Technical Manual
40 Pages
Preview
Page 1
X®
2100, 2110
Pump software version 3.0
s
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. 1265 Grey Fox Road 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
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Table of Contents Technical Assistance... 2 Introduction... 4 Limited Warranty... 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
Hardware and Software Fault Detection. . 25 System Fault Alarm... 25 Order of System Fault Alarm Events... 25 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... 39
Batteries... 18 CADD®-Solis Rechargeable Battery Pack... 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
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Introduction
Introduction This Technical Manual is applicable only to the model 2100/2110 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.
Limited Warranty The limited warranty associated with the CADD®‑Solis 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 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, please 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.
Contraindications
• The pump is not to be used for delivery of blood or cellular blood products, as blood and cellular blood products will be damaged by the pumping mechanism. • This pump is not to be used in any intra-articular space infusion.
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. 4
Introduction • 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.
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. 5
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
Continuous Rate
Time
6
PCA dose
Pump Overview
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 denied
PCA dose Next Bolus delay
PCA Lockout
Bolus Interval Type (set as PCA Lockout)
Intermittent Bolus (IB) Interval
Time
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
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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
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
Moisture protection
Splashproof ( E ) 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
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).
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
Sensitivity: • Low: Single bubble > 400 μL • High: Single bubble > 150 μL Accumulated Air: Greater than 1 mL air over 15 minutes (nominal)
Maximum volume infused under single-fault conditions
• CADD® administration set: 0.15 mL • CADD® high volume administration set: 0.30 mL
12
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
Pump Overview Maximum time to occlusion alarm and Maximum bolus volume at occlusion alarm
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. Note: Values are representative and based on actual test data. Flow Rate
Tubing Set
Max. Time to Occlusion
Max. Bolus at Occlusion
Raw Test Data (min)
Spec. (min)
Raw Test Data (mL)
Spec. (mL)
CADD™ medication cassette reservoir < 21-7002 with CADD® extension set < 21-7047
90
≤ 160
0.107
≤ 0.25
CADD® administration set < 21-7091
122
≤ 190
0.139
≤ 0.30
CADD® high volume administration set < 21-7055
1140
≤ 1200
1.250
≤ 1.40
(mL/ hr)
0.1
Flow Rate
Tubing Set
Max. Time to Occlusion
Max. Bolus at Occlusion
Raw Test Data (sec)
Spec. (sec)
Raw Test Data (mL)
Spec. (mL)
CADD™ medication cassette reservoir < 21-7002 with CADD® extension set < 21-7047
50
≤ 60
0.121
≤ 0.25
CADD® administration set < 21-7091
58
≤ 150
0.124
≤ 0.30
CADD® high volume administration set < 21-7055
545
≤ 580
0.1322
≤ 1.40
(mL/ hr)
10
13
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, which could result in patient injury or death.
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). Characterization of typical use: • An additional –4.8% change may be seen with a typical epidural catheter for use with an 18 GA needle and with a bolus rate of 40 mL/hr. • An additional –7.2% change may be seen with a typical epidural catheter for use with an 18 GA needle and with a bolus rate of 250 mL/hr.
Using CADD® administration sets
± 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). Characterization of typical use: • An additional –5.0% change may be seen with a typical epidural catheter for use with an 18 GA needle and with a bolus rate of 40 mL/hr. • An additional –8.5% change may be seen with a typical epidural catheter for use with an 18 GA needle and with a bolus rate of 250 mL/hr.
Using CADD® high volume administration sets
± 6% (nominal) at 15°C to 40°C with no back pressure • An additional ± 5% change may be seen at ± 100 mmHg (± 1.9 psi). Characterization of typical use: • An additional –7.2% change may be seen with a typical epidural catheter for use with an 18 GA needle and with a bolus rate of 40 mL/hr. • An additional –16.2% change may be seen with a typical epidural catheter for use with an 18 GA needle and with a bolus rate of 500 mL/hr.
Bolus accuracy specification: ± 6%
Actual test data for bolus accuracy at 0.05 mL: Average
0.0508 mL
% Error
1.6%
Minimum Error %
–3.0%
Maximum Error %
4.2%
Actual test data for bolus accuracy at 50 mL:
14
Average
50.77 mL
% Error
1.55%
Minimum Error %
–0.07%
Maximum Error %
2.35%
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
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
Delivery limit amount
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
Continuous rate
0 to 100 mL/hr (or the mg or mcg equivalent)
Clinician bolus
• 0 mL to 50 mL (or mg or mcg equivalent) • Delivery rate: 40 mL/hr to the maximum delivery rate in 1 mL increments.
PCA dose
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.
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
Intermittent bolus
• 0 mL to 50 mL (or the mg or mcg equivalent)
Intermittent bolus interval
0 to 4 hours
Next bolus
0 to 4 hours
Maximum doses per hour
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 2100: 250 mL/hr • 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
1 to 12 hours in increments of 1 hour
Pump stopped alarm
• Informational • High priority
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 • On • Off
Air detector
Air detector sensitivity Low Sensitivity: Single bubble > 400 μL High Sensitivity: Single bubble > 150 μL Upstream occlusion sensor
• On • Off
Downstream occlusion sensitivity
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.
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
Time format
• 00:00 to 23:59 military • 12-hour am/pm • US standard (month/day/year) • European standard (day/month/year) • International standard ISO 8601:2004 (year/month/day) • High • Medium • Low • On • Off
Date format
Alarm volume
Key beep 16
Note: The upstream occlusion sensor is automatically disabled during use with medication cassette reservoirs.
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 250 mL/hr on a model 2100 pump, and 500 mL/hr on a model
2110 pump. Programmed delivery rates exceeding 250 mL/hr require the use of a high volume administration set and a model 2110 pump. Attempting to attach a high volume administration set to a model 2100 pump will result in an alarm, and the pump will not run. 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) or the CADD®-Solis rechargeable battery pack are recommended 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).
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.
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
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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. 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
Rechargeable battery pack life with screen backlight intensity set to 3
IB Volume
IB Interval
Maximum Delivery Rate (mL/hr)
Operating Time (hrs)
Volume Delivered (mL)
(mL)
(min)
5
30
40
90
900
10
30
250
104
2080
10
30
500
88
1760
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
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Batteries
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.
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