or clinician bolus or intermittent bolus)

• Boluses may not be delivered simultaneously Delivery limit method • Delivery limit • Max doses per hour • Not in use Delivery limit period Pump stopped alarm

1 to 12 hours in increments of 1 hour • Informational • High priority Res vol low trip point 1 to 999 mL in increments of 1 mL • Insistent and one time only Res vol empty alarm • Non-insistent and repeating • On Air detector • Off Air detector sensitivity • High • Low • On Upstream occlusion • Off sensor Note: The upstream occlusion sensor is automatically disabled during use with medication cassette reservoirs. High Sensitivity: When the high pressure alarm threshold is reached, the Downstream downstream occlusion alarm is triggered immediately. occlusion sensitivity Low Sensitivity: When the high pressure alarm threshold is reached, the downstream occlusion alarm is delayed for 2 seconds. This allows for the pressure to stabilize before a possible alarm. If the pressure stabilizes below the high pressure alarm threshold before the 2 second delay is complete, the alarm will not occur.

PM reminder

Interval: 1 to 24 months in 1 month increments Enable: On or Off Custom keypad code 001 to 899 in increments of 1 Custom clinician code 001 to 899 in increments of 1 Custom admin. code 001 to 899 in increments of 1 • 00:00 to 23:59 military Time format • 12-hour am/pm Date format • US standard (month/day/year) • European standard (day/month/year) • International standard ISO 8601:2004 (year/month/day) • High Alarm volume • Medium • Low • On Key beep • Off

16

Pump Overview

Compatible Cassettes, Extension Sets, and Administration Sets The cassette is the part of the CADD™ medication cassette reservoir or CADD® administration set that attaches to the bottom of the pump. The following single-use products are compatible with the pump:

• CADD™ medication cassette reservoir with a CADD® extension set • CADD® administration set • CADD® high volume administration set (with pump model 2110 only) Notes:

• A CADD® set with free-flow protection must be used in order to prevent free-flow. • The maximum delivery rate is 500 mL/hr, however, programmed delivery rates exceeding 250 mL/ hr require the use of a high volume administration set. Do not manually adjust the delivery rate to override pump programming without written authorization from the prescribing physician.

• Smiths Medical recommends that the appropriate supplies needed to replace the cassettes are available in case of a damaged cassette.

• For detailed instructions and warnings pertaining to the CADD™ medication cassette reservoir or

CADD® administration set, refer to the instructions for use supplied with the product for preparing the product for use.

Remote Dose Cord Smiths Medical provides a remote dose cord for use by the patient. The push button is a single pole double throw (SPDT) switch. When the remote dose cord is attached to the pump, the patient may press the remote dose button to receive a PCA (PCEA) dose. For easy access, the remote dose cord may be fastened to the patient’s clothing or bedsheet with the attached clip. Note: To detach the remote dose cord from the pump, grasp the remote dose cord connector and pull back using a straight, steady motion. CAUTION: Do not twist or turn the connector or use any instrument to remove it from the pump.

For additional specifications, refer to the instructions for use provided with the product.

Pump Software Upgradeability using SureLink® Remote Support Software The CADD®-Solis Ambulatory Infusion Pump software is upgradeable (when updates are available from Smiths Medical) using SureLink® Remote Support Software – PC Direct Connect. This application, available separately, may be used to receive available pump software updates from Smiths Medical Customer Service via the Internet and install those updates onto eligible pumps via USB connection. For more information about using SureLink® Remote Support Software, see the documentation provided with the software. If you have questions about pump software updates or SureLink® Remote Support Software, contact Smiths Medical. When calling, specify the pump’s software version number. This information is located in the pump’s Device Information Report (see the Reports section in the CADD®-Solis Operator’s Manual for more information).

17

Batteries

Batteries Four AA, 1.5 volt primary (non-rechargeable) alkaline batteries (for example, Duracell® PC1500 / MN1500, IEC LR6), the Smiths Medical rechargeable battery pack, or the CADD®-Solis Communication Module (with integrated rechargeable battery) are required for use in the CADD®‑Solis pump. Note: Smiths Medical does not recommend mixing new and used batteries; doing so may affect low battery alarm times. Always select four new batteries when replacing depleted batteries. CAUTION: Inspect the AA batteries for damage or wear to the metal or plastic insulation prior to use, or after the pump has been dropped or hit. Replace the batteries if any damage is noted.

Replacing the Battery Door If the battery door is removed or needs replacing, simply snap the door onto the bar that is located on the pump (see picture).

Reverting from use of Communication module back to AA Batteries When reverting back to the use of AA batteries, ensure the pogo pin insulators are present before using the pump. Without the insulators present, the pogo pins could damage the AA battery casing, potentially resulting in unintentional electrical contact. Install three pogo pin insulators as shown in the illustrations:

CADD®-Solis Rechargeable Battery Pack The battery pack is made up of a lithium-ion cell. When fully charged, its capacity is 5.2 Wh. Each battery pack can sustain a minimum of 500 charge/discharge cycles. Within the operating temperature range of 2°C to 40°C (36°F to 104°F), the battery pack becomes fully charged in 4 hours or less. The battery pack can be recharged using the CADD®‑Solis AC adapter. It can be plugged directly into the AC adapter or it recharges in the CADD®‑Solis pump with an AC adapter attached. Note: Periodically inspect the rechargeable battery pack for damage or wear to the metal or plastic insulation. Discontinue use if any damage is noted. See the instructions for use supplied with the rechargeable battery pack for more information.

CADD®-Solis Communication Module (Internal Battery) The internal battery is made up of lithium-ion cells. When fully charged, its capacity is 18.7 Wh. Each communication module battery can sustain a minimum of 400 charge/discharge cycles (at room temperature, 23°C (73°F). Within the operating temperature range of 2°C to 40°C (36°F to 104°F), the battery becomes fully charged in 10 hours or less. The battery can be recharged when the communication module is installed within the pump and the CADD®‑Solis AC adapter is connected to the pump. 18

Batteries Note: Periodically inspect the communication module for damage or wear to the metal contacts or plastic housing. Discontinue use if any damage is noted. See the instructions for use supplied with the communication module for more information.

Battery Storage The CADD®-Solis rechargeable battery pack should not be stored in a refrigerator. Recommended storage conditions are 19°C to 25°C (66°F to 77°F). The CADD®-Solis Communication Module can be stored between the temperatures of -20°C to 60°C (-4°F to 140°F) between 20% to 90% relative humidity (non-condensing). Alkaline batteries should not be stored in a refrigerator. Recommended storage conditions are 10°C to 24°C (50°F to 75°F) with no more than 65% non-condensing relative humidity. Battery power is quickly depleted at temperatures below 10°C (50°F). After 4 years of storage at 21°C (70°F), an alkaline battery retains approximately 86% of its original capacity. Battery life is shorter if the battery is stored above room temperature. An alkaline battery stored at 43°C (110°F) discharges to approximately 80% of its capacity within one year.

Battery Life Battery life is dependent on the following factors:

• Programmed delivery rate • Operating temperatures • Battery storage conditions

• • •

Frequency of use and intensity of display backlighting Duration of use of the USB connector

Battery type and brand • Battery age The following tables may be used to predict typical alkaline battery and CADD®-Solis rechargeable battery pack life at different delivery rates. As expected, battery life decreases as the delivery rate increases. These tables are based on laboratory tests conducted at room temperature, using fresh Duracell® alkaline batteries and CADD®‑Solis rechargeable battery packs, in CADD®‑Solis ambulatory infusion pumps with CADD® administration sets. Alkaline battery life with screen backlight intensity set to 3

These estimates are based on laboratory tests conducted at room temperature using new batteries (Duracell® PC1500 / MN1500, IEC LR6). Actual battery life varies depending on the battery brand, shelf life, temperature conditions, delivery rate, and frequency of screen display and backlighting. It is recommended that new batteries be kept available for replacement. Continuous Delivery Delivery Rate (mL/hr)

Operating Time (hr)

Volume Delivered (mL)

0.4

142

56

1.

139

139

5.0

124

620

10.0

113

1130

30.0

69

2070

Intermittent Bolus Delivery IB Volume

IB Interval

(mL)

(min)

Maximum Delivery Rate (mL/hr)

Operating Time (hrs)

Volume Delivered (mL)

5

30

40

90

900

10

30

250

104

2080

10

30

500

88

1760

19

Batteries Rechargeable battery pack life with screen backlight intensity set to 3

These estimates are based on laboratory tests conducted at room temperature using a new CADD®-Solis rechargeable battery pack. Actual battery life varies depending on the temperature conditions, delivery rate, and frequency of screen display and backlighting. It is recommended that new batteries be kept available for replacement.

Continuous Delivery Delivery Rate (mL/hr)

Operating Time (hr)

Volume Delivered (mL)

0.4

74

29

1.

67

67

5.0

60

300

10.0

50

500

30.0

40

1200

Intermittent Bolus Delivery IB Volume

IB Interval

Maximum Delivery Rate (mL/hr)

Operating Time (hrs)

Volume Delivered (mL)

(mL)

(min)

5

30

40

71

710

10

30

250

60

1200

10

30

500

58

1160

Battery Status Battery State

CADD®-Solis Pump Status

25% to 100%

No alarm

Low battery

• Transition to low battery condition • Battery low message appears • Pump emits 3 beeps every 5 min • Low battery warning message appears on pump display • Pump is operable • LCD backlight flashes for 12 ms during each motor operation • Transition to depleted battery condition • Battery depleted message appears • Pump emits a continuous, variable-tone alarm • Depleted battery warning message appears on pump display • Battery power is too low to operate pump • Pump delivery operation stops

Depleted battery

Shut down

Pump shuts off due to low operating voltage

Collect Separately

This product contains electrical and electronic components (including batteries) that may contain materials, which if disposed of with general waste, could be damaging to the environment. In accordance with Directive 2002/96/EC Waste Electrical and Electronic Equipment, residents of the European Union must follow specific disposal or recycling instructions for this product. Contact your local distributor, or visit the following web site for specific instructions: http://www.smiths-medical.com/recycle/index.html Non-European Union residents must dispose of or recycle this product (including batteries) in accordance with the local laws or regulations that apply. WARNING: There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) reservoirs and extension sets. Dispose of used batteries, reservoirs, extension sets, and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply. 20