Numia Micro Fuse User manual [gb]

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Extended Rate Infuser
OPERATOR MANUAL
Page 2
Important User Information
CAUTION: Do not autoclave, steam sterilize, EtO sterilize, or subject the MicroFuse Infuser to temperatures in excess of 40oC (104oF).
CAUTION: No user-serviceable parts inside. Refer all service, repair and calibration to qualified technical personnel. Do not make unauthorized modifications.
CAUTION: USA Federal and Canadian laws restrict this device to sale by, or on the order of, a physician.
WARNING: Always ensure that medications delivered simultaneously by the pump are compatible. Refer to the drug manufacturers’ labeling when selecting drugs for use.
WARNING: Always purge the infusion lines between infusions of two separate medications to avoid inadvertent infusion of medication contained within the administration set or to avoid inadvertent mixing of incompatible medications.
WARNING: Be sure that the syringe plunger is engaged by the syringe driver arm when MicroFuse Infuser is connected to a patient, to prevent siphoning.
WARNING: Purge the system of all air bubbles before administering any medication. Failure to follow this normal infusion procedure could result in patient injury.
USER INFORMATION
WARNING: Do not expose the pump to X-rays, gamma rays, or other ionizing radiation, or to strong electric or magnetic fields.
WARNING: Do not operate the MicroFuse Infuser in the presence of flammable anesthetics mixed with air or oxygen or nitrous oxide.
For Customer Support call 802-323-0101 • FAX 802-334-6971
Page 3
Important User Information
WARNING: If an “OCCLUSION” alarm occurs, Immediately disconnect the administration set at or above the administration site to eliminate the possibility of a bolus being delivered to the patient. Inspect the administration set for kinks, closed stopcocks, clogged catheters, etc.
WARNING: Not for use with blood or blood products.
WARNING: Remember that the volume of fluid contained in the connecting tubing is a residual amount and will not be infused. Allow for this needed extra volume of fluid when initially filling the syringe.
WARNING: This device must not be used in the presence of Magnetic Resonance Imaging (MRI) machines.
WARNING: To prevent siphoning, make sure the flange of the barrel is inserted in the barrel flange slot.
WARNING: Use only the syringes listed in the specifications on page 14 of this manual. Failure to do so many result in inaccurate delivery.
IMPORTANT: Carefully read the entire contents of this manual before using the MicroFuse Infuser.
IMPORTANT: For safe disposal of administration sets and syringes, refer to facility protocol.
IMPORTANT: The release date is on the back cover. If the date is greater than two years, please contact Baxa Corporation to see if additional information related to the this product is available.
For Customer Support call 802-323-0101 • FAX 802-334-6971
USER INFORMATION
Page 4
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Syringe Compatibility . . . . . . . . . . . . . . . . . . .2
Description . . . . . . . . . . . . . . . . . . . . . . . . . .2
Applications . . . . . . . . . . . . . . . . . . . . . . . . .3
Contraindications . . . . . . . . . . . . . . . . . . . . . .3
Infuser Diagram . . . . . . . . . . . . . . . . . . . . . . .4
Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Operating Procedures . . . . . . . . . . . . . . . . . . .6
Technical Reference . . . . . . . . . . . . . . . . . . . . . . . .9
Infusion Time Charts . . . . . . . . . . . . . . . . . . .9
Occlusion Pressure Charts . . . . . . . . . . . . . . .13
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Specifications . . . . . . . . . . . . . . . . . . . . . . . .14
Maintenance . . . . . . . . . . . . . . . . . . . . . . . .15
Customer Support . . . . . . . . . . . . . . . . . . . . .17
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . .18
General Information . . . . . . . . . . . . . . . . . . . . . . .18
TABLE OF CONTENTS
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Overview
The MicroFuse™ Extended Rate Infuser is intended for small-volume infusion of intravenous drugs. Rate 1 allows a bolus dose to infuse over 20 to 40 minutes, and over an extended length of time can accommodate volumes up to 85 mL. Rate 2 will extend the infusion over 4 to 24 hours. Infusion times on both rates are dependent on syringe size and solution volume.
MicroFuse Extended Rate Infusers are:
• Durable – solid-body construction with secure motor attachment
• Easy-to-use – simple push-button controls
• Portable – lightweight and slender profile
• Reliable – low maintenance, with built-in safety features
Syringe Compatibility
The MicroFuse Extended Rate Infuser is compatible with Becton-Dickinson®(B-D), Monoject®and Terumo®disposable syringes.
Description
The infuser operates on two standard alkaline C-cell batteries. The syringe holder secures the syringe in place. Once the infuser is turned ON, the syringe driver arm depresses the plunger at a fixed rate, administering the contents of the syringe through the administration tubing and into the patient access site. A microprocessor control operates at a constant delivery rate, and can infuse syringe contents against a back pressure of ± 100 mm Hg.
The MicroFuse Extended Rate Infuser infuses at one of two pre-set flow rates. RATE 1 (rabbit) infuses most doses over 20 to 40 minutes. RATE 2 (turtle) rate infuses most therapies over 4 to 24 hours.
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INTRODUCTION
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Description (continued)
The MicroFuse Extended Rate Infuser has a full complement of alarms, which signal: end of infusion, occlusion detection, low battery, maintenance required, and internal malfunction. Alarms are indicated by flashing status lights and an audible chime. NOTE: Audible alarms may be placed in MUTE mode by pressing Alarm Mute switch for two full seconds.
WARNING: Federal and Canadian law restricts this device to sale, distribution, and use by, or on the order of, a licensed practitioner.
Applications
Use the MicroFuse Extended Rate Infuser for the following types of intermittent and continuous infusion therapies:
1. Extended infusion of other drugs for periods of 4 to 24 hours, depending on syringe size and solution volume.
2. Primary intermittent infusion through a heparin or saline
lock.
3. Piggyback through a primary IV line. Primary line flow rate is
not interrupted. The infuser administration set is attached to the primary line at the lower injection port or flashball site.
4. Piggyback with an IV controller or IV pump. No change is
required for the pump or controller. The administration set is attached to the primary line at an injection port or a flashball site downstream from the primary infusion device.
5. Piggyback in combination with a volume control chamber
(burette). Burette flow rate is not interrupted. The administration set is attached to the primary line at either the lower injection port or the flashball site.
Contraindications:
The MicroFuse Infuser is not for use in the presence of
INTRODUCTION
explosive anesthetics.
NOTE: See Infusion Time Charts to determine appropriate fluid volume and syringe combinations to achieve extended infusions up to 24 hours.
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Infuser Diagram
Mute
Alarm
Indicator
Alarm
Audible
Rate 2
Indicator
Flow Rate
Rate
Flow
Rate 1
Indicator
Flow Rate
Flange
Syringe
Switch
Switch
Slot
Syringe Driver Arm Flange
Alarm Indicator
Wire Hanger
Low Battery Indicator
Battery Caddy
IV Pole Clamp Mounting Bolts
(Remove to attach pole clamp)
Serial Number
Syringe Barrel Holder
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Switch
ON/OFF
INTRODUCTION
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Features – Light Indicators
+
-
The MicroFuse Extended Rate Infuser uses five status indicator lights:
Indicator Status
Rate 1 Flashes GREEN when Flow Rate is set to Rate 1
Rate 2 Flashes YELLOW when Flow Rate is set to Rate 2
Low Battery Flashes RED when batteries need to be changed
Alarm Flashes RED when an alarm condition is detected
Alarm Mute Flashes YELLOW when the audible alarm is muted
NOTE: If the infuser detects an internal malfunction, the audible alarm always sounds, regardless of the Alarm Mute status.
Features—Alarms
Audible alarms accompany RED status indicator lights:
Condition Light & Chime Indicators
Action Required
End of Infusion/ Occlusion
Internal Malfunction
BASIC OPERATION
Low Battery/ First 10 hours at Rate 1
Low Battery/ After 10 hours at Rate 1
NOTE: The infuser will continue to operate for approximately 10 hours at Rate 1 after a low battery condition is first detected. After 10 hours, the infuser will not function and will sound an alarm.
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Slow flashing ALARM light with slow two-tone CHIME sound.
Rapid flashing ALARM light Rapid CHIME sound.
Multi-note CHIME when Power is first switched ON. LOW BATTERY light will continue to flash during an infusion when the batteries are low.
Repeating multi-note CHIME and infuser will not function.
Turn infuser OFF, or leave infuser ON and press ALARM MUTE switch. If an alarm occurs, and infusion is not complete, the IV set or catheter may be occluded. If an occlusion occurs, clear it and restart the infuser.
Turn infuser OFF, then ON. If alarm reappears, contact Customer Support. ALARM light remains lit when unit is OFF.
Change batteries as soon as possible.
Batteries must be changed.
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Operating Procedures
Follow accepted IV therapy techniques and procedures when setting up and administering intermittent or continuous IV therapy with the MicroFuse Infuser.
A. Setup
• Eliminate any air from syringe.
• Connect an IV administration set to the drug syringe.
NOTE: Administration set should be 6 to 60 inches long with an internal diameter (ID) between 0.020 and 0.030 inches. A tubing clamp is desired, but not required.
• Prime administration set to ensure that air is eliminated from the syringe and tubing.
B. Install Syringe
1. Load the syringe into the infuser by sliding it underneath the syringe barrel holder. Alternately, pull open the barrel holder and place syringe on the infuser.
2. Position the syringe barrel flange in the syringe barrel flange slot on the infuser body.
3. Position the syringe plunger in the slot on the syringe driver arm.
Syringe
Barrel Holder
Syringe
Flange
Slot
Syringe
Driver
Arm
WARNING: The syringe driver arm can be moved only when the Power ON/OFF switch is fully in the OFF position. Syringe plunger must be secured in the slot of the syringe driver arm. If plunger is not properly secured, or unit is not completely turned OFF, gravity flow may occur when the infuser is hanging above the patient. This may cause a delay or failure to deliver when the switch is placed in the ON position.
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BASIC OPERATION
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C. Select Flow Rate
Use the infuser scales to read an approximate time to infuse a specific dose. Check the Infusion Time Charts in the Technical Reference section for actual flow rates.
1. To check the infusion flow rate, press FLOW RATE switch. This can be done with the infuser power off.
2. To change rate, hold the FLOW RATE switch for two full seconds. RATE 1 will flash green, RATE 2 will flash yellow. RATE 1 infuses a bolus dose (ex: cefazolin 1 gram in 10 mL) over 20 to 40 minutes. RATE 2 infuses recommended doses over 4 to 24 hours.
NOTE: See page 17 for procedure to make the MicroFuse Infuser a single-rate infuser.
Administration
1. Attach the administration set to the patient infusion site.
2. Secure the MicroFuse Infuser to avoid unnecessary movement at the infusion site.
• Hang the infuser from an IV pole using the attached wire hanger.
• Attach the infuser to the IV pole using the optional IV Pole Clamp.
3. Begin the infusion cycle by sliding the ON/OFF switch to ON.
4. When the infuser is turned ON it will:
• Flash all alarm and status indicators.
• Produce an audible CHIME.
• Perform an internal self-check of the microprocessor and battery power level.
BASIC OPERATION
• Rate indicator light will flash during the entire infusion.
5. Press the ALARM MUTE switch for two full seconds to deactivate the audible CHIME, if desired.
NOTE: If any malfunction or alarm condition is detected, a CHIME will sound. Refer to the Features section for detailed descriptions. If an alarm occurs, and infusion is not complete, the IV set or catheter may be occluded. If an occlusion occurs, clear it and restart the infuser.
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Administration (continued)
6. When the infusion is complete, the ALARM flashes. A CHIME is sounded unless the ALARM MUTE switch is activated. Alarm verifies end of infusion has been detected.
7. To leave the infuser in place until the next use:
• Clamp the IV line and slide the ON/OFF switch fully to OFF. This turns off all alarm functions and releases the pressure on the syringe plunger.
8. To remove the syringe after infusion is complete, lift the syringe barrel holder and slide the syringe out of the infuser.
CAUTION: Releasing pressure on the syringe plunger can allow small amounts of the primary IV solution to be pumped back up the extension set and into the syringe. This situation can occur when the Infuser is OFF and an upstream infusion device is pumping the primary IV solution down the primary tubing. See notes on preventing fluid backflow.
Preventing Fluid Backflow
• When End of Infusion Alarm occurs, leave the infuser Power ON and press the ALARM MUTE switch. This will turn off audible alarms and leave the syringe driver arm locked in place.
• Clamp the MicroFuse Administration Set with the attached slide clamp.
• Use a primary tubeset with a back check valve prior to the secondary set attachment.
Procedural Notes:
• Always follow accepted IV therapy techniques when clearing occlusions and removing syringes and administration sets from the patient infusion site.
• Infuser may be turned OFF and infusion restarted at any time without affecting the infusion rate or accuracy.
• Administration set change interval should meet accepted facility policy.
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BASIC OPERATION
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Advantages to Using a MicroFuse Extended Rate Infuser for Continuous Infusion
• Save material costs – Use inexpensive syringes instead of costly ambulatory infusion pumps, tubings and bags as with CADD setups; less need for expensive full-size infusion pumps.
• Simplicity – Few infusion devices are easier to learn and use.
• Convenience – Use generic microbore sets versus dedicated disposables.
Infusion Time Charts
These charts provide a simple method to determine: infusion time, solution volume, and syringe size.
To use the Charts:
1. Select the appropriate chart by defining the desired flow rate (1 or 2) and the brand of syringe.
2. Select two of the three variables: solution volume,
infusion time or syringe size.
3. Cross-reference the two selections on the chart to locate
the third unknown variable.
Example (Monoject®60 cc syringe)
1. For a Monoject syringe, use Chart #2
TECHNICAL REFERENCE
9
2. Flow Rate: 2
3. Solution volume: 45 mL
4. 45 cc indicates
Time to infuse: 24 hours
NOTE: The infusion time labels located on the MicroFuse
Infuser are approximate. The actual infusion time for a given solution volume and syringe size should be determined from the Infusion Time Charts.
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Page 13
Infusion Time Charts
0
10
20 30 40 50 60 70 80 90 100
5
10 15 20 25 30 35
5101520
1
23456 7 8 9 10 11 12
1
2345
6
105
15
20 3025
35
40
45 minutes
140 cc
35 cc
20 cc
12 cc
6 cc
Infusion Time
Syringe Size
Volume Infused
105
10 20 30 40 50
60 cc
55
0
10 20 30 40
5
10 15 20 25 35
5101520
1
2345678910
1
234
5
93
15 18 24 hours21
60 cc
35 cc
20 cc
12 cc
6 cc
Infusion Time
Syringe Size
Volume Infused
45 cc
126
30
11 12
6
10 20 30 40
140 cc
85 cc
50 60 70 80
Chart #1: Monoject Syringes – Rate 1
Chart #2: Monoject Syringes – Rate 2
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TECHNICAL REFERENCE
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Infusion Time Charts
0
10 20 30 40
5
10 15 20 25 30
5101520
1
2345678910
1
234
5
93
15 18 24 hours21
60 cc
30 cc
20 cc
10 cc
5 cc
Infusion Time
Syringe Size
Volume Infused
45 cc
126
0
10 20 30 40 50
5
10 15 20 25 30
5101520
1
2345678 910
1
234
5
105
15
20 3025
35
40
45 minutes
60 cc
30 cc
20 cc
10 cc
5 cc
Infusion Time
Syringe Size
Volume Infused
55
Chart #3: B-D Syringes – Rate 1
Chart #4: B-D Syringes – Rate 2
TECHNICAL REFERENCE
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Page 15
Infusion Time Charts
0105
15
20 3025
35
40 minutes
Infusion Time
Syringe Size
Volume Infused
10 20 30 40 50 60
5
10 15 20 25 30 35
5101520
1
2345678 910
1
2345
6
60 cc
30 cc
20 cc
10 cc
5 cc
25
11
12
0
10 20 30 45
5
10 15 20 25 30
51015 25
1
234567 8910
1
234
5
93
15 18 24 hours21
60 cc
30 cc
20 cc
10 cc
5 cc
Infusion Time
Syringe Size
Volume Infused
50 cc
126
40
20
6
Chart #5: Terumo Syringes – Rate 1
Chart #6: Terumo Syringes – Rate 2
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TECHNICAL REFERENCE
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Occlusion Pressure Charts
These charts indicate the pressure exerted by the infuser when an occlusion alarm occurs. When the infuser is OFF, the pressure is released from the syringe driver arm.
To determine the typical occlusion pressures for a specific syringe:
1. Select the proper chart for brand of syringe.
2. Select the syringe size.
3. Read the resulting typical occlusion pressures from the
table.
Occlusion Pressure Charts
Monoject Syringes
Syringe (cc)
Typical Pressure, psig
The Monoject 140 cc
*
syringe requires the use of a smallbore (0.05") extension set to prevent false occlusion alarms.
Terumo
TECHNICAL REFERENCE
Syringes
Syringe (cc)
5
10
20
30
60
Typical Pressure, psig
30
24
27
16
11
NOTE: Excessively viscous solutions (e.g., D25W) may cause false occlusion alarms under some delivery conditions.
6
12
20
35
60
140* 9
B-D Syringes
Syringe (cc)
5
10
20
30
60
Typical Pressure, psig
28
22
23
20
14
36
24
24
21
15
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Page 17
Specifications
Size (L, W, H): . . . . . . . . . . .9.6 in x 2.7 in x 4.0 in
(24.4 cm x 6.9 cm x 10.1 cm)
Weight: . . . . . . . . . . . . . . . .25 oz. (0.7 kg) with batteries,
20 oz. (0.6 kg) without
Storage Temperature . . . . . .14°F to 149°F
(-10°C to 65°C)
Materials of Construction: . .Injection-molded plastic housing,
battery cover, syringe driver arm and syringe holder
Compatible Syringes: . . . . . .BD, Monoject, and Terumo
disposable syringes
Syringe Sizes: . . . . . . . . . . .5 to 140 cc
Accuracy of Flow Rate: . . . . .3% over 1.18 in (29.97 mm)
Power Requirement: . . . . . . .3.0 V dc (battery only)
Batteries: . . . . . . . . . . . . . .Two (2) C-cell, alkaline only
Infusion Rates: . . . . . . . . . .Rate 1: 5.5 in/hr, 14 cm/hr
Rate 2: 0.133 in/hr, 0.338 cm/hr
Delivery Times: . . . . . . . . . .Rate 1: 20 to 40 minutes
(for most applications) Rate 2: 4 to 24 hours
See the Infusion Time Reference
Charts for flow rates with specific
syringes.
Occlusion Pressure: . . . . . . .< 45 psi, (2327 mm Hg), See the
Occlusion Pressure Reference
Charts for typical occlusion
pressures with specific syringe
sizes.
Back Pressure Effect: . . . . . .None within 100 mm Hg
pressure
Mounting Options: . . . . . . . .Built-in wire hanger or optional
IV Pole Clamp
Alarms: . . . . . . . . . . . . . . . .Occlusion, end of infusion, low
battery, return for maintenance,
and internal malfunction
For Customer Support call 802-323-0101 • FAX 802-334-6971
APPENDIX
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Maintenance
The MicroFuse Extended Rate Infuser is designed to require little maintenance. On activation, the infuser checks all major functions. Cleaning, disinfection and inspection should be performed according to users’ standard protocols.
EMI Interference
The MicroFuse Extended Rate Infuser is designed to operate normally in the presence of most encountered electromagnetic field conditions. In the event of extreme levels of interference, normal operation may be disrupted.
Cleaning and Disinfection
Do not use harsh or aggressive cleaners such as concentrated bleach or ammonia. They may cause degradation of the unit and void the unit warranty! Exterior infuser surfaces may be
cleaned using a damp cloth and mild detergent. Use either ispropyl alcohol 70% or dilute germicidal bleach to disinfect. The infuser cannot be immersed or flushed with any solution. Do not sterilize using EtO gas or steam autoclave.
Battery Replacement
The MicroFuse Extended Rate Infuser operates with two C­cell alkaline batteries. To access batteries, unlock caddy at the side of the unit and squeeze. Caddy will pull out. Load new batteries into the holders according to the orientation indicated. Replace the battery caddy.
APPENDIX
15
Inspection
If the infuser has been dropped or damaged, inspect the unit before use.
• Look for visible cracks or breaks in the case.
• Inspect the battery housing for damage.
• Batteries must fit in the battery caddy, and the caddy must seat snugly into the infuser body.
• Turn power ON and verify that the syringe driver arm is locked into position.
• Run a Flow Rate Test to verify delivery accuracy.
CAUTION: Dropped infusers may incur internal damage.
Refer to the instructions above to check for unit damage.
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Page 19
Flow Rate Test
The rate of travel of the syringe driver arm may be tested as follows:
1. Set the FLOW RATE switch to Rate 1.
2. Set the syringe driver arm as far toward the hanger as possible (maximum travel).
3. Slide the Power ON/OFF switch to ON.
4. Time until the End of Infusion alarm occurs. The time should be 44 to 47 minutes.
NOTE: Always replace both batteries at the same time with fresh batteries. Be careful to load both batteries in the correct orientation.
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APPENDIX
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Rate Lock Out
To restrict the MicroFuse Extended Rate Infuser to a single infusion rate:
Set desired infusion rate using the FLOW RATE switch. Either Rate 1 or 2 can be locked. Release and remove battery caddy. Slide the LOCK/ UNLOCK switch in the battery compartment to LOCK. This fixes the FLOW RATE at the selected rate. Replace the battery caddy. Switch to UNLOCK to allow rate selection again.
Customer Support
If the infuser malfunctions, or is defective for any reason, it should be returned to an authorized agent.
Contact Customer Service (802-323-0101) for a Returned Goods Authorization (RGA) number and shipping instructions. Please have the following information available:
• Infuser serial number • Reason for the return
Freight is prepaid. Shipping weight: 2 lb. 2 oz. (when returned in the foam-lined infuser box). Goods returned without an RGA will be refused.
Ship to: Numia Medical Technology
84 Farrant Street Newport, VT 05855
APPENDIX
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Page 21
General Information
New Product Program
Most of the products we offer were made because of customer suggestions. We welcome your suggestions for new products and improvements on existing products.
Product Warranty
The Limited Warranty provided with the purchase of the MicroFuse Extended Rate Syringe Infuser covers defects in materials or workmanship for a period of 12 months from the date of purchase. This Warranty does not cover failures due to negligence or misuse.
Numia Medical Technology may, at its sole discretion, exchange the infuser for another that is in good working order. The MicroFuse Infuser is warranted to perform in accordance with published specifications and information.
This is an exclusive warranty. Any remedies under this warranty are restricted to replacement of defective product. Numia Medial Technology is in no way liable for incidental or consequential damages.
Ordering Information
To order MicroFuse Extended Rate Infusers and accessories:
Contact Numia Medical Technology:
Phone: 802-323-0101
Fax: 802-334-6971
For Customer Support call 802-323-0101 • FAX 802-334-6971
APPENDIX
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Notes
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Page 23
Notes
For Customer Support call 802-323-0101 • FAX 802-334-6971
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6400-IFU-0006 Rev.C
Numia Medical Technology, LLC
84 Farrant Street
Newport, VT 05855
tel: 802-323-0101
fax: 802-334-6971
Manufactured by:
www.numiamedical.com
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