SMARTeZTM Pump INDICATIONS FOR USE STATEMENTS

Portable single-use elastomeric infusion pump

The SMARTeZTM Pump (Long infusion time article) is intended
Manufactured under 21 CFR 820 QS Reg. and EN ISO 13485:
for continuous infusion of medications for general infusion use
2016 compliant quality management systems.
including pain management.
• Routes of administration: intravenous and subcutaneous.
DESCRIPTION The SMARTeZTM Pump (Short infusion time article) is intended
The SMARTeZTM Pump has a specially designed multi-layered for continuous infusion of medications for general infusion use
balloon-like reservoir including antibiotic delivery.
infusion. It exerts a mechanical pressure, thereby administering the • Route of administration: intravenous.
contents through The SMARTeZTM Pump (Chemotherapy article) is intended for
continuous infusion of medications for chemotherapy.
• Routes of administration: intravenous and intra-arterial.

WARNINGS
Do not use in infusion regimens by patients who do not
possess the mental, physical or emotional capability to self-ad-
minister their therapies or who are not under the care of respon-
sible individuals. This warning includes paediatrics as they are
time are similar as shown in Figure 2.
not capable of using the devices by themselves.
Do not use if packaging or product is damaged or opened.

getting wet.
Do not use with pressure infusion device.
When administering through the intra-arterial and subcuta-
Nominal Flow Rate
+20%
decrease.
0%
caution when used with immobilized patients and to avoid
- 20%
device being slept on. Applied pressure may result in rupture or
- 40%

-60%
of medication, see drug MSDS for appropriate actions.
Do not re-sterilize. Strictly for single-use and pump must be
-80% discarded in accordance with local regulations.
-100% Store under general warehouse conditions at 68°F to 77°F
(20°C to 25°C). Protect from light sources and heat. Keep dry.
100% Infusion Time
Drug products should be stored in their approved containers
and closures.
Do not store in freezer.

Table 1: Residual volumes CONTRAINDICATIONS

Infusion of insulin, blood or blood products, TPN, lipids or fat
emulsions.
Infusion of any solutions that are not compatible. Consult the
Nominal Volume Residual Volume
pharmaceutical manufacturer’s precautions and guidelines to
50 - 125 mL 2.0 mL ensure that the medications used will not interact with the
device that may possibly cause damage, leakage or precipita-
200 - 300 mL 3.5 mL tion.
Intra-articular infusion of local anesthesia.
400 - 500 mL 5.0 mL Infusion of anesthetics in neonates, infants and children
below 5 years of age.

+20% +20%

0% 0%

Nominal Flow Rate

Flow Rate

Flow Rate

- 20% - 20%
Nominal Flow Rate
- 40% - 40%

-60% -60%

-80% -80%

Infusion Time Infusion Time

-100% -100%

135 Hours 270 Hours

-80% 30 Minutes 60 Minutes

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SMARTeZ TM Pump MIXING AND USE INFORMATION
Portable single use elastomeric infusion pump See the drug manufacturer’s package insert for drug reconstitu
tion / dilution and storage procedures. Drugs tested for stability and
1. Fill Port compatibility, representing each route of infusion, include Ceftriax-
2. Outer soft cover one, Deferoxamine, Floxuridine, and Vancomycin. Also see drug
3. Multi-layered elastomeric membrane package insert for drug compatibility with ABS, silicone elastomer,
4. ON-OFF Clamp PVC not made from phthalate (DEHP), acrylic, cellulose acetate or
5. Non DEHP PVC administration tubing
6. Air and particulate eliminating filter olume by multiplying the desired infusion time
7. Flow restrictor (hours) by the nominal e (mL/h) and adding the residual
8. Patient connector volume. Alteration of dosage is achieved by adjusting the drug
9. Patient end cap
10. Sterile color-coded fill port cap
11. Disposable protective fill port cap INSTRUCTIONS FOR FILLING
12. Labeling – Fill volume & infusion duration - Use Aseptic Technique
13. Labeling - Flowrate 1. Unscrew the port cap with the sterile
.
2.SMARTeZTM Pump can be with a syringe or automated
device. Remove trapped air from the device and
10 attach it
3. Close the ON-OFF clamp and the SMARTeZTM Pump with no
more than the maximum recommended volume. When using a
11
12 syringe t
the barrel on
1 Repeat as necessary.
4. Remove device from the port.
2

3
5. Label with appropriate pharmaceutical and patient information.

PRIMING THE ADMINISTRATION TUBING

- Use Aseptic Technique
1. Open the ON-OFF clamp.
9
the tubing. When all air is expelled, tighten the patient end cap.
4 3. Close the ON-OFF clamp.
8
PRIMING TECHNIQUE FOR DRUGS
9
5 - (for drugs prone to precipitation)
7
1. Fill SMARTeZTM
2. Using the above priming method, prime the tubing.
3. Fill the remaining volume with diluent and medication. At
6
precipitation, while the pump reservoir will contain medication.
13
STARTING INFUSION
- Use Aseptic Technique
1. Allow SMARTeZTM Pump to warm to room temperature before
use, especially when infusate has been refrigerated.

3. Verify that the ON-OFF clamp is close.

4. Clean patient access site as directed by the hospital or healthcare
OPERATING CONDITIONS AND SAFETY provider. Attach the patient connector to the injection site.
Actual infusion time may vary due to the following: 5. Begin infusion by opening the ON-OFF clamp.
Filling the device less than the nominal volume generally results in
w rate.
Filling the device more than the nominal volume generally results in SINGLE USE ONLY
ate.
SMARTeZTM -
. ness and safety as a single-use device and not for reuse.
The safety of the device is validated based on infusion time and an
additional 8 hour drug/device contact time. device is reused.

resulting in shorter delivery times , while lower temperature increases CAUTION : Federal ( USA ) Law restricts this device to be sold by or on
viscosity resulting in longer delivery times. the order of a physician.

skin (31 deg C / 88 deg F) and the tubing and pump should be under
the patients clothing ( 25 deg C/ 77 deg F ). For an increase of every one Distributed by : Progressive Medical Inc., St. Louis, MO.
800-969-6331.

C / 88 deg F) as reference. Use of 5% dextrose will result in 10% slower

leakage from the air elimina

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 LIST OF ARTICLES / MODEL NUMBERS - SMARTeZ TM PUMPS
REF No. Nominal Fill Nominal Flow Nominal Time Approx. Nominal Qty Per
Type
(Article/ Model) Volume (mL) Rate (mL/h) (Hr) Time (Day) Carton
480151 65 mL 0.5 mL /h 130 Hr 5.5 Days 12
480181 100 mL 0.5 mL/h 200 Hr 8 Days 12
480191 270 mL 1 mL /h 270 Hr 11 Days 12
480121 100 mL 1.5 mL /h 67 Hr 3 Days 12
480051 60 mL 2 mL/h 30 Hr 1 Day 12
480081 100 mL 2 mL/h 50 Hr 2 Days 12
480101 120 mL 2 mL/h 60 Hr 2.5 Days 12
Long infusion time

480161 270 mL 2 mL/h 135 Hr 5.5 Days 12

480171 300 mL 2 mL/h 150 Hr 6 Days 12
480061 120 mL 4 mL/h 30 Hr 1 Day 12
480131 270 mL 4 mL/h 68 Hr 3 Days 12
480141 400 mL 4 mL/h 100 Hr 4 Days 12
480011 60 mL 5 mL/h 12 Hr 0.5 Day 12
480021 80 mL 5 mL/h 16 Hr 0.5 Day 12
480031 125 mL 5 mL/h 25 Hr 1 Day 12
480091 270 mL 5 mL/h 54 Hr 2 Days 12
480111 400 mL 5 mL/h 80 Hr 3 Days 12
480041 270 mL 10 mL /h 27 Hr 1 Day 12
480071 400 mL 10 mL /h 40 Hr 1.5 Days 12
REF No. Nominal Fill Nominal Flow Rate Nominal Time Approx. Nominal Qty Per
Type
(Article/ Model) Volume (mL) (mL/h) (Min) Time (Hr) Carton
481032 50 mL 50 mL /h 60 Min 1 Hr 24
481092 100 mL 50 mL/h 120 Min 2 Hrs 24
481152 250 mL 50 mL/h 300 Min 5 Hrs 24
481042 100 mL 100 mL/h 60 Min 1 Hr 24
481112 200 mL 100 mL/h 120 Min 2 Hrs 24
Short infusion time

481122 250 mL 100 mL /h 150 Min 2.5 Hrs 24

481101 400 mL 100 mL/h 240 Min 4 Hrs 12
481132 250 mL 125 mL/h 120 Min 2 Hrs 24
481062 250 mL 175 mL/h 90 Min 1.5 Hrs 24
481012 100 mL 200 mL/h 30 Min 0.5 Hr 24
481142 200 mL 200 mL/h 60 Min 1 Hr 24
481071 400 mL 200 mL/h 120 Min 2 Hrs 12
481052 250 mL 250 mL/h 60 Min 1 Hr 24
481081 500 mL 250 mL/h 120 Min 2 Hrs 12
481022 250 mL 500 mL /h 30 Min 0.5 Hr 24
484011 100 mL 2 mL/h 50 Hr 2 Days 12
Chemotherapy

484021 270 mL 2 mL/h 135 Hr 5.5 Days 12

484031 120 mL 4 mL/h 30 Hr 1 Day 12
484041 270 mL 5 mL/h 54 Hr 2 Days 12
484051 270 mL 10 mL/h 27 Hr 1 Day 12

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 Table 3: Definitions of symbols

QTY QuanTitY EA EAch

Use by YYYY-MM -DD Manufactured on YYYY-MM -DD

LOT Batch code Article number/ model number

REF
Authorized representative in the
EC REP Manufacturer
European Union and EFTA

CE Marking of Conformity,
Sterilized using ethyleneoxide 0086 Certi cation by BSi

Single-use only, do not reuse Consult instructions for use

Do not use if package is damaged Keep dry

Keep away from sunlight Packaging is able to be recycled

Not made with natural rubber latex Not made with phthalate(DEHP)

Rx only CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician

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