Medtronic 8626, 8627L, 8626L, 8627 User Manual

SYNCHROMED® EL

8626

Programmable pumps

8626L

8627

8627L

Implant manual

! USA

Rx only

1999

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Open here

Do not reuse

Sterilization: ethylene-oxide gas

STERILE

EO

Caution, consult accompanying documents

Use by

Manufacturing date

Storage temperature

Serial number

Conformité Européenne (European Conformity). This symbol means
that the device fully complies with AIMD Directive 90/385/EEC and
R&TTE Directive 1999/5/EC.

The use of this device might be subject to individual country licensing
regimes in Europe.

For USA audiences only

1

Medtronic® and SynchroMed® are registered trademarks of Medtronic, Inc.

2

Table of contents

Device description 5

Package contents 6

Patient identification card and registration 6

Device specifications 7

Device longevity 10

Flow rate accuracy 14

Declaration of conformity 14

Instruction for use 15

Preparing for pump implant 15
Sterile procedure 17
Emptying the pump 17
Preparing to fill the pump 18
Filling the pump 18
Replacing an implanted pump 19
Preparing the pump pocket 21
Implanting the pump 21
Programming the pump 22
Refilling the pump 23
Accessing the catheter access port 23

Appendix A — Refilling the pump 25

Contraindication 25
Preliminary procedures 25
Emptying the pump 26
Performing a reservoir rinse 27

Refer to the Indications, Drug Stability, and Emergency Procedures, reference
manual for indications and related information.

Refer to the appropriate information for prescribers booklet for contraindications,
warnings, precautions, adverse events summary, individualization of treatment,
patient selection, use in specific populations, and component disposal.

Refer to the appropriate drug labeling for indications, contraindications, warnings,
precautions, dosage and administration information, and screening procedures.

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Refilling the pump 28
Programming the pump 30
After the refill procedure 30

Appendix B — Accessing the catheter access port 31

Contraindications 31
Preliminary procedures 32
Preparing the access site 32
Intraspinal applications only 32
Vascular applications only 34
Flushing the catheter access port 35
Clearing a catheter occlusion 36

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Device description

The implantable Medtronic SynchroMed EL programmable pump is part of an infusion system
that stores and delivers a prescribed drug to a specific site. The implanted infusion system
consists of a SynchroMed EL pump and a catheter.

The catheter connects to the pump catheter port. The pump is anchored in the pump pocket
using the suture loops on the outside of pump models 8626L-10, 8626L-18, 8627L-10, and
8627L-18. Pump models 8626-10, 8626-18, 8627-10, and 8627-18 are anchored to the pump
pocket using a mesh pouch.

The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from
the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site.

Pump models 8627-10, 8627-18, 8627L-10, and 8627L-18 have a catheter access port (CAP)
(Figure 1). The CAP allows injection of drug directly into the implanted catheter for drug
administration and diagnostic purposes. Drug injected into the CAP bypasses the pump
mechanism and goes directly through the catheter port into the implanted catheter to the
infusion site. The CAP allows entry of a 25-gauge noncoring needle to prevent accidental
injection during refill procedures (which use the 22-gauge noncoring needle supplied in the
refill kit).

Catheter

access port

Pump with catheter access port Pump without catheter access port

Catheter port

Reservoir fill

port

Figure 1. Pump exterior view.

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Package contents

■

Pump

■

Needle, 22-gauge (black sheath)

■

Needle, 25-gauge (orange sheath) (models 8627-10, 8627-18, 8627L-10, and 8627L-18)

■

Mesh pouch (models 8626-10, 8626-18, 8627-10, and 8627-18)

■

Product literature

■

Registration form

■

Patient identification card

■

c

Warranty card

Patient identification card and registration

A patient identification card is packaged with this device. Advise the patient to carry the
identification card at all times.

c

The patient identification card packaged with the device is temporary; a permanent card

is mailed to the patient when Medtronic receives the registration form.

c

The implant registration form registers the device warranties and creates a record of the

device in the Medtronic implant data system.

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Device specifications

Table 1. Shipping and operating values for the SynchroMed EL pumps

Shipping Operating

Fluid in reservoir 10 mL models:

minimum 8 mL sterile
water when
manufactured

18 mL models:
minimum 15 mL sterile
water when
manufactured

Shipping flow rate 0.007 to 0.012 mL/day

Infusion modes

Simple continuous Single bolus

a

a

Priming bolus
Purge bolus
Stopped pump

Periodic bolus
Simple continuous
Complex continuous

Bridge bolus and simple continuous
Priming bolus and simple continuous
Single bolus and simple continuous

Alarms

Low battery alarm
Low reservoir alarm
Pump memory error

Disabled
Enabled
Enabled

Enabled/disabled
Enabled/postponed
Enabled

Audible alarms Enabled Enabled/disabled

a

The volume of sterile water in the pump reservoir when the package is opened depends on the amount of
time that has elapsed since the pump was manufactured (the more time that has elapsed, the less sterile
water will be in the pump reservoir). The volume of sterile water that is removed from the pump reservoir
before implant will be at least the amount that the programmer calculates is in the pump during the initial
interrogation.

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Table 2. Device specifications for the SynchroMed EL 10 mL pumps

a

Models 8626-10 and
8626L-10

Models 8627-10 and
8627L-10

Pump

Thickness
Weight (empty)
Displacement volume
Diameter (without CAP or

21.6 mm
165 g

83.1 mL

70.4 mm

21.6 mm
185 g

105.0 mL

70.4 mm
silicone rubber surface pad)
Diameter (with CAP or silicone

85.2 mm

85.2 mm
rubber surface pad)

Pump reservoir

Volume
Residual volume

10.0 mL

1.2 mL

10.0 mL

1.2 mL

Pump tubing

Volume 0.23 or 0.32 mL 0.26 or 0.36 mL

Reservoir fill port

Septum puncture life 500 punctures 500 punctures

Catheter access port

Prime volume
Septum puncture life
Recommended maximum
injection rate

-----

-----

-----

0.4 mL

2000 punctures
15 mL/min saline/drug;
3 mL/min radiopaque
compounds

Flow rate

Maximum programmable
Minimum programmable
Stopped pump maximum

b

c

21.6 mL/day

0.048 mL/day

0.120 mL/day

21.6 mL/day

0.048 mL/day

0.120 mL/day
leakage

Bacterial retentive filter

Pore size 0.22 µm (micron) 0.22 µm (micron)

Power source

Battery
Longevity

a

All measurements are approximate.

b

Actual limits depend on pump calibration constant and selected infusion mode. The programmer may further
narrow these limits.

c

At rates less than 0.048 mL/day, the flow accuracy may exceed the ±15% specification.

Lithium thionyl-chloride
Rate dependent
(Figure 3)

Lithium thionyl-chloride
Rate dependent
(Figure 3)

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Table 3. Device specifications for the SynchroMed EL 18 mL pumps

a

Models 8626-18 and
8626L-18

Models 8627-18 and
8627L-18

Pump

Thickness
Weight (empty)
Displacement volume
Diameter (without CAP or

27.5 mm
185 g

107.0 mL

70.4 mm

27.5 mm
205 g

125.0 mL

70.4 mm
silicone rubber surface pad)
Diameter (with CAP or silicone

85.2 mm

85.2 mm
rubber surface pad)

Pump reservoir

Volume
Residual volume

18.0 mL

2.4 mL

18.0 mL

2.4 mL

Pump tubing

Volume 0.23 or 0.32 mL 0.26 or 0.36 mL

Reservoir fill port

Septum puncture life

500 punctures 500 punctures

Catheter access port

Prime volume
Septum puncture life
Recommended maximum
injection rate

-----

-----

-----

0.4 mL

2000 punctures
15 mL/min
saline/drug; 3 mL/min
radiopaque compounds

Flow rate

Maximum programmable
Minimum programmable
Stopped pump maximum

b

21.6 mL/day

0.048 mL/day

0.120 mL/day

21.6 mL/day

0.048 mL/day

0.120 mL/day
leakage

Bacterial retentive filter

Pore size 0.22 µm (micron) 0.22 µm (micron)

Power source

Battery
Longevity

a

All measurements are approximate.

b

Actual limits depend on pump calibration constant and selected infusion mode. The programmer may further
narrow these limits.

Lithium thionyl-chloride
Rate dependent
(Figure 2)

Lithium thionyl-chloride
Rate dependent
(Figure 2)

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Table 4. Material of components in the SynchroMed EL sterile package

Component Material Material contacts

Material contacts

human tissue

Pump

Exterior Titanium Yes No
Reservoir Titanium No Yes
Reservoir valve Titanium No Yes
Tubing Silicone rubber No Yes
Reservoir fill port

Silicone rubber Yes Yes

septum
Catheter access

port septum

a

Silicone rubber Yes Yes

Catheter port Titanium Yes Yes
Bacterial

retentive filter
Suture loops

b

Polyvinylidene

No Yes

fluoride
Titanium Yes No

Propellant Inert gas No No

drug

Needles Stainless steel Yes Yes

a

Models 8627-10, 8627-18, 8627L-10, and 8627L-18

b

Models 8626L-10, 8626L-18, 8627L-10, and 8627L-18

Device longevity

Pump service life is a function of flow rate and shelf time. Shelf time is the number of months
between the date of manufacture and the implant date. (The date of manufacture is located on
the package label.) Service life is the number of months from implant to pump stoppage due to
battery depletion. With a higher flow rate and longer shelf time, service life is reduced
(Figure 2).

To determine service life, first determine the shelf time and flow rate. Then refer to
Figures 3 to 6 to read service life for 15-, 24-, 36-, or 48-month shelf time.

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