Attachment G - Label Version 3

Attachment G - Label Version 3.pdf

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Attachment G - Label Version 3

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Tohamadi Large Volume
Infusion Pump

Brand Name
Manufacturer

Ivy Test Systems

Model

TOW724

Table of Contents
Description	1
Uses 	
1
Contraindications 	
1
Risks	1
Instructions for Use 	
2
Warnings and Precautions 	
2
Cleaning the Pump 	
2
Compatible Accessories 	
2
Common Alarms	
3
Troubleshooting	3

Customer Service: 1-800-555-1212
www.tohamadi.com
Last Updated: 03/25/2010

Display
Screen

Charger

Battery
Charge
Indicator
Numeric
Keypad

1

2

4

3

5

7

6

8

E

9

0

C

START Button
1

2

3

ALARM Button

Door
Latch

4

5

6

PAUSE Button

7

8

9

Infusion
Catheter
Line In

E

0

C

AC Adapter

UP/DOWN Buttons
STOP Button
CLEAR Button
ENTER Button

Description	

Single channel large volume infusion pump. Features: flow
sensor, alarms for occlusions, air in line, and low battery;
Enter
no lockout mechanism; and can be mounted
on pole.

Uses 	

1
2
3
Clearviscous liquids: general
Continuous or intermittent
infusions
of
IV fluids, blood, antibiotics,
lipids,
TPN, and enteral feedings.
4
5
6

Contraindications	

Enter

Not to be used for:
7
8
9
	insulin
0
pain medication
antispasmodics
	
Not for use in children under 5 years of age.
1

2

4

3

5

7

8

Clear

6

9

0

Risks 	

Air embolism
	
Delay in therapy
	
Incorrect therapy
	Overdose
	Underdose

Report problems to the Food and Drug Administration at: 1-800-FDA-1088
or online at http://www.FDA.gov/Safety/Report

1

Instructions for Use
Verify you have the custom tubing and the pole clamp.
Connect the pump to the charger. Mount the charger on an IV pole.
Connect the charger to the power cord and into a standard AC outlet.
Open the door and thread infusion catheter through pump mechanism.
Close the door.
Connect the infusion set to the medication bag. Mount the bag on the
IV pole.
Prime the primer line.
Connect the infusion set to the patient.
Press the 1START
button once. You will hear 4 beeps and the display
2
3
screen will
light
up.
4
5
6
The pump
ready to use.
7 is8 now
9
1
2
3

How to Operate the Pump

Programming the Pump

1
4
7
E
1
4
7
E

2

3

Enter

4
1

2

4

5

6

7

8

9

3

Clear

7

5
8

1

2

3

4

5

6

7
1

8
2
6 01
5
4

9
3
2

3

6
5

6

4

9

To Clear All Programming
To Pause or Reprogram

Clear

Enter

Clear

7

8
7
0

Enter

2

9
8

3

0

1
4

Clear

2

7

5

Warnings and Precautions	
	
	
	

Cleaning the Pump	

9

1
4

3

78

E 0
Press the 1CLEAR
2
3

4

5

6

7

8

9

7

8

Clear
Enter

1

6
9

2

3
Enter

5

6
9

button.

8

Enter

2

3

4

5

6

7

8

9

3

Clear

6

button.
9

0

0 C
Press theE STOP
1

Enter

2

7

Press the4 7PAUSE
58 69

Clear

0C

5

0

Clear

89

1 4 2 5 3 60 4
7E 8 0 9C

To Stop the Pump

Enter

Lift the
E latch
0 C 1at 2the3 top of the pump where it is attached to the charger.
The pump will
from the charger.
4 release
5
6

0
1

2
3
C
6
5
6
9
81 92
C
04 C5
2
3
7
8
5
6
E 0
81 92

7
Press
button to see the volume to be infused (VTBI).
6 the PAUSE
3
E
8Use
9 UP
or DOWN
button to adjust the volume or enter the
6
0volume
C
on the keypad.
9
2
3
4
C
to save
the VTBI.
5Press
6 ENTER
7
3
8Use
9 UP
E DOWN
04 C5
or
button to adjust the rate or enter the rate
6
0onCthe keypad. 7
8
9
0 save
C
Press ENTER E to
the rate.
2
3
Press 1START
to begin the infusion.
5

Enter

For Battery Operation and
to Use the Pump in Transit

1
0
5
4
8
7
0
E
1

E
4

button to stop the infusion.

Clear

Enter

This pump has not been tested for administration of infusion to
pregnant women.
Use only accessories designed for this system.
Do not reuse tubing or other disposables.
Do not use in the presence of flammable anesthetics.
0

1

2

3

4

5

6

7

8

Clear

9

Enter

0

1

1
4

4
7

2

2
5

5
8

3

3
6

6

Enter
Clear

Clear

9

For general cleaning, clean exterior surfaces with a damp cloth.
For disinfection, use only cleaners listed in the full device labeling.
7

8

0

9

0

Compatible Accessories	
	
	
	

Custom Tohamadi 9.2” intravenous tubing
AC adapter/charger
Rechargeable battery pack
Reusable pole clamps

2

Common Alarms
Alarm
Air In Line
Battery Low
Occlusion
Volume Low
Door Open
Refer to full device labeling for more information on alarms.

Troubleshooting

1

2

3

4

5

6

1

2

3

9

4

5

6

7

8

Air in the Line	

0 C
8
9
If there’s air in the line, pressE STOP
or 7PAUSE
and check to see if
E
0
C
the tubing is properly inserted. Remove the air from the line by closing
the clamps, disconnecting the pump from the patient, and priming the
2
3
fluid path. Press 1START
to restart the pump.

Low Battery	

3
If the battery is low,
plug
the cord into1 an2 AC
electrical source within
7
8
9
1
2
3
4
5
6
10 minutes of the
alarm.
E 0 C

4

5

6

7

Enter

Occlusion	

8

4

9

5

6

9
If there’s an occlusion in the line, press STOP
or PAUSE
and
E 0 the
C
open the clamps. Check for a bend or kink in the tubing,
occlusion
2
3
pressure1 setting,
and the IV site for any signs of infiltration. Remove the
4
5
6
2
3
obstruction and press 1START
to restart the pump.
E

0

8

9

4

5

Enter7

1

2

3

4

5

6

1

2

3

7

8

9

4

5

6

7

8

9

Clear

0

7

C

6

8

Clear

0

Low Volume 	

1
2
3
0 C
Press theE STOP
button
and
change the medication bag. Restart the
7
8
9
1
2
3
4
5
6
2
3
infusion and press 1START
to
restart the pump.
E 0 C

Door Will not Close 	

E STOP
0 C
8
9
If the door is open,7 press
or 7PAUSE
and check to make sure
8
9
E
0
C
the tubing is aligned
properly in the pump. Check to make sure the latch
E 0 C
1
2
3
is in the proper position. Close the door and press START
.

Enter

1

4

2

5

3

4

5

6

7

8

9

7
6

8

4

9

Clear

0

Display Does not Light	

5

6

Enter
Enter

1

2

3

4

5

6

1

2

3

7

8

9

4

5

6

75

8

Clear

4

0

6

Clear

9

If operating on battery power, the battery may need7 recharging.
8
9
Connect the power cable to the pump and plug it into
E 0 a Cregular 120V
outlet. Check to make sure the power cables are firmly attached and
the pump is switched to the ON position.
Enter

1

2

3

4

5

6

7

8

9

0

Clear

Enter

1

2

3

4

5

6

0
7

1

8

4

5

4
3
0
7
6

7

8

9

1

2

2
5

Enter

9

Clear Enter

3

Enter

Clear

6

1

2

3

9

4

5

6

7

8

9

Clear

Clear

8
0

0

Enter

0
1

2

3

4

5

6

Clear

ATTENTION: These instructions do not include all the information needed for the safe and effective use
of this pump. See the full device labeling for more complete information on the use of this device.
7

8
0

9

3


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File Modified2011-10-11
File Created2011-09-14

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