CADD Solis VIP Model 2120 Technical Manual Oct 2012

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 VIP ambulatory infusion pump, refer to the Operator’s Manual supplied with the product. Smiths Medical is available to help with the programming and operation of the CADD®-Solis VIP 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 VIP Operator’s Manual for more information). Your facility may load a unique single protocol or protocol library on the CADD®-Solis VIP ambulatory infusion pump. When a pump is returned to Smiths Medical for service, the protocol or protocol library may be cleared as part of the service or repair process. If this occurs, the pump will be labeled with a sticker indicating the change. Before returning the pump to use, follow your facility’s policies and procedures to load the correct protocol or protocol library back onto the pump. If necessary, contact your CADD®-Solis administrator or Smiths Medical for assistance. U.S. Distribution: Smiths Medical ASD, Inc. St. Paul, MN 55112 USA 1 800.258.5361 (USA) 1 214.618.0218 www.smiths-medical.com European Distribution: Smiths Medical International Ltd. TN25 4BF, UK +44 (0) 1233 722100 Australian Distribution: Smiths Medical Australasia Pty. Ltd. 61 Brandl Street Eight Mile Plains, QLD 4113, Australia +61 (0) 7 3340 1300

2

Table of Contents Technical Assistance... 2

Hardware and Software Fault Detection. 25

Introduction... 4

System Fault Alarm... 25 Order of System Fault Alarm Events... 25

Limited Warranty... 4 Warnings... 4 Cautions... 5

Pump Overview... 6 Delivery Modes... 6 PCA Delivery Profile... 6 Continuous Delivery Profile... 6 Intermittent Delivery Profile... 7 Step Delivery Profile... 7 Taper Delivery Profile... 7 Pump Diagram... 8 PCA Delivery Mode Scroll Ranges... 9 Specifications (Nominal)... 11 General Pump Specifications... 11 Delivery Specifications... 14 Remote Dose Cord... 16

Cleaning Procedures... 26 Cleaning Solutions... 26 Cleaning 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... 39

Batteries... 17 Recommended Batteries... 17 Replacing the Battery Door... 17 CADD®-Solis Rechargeable Battery Pack... 17 Battery Storage... 17 Battery Life... 17 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 Battery Status... 23 Pumping Mechanism... 23 Pumping Characteristics... 24 Cassette “Type” Sensor Circuit... 24 Latch/Lock Sensor Circuit... 24

3

Introduction

Introduction

This Technical Manual is applicable only to the model 2120 CADD®‑Solis VIP ambulatory infusion pump. It is intended to provide a basic but limited understanding of the mechanical and electrical operation of the CADD®‑Solis VIP 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 VIP Operator’s Manual should be used in conjunction with this manual for complete information. IMPORTANT NOTICE: CADD®‑Solis VIP 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 VIP 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.

Limited Warranty

The limited warranty associated with the CADD®‑Solis VIP ambulatory infusion pump can be found in the product literature supplied with the product when originally purchased, which is incorporated herein by reference. SMITHS MEDICAL SPECIFICALLY DISCLAIMS ANY OTHER WARRANTY, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING, WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR USE. Smiths Medical further disclaims any responsibility for the suitability of the system for a particular medical treatment or for any medical complications resulting from the use of the system. The manufacturer shall not be responsible for any incidental damages or consequential damages to property, loss of profits, or loss of use caused by any defect or malfunction of the system. If you wish to receive additional information about the extent of the warranty on these products, contact your Smiths Medical representative or call Customer Service at 1 800.258.5361 (USA) or +1 214.618.0218. All recommendations, information, and literature supplied by Smiths Medical with respect to the CADD® product line are believed to be accurate and reliable, but do not constitute warranties. No agent, representative, or employee of Smiths Medical has authority to bind Smiths Medical to any representation or warranty, expressed or implied.

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.

4

Introduction

• 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.

• 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.

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 clean the pump with acetone, other plastic solvents, or abrasive cleaners, as damage to the pump may occur.

• 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.

• 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.

5

Pump Overview

Pump Overview Delivery Modes

The CADD®-Solis VIP ambulatory infusion pump system provides measured drug therapy to patients in hospital or outpatient settings. The CADD®-Solis VIP 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. This pump is not to be used in any intra-articular space infusion. Epidural administration is limited to short-term infusion of anesthetics, and either long- or short-term infusion of analgesics. Subarachnoid administration is limited to short-term infusion of analgesics.

PCA Delivery Profile PCA (patient controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patient-controlled analgesia. Clinician Bolus (used here as a loading dose)

Dosage

PCA Doses Delayed start (optional)

Continuous Rate

KVO

Time

Continuous Delivery Profile

Delivery Rate

Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate.

Delayed start (optional) Continuous Rate KVO

Time

6

Pump Overview

Intermittent Delivery Profile Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval.

Delivery Rate

Cycle

Delayed start (optional)

KVO

Duration

Duration

Dose

KVO

Dose

KVO

Time

Step Delivery Profile

Delivery Rate

Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume.

Delayed start (optional)

Rate (step) increase

Rate (step) increase

Plateau rate

Step duration

Initial rate Infusion volume

KVO

KVO

Time

Taper Delivery Profile Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion.

Delivery Rate

Infusion Duration Taper Up Delayed start (optional)

Plateau Rate

Taper Down

Infusion Volume

KVO

KVO

Time

7

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)

8

Serial number

Pump Overview

PCA Delivery Mode Scroll Ranges PCA Continuous Rate Scroll Ranges Units

Starting Value

Increment

Maximum 0.10

100.00

Milliliters

0

Milligrams only

10% of concentration

Values between 0.01 and 0.5:

0.01 Concentration x 100

Micrograms 10% of only concentration

Values between 0.1 and 0.5:

0.1

Concentration x 100

Milligrams 10% of and concentration Micrograms

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 and Clinician Bolus Scroll Ranges Units

Starting Value

Increment

Max.

Milliliters

0

0.05

50

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

Increment (mg) 0.01

Max. (mg) 5

Concentration (mg/mL) 20

Increment (mg) 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 and Clinician Bolus Scroll Ranges: Micrograms

10

Concentration (mcg/mL) 1

Increment (mcg) 0.05

Max. (mcg) 50

Concentration (mcg/mL) 35

Increment (mcg) 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 Used to test the pump

• CADD™ medication cassette reservoirs, < 21-7002, 21-7308, 21-7302 • CADD® extension sets, < 21-7045, 21-7046, 21-7047 • CADD® administration sets, < 21-7091, 21-7034, 21-7021, 21-7321 • CADD® high volume administration sets, < 21-7057, 21-7357

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

Pump alarms

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

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.

Classification

CF J Class II K

Moisture protection

Splashproof ( E ) per IEC 60529

Maximum infusion pressure

1.86 bar 27.0 psi

Battery removed while delivering, Battery unusable while delivering, Disposable attached improperly, 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: 23 • Low priority alarms: 10 • Informational messages/alerts: 23

11

Pump Overview Maximum time to occlusion alarm and Bolus volume at occlusion alarm

Max. Time to Occlusion

Flow Rate (mL/hr)

0.1

Raw Test Data (min)

Spec.

CADD™ medication cassette reservoir < 21-7002 with CADD® extension set < 21-7045

90

CADD® administration set < 21-7091 CADD® high volume administration set < 21-7055

Tubing Set

150

Raw Test Data (mL)

Spec.

≤ 160

0.107

≤ 0.25

122

≤ 190

0.139

≤ 0.30

1140

≤ 1200

1.250

≤ 1.40

(min)

Max. Time to Occlusion

Flow Rate (mL/hr)

Tubing Set

Bolus at Occlusion

Raw Test Data (sec)

Spec.

CADD™ medication cassette reservoir < 21-7002 with CADD® extension set < 21-7045

4

CADD® administration set < 21-7091 CADD® high volume administration set < 21-7055

(mL)

Bolus at Occlusion Raw Test Data (mL)

Spec.

≤ 45

0.069

≤ 0.25

4

≤ 45

0.072

≤ 0.30

32

≤ 90

1.059

≤ 1.40

(sec)

(mL)

Power sources

• AC adapter • CADD®-Solis rechargeable battery pack • 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).

System operating temperature

15°C to 40°C 59°F to 104°F

System storage and transportation temperature

–20°C to 60°C –4°F to 140°F

Relative humidity

20% to 90% relative humidity, non-condensing

Atmospheric pressure

70 kPa to 106 kPa 10.2 psi to 15.4 psi

12

Pump Overview System delivery accuracy

± 6% (nominal). At low infusion rates, this accuracy may not be achieved for short periods. During the total infusion time, the accuracy averages out. 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 overdelivery of medication.

Using CADD™ medication cassette reservoirs

± 6% (nominal) at 15°C to 40°C with no back pressure • An additional ± 2.5% change may be seen at ± 100 mmHg (± 1.9 psi).

± 6% (nominal) at 15°C to 40°C with no back pressure. Using CADD® administration sets • An additional ± 2.5% change may be seen at ± 100 mmHg (± 1.9 psi). ± 6% (nominal) at 15°C to 40°C with no back pressure Using CADD® • An additional ± 5% change may be seen at ± 100 mmHg (± 1.9 psi). high volume administration sets 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

High pressure alarm threshold

1.24 bar ± 0.62 bar 18 ± 9 psi

Air detector alarm

Sensitivity: • Low: Single bubble > 400 μL • High: Single bubble > 150 μL Accumulated Air: Greater than 1 mL air over 15 minutes (nominal)

Bolus accuracy specification: ± 6% Average

Actual test data for bolus accuracy at 0.05 mL: 0.0508 mL

% Error

1.6%

Minimum Error %

–3.0%

Maximum Error %

4.2%

Actual test data for bolus accuracy at 50 mL:

Maximum volume infused under single-fault conditions

Average

50.77 mL

% Error

1.55%

Minimum Error %

–0.07%

Maximum Error %

2.35%

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

13

Pump Overview Delivery rate during priming

• Standard volume administration set: approx. 250 mL/hr • High volume administration set: approx. 500 mL/hr

Alarm disabled during priming

Air-In Line

Delivery Specifications Common Delivery Specifications Reservoir volume

0 to 9999 Programmable in 1 mL increments. Displayed in 0.1 mL increments.

Given

0 to 99,999.99 in 0.01 unit increments

Res vol low trip point

1 to 999 mL in increments of 1 mL

Res vol empty alarm

• Insistent and one time only • Non-insistent and repeating

Delayed start

0 to 96 hr in 5 min increments

Pump stopped alarm

• Informational • High priority • On • Off

Air detector Air detector sensitivity

Low Sensitivity: Single bubble > 400 μL High Sensitivity: Single bubble > 150 μL

Alarm volume

• High • Medium • Low

PM (preventive maintenance) 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 001 to 899 in increments of 1 administrator code Date format

Time format Downstream occlusion sensitivity

14

• US standard (month/day/year) • European standard (day/month/year) • International standard ISO 8601:2004 (year/month/day) • 00:00 to 23:59 military • 12-hour am/pm High Sensitivity: When the high pressure alarm threshold is reached, the downstream occlusion alarm is triggered immediately. 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.

Pump Overview Common Delivery Specifications Upstream occlusion sensor

• On • Off

Note: The upstream occlusion sensor is automatically disabled during use with medication cassette reservoirs. PCA Delivery Specifications

Programming units If programming through manual mode. Otherwise the programming units are preset through the CADD™-Solis Medication Safety Software. • 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

Continuous rate

0 to 100 mL/hr (or the mg or mcg equivalent)

PCA dose

0 mL to 50 mL (or the mg or mcg equivalent) Max delivery rate (continuous rate + PCA dose): 40 to 250 mL/hr

PCA dose lockout

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

Max doses per hour

1 to 60

Delivery limit amount

0.1 to 1900 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

Clinician bolus

0 to 50 mL (or mg or mcg equivalent)

Delivery limit method

• Delivery limit • Max doses per hour • Not in use

Delivery limit period

1 to 12 hours in increments of 1 hour

Max delivery rate, combined bolus and continuous rate

40 to 250 mL/hr in increments of 1 mL

KVO rate

• 0 mL/hr • 0.1 mL/hr Continuous Delivery Specifications

Continuous rate

0.1 to 500 mL/hr

KVO rate

0.1 to 10 mL/hr Intermittent Delivery Specifications

Dose volume

0.1 to 1000 mL

Dose duration

1 min to 24 hr 15

Pump Overview Intermittent Delivery Specifications Dose cycle

10 min to 96 hr

Next dose start time

0 to 96 hr in 5 min increments

KVO rate

0 to 10 mL/hr

Step Delivery Specifications Initial rate

0.4 to 499 mL/hr

Plateau rate

0.4 to 500 mL/hr

Rate increment

0.4 to 499 mL/hr

Infusion volume

1 to 9990 mL

Step duration

15 min to 24 hr

KVO rate

0 to 10 mL/hr

Step infusion alerts

• On • Off Taper Delivery Specifications

Infusion volume

1 to 9990 mL

Taper up

0 min to 99:40 hr:min

Taper down

0 min to 99:40 hr:min

Infusion duration

10 min to 99:50 hr:min

KVO rate

0 to 10 mL/hr

Plateau rate upper limit

0.1 to 500 mL/hr

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 VIP 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

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 cord button to receive a PCA 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 straight back using a straight, steady motion. CAUTION: Do not twist or turn the remote dose cord connector, or use any instrument to remove it from the pump.

For additional specifications, refer to the instructions for use provided with the product. 16

Batteries

Batteries Recommended Batteries

AA 1.5 volt primary (non-rechargeable) alkaline batteries (for example, Duracell ® PC1500 / MN1500, IEC LR6) or the CADD®-Solis rechargeable battery pack are recommended for use in the CADD®-Solis VIP ambulatory infusion 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.

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 VIP 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.

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). 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 Frequency of use and intensity of display backlighting Duration of use of the USB connector Battery storage conditions Battery type and brand Battery age

17

Batteries 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. Alkaline battery life with screen backlight intensity set to 3 PCA and Continuous delivery

These estimates are based on laboratory tests conducted at room temperature using new batteries (Duracell® PC1500 / MN 1500, 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. Delivery Rate (mL/hr)

Operating Time (hrs)

Vol. Delivered (mL)

0.4

142

56

1.0

139

139

5.0

124

620

(Max. delivery rate = 100 mL/hr, when using the PCA delivery mode)

Intermittent delivery

Step delivery

Taper delivery

18

10.0

113

1130

30.0

69

2070

50.0

59

2950

125.0

37

4625

200.0

29

5800

350.0

15

5250

500.0

11

5500

Volume (mL)

Duration (hr)

Cycle (hr)

KVO (mL/hr)

Operating Time (hrs)

Vol. Delivered (mL)

20.2

1

4

0.2

131

684

40.7.0

1

4

0.2

116

1221

61 .0

1

6

0.2

111

1177

125 .0

1

6

0.2

75

1637

200 0

1

12

0.2

111

2020

Volume to Deliver (mL)

Starting Rate (mL/hr)

Step Duration (min)

Step Rate Max Rate No. Increase of (mL/hr) (mL/hr) Steps

Operating Time (hrs)

900

45

15

45

315

7

23

1500

37.5

30

80

300

5

24

2500

30

30

90

300

4

19

Volume Period Taper Up

Taper Down

KVO (mL/hr)

Operating Time (hrs)

Vol. Delivered (mL)

(mL)

(hr)

(hr)

2000

12

1

1

5

31

5800

3000

12

1

1

5

23

6460

(hr)

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 temperature conditions, delivery rate, and frequency of screen display and backlighting. It is recommended that new batteries be kept available for replacement.

PCA and Continuous delivery

Rate (mL/hr)

Life (hrs)

Volume (mL)

0.4

74

29

1.0

67

67

5.0

60

300

10.0

50

500

30.0

40

1200

50.0

35

1750

125.0

30

3750

200.0

20

4000

350.0

13

4550

500.0

10

5000

(Max. delivery rate = 100 mL/hr, when using the PCA delivery mode)

Intermittent delivery

Step delivery

Taper delivery

Volume (mL)

Duration (hr)

Cycle (hr)

KVO (mL/hr)

Operating Time (hrs)

Vol. Delivered (mL)

20.2

1

4

0.2

81

436

40.7.0

1

4

0.2

68

702

61 .0

1

6

0.2

85

929

125 .0

1

6

0.2

53

1133

200 0

1

12

0.2

95

2424

Volume to Deliver (mL)

Starting Rate (mL/hr)

900

45

15

45

315

7

17

1500

37.5

30

80

300

5

17

2500

30

30

90

300

4

15

Volume Period

Step Step Rate Max Rate No. Duration Increase of (min) (mL/hr) (mL/hr) Steps

Taper Up

Taper Down

(hr)

(hr)

KVO

Operating Time (hrs)

(mL/hr)

Operating Time (hrs)

Vol. Delivered (mL)

(mL)

(hr)

2000

12

1

1

5

21

3830

3000

12

1

1

5

17

4640

19

Batteries

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