Intended Use:
VIVI CAP is a reusable replacement cap for insulin pens. It is intended to keep
insulin cool within safe temperatures below 30°C (86°F) for minimum of 12
hours even in a constant environmental temperature of 37.8°C (100°F), when the
device is placed inside a personal handbag. The cap temperature regulation is
passive and combines thermal insulation with heat absorbent material. The cap is
‘reactivated’/’filled up’ to provide safe storage conditions, whenever the ambient
temperature gets below 26°C (78.8°F), for subsequent periods of 12 hours all
year long.
Note that insulin must always be at the manufacturer’s recommended
temperature. Please refer to the insulin package insert of your specific insulin pen.
Device Components:
The device consists of the following components:
• Thermal insulation (stainless steel), held between the outer plastic cover
and the inner plastic adaptor.
• Inner filling of Phase Change Material (non-toxic & non-flammable –
Safety Data Sheet available if required), held between the thermal
insulation and the inner plastic adaptor.
• Inner plastic adaptor that fits the pen type
• Outer plastic cover
• Primary (non-rechargeable) battery, switch, Green/Red indicator light and
temperature sensor
• Ring shaped plastic pen-adaptors with breakable key code letters
Operating Instructions:
1. Release the cap from the package, press & release the switch [there is
no need to continue pressing the switch] and check the indicator light.
If the indicator light does not turn on, contact the manufacturer. DO NOT
USE the device.
2. If the indicator light is RED, DO NOT USE the device, leave it in an ambient
temperature of less than 26°C (78.8°F) for at least 5 hours or place it
inside a refrigerator for about an hour. Then, press & release the switch
and check that the indicator light is GREEN.
3. If after step 2 the indicator light is not GREEN, contact the manufacturer.
DO NOT USE the device.
4. When the indicator light is GREEN, you are ready to use the activated VIVI
CAP with your medication pen. But first you should fit the proper pen type
ring adaptor to VIVI CAP. This procedure should be performed once only.
5. Choose the proper pen adaptor according to your pen name and the
letters marked next to the plastic ring adaptor : F/S – for FlexPen® or
SoloStar®, K-for KwikPen®, T-for FlexTouch®*. Remove your pen cap
and slide the pen adaptor over your pen starting with the needle side
while the adaptor letter faces the needle side (see Fig 1-3) until it locks
with a “click” sound”. For FlexTouch®* note that the Pen is aligned
properly to the adaptor- Fig 2. If the adaptor doesn’t lock, make sure you
have matched the pen adaptor to your pen. While holding the pen around
the pen adaptor with fingers of one hand, with your other hand tilt “back
and forth” the adaptor letter until it breaks off Fig 4. While aligning the
grove on the adaptor to the rail on the top part of VIVI CAP Fig 5, insert the
pen with the ring adaptor to VIVI CAP until it locks with a “click “sound
Fig 6. The ring adaptor will connect “flat” to the top part of VIVI CAP, will
remain inside VIVI CAP and will fit it to your your pen
6. Use your pen as prescribed.
7. Always remove the used needle after each injection and store the insulin
pen without a needle attached.
8. During daily use, the indicator light should be checked by pressing the
switch and observing the indicator light color. Even if the indicator light
is GREEN, to assure proper operation, the device should be placed for
about 6 hours in an ambient temperature of less 26°C (78.8°F) at least
once every 12 hours.
9. At any time if the indicator light is RED when checking it, stop using the
device. Place the device in an ambient temperature of less than 26°C
(78.8°F) and start using it again when while checking it, the GREEN
indicator light has turned on.
10. If during normal use, after 1 year from first activation while in room
temperature, the indicator light does not turn on, the battery is depleted.
The cap must be disposed of properly.
Device Signals:
The device has one indicator light, which changes color according to the
system status, after the switch is pressed and released:
Maintenance Troubleshooting & Disposal
WARNING: The device contains no user-serviceable parts. Do NOT try to
open the cap. In any case of malfunction contact TempraMed.
You can clean the exterior and interior of VIVI CAP by wiping it with a
medicinal swab. Do not soak, wash or lubricate VIVI CAP, as it may leave
residue on the interior of the cap
Dispose of the device according to local regulations for electrical/electronic
waste
Storage and handling
• The VIVI CAP is designed to work accurately and safely. It must be handled
with care. If dropped or crushed, there is a risk of damage to the insulation,
leakage of phase change material or damage to the indicator light.
• Do not use the VIVI CAP with insulin pen if there is no indicator light, while
in room temperature, or if the indicator light shows RED or if the cap is
broken or otherwise damaged.
• Do not store the VIVI CAP exposed to water or other liquids.
• VIVI CAP should only be stored at temperatures between -10°C to 60°C
Device Physical Specifications:
Length 90mm (3.5”), Diameter 30mm (1.18”), Weight <70gr (2.5oz)Contains
1x3V primary battery
Support and Contact Information
For answers to questions regarding the use of the VIVI CAP contact:
TempraMed Israel Ltd. www.my-vivi.com
AMAR registration No 30240001 by TempraMed Israel Ltd. 64 Heh B’Iyar Tel Aviv
62198. Tel: 03 9195335
E mail - [email protected] Website - www.my-vivi.com
VIVI CAP is Patent Pending: PCT/US2015/040655 and other patent
applications.
VIVI CAP, the VIVI logo, TempraMed, TempraMed logo, are TM ® and ©,
TempraMed Ltd. 2016.
Warranty
: This product is guaranteed against manufacturing defects for
a warranty period of one year from the date of purchase. In the event of
any mechanical problems, the product should be returned to the place of
purchase with the relevant proof of purchase for a replacement within the
warranty period
Disclaimer
: These instructions are only a guide. Due to varying
environmental conditions around the world, VIVI CAP will respond differently
according to the location.
Always follow the insulin manufacturer’s recommendations, regarding
storage of insulin pen. The user maintains full responsibility regarding proper
use and storage of insulin
pen
. TempraMed assumes no responsibility for
incidental or consequential damages including and without limitation to
damages or injuries resulting from product malfunction.
TempraMed’s liability will never exceed the purchase price paid by the user.
Proof of purchase is required.
Document updated January 1, 2020
For further support please visit http://my-vivi.com
Copyright © TempraMed Inc., 2020. All rights reserved.
Document Number 2020
No part of this publication may be reproduced in any material form (including
photocopying, or storing it in any medium by electronic means whether or
not transiently or incidentally to some other use of this publication) without
the prior written permission of the copyright owner, or under the terms of a
license issued by the copyright owner.
The information contained in this document is subject to change without
notice. TempraMed is neither responsible for nor liable to anyone in
connection with this document.
*Registered trademarks of: Novo Nordisk, Sanofi, Eli Lilly
GREEN
RED
No lights
Indicates proper operation and temperature below limit.
Safe to use the device
Temperature above limit.
Do not use the cap on the pen. Remove the pen from the cap.
Place the cap in ambient temperature of less than 26°C (78.8°F)
until while checking it, GREEN indicator turns on.
Battery is depleted, stop using the device and dispose properly.
VIVI CAP1
Insulin Temperature Shield
eng
Problem
The insulin pen does
not fit to the cap
No indicator lights
RED indicator light
Solution
Identify and use the correct pen ring adaptor to match
the pen model.
1. At first use, do not use the product.
Contact the manufacturer.
2. After and during use, the battery is depleted.
Do not use the product and dispose of properly.
Stop using with the pen.
Place in refrigerator for about one hour or in an ambient
temperature of less than 26°C (78.8°F) for at least 5 hours.
Press and release the switch and check for a GREEN light.
If light is still RED, contact the manufacturer for support.
VIVI CAP1
Insulin Temperature Shield
Switch
Indicator
Cooling to recommended temperature | Just put it on and it works
No need for refrigeration to activate | Temperature assurance indicator
Replacement to pen cap | Small and lightweight
Fits your pocket | One year
of daily use
Keeping insulin cool 365-day maintenance free Confidence on the go
Learn more at www.my-vivi.com
Pen Adaptors with code letters
Fig 1.
Push!
Push!
Fig 4.
Fig 2.
Attention!
For FlexTouch only
“Click” sound
“Click” sound
OK
Fig 5.
Fig 3.
Fig 6.
T
K
F S
